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Depending on local site requirements, patients may sign a single study ICF prior to the screening period to facilitate early gBRCAmut testing only. All other study tests and procedures must be done in the screening window (Day -28 to Day -1)." } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-002", "activity_name": "Demographics", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Demographics" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Demographics", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 5, "verbatim_name": "Demographics", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-003", "activity_name": "Medical, surgical, cancer, medication history", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Medical, surgical, cancer, medication history", "Medical, cancer, surgical, medication history" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Medical, surgical, cancer, medication history", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 6, "verbatim_name": "Medical, cancer, surgical, medication history", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-004", "activity_name": "Record local gBRCA mutation result, if done", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Record local gBRCA mutation result, if done" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Record local gBRCA mutation result, if done", "has_schedule_data": true } ], "annotations": [ { "marker": "5", "table_number": 1, "text": "Local gBRCAmut results that had been performed previously should be entered into eCRF at screening." } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-005", "activity_name": "Blood sample for centralized gBRCA mutation testing", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Blood sample for centralized gBRCA mutation testing" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Blood sample for centralized gBRCA mutation testing", "has_schedule_data": true } ], "annotations": [ { "marker": "6", "table_number": 1, "text": "Centralized gBRCAmut testing of DNA by Integrated BRACAnalysis® at Myriad must be completed prior to randomization. The sample may be submitted prior to the screening period for patients who are identified for a Screening Visit to occur. DNA from this sample will be stored and may be used at a later time for biomarker testing including potential to bridging to candidate companion diagnostic assays.", "columns": [ "Screening / -28 to -1" ] } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-006", "activity_name": "Blood sample for DNA repair typing", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Blood sample for DNA repair typing" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Blood sample for DNA repair typing", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-007", "activity_name": "Pregnancy test", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Pregnancy test" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Pregnancy test", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 7, "verbatim_name": "Pregnancy test", "has_schedule_data": true } ], "annotations": [ { "marker": "7", "table_number": 1, "text": "Negative serum pregnancy test required within 72 hours from first dose of study treatment for females of childbearing potential; repeated every 3 months for duration of study (ie, Cycle 4, Cycle 7, etc).", "columns": [ "Screening / -28 to -1", "Subsequent Cycles / Cycle n, Day 1" ] }, { "marker": "3", "table_number": 2, "text": "Negative serum pregnancy test required within 72 hours prior to study treatment for females of childbearing potential; repeated every 3 months for duration of study (ie, Cycle 4, Cycle 7, etc).", "columns": [ "Screening / -28 to -1", "Cycle / C1 / 1" ] } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-008", "activity_name": "Randomization", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Randomization" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Randomization", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 8, "verbatim_name": "Randomization", "has_schedule_data": true } ], "annotations": [ { "marker": "8", "table_number": 1, "text": "Randomization must occur within 72 hours prior to first dose.", "columns": [ "Screening / -28 to -1" ] }, { "marker": "4", "table_number": 2, "text": "Patients will be randomized in a crossover design within 72 hours prior to FE Day 1 (first single dose).", "columns": [ "Screening / -28 to -1" ] } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-009", "activity_name": "Physical examination", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Physical examination" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Physical examination", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 11, "verbatim_name": "Physical examination", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 4, "verbatim_name": "Physical examination", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-010", "activity_name": "Vital signs, height, weight", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Vital signs, height, weight", "Vital signs, weight" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Vital signs, height, weight", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 12, "verbatim_name": "Vital signs, height, weight", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 5, "verbatim_name": "Vital signs, weight", "has_schedule_data": true } ], "annotations": [ { "marker": "9", "table_number": 1, "text": "Height obtained at screening only." }, { "marker": "4", "table_number": 3, "text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3); no confident Table 7 (Main Study) equivalent for this Vital signs cell in the 'Patient Visit to Local Clinic or In-Home Nursing' column. Clinical review 2026-08-15: remains unresolved — no Table 7 candidate (Table 7's vital-signs footnote is \"Height obtained at screening only\"); §7.4.1 confirms vital signs at the local clinic/in-home nursing visit, content already covered by printed footnote 3.", "columns": [ "Subsequent Cycles / Cycle n, Day 1 / Patient Visit to Local Clinic or In-Home Nursing" ] } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-011", "activity_name": "ECOG performance status", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "ECOG performance status" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "ECOG performance status", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 13, "verbatim_name": "ECOG performance status", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 6, "verbatim_name": "ECOG performance status", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-012", "activity_name": "Adverse event monitoring", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Adverse event monitoring" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Adverse event monitoring", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 18, "verbatim_name": "Adverse event monitoring", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 7, "verbatim_name": "Adverse event monitoring", "has_schedule_data": true } ], "annotations": [ { "marker": "10", "table_number": 1, "text": "SAEs recorded up to 30 days after study treatment discontinuation.", "columns": [ "Study Treatment Discontinuation (visit within 7 days of last dose)" ] }, { "marker": "5", "table_number": 3, "text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 10: \"SAEs recorded up to 30 days after study treatment discontinuation.\" Mapping confirmed by clinical review (2026-08-15): §7.4.3 lists \"AEs (SAEs recorded 30 days post study treatment discontinuation)\".", "columns": [ "Study Treatment Discontinuation (visit within 7 days of last dose) / In Clinic" ] } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-013", "activity_name": "Concomitant medications", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Concomitant medications" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Concomitant medications", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 19, "verbatim_name": "Concomitant medications", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 8, "verbatim_name": "Concomitant medications", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-014", "activity_name": "Coagulation/serum chemistry", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 2, "tables": [ 1, 3 ], "any_marks": true, "variants": [ "Coagulation/serum chemistry", "Serum chemistry" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Coagulation/serum chemistry", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 9, "verbatim_name": "Serum chemistry", "has_schedule_data": true } ], "annotations": [ { "marker": "11", "table_number": 1, "text": "If Screening laboratory testing (serum chemistry, CBC, coagulation) performed within 72 hours of Day 1, repeat testing not required.", "columns": [ "1 / 1" ] } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-015", "activity_name": "CBC", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 3 ], "any_marks": true, "variants": [ "CBC" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "CBC", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 10, "verbatim_name": "CBC", "has_schedule_data": true } ], "annotations": [ { "marker": "12", "table_number": 1, "text": "If dose interruption or modification is required at any point on study because of hematologic toxicity, weekly blood draws for CBC will be monitored until the adverse event resolves, and to ensure safety of the new dose, weekly blood draws for CBC will be also be required for an additional 4 weeks after the adverse event has been resolved to the specified levels, after which monitoring every 4 weeks may resume." }, { "marker": "6", "table_number": 3, "text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, so this most likely corresponds to Table 7 (Main Study) footnote 12: \"If dose interruption or modification is required at any point on study because of hematologic toxicity, weekly blood draws for CBC will be monitored until the adverse event resolves, and to ensure safety of the new dose, weekly blood draws for CBC will be also be required for an additional 4 weeks after the adverse event has been resolved to the specified levels, after which monitoring every 4 weeks may resume.\" Clinical review 2026-08-15: hypothesis retained; §7.4 does not restate this rule." } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-016", "activity_name": "Serum CA-125", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 3 ], "any_marks": true, "variants": [ "Serum CA-125" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Serum CA-125", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 11, "verbatim_name": "Serum CA-125", "has_schedule_data": true } ], "annotations": [ { "marker": "13", "table_number": 1, "text": "CA-125 levels must be normal at screening or > 90% decrease as compared with baseline prior to last platinum-based chemotherapy course. Abnormal CA-125 levels during study do not represent disease progression; however, they may prompt imaging if clinically indicated. CA-125 sample within 72 hours of dose on Cycle 1/Day 1." }, { "marker": "14", "table_number": 1, "text": "For determination of CA-125 progression, at least 2 CA-125 values at least 1 week apart are required for confirmation (Section 6.1).", "document_references": [ { "kind": "section", "target": "6.1" } ] }, { "marker": "7", "table_number": 3, "text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, so this most likely corresponds to Table 7 (Main Study) footnote 13: \"CA-125 levels must be normal at screening or > 90% decrease as compared with baseline prior to last platinum-based chemotherapy course. Abnormal CA-125 levels during study do not represent disease progression; however, they may prompt imaging if clinically indicated. CA-125 sample within 72 hours of dose on Cycle 1/Day 1.\" Clinical review 2026-08-15: hypothesis retained; note the screening and Cycle 1/Day 1 clauses of footnote 13 are phase-specific and may not apply in extended cycles; §7.4 is silent on CA-125 rules." }, { "marker": "8", "table_number": 3, "text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, so this most likely corresponds to Table 7 (Main Study) footnote 14: \"For determination of CA-125 progression, at least 2 CA-125 values at least 1 week apart are required for confirmation (Section 6.1).\" Clinical review 2026-08-15: hypothesis retained; content is phase-independent; §7.4 does not restate it." } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-017", "activity_name": "Urinalysis", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Urinalysis" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Urinalysis", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 15, "verbatim_name": "Urinalysis", "has_schedule_data": true } ], "annotations": [ { "marker": "15", "table_number": 1, "text": "Urinalysis parameters must include: specific gravity, leukocyte esterase, nitrite, blood, protein, glucose, ketones, urobilinogen, and bilirubin." }, { "marker": "8", "table_number": 2, "text": "Urinalysis parameters must include: specific gravity, leukocyte esterase, nitrite, blood, protein, glucose, ketones, urobilinogen and bilirubin." } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-018", "activity_name": "12-lead ECG", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "12-lead ECG" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "12-lead ECG", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 16, "verbatim_name": "12-lead ECG", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 12, "verbatim_name": "12-lead ECG", "has_schedule_data": true } ], "annotations": [ { "marker": "16", "table_number": 1, "text": "Patients will have a 12-lead ECG at Screening, Baseline (predose, within 30 minutes), 2 hours postdose on Day 1(within 30 minutes), Cycle 2/Day 1, (predose, 2 hours postdose, within 30 minutes) and upon study treatment discontinuation. Note that the ECG is to be completed prior to the PK blood draw." }, { "marker": "9", "table_number": 2, "text": "12-lead ECG at Screening, Cycle 1/Day 1 (predose and 2 hours postdose), Cycle 2/Day 1 (predose and 2 hours postdose), and at treatment discontinuation. ECG monitoring is to be performed prior to PK blood draws." }, { "marker": "10", "table_number": 2, "text": "Triplicate ECG monitoring to coincide with PK on FE Days 1 and 8 at baseline (predose) and at 1, 1.5, 2, 3, 4, 6, and 8 hours post-dose. Triplicate ECGs should be performed between 2-5 minutes apart and should be performed prior to blood draws for PK.", "columns": [ "14-Day Food Effect / FE 1", "14-Day Food Effect / FE 8" ] }, { "marker": "9", "table_number": 3, "text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 16: \"Patients will have a 12-lead ECG at Screening, Baseline (predose, within 30 minutes), 2 hours postdose on Day 1(within 30 minutes), Cycle 2/Day 1, (predose, 2 hours postdose, within 30 minutes) and upon study treatment discontinuation. Note that the ECG is to be completed prior to the PK blood draw.\" Mapping confirmed by clinical review (2026-08-15): §7.4.3 lists 12-lead ECG at study treatment discontinuation — the only ECG mark in this table; the screening/PK clauses of footnote 16 do not apply in extended cycles." } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-019", "activity_name": "Triplicate ECGs (selected sites only)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Triplicate ECGs (selected sites only)" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Triplicate ECGs (selected sites only)", "has_schedule_data": true } ], "annotations": [ { "marker": "17", "table_number": 1, "text": "At selected sites, a subset of patients (approximately 24) will undergo triplicate ECG testing on Day 1 only at baseline (predose) and 1, 1.5, 2, 3, 4, 6 and 8 hours postdose. Triplicate ECGs should be performed between 2-5 minutes apart and should be performed prior to blood draws for PK.", "columns": [ "1 / 1" ] } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-020", "activity_name": "Tumor sample", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Tumor sample" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "Tumor sample", "has_schedule_data": true } ], "annotations": [ { "marker": "18", "table_number": 1, "text": "Formalin fixed, paraffin-embedded tumor sample (primary or metastatic site) consisting of 100 micron thickness of sections (≥ 80 micron minimum) or unsectioned paraffin block." } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-021", "activity_name": "Blood sample for PK", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Blood sample for PK" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 23, "verbatim_name": "Blood sample for PK", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 17, "verbatim_name": "Blood sample for PK", "has_schedule_data": true } ], "annotations": [ { "marker": "19", "table_number": 1, "text": "Blood samples for PK collected on Cycle 1/Day 1 and Cycle 2/Day 1 collected predose (within 30 minutes) and 2 hours postdose (within 30± 15 minutes Note: The exact time of the PK blood draw will be recorded and ECG monitoring is to be completed prior to the PK blood draw.", "columns": [ "1 / 1" ] }, { "marker": "20", "table_number": 1, "text": "At selected sites, a subset of patients (approximately 12) undergoing intensive PK on Day1 will have samples collected at baseline (within 30 minutes predose) and 1, 1.5, 2, 3, 4, 6 and 8 hours (± 2 minutes at all time points) postdose. Note: The exact time of the PK blood draw will be recorded and the ECG monitoring is to be completed prior to the PK blood draw.", "columns": [ "1 / 1" ] }, { "marker": "21", "table_number": 1, "text": "Additional blood samples for PK on Cycle 4/Day 1 and Cycle 8/Day 1 will be collected at predose (trough) within 30 minutes only.", "columns": [ "Subsequent Cycles / Cycle n, Day 1" ] }, { "marker": "11", "table_number": 2, "text": "Blood samples for PK will be taken on FE Days 1 and 8 at baseline (within 30 minutes prior to dosing) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose. Additional blood samples will be collected predose and 2 hours postdose on Day 1 of Cycles 1 and 2 and predose only on Day 1 of Cycles 4 and 8. The exact time of the PK blood draw will be recorded and PK blood draws are to be completed after ECG monitoring." } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-022", "activity_name": "Tumor Assessment (RECIST)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 3 ], "any_marks": true, "variants": [ "Tumor Assessment (RECIST)" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "Tumor Assessment (RECIST)", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 13, "verbatim_name": "Tumor Assessment (RECIST)", "has_schedule_data": true } ], "annotations": [ { "marker": "22", "table_number": 1, "text": "RECIST tumor assessment via CT or MRI scan of abdomen/pelvis and clinically indicated areas required at baseline, then after every 2 cycles (ie, 8 weeks with a window of ± 7 days from date of visit) through Cycle 14 (56 weeks), then after every 6 cycles (24 weeks with a window of ± 7 days) until study treatment discontinuation; at this point, a final follow-up set of imaging is required. PET/CT may be used according to RECIST guidelines. Cycle timing will not be delayed for treatment interruptions, and tumor assessment should occur according to this schedule regardless of whether study treatment is interrupted. If a patient discontinues treatment for clinical progression and does not meet the criteria specified in the protocol, scans and CA-125 testing should continue at the specified intervals until progression is confirmed or until the start of subsequent anticancer treatment." }, { "marker": "10", "table_number": 3, "text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, so this most likely corresponds to Table 7 (Main Study) footnote 22: \"RECIST tumor assessment via CT or MRI scan of abdomen/pelvis and clinically indicated areas required at baseline, then after every 2 cycles (ie, 8 weeks with a window of ± 7 days from date of visit) through Cycle 14 (56 weeks), then after every 6 cycles (24 weeks with a window of ± 7 days) until study treatment discontinuation; at this point, a final follow-up set of imaging is required. PET/CT may be used according to RECIST guidelines. Cycle timing will not be delayed for treatment interruptions, and tumor assessment should occur according to this schedule regardless of whether study treatment is interrupted. If a patient discontinues treatment for clinical progression and does not meet the criteria specified in the protocol, scans and CA-125 testing should continue at the specified intervals until progression is confirmed or until the start of subsequent anticancer treatment.\" NOTE (clinical review 2026-08-15): §7.4.2 states RECIST \"after every 2 cycles through Cycle 14 and then after every 3 cycles\", which conflicts with footnote 22's post-Cycle-14 cadence of every 6 cycles (24 weeks) — a source-internal contradiction, left unresolved; hypothesis retained." } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-023", "activity_name": "Chest CT/MRI", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Chest CT/MRI" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 25, "verbatim_name": "Chest CT/MRI", "has_schedule_data": true } ], "annotations": [ { "marker": "23", "table_number": 1, "text": "Chest CT/MRI if not done as part of RECIST tumor assessment at Screening. If the chest CT/MRI is clear at screening, repeat chest imaging is not required in the absence of lesions to be followed or in the absence of clinical indication requiring follow‐up." } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-024", "activity_name": "FOSI, EQ-5D-5L, neuropathy questionnaire", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 3 ], "any_marks": true, "variants": [ "FOSI, EQ-5D-5L, neuropathy questionnaire" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 26, "verbatim_name": "FOSI, EQ-5D-5L, neuropathy questionnaire", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 14, "verbatim_name": "FOSI, EQ-5D-5L, neuropathy questionnaire", "has_schedule_data": true } ], "annotations": [ { "marker": "24", "table_number": 1, "text": "PROs (FOSI, EQ-5D-5L, neuropathy questionnaire) will be collected while on study treatment every 8 weeks through the first year, then every 12 weeks thereafter. If the patient discontinues study treatment, assessment will occur at that time and then 8 weeks (± 2 weeks) later, regardless of status of subsequent treatment. PROs should be administered before conducting any other procedures." }, { "marker": "11", "table_number": 3, "text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 24: \"PROs (FOSI, EQ-5D-5L, neuropathy questionnaire) will be collected while on study treatment every 8 weeks through the first year, then every 12 weeks thereafter. If the patient discontinues study treatment, assessment will occur at that time and then 8 weeks (± 2 weeks) later, regardless of status of subsequent treatment. PROs should be administered before conducting any other procedures.\" Mapping confirmed by clinical review (2026-08-15): §7.4.2 states PROs every 3 cycles (= every 12 weeks, matching footnote 24) and repeats \"PROs should be administered before conducting any other procedures\" verbatim; §7.4.4 matches the 8 (± 2) weeks post-discontinuation assessment." } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-025", "activity_name": "Study treatment dispensed/collected", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Study treatment dispensed/collected" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 27, "verbatim_name": "Study treatment dispensed/collected", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 9, "verbatim_name": "Study treatment dispensed/collected", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 15, "verbatim_name": "Study treatment dispensed/collected", "has_schedule_data": true } ], "annotations": [ { "marker": "25", "table_number": 1, "text": "No new capsules dispensed", "columns": [ "Study Treatment Discontinuation (visit within 7 days of last dose)" ] }, { "marker": "5", "table_number": 2, "text": "Patients receive a single oral dose of niraparib 300 mg on FE Days 1 and 8.", "columns": [ "14-Day Food Effect / FE 1", "14-Day Food Effect / FE 8" ] }, { "marker": "6", "table_number": 2, "text": "No new capsules dispensed.", "columns": [ "Treatment Discontinuation (within 7 days of last dose)" ] }, { "marker": "12", "table_number": 3, "text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 25: \"No new capsules dispensed\" Mapping confirmed by clinical review (2026-08-15): §7.4.3 lists \"Study treatment capsules collected\" (no dispensing) at discontinuation.", "columns": [ "Study Treatment Discontinuation (visit within 7 days of last dose) / In Clinic" ] } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-026", "activity_name": "Anti-cancer therapies assessment", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Anti-cancer therapies assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 28, "verbatim_name": "Anti-cancer therapies assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "26", "table_number": 1, "text": "Every 90 days following study treatment discontinuation.", "columns": [ "Post Treatment Assessments" ] } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-027", "activity_name": "Survival assessment", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 3 ], "any_marks": true, "variants": [ "Survival assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 29, "verbatim_name": "Survival assessment", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 17, "verbatim_name": "Survival assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "27", "table_number": 1, "text": "In addition to survival, this assessment includes outcomes for subsequent anticancer therapies including any new malignancy information." }, { "marker": "14", "table_number": 3, "text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 27: \"In addition to survival, this assessment includes outcomes for subsequent anticancer therapies including any new malignancy information.\" Mapping confirmed by clinical review (2026-08-15): §7.4.4: survival status every 90 days (± 28 days) post-discontinuation; \"New malignancy information will also be collected as part of this assessment.\"" } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-028", "activity_name": "Bone marrow aspirate and biopsy", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Bone marrow aspirate and biopsy" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events – Main Study", "table_type": "main_soa", "track_label": null, "row_position": 30, "verbatim_name": "Bone marrow aspirate and biopsy", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 20, "verbatim_name": "Bone marrow aspirate and biopsy", "has_schedule_data": true }, { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 18, "verbatim_name": "Bone marrow aspirate and biopsy", "has_schedule_data": true } ], "annotations": [ { "marker": "28", "table_number": 1, "text": "For any suspected MDS/AML case reported while a patient is receiving treatment or being followed for post-treatment assessments, bone marrow aspirate and biopsy testing must be completed by a local hematologist. Testing completed as part of standard of care is sufficient as long as the methods are acceptable to the Sponsor’s Medical Monitor. The study site must receive a copy of the hematologist's report of aspirate/biopsy findings (which must include a classification according to WHO criteria²⁰) and other sample testing results related to MDS/AML.", "columns": [ "1 / 1", "1 / 8", "1 / 15", "1 / 21", "2 / 1", "Subsequent Cycles / Cycle n, Day 1", "Study Treatment Discontinuation (visit within 7 days of last dose)", "Post Treatment Assessments" ] }, { "marker": "15", "table_number": 3, "text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 28: \"For any suspected MDS/AML case reported while a patient is receiving treatment or being followed for post-treatment assessments, bone marrow aspirate and biopsy testing must be completed by a local hematologist. Testing completed as part of standard of care is sufficient as long as the methods are acceptable to the Sponsor’s Medical Monitor. The study site must receive a copy of the hematologist's report of aspirate/biopsy findings (which must include a classification according to WHO criteria) and other sample testing results related to MDS/AML.\" Mapping confirmed by clinical review (2026-08-15): §7.4.5 (Unscheduled Assessments) reproduces this text verbatim.", "columns": [ "Subsequent Cycles / Extended Cycle, Day 1 / In Clinic", "Subsequent Cycles / Cycle n, Day 1 / Site Staff Telephone Contact to Patient", "Subsequent Cycles / Cycle n, Day 1 / Patient Visit to Local Clinic or In-Home Nursing", "Study Treatment Discontinuation (visit within 7 days of last dose) / In Clinic", "Post-Treatment Assessments" ] } ] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-029", "activity_name": "Consumption of high fat meal, as applicable", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Consumption of high fat meal, as applicable" ], "occurrences": [ { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 10, "verbatim_name": "Consumption of high fat meal, as applicable", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-030", "activity_name": "Hematology/serum chemistry", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Hematology/serum chemistry" ], "occurrences": [ { "table_number": 2, "table_title": "Schedule of Events – Open-Label Food Effect Sub-Study (Study Completed)", "table_type": "track", "track_label": "Food Effect Sub-Study", "row_position": 14, "verbatim_name": "Hematology/serum chemistry", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT01847274", "sponsor": "Tesaro", "d4k_folder": "Tesaro_NCT01847274_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-031", "activity_name": "Anticancer therapies assessment", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Anticancer therapies assessment" ], "occurrences": [ { "table_number": 3, "table_title": "Schedule of Events – Main Study –Extended Visit Cycle", "table_type": "track", "track_label": "Extended Visit Cycle", "row_position": 16, "verbatim_name": "Anticancer therapies assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "13", "table_number": 3, "text": "Footnote not printed in the source (Table 9 prints only footnotes 1-3). Table 9 is the Extended-Visit-Cycle variant of the Main Study, this corresponds to Table 7 (Main Study) footnote 26: \"Every 90 days following study treatment discontinuation.\" Mapping confirmed by clinical review (2026-08-15): §7.4.4: \"Assessment of next subsequent anticancer therapies will be assessed every 90 days (± 28 days) following study treatment discontinuation visit.\"", "columns": [ "Post-Treatment Assessments" ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-001", "activity_name": "Study Entry /Enrollment", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Study Entry /Enrollment" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Study Entry /Enrollment", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-002", "activity_name": "Informed Consent Form signed", "parent_name": "Study Entry /Enrollment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed Consent Form signed" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Informed Consent Form signed", "has_schedule_data": true } ], "annotations": [ { "marker": "q", "table_number": 1, "text": "Informed Consent Form is signed within 28 days prior to randomization of study drug and prior to performance of any protocol-specific tests/procedures." }, { "marker": "pr1", "table_number": 1, "text": "Section 8.1", "document_references": [ { "kind": "section", "target": "8.1" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-003", "activity_name": "Inclusion/Exclusion evaluation", "parent_name": "Study Entry /Enrollment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Inclusion/Exclusion evaluation" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Inclusion/Exclusion evaluation", "has_schedule_data": true } ], "annotations": [ { "marker": "pr2", "table_number": 1, "text": "Section 7", "document_references": [ { "kind": "section", "target": "7" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-004", "activity_name": "Medical History", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Medical History" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Medical History", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-005", "activity_name": "Medical History", "parent_name": "Medical History", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], 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For patients who discontinue study treatment without objectively measured progressive disease (PD), continue to evaluate tumor response approximately every 8 weeks for the first 12 months following randomization and thereafter approximately every 12 weeks by the same method used at baseline and throughout the study until the patient has objective disease progression or until study completion. After the patient has objective disease progression, tumor assessments are no longer required and the patient will continue with post-discontinuation follow-up until the patient’s death or overall study completion." }, { "marker": "pr6", "table_number": 1, "text": "Section 10.1.1", "document_references": [ { "kind": "section", "target": "10.1.1" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-015", "activity_name": "Radiologic imaging according to RECIST", "parent_name": "Tumor Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Radiologic imaging according to RECIST" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Radiologic imaging according to RECIST", "has_schedule_data": true } ], "annotations": [ { "marker": "b", "table_number": 1, "text": "For patients with inoperable locally advanced breast cancer, MRI scan of the breast is performed locally at baseline (Day -28 to Day -1), between Day 1 and Day 7 of every second cycle beginning with Cycle 3 and continuing through Cycle 13, between Day 1 and Day 7 of every third cycle after Cycle 13, and within 14 days of clinical progression. For all patients, CT or MRI scan of the chest, abdomen, and pelvis is performed locally at baseline (Day -28 to Day -1), between Day 1 and Day 7 of every second cycle beginning with Cycle 3 and continuing through Cycle 13, between Day 1 and Day 7 of every third cycle after Cycle 13, and within 14 days of clinical progression. It is recommended that CT imaging of the abdomen and pelvis be performed with IV contrast whenever possible. If this is not feasible due to hypersensitivity or other conditions, then gadolinium-enhanced MRI is preferred. For patients with known serious allergic reactions to CT contrast material, a CT of the chest without contrast and gadolinium-enhanced MRI of the abdomen/pelvis are encouraged. For patients who discontinue study treatment without objectively measured progressive disease (PD), continue to evaluate tumor response approximately every 8 weeks for the first 12 months following randomization and thereafter approximately every 12 weeks by the same method used at baseline and throughout the study until the patient has objective disease progression or until study completion. After the patient has objective disease progression, radiologic tests are no longer required and the patient will continue with post-discontinuation follow-up until the patient’s death or overall study completion." }, { "marker": "pr6", "table_number": 1, "text": "Section 10.1.1", "document_references": [ { "kind": "section", "target": "10.1.1" } ] }, { "marker": "pr7", "table_number": 1, "text": "Attachment 5", "document_references": [ { "kind": "attachment", "target": "5" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-016", "activity_name": "Bone Scintigraphy", "parent_name": "Tumor Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Bone Scintigraphy" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "Bone Scintigraphy", "has_schedule_data": true } ], "annotations": [ { "marker": "i", "table_number": 1, "text": "Bone scintigraphy is performed locally at baseline (Day -28 to Day -1) for all patients. If available, prior bone scintigraphy (obtained as part of routine clinical care) within 45 days before Day 1 of Cycle 1 is also acceptable. Bone scintigraphy should be repeated for all patients between Day 1 and Day 7 of every sixth cycle beginning with Cycle 7, when complete response is identified in target disease, or when progression in bone is suspected. Importantly, RECIST v1.1 emphasizes that bone scintigraphy is not adequate to measure bone lesions; however, bone scintigraphy can be used to confirm the presence or disappearance of bone lesions. For patients who discontinue study treatment without objectively measured progressive disease (PD), continue to evaluate tumor response approximately every 6 months until the patient has objective disease progression or until study completion. After the patient has objective disease progression, bone scintigraphy is no longer required and the patient will continue with post-discontinuation follow-up until the patient’s death or overall study completion." }, { "marker": "pr6", "table_number": 1, "text": "Section 10.1.1", "document_references": [ { "kind": "section", "target": "10.1.1" } ] }, { "marker": "pr7", "table_number": 1, "text": "Attachment 5", "document_references": [ { "kind": "attachment", "target": "5" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-017", "activity_name": "X-ray or CT scan with bone windows or MRI", "parent_name": "Tumor Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "X-ray or CT scan with bone windows or MRI" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 23, "verbatim_name": "X-ray or CT scan with bone windows or MRI", "has_schedule_data": true } ], "annotations": [ { "marker": "j", "table_number": 1, "text": "One or more of these studies [X-ray, CT scan with bone windows, or MRI] is performed locally at baseline (Day -28 to Day -1), between Day 1 and Day 7 of every second cycle beginning with Cycle 3 and continuing through Cycle 13, between Day 1 and Day 7 of every third cycle after Cycle 13, and within 14 days of clinical progression only for patients with bone lesions identified by bone scintigraphy at baseline. For patients with new lesions identified by post-baseline bone scintigraphy, targeted assessment by X-ray, CT scan with bone windows, or MRI will be performed to confirm findings. For patients who discontinue study treatment without objectively measured progressive disease (PD), continue to evaluate tumor response approximately every 8 weeks for the first 12 months following randomization and thereafter approximately every 12 weeks by the same method used at baseline and throughout the study until the patient has objective disease progression or until study completion. After the patient has objective disease progression, radiologic tests are no longer required and the patient will continue with post-discontinuation follow-up until the patient’s death or overall study completion." }, { "marker": "pr6", "table_number": 1, "text": "Section 10.1.1", "document_references": [ { "kind": "section", "target": "10.1.1" } ] }, { "marker": "pr7", "table_number": 1, "text": "Attachment 5", "document_references": [ { "kind": "attachment", "target": "5" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-018", "activity_name": "Survival Information", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Survival Information" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "Survival Information", "has_schedule_data": true } ], "annotations": [ { "marker": "d", "table_number": 1, "text": "Survival information is collected at baseline and during both study treatment and postdiscontinuation follow-up. During Long-Term Follow-Up, survival information is collected approximately every 12 weeks for the duration of this period. Although preferable to collect during a clinic visit, survival information may be collected by contacting the patient or family directly (for example, via telephone). Long-Term Follow-up data collection may include anticancer therapies." }, { "marker": "pr8", "table_number": 1, "text": "Section 10.1", "document_references": [ { "kind": "section", "target": "10.1" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-019", "activity_name": "Adverse Event Collection/CTCAE Grading", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Adverse Event Collection/CTCAE Grading", "Adverse Events Collection/CTCAE Grading" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 25, "verbatim_name": "Adverse Event Collection/CTCAE Grading", "has_schedule_data": true }, { "table_number": 2, "table_title": "Study Schedule for the extension period only, Protocol I3Y-MC-JPBL", "table_type": "track", "track_label": "Extension period", "row_position": 7, "verbatim_name": "Adverse Events Collection/CTCAE Grading", "has_schedule_data": true } ], "annotations": [ { "marker": "f", "table_number": 1, "text": "Data on SAEs that occur before the end of trial will be stored in the collection database and the Lilly Safety System. During Long-Term Follow-Up, only SAEs that are related to study drugs or protocol procedures will be collected. All adverse events possibly related to study drugs or protocol procedures should be followed until they resolve, are no longer considered to be possibly related, become stable or return to baseline, the patient starts a new therapy, the patient expires, or the patient becomes lost to follow-up. 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"occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 31, "verbatim_name": "Local serum pregnancy test", "has_schedule_data": true } ], "annotations": [ { "marker": "o", "table_number": 1, "text": "A serum pregnancy test is required only for patients receiving ovarian suppression with a GnRH agonist." }, { "marker": "pr11", "table_number": 1, "text": "Attachment 2", "document_references": [ { "kind": "attachment", "target": "2" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-026", "activity_name": "Central pharmacokinetic (PK) sampling", "parent_name": "Lab/Diagnostic Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Central pharmacokinetic (PK) sampling" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 32, "verbatim_name": "Central pharmacokinetic (PK) sampling", "has_schedule_data": true } ], "annotations": [ { "marker": "m", "table_number": 1, "text": "See Pharmacokinetic Sampling Schedule (Attachment 7).", "document_references": [ { "kind": "attachment", "target": "7" } ] }, { "marker": "pr12", "table_number": 1, "text": "Attachment 7", "document_references": [ { "kind": "attachment", "target": "7" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-027", "activity_name": "Pharmacogenetic blood sample", "parent_name": "Lab/Diagnostic Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Pharmacogenetic blood sample" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 33, "verbatim_name": "Pharmacogenetic blood sample", "has_schedule_data": true } ], "annotations": [ { "marker": "pr13", "table_number": 1, "text": "Section 10.4.2.2", "document_references": [ { "kind": "section", "target": "10.4.2.2" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-028", "activity_name": "Biomarker plasma sample", "parent_name": "Lab/Diagnostic Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Biomarker plasma sample" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 34, "verbatim_name": "Biomarker plasma sample", "has_schedule_data": true } ], "annotations": [ { "marker": "pr14", "table_number": 1, "text": "Section 10.4.2.3", "document_references": [ { "kind": "section", "target": "10.4.2.3" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-029", "activity_name": "Local ECG", "parent_name": "Lab/Diagnostic Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Local ECG" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 35, "verbatim_name": "Local ECG", "has_schedule_data": true } ], "annotations": [ { "marker": "e", "table_number": 1, "text": "A local ECG (no replicates required) should be obtained at baseline (Day -14 to Day -1), 2 to 4 hours after the LY dose on Cycle 1 Day 1, upon arrival at site but prior to fulvestrant dose on Cycle 1 Day 15, 2 to 4 hours after the LY dose on Cycle 4 Day 1, and at the short-term follow-up visit." }, { "marker": "pr15", "table_number": 1, "text": "Section 10.3.2.1", "document_references": [ { "kind": "section", "target": "10.3.2.1" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-030", "activity_name": "Archived Tumor Sample", "parent_name": "Lab/Diagnostic Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Archived Tumor Sample" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 36, "verbatim_name": "Archived Tumor Sample", "has_schedule_data": true } ], "annotations": [ { "marker": "h", "table_number": 1, "text": "Formalin-fixed paraffin-embedded tumor tissue (either block or 15-20 unstained slides) should be requested at the time of randomization. However, if this sample is not available for a patient, it will not constitute a protocol deviation" }, { "marker": "pr16", "table_number": 1, "text": "Section 10.4.2.1", "document_references": [ { "kind": "section", "target": "10.4.2.1" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-031", "activity_name": "Study Drug", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": false, "variants": [ "Study Drug" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 37, "verbatim_name": "Study Drug", "has_schedule_data": false }, { "table_number": 2, "table_title": "Study Schedule for the extension period only, Protocol I3Y-MC-JPBL", "table_type": "track", "track_label": "Extension period", "row_position": 8, "verbatim_name": "Study Drug", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-032", "activity_name": "Fulvestrant Therapy", "parent_name": "Study Drug", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Fulvestrant Therapy" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 38, "verbatim_name": "Fulvestrant Therapy", "has_schedule_data": true }, { "table_number": 2, "table_title": "Study Schedule for the extension period only, Protocol I3Y-MC-JPBL", "table_type": "track", "track_label": "Extension period", "row_position": 9, "verbatim_name": "Fulvestrant Therapy", "has_schedule_data": true } ], "annotations": [ { "marker": "g", "table_number": 1, "text": "LY2835219 should be administered orally every 12 hours on Days 1 through 28 of each cycle; patients should not consume food beginning 1 hour before and ending 1 hour after taking LY2835219. Fulvestrant 500 mg should be administered intramuscularly into the buttocks slowly (1 to 2 minutes per injection) as two 250-mg injections, one in each buttock; however, for patients with moderate hepatic impairment (defined as Child-Pugh Class B), including any patient who develops moderate hepatic impairment during study treatment, fulvestrant 250 mg should be administered intramuscularly into the buttock slowly (1 to 2 minutes) as one 250-mg injection." }, { "marker": "pr17", "table_number": 1, "text": "Section 9.1", "document_references": [ { "kind": "section", "target": "9.1" } ] }, { "marker": "c", "table_number": 2, "text": "LY2835219 should be administered every 12 hours on Days 1 through 28 of each cycle. Patients should not consume food beginning 1 hour before and ending hour after taking study drug. Fulvestrant 500 mg should be administered intramuscularly into the buttocks slowly (1 to 2 minutes per injection) as two 250-mg injections, one in each buttock; however, for patients with moderate hepatic impairment (defined as Child-Pugh Class B), including any patient who develops moderate hepatic impairment during study treatment, fulvestrant 250 mg should be administered intramuscularly into the buttock slowly (1 to 2 minutes) as one 250-mg injection." }, { "marker": "pr20", "table_number": 2, "text": "Section 8.1.2", "document_references": [ { "kind": "section", "target": "8.1.2" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-033", "activity_name": "LY2835219 Therapy", "parent_name": "Study Drug", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "LY2835219 Therapy" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 39, "verbatim_name": "LY2835219 Therapy", "has_schedule_data": true }, { "table_number": 2, "table_title": "Study Schedule for the extension period only, Protocol I3Y-MC-JPBL", "table_type": "track", "track_label": "Extension period", "row_position": 10, "verbatim_name": "LY2835219 Therapy", "has_schedule_data": true } ], "annotations": [ { "marker": "g", "table_number": 1, "text": "LY2835219 should be administered orally every 12 hours on Days 1 through 28 of each cycle; patients should not consume food beginning 1 hour before and ending 1 hour after taking LY2835219. Fulvestrant 500 mg should be administered intramuscularly into the buttocks slowly (1 to 2 minutes per injection) as two 250-mg injections, one in each buttock; however, for patients with moderate hepatic impairment (defined as Child-Pugh Class B), including any patient who develops moderate hepatic impairment during study treatment, fulvestrant 250 mg should be administered intramuscularly into the buttock slowly (1 to 2 minutes) as one 250-mg injection." }, { "marker": "pr17", "table_number": 1, "text": "Section 9.1", "document_references": [ { "kind": "section", "target": "9.1" } ] }, { "marker": "c", "table_number": 2, "text": "LY2835219 should be administered every 12 hours on Days 1 through 28 of each cycle. Patients should not consume food beginning 1 hour before and ending hour after taking study drug. Fulvestrant 500 mg should be administered intramuscularly into the buttocks slowly (1 to 2 minutes per injection) as two 250-mg injections, one in each buttock; however, for patients with moderate hepatic impairment (defined as Child-Pugh Class B), including any patient who develops moderate hepatic impairment during study treatment, fulvestrant 250 mg should be administered intramuscularly into the buttock slowly (1 to 2 minutes) as one 250-mg injection." }, { "marker": "pr20", "table_number": 2, "text": "Section 8.1.2", "document_references": [ { "kind": "section", "target": "8.1.2" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-034", "activity_name": "Health Outcomes", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Health Outcomes" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 40, "verbatim_name": "Health Outcomes", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-035", "activity_name": "BPI, EORTC QLQ-C30, EORTC BR23, EQ-5D 5L", "parent_name": "Health Outcomes", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "BPI, EORTC QLQ-C30, EORTC BR23, EQ-5D 5L" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 41, "verbatim_name": "BPI, EORTC QLQ-C30, EORTC BR23, EQ-5D 5L", "has_schedule_data": true } ], "annotations": [ { "marker": "k", "table_number": 1, "text": "mBPI-sf, EORTC QLQ-C30, EORTC QLQ-BR23 and EQ-5D 5L should be administered at baseline (Day -14 to Day -1), Cycle 2 Day 1, and then on Day 1 of every second cycle beginning with Cycle 3 and continuing through Cycle 13, on Day 1 of every third cycle after Cycle 13, and at Short-Term Follow-Up. Patients should complete these assessments before extensive interaction with site staff." }, { "marker": "pr18", "table_number": 1, "text": "Section 12.2.11", "document_references": [ { "kind": "section", "target": "12.2.11" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-036", "activity_name": "Skeletal-Related Events assessment", "parent_name": "Health Outcomes", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Skeletal-Related Events assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 42, "verbatim_name": "Skeletal-Related Events assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "l", "table_number": 1, "text": "Skeletal-Related Events include pathological fracture, spinal cord compression, radiation to bone, and surgery to bone." }, { "marker": "pr18", "table_number": 1, "text": "Section 12.2.11", "document_references": [ { "kind": "section", "target": "12.2.11" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-037", "activity_name": "Hospitalization", "parent_name": "Health Outcomes", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Hospitalization" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 43, "verbatim_name": "Hospitalization", "has_schedule_data": true } ], "annotations": [ { "marker": "pr19", "table_number": 1, "text": "Section 12.2.11.4", "document_references": [ { "kind": "section", "target": "12.2.11.4" } ] } ] }, { "protocol_id": "NCT02107703", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT02107703_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-038", "activity_name": "Transfusion", "parent_name": "Health Outcomes", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Transfusion" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule, Protocol I3Y-MC-JPBL", "table_type": "main_soa", "track_label": null, "row_position": 44, "verbatim_name": "Transfusion", "has_schedule_data": true } ], "annotations": [ { "marker": "pr19", "table_number": 1, "text": "Section 12.2.11.4", "document_references": [ { "kind": "section", "target": "12.2.11.4" } ] } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-001", "activity_name": "Informed consent", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed consent" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Informed consent", "has_schedule_data": true } ], "annotations": [ { "marker": "d", "table_number": 1, "text": "Written informed consent for participation in the study must be obtained before performing any study-specific screening tests or evaluations and before shipping primary tumour blocks or slides to the Sponsor-designated laboratory. However, results from routine assessments conducted prior to informed consent signature may be used as screening assessments as long as they were done within 7 days prior to informed consent signature." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-002", "activity_name": "Confirmation of general eligibility", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Confirmation of general eligibility" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Confirmation of general eligibility", "has_schedule_data": true } ], "annotations": [ { "marker": "e", "table_number": 1, "text": "The “All Cohort” eligibility criteria are evaluated prior to initiating the first cycle of study treatment during the Induction Treatment Phase." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-003", "activity_name": "Demographics and medical history", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Demographics and medical history" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Demographics and medical history", "has_schedule_data": true } ], "annotations": [ { "marker": "f", "table_number": 1, "text": "Medical history includes clinically significant diseases, surgeries, cancer history (including prior cancer therapies and procedures), reproductive status, smoking history, use of alcohol and drugs of abuse, and all medications (e.g., prescription drugs, over-the-counter drugs, herbal or homeopathic remedies, nutritional supplements) used by the patient within 7 days prior to the Screening visit. Demographic data will include age, sex, and self-reported race/ethnicity (where permitted by federal regulations)." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-004", "activity_name": "Vital signs and weight", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Vital signs and weight" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Vital signs and weight", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 7, "verbatim_name": "Vital signs and weight", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 7, "verbatim_name": "Vital signs and weight", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 7, "verbatim_name": "Vital signs and weight", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 7, "verbatim_name": "Vital signs and weight", "has_schedule_data": true } ], "annotations": [ { "marker": "g", "table_number": 1, "text": "Vital signs include measurements of systolic and diastolic blood pressure while the patient is in a seated position, and temperature. During Screening, weight only required ≤ 7 days." }, { "marker": "g", "table_number": 2, "text": "Vital signs include measurements of systolic and diastolic blood pressure while the patient is in a seated position, and temperature." }, { "marker": "g", "table_number": 3, "text": "Vital signs include measurements of systolic and diastolic blood pressure while the patient is in a seated position, and temperature. Experimental arm only: For the first atezolizumab infusion, the patient’s vital signs (heart rate, respiratory rate, blood pressures, and temperature) should be determined within 60 minutes before the infusion, every 15 ± 5 minutes during the infusion, and 30 ± 10 minutes after the infusion. For subsequent infusions, vital signs will be collected within 60 minutes before the infusion and should be collected during or after the infusion if clinically indicated or if symptoms occurred in the prior infusion. Vital sign measurements from every second treatment cycle only will be recorded in the CRF." }, { "marker": "g", "table_number": 4, "text": "Vital signs include measurements of systolic and diastolic blood pressure while the patient is in a seated position, and temperature. For the control arm only, vitals conducted every second treatment cycle only will be recorded in the eCRF." }, { "marker": "g", "table_number": 5, "text": "Vital signs include measurements of systolic and diastolic blood pressure while the patient is in a seated position, and temperature. Experimental arm only: For the first atezolizumab infusion, the patient’s vital signs (heart rate, respiratory rate, blood pressures, and temperature) should be determined within 60 minutes before the infusion, every 15 ± 5 minutes during the infusion, and 30 ± 10 minutes after the infusion. For subsequent infusions, vital signs will be collected within 60 minutes before the infusion and should be collected during or after the infusion if clinically indicated or if symptoms occurred in the prior infusion. Vital sign measurements from every second treatment cycle only will be recorded in the eCRF." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-005", "activity_name": "Physical examination", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Physical examination" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Physical examination", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 8, "verbatim_name": "Physical examination", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 8, "verbatim_name": "Physical examination", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 8, "verbatim_name": "Physical examination", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 8, "verbatim_name": "Physical examination", "has_schedule_data": true } ], "annotations": [ { "marker": "h", "table_number": 1, "text": "Baseline assessment requires a complete physical exam. A complete physical examination should include an evaluation of the head, eyes, ears, nose, and throat, and the cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems. Abnormalities identified at Screening / Baseline will be recorded as baseline conditions. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations should be performed. Changes from Baseline, with new or worsened clinically significant abnormalities, should be reported as AEs if appropriate." }, { "marker": "h", "table_number": 2, "text": "Physical examinations will be symptom-directed, and will include changes from Baseline (pre-Induction) with new or worsened clinically significant abnormalities being reported as AEs if appropriate." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-006", "activity_name": "ECOG performance status", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "ECOG performance status" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "ECOG performance status", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 13, "verbatim_name": "ECOG performance status", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 9, "verbatim_name": "ECOG performance status", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 9, "verbatim_name": "ECOG performance status", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 9, "verbatim_name": "ECOG performance status", "has_schedule_data": true } ], "annotations": [ { "marker": "i", "table_number": 1, "text": "ECOG status assessed within 7 days prior to Day 1 of Cycle 1 (Induction Treatment Phase) for eligibility determination. See Appendix 8.", "document_references": [ { "kind": "appendix", "target": "8" } ] }, { "marker": "m", "table_number": 2, "text": "See Appendix 8.", "document_references": [ { "kind": "appendix", "target": "8" } ] } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-007", "activity_name": "Concomitant medications", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Concomitant medications" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Concomitant medications", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 15, "verbatim_name": "Concomitant medications", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 10, "verbatim_name": "Concomitant medications", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 10, "verbatim_name": "Concomitant medications", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 10, "verbatim_name": "Concomitant medications", "has_schedule_data": true } ], "annotations": [ { "marker": "j", "table_number": 1, "text": "Concomitant medication includes any prescription medications or over-the-counter preparations used by a patient between the 7 days prior to the date of informed consent up until the date of study discontinuation. Only concomitant medications used for supportive care, to alleviate symptoms of mCRC, or to treat adverse drug reactions should be recorded on the Concomitant Medications eCRF. At subsequent visits, only changes to current medications or medications used since the last documentation of medications will be recorded. Concomitant medications for treatment of AEs related to study medication will continue to be recorded while the AE is being followed. For permitted and prohibited concomitant medications, see Section 4.4.", "document_references": [ { "kind": "section", "target": "4.4" } ] }, { "marker": "o", "table_number": 2, "text": "Concomitant medication includes any prescription medications or over-the-counter preparations used by a patient between the 7 days prior to the date of informed consent up until the Study Treatment Discontinuation visit. Only concomitant medications used for supportive care, to alleviate symptoms of mCRC, or to treat adverse drug reactions should be recorded on the Concomitant Medications eCRF. At subsequent visits, only changes to current medications or medications used since the last documentation of medications will be recorded. Concomitant medications for treatment of AEs related to study medication will continue to be recorded while the AE is being followed. For permitted and prohibited concomitant medications, see Section 4.4.", "document_references": [ { "kind": "section", "target": "4.4" } ] } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-008", "activity_name": "Haematology and blood chemistry", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Haematology and blood chemistry" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Haematology and blood chemistry", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 16, "verbatim_name": "Haematology and blood chemistry", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 11, "verbatim_name": "Haematology and blood chemistry", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 11, "verbatim_name": "Haematology and blood chemistry", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 11, "verbatim_name": "Haematology and blood chemistry", "has_schedule_data": true } ], "annotations": [ { "marker": "k", "table_number": 1, "text": "Haematology includes haemoglobin, haematocrit, platelet count, red blood cell count, white blood cell count, and differential. Blood chemistry includes ALT, AST, alkaline phosphatase, total bilirubin, total protein, albumin, blood urea nitrogen or urea, LDH, creatinine, glucose, calcium, phosphorus, sodium, potassium, chloride, and bicarbonate. Hematology and blood chemistry tests must be conducted prior to each treatment cycle, with the results available for review prior to start of treatment according to local standards for treatment management. However, only tests conducted every second treatment cycle will be recorded in the eCRF. Clinical laboratory results constituting a clinically significant AE should be recorded as such." }, { "marker": "p", "table_number": 2, "text": "Haematology includes haemoglobin, haematocrit, platelet count, red blood cell count, white blood cell count, and differential. Blood chemistry includes ALT, AST, alkaline phosphatase, total bilirubin, total protein, albumin, blood urea nitrogen or urea, LDH, creatinine, glucose, calcium, phosphorus, sodium, potassium, chloride and bicarbonate. Patients in the experimental arm will also have magnesium, amylase and lipase tested. Haematology and blood chemistry tests must be conducted prior to each treatment cycle, with the results available for review prior to start of treatment according to local standards for treatment management. However, only tests conducted every second treatment cycle will be recorded in the eCRF. Clinical laboratory results constituting a clinically significant AE should be recorded as such." }, { "marker": "k", "table_number": 4, "text": "Haematology includes haemoglobin, haematocrit, platelet count, red blood cell count, white blood cell count, and differential. Blood chemistry includes ALT, AST, alkaline phosphatase, total bilirubin, total protein, albumin, blood urea nitrogen or urea, LDH, creatinine, glucose, calcium, phosphorus, sodium, potassium, chloride, and bicarbonate. Haematology and blood chemistry tests must be conducted prior to each treatment cycle, with the results available for review prior to start of treatment according to local standards for treatment management. For the control arm only, tests conducted every second treatment cycle only will be recorded in the eCRF. Clinical laboratory results constituting a clinically significant AE should be recorded as such." }, { "marker": "k", "table_number": 5, "text": "Haematology includes haemoglobin, haematocrit, platelet count, red blood cell count, white blood cell count, and differential. Blood chemistry includes ALT, AST, alkaline phosphatase, total bilirubin, total protein, albumin, blood urea nitrogen or urea, LDH, creatinine, glucose, calcium, phosphorus, sodium, potassium, chloride, bicarbonate. For experimental arm only patients, blood chemistry will also include magnesium, creatine phosphokinase, lipase and amylase. Haematology and blood chemistry tests must be conducted prior to treatment administration on Day 1 of each treatment cycle with the results available for review prior to start of treatment according to local standards for treatment management. Clinical laboratory results from every second cycle only will be recorded in the CRF. Clinical laboratory results constituting a clinically significant AE should be recorded as such." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-009", "activity_name": "INR, aPTT (select patients)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "INR, aPTT (select patients)" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "INR, aPTT (select patients)", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 17, "verbatim_name": "INR, aPTT (select patients)", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 12, "verbatim_name": "INR, aPTT (select patients)", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 12, "verbatim_name": "INR, aPTT (select patients)", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 12, "verbatim_name": "INR, aPTT (select patients)", "has_schedule_data": true } ], "annotations": [ { "marker": "l", "table_number": 1, "text": "INR and aPTT are required for all patients at screening but only for patients receiving anticoagulants while on protocol-specified treatment." }, { "marker": "q", "table_number": 2, "text": "INR and aPTT only for patients receiving anticoagulants while on protocol-specified treatment." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-010", "activity_name": "Urinalysis (dipstick)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Urinalysis (dipstick)" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Urinalysis (dipstick)", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 18, "verbatim_name": "Urinalysis (dipstick)", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 13, "verbatim_name": "Urinalysis (dipstick)", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 13, "verbatim_name": "Urinalysis (dipstick)", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 13, "verbatim_name": "Urinalysis (dipstick)", "has_schedule_data": true } ], "annotations": [ { "marker": "m", "table_number": 1, "text": "Urinalysis must be performed by dipstick at Baseline and within 48 hours prior to every cycle. A 24-hour urine collection is needed in the event of proteinuria ≥ ± 2 by dipstick test." }, { "marker": "r", "table_number": 2, "text": "Urinalysis must be performed by dipstick within 48 hours prior to every cycle. A 24-hour urine collection is needed in the event of proteinuria ≥ ± 2 by dipstick test. Urinalysis results from every second cycle only will be recorded in the CRF." }, { "marker": "m", "table_number": 3, "text": "Urinalysis must be performed by dipstick within 48 hours prior to every cycle. A 24-hour urine collection is needed in the event of proteinuria ≥ ± 2 by dipstick test. Results from every second cycle only will be recorded in the CRF." }, { "marker": "m", "table_number": 4, "text": "Urinalysis must be performed by dipstick within 48 hours prior to every cycle. A 24-hour urine collection is needed in the event of proteinuria ≥ ± 2 by dipstick test. For the control arm only, tests conducted every second treatment cycle only will be recorded in the eCRF." }, { "marker": "m", "table_number": 5, "text": "Urinalysis must be performed by dipstick within 48 hours prior to every treatment cycle. A 24-hour urine collection is needed in the event of proteinuria ≥ ± 2 by dipstick test. Urinalysis results from every second cycle only will be recorded in the CRF." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-011", "activity_name": "Pregnancy test", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Pregnancy test" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Pregnancy test", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 19, "verbatim_name": "Pregnancy test", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 14, "verbatim_name": "Pregnancy test", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 14, "verbatim_name": "Pregnancy test", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 14, "verbatim_name": "Pregnancy test", "has_schedule_data": true } ], "annotations": [ { "marker": "n", "table_number": 1, "text": "Urine or blood pregnancy test, only for women of childbearing potential (i.e. not post-menopausal as indicated by < 12 months of non-therapy-induced amenorrhea, nor surgically sterile [absence of ovaries and/or uterus]), including those who have had a tubal ligation. A serum pregnancy test is required within 7 days prior to start of study induction treatment, or within 14 days with a confirmatory urine pregnancy test within 7 days prior start of study induction treatment" }, { "marker": "s", "table_number": 2, "text": "Urine or blood pregnancy test, only for women of childbearing potential (i.e. not post-menopausal as indicated by < 12 months of non-therapy-induced amenorrhea, nor surgically sterile [absence of ovaries and/or uterus]), including those who have had a tubal ligation. If urine pregnancy test is positive, it must be confirmed by a serum pregnancy test." }, { "marker": "n", "table_number": 4, "text": "Urine or blood pregnancy test, only for women of childbearing potential (i.e. not post-menopausal as indicated by < 12 months of non-therapy-induced amenorrhea, nor surgically sterile [absence of ovaries and/or uterus]), including those who have had a tubal ligation. If a urine pregnancy test is positive, it must be confirmed by a serum pregnancy test. In the experimental arm, a serum pregnancy test must be done ≤ 7 days from maintenance treatment start. Urine pregnancy tests must also be done every 3 cycles during treatment (with result available prior to Day 1 dose of the next cycle), and every 3 months until 7 months after the last doses of trastuzumab and pertuzumab." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-012", "activity_name": "Tumour assessments", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Tumour assessments" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Tumour assessments", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 20, "verbatim_name": "Tumour assessments", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 19, "verbatim_name": "Tumour assessments", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 17, "verbatim_name": "Tumour assessments", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 21, "verbatim_name": "Tumour assessments", "has_schedule_data": true } ], "annotations": [ { "marker": "o", "table_number": 1, "text": "Will include radiology, chest and abdominal CT or MRI, and other scans to document all sites of disease. Include upper abdomen at Baseline. A CT or MRI scan of the brain is required if there is clinical suspicion of CNS metastases at screening/Baseline or at any time during the Induction Treatment Phase. Subsequent tumour assessments will be done according to standard of care at each study centre, with the exception that all patients must have a tumour assessment at the end of the Induction Treatment Phase. Tumour assessments are not required for study purposes after disease progression has been documented. Patients who discontinue study treatment during the Induction Treatment Phase prior to disease progression will also continue to be followed for progressive disease, with disease status followed according to local practice until progression or May 31, 2019, whichever comes first. After May 31, 2019, disease status will not be collected for the study." }, { "marker": "t", "table_number": 2, "text": "Up to and including May 31, 2019, tumour assessments will be conducted according to RECIST 1.1 for Cohort 1 with disease status during maintenance treatment determined based on comparison with the tumour assessment done at the end of induction treatment. Assessments will include radiology, chest and abdominal CT or MRI, and other scans to document all sites of disease. A CT or MRI scan of the brain is required if there is a clinical suspicion of CNS metastases. Up to and including May 31, 2019, tumour assessments will be conducted every eight weeks from the start of maintenance treatment regardless of treatment delays. After May 31, 2019, disease status will not be collected for the study and tumour assessments may be conducted per local practice. Patients who discontinue study treatment during the Maintenance Treatment Phase prior to disease progression will also continue to be followed for progressive disease, with disease assessments per RECIST 1.1 conducted every eight weeks until progression or May 31, 2019, whichever comes first." }, { "marker": "q", "table_number": 3, "text": "Up to and including May 31, 2019, tumour assessments will be conducted according to RECIST1.1 for Cohort 2, and additionally according to mRECIST for the experimental arm of Cohort 2. Assessments will include radiology, chest and abdominal CT or MRI, and other scans to document all sites of disease. A CT or MRI scan of the brain is required if there is a clinical suspicion of CNS metastases. Disease status during maintenance treatment will be determined based on comparison with the tumour assessment done at the end of induction treatment. Up to and including May 31, 2019, tumour assessments will be conducted every 8 weeks from the start of maintenance treatment regardless of treatment cycle delays. After May 31, 2019, disease status will not be collected for the study and tumour assessments may be conducting per local practice. Tumour assessments for Cohort 2 control arm patients will not be collected for study purposes after disease progression per RECIST 1.1 has been documented or May 31, 2019, whichever occurs first. Tumour assessments for Cohort 2 experimental arm patients will not be collected for study purposes after disease progression per mRECIST has been documented or May 31, 2019, whichever occurs first. Patients who discontinue study treatment during the Maintenance Treatment Phase prior to disease progression will also continue to be followed for progressive disease, with disease assessments per RECIST 1.1 or mRECIST (as described above) conducted every 8 weeks until progression or May 31, 2019, whichever comes first." }, { "marker": "q", "table_number": 4, "text": "Up to and including May 31, 2019, tumour assessments will be conducted according to RECIST1.1 and will include radiology, chest and abdominal CT or MRI, and other scans to document all sites of disease. A CT or MRI scan of the brain is required if there is a clinical suspicion of CNS metastases. Disease status during maintenance treatment will be determined based on comparison with the tumour assessment done at the end of induction treatment. Up to and including May 31, 2019, tumour assessments will be conducted every 8 weeks from the start of maintenance treatment regardless of treatment delays. After May 31, 2019, disease status will not be collected for the study and tumour assessments may be conducting per local practice. Patients who discontinue study treatment during the Maintenance Treatment Phase prior to disease progression will also continue to be followed for progressive disease, with disease assessments per RECIST 1.1 conducted every 8 weeks until progression or May 31, 2019, whichever comes first." }, { "marker": "s", "table_number": 5, "text": "Up to and including May 31, 2019, tumour assessments will be conducted according to RECIST1.1, and additionally according to mRECIST for patients in the experimental arm. Assessments will include radiology, chest and abdominal CT or MRI, and other scans to document all sites of disease. A CT or MRI scan of the brain is required if there is a clinical suspicion of CNS metastases. Disease status during maintenance treatment will be determined based on comparison with the tumour assessment done at the end of induction treatment. Up to and including May 31, 2019, tumour assessments will be conducted every 8 weeks from the start of maintenance treatment regardless of treatment cycle delays. After May 31, 2019, disease status will not be collected for the study and tumour assessments may be conducting per local practice. Tumour assessments for control arm patients will not be collected for study purposes after disease progression per RECIST 1.1 has been documented or May 31, 2019, whichever occurs first. Tumour assessments for experimental arm patients will not be collected for study purposes after disease progression per mRECIST has been documented or May 31, 2019, whichever occurs first. Patients who discontinue study treatment during the Maintenance Treatment Phase prior to disease progression will also continue to be followed for progressive disease, with disease assessments per RECIST 1.1 or mRECIST (as described above) conducted every 8 weeks until progression or May 31, 2019, whichever comes first." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-013", "activity_name": "Archival primary tumour tissue for biomarker assessment", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Archival primary tumour tissue for biomarker assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Archival primary tumour tissue for biomarker assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "p", "table_number": 1, "text": "Archival tumour tissue (FFPET) block from the primary tumour obtained at the time of the initial diagnosis. If the tumour block is not available, ≥ 20 slides cut from the primary tumour sample will be accepted as an alternative. Before a patient can be enrolled, the sample (block or slides) must be shipped to the designated laboratory with the corresponding pathology report and receipt of the shipment must be confirmed by the laboratory. See Appendix 17.", "document_references": [ { "kind": "appendix", "target": "17" } ] } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-014", "activity_name": "Metastatic tumour tissue for exploratory biomarker assessment", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Metastatic tumour tissue for exploratory biomarker assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Metastatic tumour tissue for exploratory biomarker assessment", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 21, "verbatim_name": "Metastatic tumour tissue for exploratory biomarker assessment", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 20, "verbatim_name": "Metastatic tumour tissue for exploratory biomarker assessment", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 18, "verbatim_name": "Metastatic tumour tissue for exploratory biomarker assessment", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 22, "verbatim_name": "Metastatic tumour tissue for exploratory biomarker assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "q", "table_number": 1, "text": "Collection of the optional core biopsy of metastatic tumours was discontinued as of May 2018. (See Appendix 18).", "document_references": [ { "kind": "appendix", "target": "18" } ] }, { "marker": "n1", "table_number": 1, "text": "Collection of these samples discontinued as of May 2018" }, { "marker": "u", "table_number": 2, "text": "Supplemental Biomarker Program closed as of May 2018. Collection of these samples has been discontinued (see Appendix 18).", "document_references": [ { "kind": "appendix", "target": "18" } ] }, { "marker": "n1", "table_number": 2, "text": "Supplemental Biomarker Program closed as of May 2018. Collection of these samples has been discontinued." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-015", "activity_name": "Whole blood sample", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Whole blood sample" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Whole blood sample", "has_schedule_data": true } ], "annotations": [ { "marker": "r", "table_number": 1, "text": "Whole blood and plasma samples will be collected from all study patients for exploratory biomarker analyses unless genomic analysis is not allowed per local regulations. In such instances, only plasma samples will be collected. All samples will be sent to a designated laboratory. Samples during treatment should be taken within 48 hours prior to study treatment Day 1 of each cycle indicated, unless otherwise specified (see Appendix 17 and Laboratory Manual).", "document_references": [ { "kind": "appendix", "target": "17" } ] } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-016", "activity_name": "Plasma samples", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Plasma samples" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Plasma samples", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 22, "verbatim_name": "Plasma samples", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 21, "verbatim_name": "Plasma samples", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 19, "verbatim_name": "Plasma samples", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 23, "verbatim_name": "Plasma samples", "has_schedule_data": true } ], "annotations": [ { "marker": "r", "table_number": 1, "text": "Whole blood and plasma samples will be collected from all study patients for exploratory biomarker analyses unless genomic analysis is not allowed per local regulations. In such instances, only plasma samples will be collected. All samples will be sent to a designated laboratory. Samples during treatment should be taken within 48 hours prior to study treatment Day 1 of each cycle indicated, unless otherwise specified (see Appendix 17 and Laboratory Manual).", "document_references": [ { "kind": "appendix", "target": "17" } ] }, { "marker": "v", "table_number": 2, "text": "Plasma samples will be collected from all patients for exploratory biomarker analyses. These samples will be sent to a designated laboratory. Samples during treatment should be taken within 48 hours prior to study treatment Day 1 of each cycle indicated, unless otherwise specified (see Appendix 17 and the Laboratory Manual).", "document_references": [ { "kind": "appendix", "target": "17" } ] }, { "marker": "u", "table_number": 5, "text": "Plasma samples will be collected from all patients for exploratory biomarker analyses. These samples will be sent to a designated laboratory. Samples during treatment should be taken within 48 hours prior to study treatment on the days indicated, unless otherwise specified (see Appendix 17 and the Laboratory Manual).", "document_references": [ { "kind": "appendix", "target": "17" } ] } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-017", "activity_name": "Stool sample", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Stool sample" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Stool sample", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 23, "verbatim_name": "Stool sample", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 22, "verbatim_name": "Stool sample", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 20, "verbatim_name": "Stool sample", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 24, "verbatim_name": "Stool sample", "has_schedule_data": true } ], "annotations": [ { "marker": "n2", "table_number": 1, "text": "Supplemental Biomarker Program closed as of May 2018. Collection of these samples has been discontinued." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-018", "activity_name": "Adverse events (including SAEs)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Adverse events (including SAEs)" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Adverse events (including SAEs)", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 24, "verbatim_name": "Adverse events (including SAEs)", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 23, "verbatim_name": "Adverse events (including SAEs)", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 21, "verbatim_name": "Adverse events (including SAEs)", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 25, "verbatim_name": "Adverse events (including SAEs)", "has_schedule_data": true } ], "annotations": [ { "marker": "s", "table_number": 1, "text": "After the signing of the informed consent form, and prior to Day 1 of Cycle 1 (Induction Treatment Phase), any SAEs thought to be related to a protocol-mandated intervention should be reported. Adverse events will be documented at every cycle during treatment. All patients will be followed for new AEs for 28 days following the discontinuation of study treatment. At the time of treatment discontinuation, any ongoing AE/SAE will be followed until the event resolves, the Investigator assesses the event as stable, the patient is lost to follow-up, dies or withdraws consent. Death related to disease progression is not considered to be an SAE. The Sponsor should be notified if the Investigator becomes aware of any SAE or AEs of special interest occurring after the end of the adverse event reporting period if the event is believed to be related to prior study treatment." }, { "marker": "w", "table_number": 2, "text": "Adverse events will be documented at every cycle during treatment. All patients will be followed for new AEs for 28 days following the discontinuation of study treatment. At the time of treatment discontinuation, any ongoing AE/SAE will be followed until the event resolves, the Investigator assesses the event as stable, the patient is lost to follow-up, dies or withdraws consent. Death related to disease progression is not considered to be an SAE. The Sponsor should be notified if the Investigator becomes aware of any SAE or AEs of special interest occurring after the end of the adverse event reporting period if the event is believed to be related to prior study treatment." }, { "marker": "t", "table_number": 3, "text": "Adverse events will be documented at every cycle during treatment. Patients in the experimental arm of Cohort 2 will be followed for new AEs for 90 days following the discontinuation of study treatment. Patients in the control arm will be followed for new AEs for 28 days following the discontinuation of study treatment. At the time of treatment discontinuation, any ongoing AE/SAE will be followed until the event resolves, the Investigator assesses the event as stable, the patient is lost to follow-up, dies or withdraws consent. Death related to disease progression is not considered to be an SAE. The Sponsor should be notified if the Investigator becomes aware of any SAE or AEs of special interest occurring after the end of the adverse event reporting period if the event is believed to be related to prior study treatment." }, { "marker": "t", "table_number": 4, "text": "Adverse events will be documented at every cycle during treatment. Patients in the experimental arm of Cohort 3 will be followed for new AEs for 90 days following the discontinuation of study treatment. Patients in the control arm will be followed for new AEs for 28 days following the discontinuation of study treatment. At the time of treatment discontinuation, any ongoing AE/SAE will be followed until the event resolves, the Investigator assesses the event as stable, the patient is lost to follow-up, dies or withdraws consent. Death related to disease progression is not considered to be an SAE. The Sponsor should be notified if the Investigator becomes aware of any SAE or AEs of special interest occurring after the end of the adverse event reporting period if the event is believed to be related to prior study treatment." }, { "marker": "v", "table_number": 5, "text": "Patients in the experimental arm of Cohort 4 will be followed for new AEs for 90 days following the discontinuation of study treatment. Patients in the control arm will be followed for new AEs for 28 days following the discontinuation of study treatment. At the time of treatment discontinuation, any ongoing AE/SAE will be followed until the event resolves, the Investigator assesses the event as stable, the patient is lost to follow-up, dies or withdraws consent. Death related to disease progression is not considered to be an SAE. The Sponsor should be notified if the Investigator becomes aware of any SAE or AEs of special interest occurring after the end of the adverse event reporting period if the event is believed to be related to prior study treatment." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-019", "activity_name": "Study medication administration", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Study medication administration" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "Study medication administration", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 25, "verbatim_name": "Study medication administration", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 24, "verbatim_name": "Study medication administration", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 22, "verbatim_name": "Study medication administration", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 26, "verbatim_name": "Study medication administration", "has_schedule_data": true } ], "annotations": [ { "marker": "t", "table_number": 1, "text": "Eligible patients will enter a 4-month Induction Treatment Phase. Treatment during this phase, based on Investigator’s choice, will be either eight 2-week cycles of 5-FU, LV and oxaliplatin (FOLFOX) in combination with bevacizumab or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab." }, { "marker": "x", "table_number": 2, "text": "Patients in the Experimental Arm will receive: The first six patients in this cohort received 1,600 mg/m2 5-FU administered via 46-hour IV infusion, in combination with LV 400 mg/m2 administered via 2-hour infusion, on Day 1 of every 2-week cycle. Based on results of February 2016 iDMC recommendations, subsequent patients in this cohort will receive 1,600 - 2,400 mg/m2 5-FU administered via 46-hour IV infusion (IV bolus is not permitted), in combination with LV 400 mg/m2 administered via 2-hour infusion, on Day 1 of every 2-week cycle. In addition, patients will receive cetuximab 500 mg/m2 via IV infusion on Day 1 of every 2-week cycle and vemurafenib 960 mg b.i.d. orally. Patients in the Control arm will receive: 5-FU or capecitabine, dose and schedule will be according to local label, where applicable, or otherwise will be determined per the Investigator’s discretion, with bevacizumab 5 mg/kg via 15 – 30 minute IV infusion on Day 1 of every 2-week cycle. If a control arm patient receives capecitabine administered according to a 3- week cycle, timing of all study procedures and assessments scheduled according to 2-week treatment cycles (e.g. ECOG performance status) will be defined by the treatment cycles of concurrently administered bevacizumab." }, { "marker": "u", "table_number": 3, "text": "Patients in the Experimental Arm will receive 5-FU or capecitabine 1,600 – 2,400 mg/m2 5-FU administered via 46-hour IV infusion (IV bolus is not permitted) and LV 400 mg/m2 administered via a 2-hour infusion given day 1 every 2 weeks; or 1000 mg/m2 b.i.d. capecitabine given days 1-14 every 2 weeks followed by a one-week treatment break. Atezolizumab at a fixed dose of 800 mg administered via 60-minute IV infusion on Day 1 of every 2-week cycle (if initial infusion is well tolerated, subsequent infusions will be done over a 30-minute time period) and bevacizumab 5 mg/kg via 15 – 30 minute IV infusion on Day 1 of every 2-week cycle. Patients in the Control arm will receive: 5-FU or capecitabine, dose and schedule will be according to local label, where applicable, or otherwise will be determined per the Investigator’s discretion, with bevacizumab 5 mg/kg via 15 – 30 minute IV infusion on Day 1 of every 2-week cycle. If a patient receives capecitabine administered according to a 3-week cycle, timing of all study procedures and assessments scheduled according to 2-week treatment cycles (e.g. ECOG performance status) will be defined by the treatment cycles of concurrently administered bevacizumab (control arm) or concurrently administered bevacizumab and atezolizumab (experimental arm)." }, { "marker": "u", "table_number": 4, "text": "Patients in the experimental arm will receive capecitabine 1000 mg/m2 b.i.d. Days 1-14 followed by a one-week treatment break for every 3-week treatment cycle. Capecitabine dose calculations by body surface area with corresponding tablet counts are provided in Appendix 7. Trastuzumab will be administered by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses. Pertuzumab will be administered by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses. Patients in the control arm will receive: 5-FU or capecitabine, dose and schedule will be according to local label, where applicable, or otherwise will be determined per the Investigator’s discretion, with bevacizumab 5 mg/kg via 15 – 30 minute IV infusion on Day 1 of every 2-week cycle. If a control arm patient receives capecitabine administered according to a 3- week cycle, timing of all study procedures and assessments scheduled according to 2-week control arm treatment cycles (e.g. ECOG performance status) will be defined by the treatment cycles of concurrently administered bevacizumab.", "document_references": [ { "kind": "appendix", "target": "7" } ] }, { "marker": "w", "table_number": 5, "text": "Patients in the experimental arm will receive cobimetinib 60 mg orally once daily for 3 weeks followed by a 1 week treatment break (21/7 schedule). Treatment cycle length in this arm is 2 weeks. Cobimetinib will be administered daily every day of each odd numbered 2-week treatment cycle, and for the first 7 days only of each even numbered 2-week treatment cycle. Atezolizumab will be administered at a fixed dose of 840 mg administered via 60-minute IV infusion on Day 1 of every 2-week cycle (if initial infusion is well tolerated, subsequent infusions will be done over a 30-minute time period). Patients in the control arm will receive: 5-FU or capecitabine, dose and schedule will be according to local label, where applicable, or otherwise will be determined per the Investigator’s discretion, with bevacizumab 5 mg/kg via 15 – 30 minute IV infusion on Day 1 of every 2-week cycle. If a control arm patient receives capecitabine administered according to a 3- week cycle, timing of all study procedures and assessments scheduled according to 2-week treatment cycles (e.g. ECOG performance status) will be defined by the treatment cycles of concurrently administered bevacizumab." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-020", "activity_name": "Subsequent anti-cancer therapies", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Subsequent anti-cancer therapies" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 23, "verbatim_name": "Subsequent anti-cancer therapies", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 26, "verbatim_name": "Subsequent anti-cancer therapies", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 25, "verbatim_name": "Subsequent anti-cancer therapies", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 23, "verbatim_name": "Subsequent anti-cancer therapies", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 27, "verbatim_name": "Subsequent anti-cancer therapies", "has_schedule_data": true } ], "annotations": [ { "marker": "c", "table_number": 1, "text": "Patients in the Post-Treatment Follow-up Phase will be followed up every 3 months after their Study Treatment Discontinuation Visit. During post-treatment follow-up subsequent anti-cancer therapies will be recorded and survival assessed up to May 31, 2019 only. Refer to Appendix 19 for management of patients based on their study status on May 31, 2019. Treatment during the Post-Treatment Follow-up Phase is at the Investigator’s discretion; BRAFmut/MSS patients experiencing early disease progression during induction treatment will have the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib; BRAFmut/MSI-H patients experiencing early disease progression during induction treatment will have the option of proceeding immediately to receive second-line treatment with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab and atezolizumab. See Section 3.1.1.1 for further details including if disease progression occurs prior to availability of study biomarker test results in a patient with a previous BRAF mutation-positive result (e.g. by local test). Patients who discontinue study treatment during the Induction Treatment Phase prior to disease progression will also continue to be followed for PFS, with disease status followed according to local practice until progression or May 31, 2019, whichever comes first. Disease status will not be collected for the study after May 31, 2019.", "document_references": [ { "kind": "section", "target": "3.1.1.1" }, { "kind": "appendix", "target": "19" } ] }, { "marker": "c", "table_number": 2, "text": "After discontinuation of study treatment and the Study Discontinuation Visit, patients will enter the Post-Treatment Follow-up Phase. Beginning after the Study Treatment Discontinuation visit, patients will be followed up every 3 months. Up to and including May 31, 2019, follow-up will include disease status (patients discontinuing study treatment prior to disease progression only) in addition to safety evaluations and recording of subsequent anti-cancer therapies and survival. After May 31, 2019, disease status will not be documented for study purposes. Treatment during the Post-Treatment Follow-up Phase is at the Investigator’s discretion. Patients who discontinue study treatment prior to disease progression will be followed for PFS, with disease status followed every 8 weeks until progression or May 31, 2019, whichever comes first." }, { "marker": "c", "table_number": 3, "text": "After discontinuation of study treatment and the Study Treatment Discontinuation Visit, patients will enter the Post-Treatment Follow-up Phase. Beginning after the Study Treatment Discontinuation Visit, patients will be followed up every 3 months. Up to and including May 31, 2019, follow-up will include recording subsequent anti-cancer therapies, disease status (until progression as applicable), survival and safety evaluations. Patients who have completed the adverse event reporting period will be discontinued from the study at the post-treatment follow-up visit within the 3 months prior to and including May 31, 2019 (i.e. at the visit on/after March 1, 2019). After May 31, 2019, patients who have not yet completed the adverse event reporting period will be discontinued from the study after completion of the adverse event reporting period. Refer to Appendix 19 for the management of patients based on their study status as of May 31, 2019. Treatment during the Post-Treatment Follow-up Phase is at the Investigator’s discretion, however, patients treated with atezolizumab should not receive other immunomodulatory agents for 10 weeks after study treatment discontinuation. Patients who discontinue study treatment prior to disease progression will be followed for PFS, with disease status followed every 8 weeks until progression or May 31, 2019, whichever comes first.", "document_references": [ { "kind": "appendix", "target": "19" } ] }, { "marker": "c", "table_number": 4, "text": "After discontinuation of study treatment and the Study Treatment Discontinuation Visit, patients will enter the Post-Treatment Follow-up Phase. Beginning after the Study Treatment Discontinuation Visit, patients will be followed up every 3 months. Up to and including May 31, 2019, follow-up will include recording subsequent anti-cancer therapies, disease status (until progression as applicable), survival and safety evaluations. Patients who have completed the adverse event reporting period and, if applicable, 7 month post-treatment pregnancy test will be discontinued from the study at the post-treatment follow-up visit within the 3 months prior to and including May 31, 2019 (i.e. at the visit on/after March 1, 2019). After May 31, 2019, patients who have not yet completed the adverse event reporting period (and 7 month pregnancy test as applicable) will be discontinued from the study after completion of the adverse event reporting period (and 7 month pregnancy test as applicable). Refer to Appendix 19 for the management of patients based on their study status as of May 31, 2019. Treatment during the Post-Treatment Follow-up Phase is at the Investigator’s discretion. Patients who discontinue study treatment prior to disease progression will be followed for PFS, with disease status followed every 8 weeks until progression or May 31, 2019, whichever comes first.", "document_references": [ { "kind": "appendix", "target": "19" } ] }, { "marker": "c", "table_number": 5, "text": "After discontinuation of study treatment and the Study Treatment Discontinuation Visit, patients will enter the Post-Treatment Follow-up Phase. Beginning after the Study Treatment Discontinuation Visit, patients will be followed up every 3 months. Up to and including May 31, 2019, follow-up will include disease status (patients discontinuing study treatment prior to disease progression only), in addition to safety evaluations and recording of subsequent anti-cancer therapies and survival. After May 31, 2019, disease status will not be collected for the study. Treatment during the Post-Treatment Follow-up Phase is at the Investigator’s discretion, however, patients treated with atezolizumab should not receive other immunomodulatory agents for 10 weeks after study treatment discontinuation. Patients who discontinue study treatment prior to disease progression will be followed for PFS, with disease status followed every 8 weeks until progression or May 31, 2019, whichever comes first." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-021", "activity_name": "Patient survival", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 5, "tables": [ 1, 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Patient survival" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Assessments for All Patients (Screening / Baseline and Induction Treatment Phase)", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "Patient survival", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 27, "verbatim_name": "Patient survival", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 26, "verbatim_name": "Patient survival", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 24, "verbatim_name": "Patient survival", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 28, "verbatim_name": "Patient survival", "has_schedule_data": true } ], "annotations": [ { "marker": "c", "table_number": 1, "text": "Patients in the Post-Treatment Follow-up Phase will be followed up every 3 months after their Study Treatment Discontinuation Visit. During post-treatment follow-up subsequent anti-cancer therapies will be recorded and survival assessed up to May 31, 2019 only. Refer to Appendix 19 for management of patients based on their study status on May 31, 2019. Treatment during the Post-Treatment Follow-up Phase is at the Investigator’s discretion; BRAFmut/MSS patients experiencing early disease progression during induction treatment will have the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib; BRAFmut/MSI-H patients experiencing early disease progression during induction treatment will have the option of proceeding immediately to receive second-line treatment with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab and atezolizumab. See Section 3.1.1.1 for further details including if disease progression occurs prior to availability of study biomarker test results in a patient with a previous BRAF mutation-positive result (e.g. by local test). Patients who discontinue study treatment during the Induction Treatment Phase prior to disease progression will also continue to be followed for PFS, with disease status followed according to local practice until progression or May 31, 2019, whichever comes first. Disease status will not be collected for the study after May 31, 2019.", "document_references": [ { "kind": "section", "target": "3.1.1.1" }, { "kind": "appendix", "target": "19" } ] }, { "marker": "c", "table_number": 2, "text": "After discontinuation of study treatment and the Study Discontinuation Visit, patients will enter the Post-Treatment Follow-up Phase. Beginning after the Study Treatment Discontinuation visit, patients will be followed up every 3 months. Up to and including May 31, 2019, follow-up will include disease status (patients discontinuing study treatment prior to disease progression only) in addition to safety evaluations and recording of subsequent anti-cancer therapies and survival. After May 31, 2019, disease status will not be documented for study purposes. Treatment during the Post-Treatment Follow-up Phase is at the Investigator’s discretion. Patients who discontinue study treatment prior to disease progression will be followed for PFS, with disease status followed every 8 weeks until progression or May 31, 2019, whichever comes first." }, { "marker": "c", "table_number": 3, "text": "After discontinuation of study treatment and the Study Treatment Discontinuation Visit, patients will enter the Post-Treatment Follow-up Phase. Beginning after the Study Treatment Discontinuation Visit, patients will be followed up every 3 months. Up to and including May 31, 2019, follow-up will include recording subsequent anti-cancer therapies, disease status (until progression as applicable), survival and safety evaluations. Patients who have completed the adverse event reporting period will be discontinued from the study at the post-treatment follow-up visit within the 3 months prior to and including May 31, 2019 (i.e. at the visit on/after March 1, 2019). After May 31, 2019, patients who have not yet completed the adverse event reporting period will be discontinued from the study after completion of the adverse event reporting period. Refer to Appendix 19 for the management of patients based on their study status as of May 31, 2019. Treatment during the Post-Treatment Follow-up Phase is at the Investigator’s discretion, however, patients treated with atezolizumab should not receive other immunomodulatory agents for 10 weeks after study treatment discontinuation. Patients who discontinue study treatment prior to disease progression will be followed for PFS, with disease status followed every 8 weeks until progression or May 31, 2019, whichever comes first.", "document_references": [ { "kind": "appendix", "target": "19" } ] }, { "marker": "c", "table_number": 4, "text": "After discontinuation of study treatment and the Study Treatment Discontinuation Visit, patients will enter the Post-Treatment Follow-up Phase. Beginning after the Study Treatment Discontinuation Visit, patients will be followed up every 3 months. Up to and including May 31, 2019, follow-up will include recording subsequent anti-cancer therapies, disease status (until progression as applicable), survival and safety evaluations. Patients who have completed the adverse event reporting period and, if applicable, 7 month post-treatment pregnancy test will be discontinued from the study at the post-treatment follow-up visit within the 3 months prior to and including May 31, 2019 (i.e. at the visit on/after March 1, 2019). After May 31, 2019, patients who have not yet completed the adverse event reporting period (and 7 month pregnancy test as applicable) will be discontinued from the study after completion of the adverse event reporting period (and 7 month pregnancy test as applicable). Refer to Appendix 19 for the management of patients based on their study status as of May 31, 2019. Treatment during the Post-Treatment Follow-up Phase is at the Investigator’s discretion. Patients who discontinue study treatment prior to disease progression will be followed for PFS, with disease status followed every 8 weeks until progression or May 31, 2019, whichever comes first.", "document_references": [ { "kind": "appendix", "target": "19" } ] }, { "marker": "c", "table_number": 5, "text": "After discontinuation of study treatment and the Study Treatment Discontinuation Visit, patients will enter the Post-Treatment Follow-up Phase. Beginning after the Study Treatment Discontinuation Visit, patients will be followed up every 3 months. Up to and including May 31, 2019, follow-up will include disease status (patients discontinuing study treatment prior to disease progression only), in addition to safety evaluations and recording of subsequent anti-cancer therapies and survival. After May 31, 2019, disease status will not be collected for the study. Treatment during the Post-Treatment Follow-up Phase is at the Investigator’s discretion, however, patients treated with atezolizumab should not receive other immunomodulatory agents for 10 weeks after study treatment discontinuation. Patients who discontinue study treatment prior to disease progression will be followed for PFS, with disease status followed every 8 weeks until progression or May 31, 2019, whichever comes first." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-022", "activity_name": "Assignment of cohort", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Assignment of cohort" ], "occurrences": [ { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 3, "verbatim_name": "Assignment of cohort", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 3, "verbatim_name": "Assignment of cohort", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 3, "verbatim_name": "Assignment of cohort", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 3, "verbatim_name": "Assignment of cohort", "has_schedule_data": true } ], "annotations": [ { "marker": "d", "table_number": 2, "text": "Patients completing the Induction Treatment Phase, and who have not experienced PD can then proceed to the Maintenance Treatment Phase. Depending on the patient’s biomarker status (based on the archival sample from initial diagnosis), these patients will be assigned to a maintenance treatment cohort. Cohorts 2 and 4 are closed to further enrolment. Patients with an adequate tumour sample but with unknown biomarker status due to lack of determinant result (e.g. due to technical issues) may still be included in the study depending on the addition of future cohorts." }, { "marker": "d", "table_number": 3, "text": "Patients completing the Induction Treatment Phase, and who have not experienced PD can then proceed to the Maintenance Treatment Phase. Depending on the patient’s biomarker status (based on the archival sample from initial diagnosis), these patients will be assigned to a maintenance treatment cohort. Cohorts 2 and 4 are closed to further accrual. Patients with an adequate tumour sample but with unknown biomarker status due to lack of determinant result (e.g. due to technical issues) may still be included in the study depending on the addition of future cohorts." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-023", "activity_name": "Cohort-specific informed consent", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Cohort-specific informed consent" ], "occurrences": [ { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 4, "verbatim_name": "Cohort-specific informed consent", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 4, "verbatim_name": "Cohort-specific informed consent", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 4, "verbatim_name": "Cohort-specific informed consent", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 4, "verbatim_name": "Cohort-specific informed consent", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-024", "activity_name": "Confirmation of cohort-specific eligibility", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Confirmation of cohort-specific eligibility" ], "occurrences": [ { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 5, "verbatim_name": "Confirmation of cohort-specific eligibility", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 5, "verbatim_name": "Confirmation of cohort-specific eligibility", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 5, "verbatim_name": "Confirmation of cohort-specific eligibility", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 5, "verbatim_name": "Confirmation of cohort-specific eligibility", "has_schedule_data": true } ], "annotations": [ { "marker": "e", "table_number": 2, "text": "The cohort-specific exclusion criteria must be assessed prior to randomization to study maintenance treatment but assessment of cohort-specific eligibility can only be completed after the biomarker analysis results from the patient’s archival tumour tissue from initial diagnosis are known. Patients found ineligible for any cohort will undergo a Study Treatment Discontinuation Visit and enter the Post-Treatment Follow-up Phase." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-025", "activity_name": "Randomisation", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 2, 3, 4, 5 ], "any_marks": true, "variants": [ "Randomisation" ], "occurrences": [ { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 6, "verbatim_name": "Randomisation", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 6, "verbatim_name": "Randomisation", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 6, "verbatim_name": "Randomisation", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 6, "verbatim_name": "Randomisation", "has_schedule_data": true } ], "annotations": [ { "marker": "f", "table_number": 2, "text": "Each cohort will consist of an experimental treatment arm and a control arm. Randomised on a 2:1 (experimental:control) basis to either the experimental treatment arm or the control arm of that cohort. See Section 4.2.", "document_references": [ { "kind": "section", "target": "4.2" } ] } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-026", "activity_name": "Head and neck assessment for SCC", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Head and neck assessment for SCC" ], "occurrences": [ { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 9, "verbatim_name": "Head and neck assessment for SCC", "has_schedule_data": true } ], "annotations": [ { "marker": "i", "table_number": 2, "text": "To be performed by the Investigator or other qualified physician as part of the evaluation for SCC. The head and neck examination will consist of at least a visual inspection of the oral mucosa and lymph node palpation. Any suspicious findings will be referred to an appropriate specialist." }, { "marker": "n2", "table_number": 2, "text": "Experimental Arm only" } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-027", "activity_name": "Chest CT assessment for SCC", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Chest CT assessment for SCC" ], "occurrences": [ { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 10, "verbatim_name": "Chest CT assessment for SCC", "has_schedule_data": true } ], "annotations": [ { "marker": "j", "table_number": 2, "text": "The routinely scheduled radiographic assessment for tumour burden may be used (if available) as the chest CT for the evaluation of non-cutaneous SCC. MRI may be used if a CT scan is contra-indicated for the patient." }, { "marker": "n2", "table_number": 2, "text": "Experimental Arm only" } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-028", "activity_name": "Dermatology evaluation", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Dermatology evaluation" ], "occurrences": [ { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 11, "verbatim_name": "Dermatology evaluation", "has_schedule_data": true } ], "annotations": [ { "marker": "k", "table_number": 2, "text": "Evaluation to be performed by a dermatologist, the Investigator or other qualified physician." }, { "marker": "n2", "table_number": 2, "text": "Experimental Arm only" } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-029", "activity_name": "Anal and pelvic exam", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Anal and pelvic exam" ], "occurrences": [ { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 12, "verbatim_name": "Anal and pelvic exam", "has_schedule_data": true } ], "annotations": [ { "marker": "l", "table_number": 2, "text": "Pelvic examinations for women (with special attention to cervix) and anal examinations for all patients will be performed by the Investigator or other qualified physician prior to start of Experimental Therapy and at the Study Treatment Discontinuation Visit for the evaluation of SCC. The pelvic examination should include a complete external and internal examination (internal examination of uterine cervix may include a Pap smear, which would be a decision of the Investigator). The anal examination should include external examination, digital anorectal examination and anoscopy or proctoscopy. However, if in opinion of the Investigator the presence of “abnormal lesions including SCC” can be excluded by the external inspection and the manual examination, this is acceptable. However, if the presence of a lesion is suspected, an anoscopy or proctoscopy are recommended." }, { "marker": "n2", "table_number": 2, "text": "Experimental Arm only" } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-030", "activity_name": "12-lead ECG", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "12-lead ECG" ], "occurrences": [ { "table_number": 2, "table_title": "Appendix 2 Schedule of Assessments during Maintenance Phase (Cohort 1)", "table_type": "track", "track_label": "Cohort 1", "row_position": 14, "verbatim_name": "12-lead ECG", "has_schedule_data": true } ], "annotations": [ { "marker": "n", "table_number": 2, "text": "ECG to determine Cohort 1 eligibility must conducted within 3 weeks of randomization. During maintenance treatment, ECGs will be required in experimental arm patients only. Measurements include heart rate, PR interval, QRS duration, and QT and QTc intervals." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-031", "activity_name": "TSH, free or total T3, free or total T4", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 3, 5 ], "any_marks": true, "variants": [ "TSH, free or total T3, free or total T4" ], "occurrences": [ { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 15, "verbatim_name": "TSH, free or total T3, free or total T4", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 15, "verbatim_name": "TSH, free or total T3, free or total T4", "has_schedule_data": true } ], "annotations": [ { "marker": "n2", "table_number": 3, "text": "Experimental Arm only" } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-032", "activity_name": "Pulse oximetry", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 3, 5 ], "any_marks": true, "variants": [ "Pulse oximetry" ], "occurrences": [ { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 16, "verbatim_name": "Pulse oximetry", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 16, "verbatim_name": "Pulse oximetry", "has_schedule_data": true } ], "annotations": [ { "marker": "n2", "table_number": 3, "text": "Experimental Arm only" } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-033", "activity_name": "Tuberculosis test", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 3, 5 ], "any_marks": true, "variants": [ "Tuberculosis test" ], "occurrences": [ { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 17, "verbatim_name": "Tuberculosis test", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 17, "verbatim_name": "Tuberculosis test", "has_schedule_data": true } ], "annotations": [ { "marker": "o", "table_number": 3, "text": "Patients with active tuberculosis are not eligible for Cohort 2 and will be excluded from entering the Maintenance Phase of the study. Investigators must confirm absence of active disease in patients with a positive test." }, { "marker": "o", "table_number": 5, "text": "Patients with active tuberculosis are not eligible for Cohort 4 and will be excluded from entering the Maintenance Phase of the study. Investigators must confirm absence of active disease in patients with a positive test." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-034", "activity_name": "HIV, HBV, HCV serology", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 3, 4, 5 ], "any_marks": true, "variants": [ "HIV, HBV, HCV serology" ], "occurrences": [ { "table_number": 3, "table_title": "Appendix 3 Schedule of Assessments during Maintenance Phase (Cohort 2)", "table_type": "track", "track_label": "Cohort 2", "row_position": 18, "verbatim_name": "HIV, HBV, HCV serology", "has_schedule_data": true }, { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 15, "verbatim_name": "HIV, HBV, HCV serology", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 18, "verbatim_name": "HIV, HBV, HCV serology", "has_schedule_data": true } ], "annotations": [ { "marker": "p", "table_number": 3, "text": "HIV testing performed in accordance with national and/or institutional guidelines. HBV serology includes HBsAg and anti-HBc. HCV serology includes anti-HCV. Results required to determine eligibility for Cohort 2." }, { "marker": "o", "table_number": 4, "text": "HIV testing performed in accordance with national and/or institutional guidelines. HBV serology includes HBsAg and anti-HBc. HCV serology includes anti-HCV. Results required to determine eligibility for Cohort 3." }, { "marker": "p", "table_number": 5, "text": "HIV testing performed in accordance with national and/or institutional guidelines. HBV serology includes HBsAg and anti-HBc. HCV serology includes anti-HCV. Results required to determine eligibility for Cohort 4." } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-035", "activity_name": "LVEF", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 4, 5 ], "any_marks": true, "variants": [ "LVEF" ], "occurrences": [ { "table_number": 4, "table_title": "Appendix 4 Schedule of Assessments during Maintenance Phase (Cohort 3)", "table_type": "track", "track_label": "Cohort 3", "row_position": 16, "verbatim_name": "LVEF", "has_schedule_data": true }, { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 19, "verbatim_name": "LVEF", "has_schedule_data": true } ], "annotations": [ { "marker": "p", "table_number": 4, "text": "LVEF must be assessed in all Cohort 3 patients prior to randomization. Only experimental arm patients require subsequent LVEF monitoring. Subsequent LVEF measurements (using the same method as at baseline) will be conducted every third cycle until Cycle 6 and then every fourth cycle until termination of study treatment (i.e., during Cycles 3, 6, 10, 14, etc.), with the results made available prior to administration of the subsequent treatment cycle (i.e., prior to Cycles 4, 7, 11, 15, etc.). For patients who stop study drug(s) because of a decrease in LVEF, LVEF should be assessed at least every 6 weeks to determine recovery/stabilization (until LVEF recovers to ≥ 50% or 2 years, whichever occurs first). In patients who required a repeat LVEF assessment to ensure an acceptable LVEF before continuing trastuzumab/pertuzumab treatment, an additional LVEF assessment is to be performed at the next treatment cycle. Note: approval of the Medical Monitor must be obtained before continuation of study treatment after delays > 21 days." }, { "marker": "q", "table_number": 5, "text": "LVEF must be assessed in all Cohort 4 patients prior to randomization. Only experimental arm patients require subsequent LVEF monitoring which should be conducted every 6 cycles after Cycle 4. In addition, if any experimental arm patient develops clinical signs or symptoms suspicious of cardiac failure they should undergo an LVEF assessment without delaying until the next scheduled assessment (i.e. if indicated prior to the next scheduled assessment). For experimental arm patients who restart cobimetinib following a delay due to asymptomatic or symptomatic LVEF decrease, LVEF must be assessed at 2, 4, 10, and 16 weeks, then every 6 cycles after restarting treatment (see Appendix 16). Evaluation of LVEF must be performed by the same method (ECHO or MUGA) for each patient. It is strongly encouraged that the same laboratory and operator perform ECHO/MUGA scans for each individual patient. The treatment discontinuation visit evaluation of LVEF does not need to be performed at the treatment discontinuation visit if an evaluation has been performed within the last 12 weeks and there are no clinically significant findings and/or changes from baseline.", "document_references": [ { "kind": "appendix", "target": "16" } ] } ] }, { "protocol_id": "NCT02291289", "sponsor": "Roche", "d4k_folder": "Roche_NCT02291289_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-036", "activity_name": "Ophthalmology exam", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 5 ], "any_marks": true, "variants": [ "Ophthalmology exam" ], "occurrences": [ { "table_number": 5, "table_title": "Appendix 5 Schedule of Assessments during Maintenance Phase (Cohort 4)", "table_type": "track", "track_label": "Cohort 4", "row_position": 20, "verbatim_name": "Ophthalmology exam", "has_schedule_data": true } ], "annotations": [ { "marker": "r", "table_number": 5, "text": "If an ophthalmology exam was done within 12 weeks of the discontinuation visit and was normal, it does not need to be repeated." } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-001", "activity_name": "Informed consent", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed consent" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 3, "verbatim_name": "Informed consent", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-002", "activity_name": "Eligibility", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Eligibility" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Eligibility", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-003", "activity_name": "Medical and surgical history", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Medical and surgical history" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Medical and surgical history", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-004", "activity_name": "Demographics", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Demographics" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Demographics", "has_schedule_data": true } ], "annotations": [ { "marker": "i", "table_number": 1, "text": "Demographic information collected at screening includes sex, age, race, and ethnicity." } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-005", "activity_name": "Prior medications", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Prior medications" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Prior medications", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-006", "activity_name": "Body Height", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Body Height" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Body Height", "has_schedule_data": true } ], "annotations": [ { "marker": "b", "table_number": 1, "text": "A physical examination will be performed at screening. Abbreviated physical examinations will be performed on day 1 (unless day 1 occurred more than 2 weeks after screening physical examination), Days 15, 29 and 55. Height will be captured once at screening. Weight will be recorded before dialysis." } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-007", "activity_name": "Body Weight", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Body Weight" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Body Weight", "has_schedule_data": true } ], "annotations": [ { "marker": "b", "table_number": 1, "text": "A physical examination will be performed at screening. Abbreviated physical examinations will be performed on day 1 (unless day 1 occurred more than 2 weeks after screening physical examination), Days 15, 29 and 55. Height will be captured once at screening. Weight will be recorded before dialysis." } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-008", "activity_name": "Physical exam", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Physical exam" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Physical exam", "has_schedule_data": true } ], "annotations": [ { "marker": "b", "table_number": 1, "text": "A physical examination will be performed at screening. Abbreviated physical examinations will be performed on day 1 (unless day 1 occurred more than 2 weeks after screening physical examination), Days 15, 29 and 55. Height will be captured once at screening. Weight will be recorded before dialysis." } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-009", "activity_name": "Hemodialysis symptoms", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Hemodialysis symptoms" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Hemodialysis symptoms", "has_schedule_data": true } ], "annotations": [ { "marker": "c", "table_number": 1, "text": "Common symptoms associated with hemodialysis will be captured at screening. Any worsening of hemodialysis symptoms will be reported as an adverse event." } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-010", "activity_name": "Investigational product administration", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Investigational product administration" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Investigational product administration", "has_schedule_data": true } ], "annotations": [ { "marker": "d", "table_number": 1, "text": "Investigational product will be administered by intravenous (IV) injection over approximately 30 seconds into the venous line with dialysis rinse back at the end of the dialysis session." } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-011", "activity_name": "Vital Signs (BP, HR, RR, TEMP)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Vital Signs (BP, HR, RR, TEMP)" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Vital Signs (BP, HR, RR, TEMP)", "has_schedule_data": true } ], "annotations": [ { "marker": "e", "table_number": 1, "text": "Subjects will remain seated for at least 10 minutes prior to measurement of predialysis heart rate and blood pressure. Vital signs will include blood pressure, heart rate, respiratory rate, and oral or ear temperature. Vital signs will be obtained pre-dialysis treatments on scheduled dialysis days, and at ET and on Day 55 (EOS)." } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-012", "activity_name": "12-lead electrocardiogram", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "12-lead electrocardiogram" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "12-lead electrocardiogram", "has_schedule_data": true } ], "annotations": [ { "marker": "f", "table_number": 1, "text": "Subjects will remain supine for at least 5 minutes prior to recording 12-lead electrocardiogram (ECG). Screening 12-lead ECG will be recorded prior to hemodialysis. The Day -2 12-lead ECG will be recorded within 4 hours after hemodialysis rinse back. After the last dose of investigational product on Day 27, 12-lead ECGs will be recorded between 18 and 30 hours (recorded on day 28) post-dose." } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-013", "activity_name": "Adverse Event Monitoring", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Adverse Event Monitoring" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Adverse Event Monitoring", "has_schedule_data": true } ], "annotations": [ { "marker": "g", "table_number": 1, "text": "Adverse events will be monitored and recorded from the dose of investigational product (AMG 416) or placebo. Serious adverse events will be monitored and recorded from the time of informed consent through Day 55." } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-014", "activity_name": "Concomitant Medications", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Concomitant Medications" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1a. Schedule of Non-laboratory Assessments", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Concomitant Medications", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-015", "activity_name": "Laboratory Assessments", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": false, "variants": [ "Laboratory Assessments" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 3, "verbatim_name": "Laboratory Assessments", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-016", "activity_name": "Hematology, PT, aPTT", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Hematology, PT, aPTT" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 4, "verbatim_name": "Hematology, PT, aPTT", "has_schedule_data": true } ], "annotations": [ { "marker": "c", "table_number": 2, "text": "Blood sample for PT and aPTT will be drawn prior to heparin administration for dialysis. Day 1 hematology and coagulation tests will be performed only if day 1 occurs more than 2 weeks after the screening hematology and coagulation tests." }, { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-017", "activity_name": "Clinical Chemistry", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Clinical Chemistry" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 5, "verbatim_name": "Clinical Chemistry", "has_schedule_data": true } ], "annotations": [ { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-018", "activity_name": "Albumin", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Albumin" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 6, "verbatim_name": "Albumin", "has_schedule_data": true } ], "annotations": [ { "marker": "d", "table_number": 2, "text": "Serum samples for albumin and calcium for screening and routine monitoring of predialysis cCa. When albumin is less than 4.0 g/dL, the calcium level will be corrected according to the formula: cCa (mg/dL) = total Ca (mg/dL) + (4 – albumin (g/dL))*0.8. Corrected calcium results will inform dosing/dose withholding at the next hemodialysis treatment." }, { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" }, { "marker": "b", "table_number": 2, "text": "If screening albumin, phosphorus, cCa, pregnancy, and iPTH tests occur within 7 days prior to start of IP, then Day -2 lab tests can be waived", "columns": [ "Study Visit (Day) / -2" ] } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-019", "activity_name": "Phosphorus", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Phosphorus" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 7, "verbatim_name": "Phosphorus", "has_schedule_data": true } ], "annotations": [ { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" }, { "marker": "b", "table_number": 2, "text": "If screening albumin, phosphorus, cCa, pregnancy, and iPTH tests occur within 7 days prior to start of IP, then Day -2 lab tests can be waived", "columns": [ "Study Visit (Day) / -2" ] } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-020", "activity_name": "Calcium (cCa)", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Calcium (cCa)" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 8, "verbatim_name": "Calcium (cCa)", "has_schedule_data": true } ], "annotations": [ { "marker": "d", "table_number": 2, "text": "Serum samples for albumin and calcium for screening and routine monitoring of predialysis cCa. When albumin is less than 4.0 g/dL, the calcium level will be corrected according to the formula: cCa (mg/dL) = total Ca (mg/dL) + (4 – albumin (g/dL))*0.8. Corrected calcium results will inform dosing/dose withholding at the next hemodialysis treatment." }, { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" }, { "marker": "b", "table_number": 2, "text": "If screening albumin, phosphorus, cCa, pregnancy, and iPTH tests occur within 7 days prior to start of IP, then Day -2 lab tests can be waived", "columns": [ "Study Visit (Day) / -2" ] } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-021", "activity_name": "Serum or Urine Pregnancy (females only)", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Serum or Urine Pregnancy (females only)" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 9, "verbatim_name": "Serum or Urine Pregnancy (females only)", "has_schedule_data": true } ], "annotations": [ { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" }, { "marker": "b", "table_number": 2, "text": "If screening albumin, phosphorus, cCa, pregnancy, and iPTH tests occur within 7 days prior to start of IP, then Day -2 lab tests can be waived", "columns": [ "Study Visit (Day) / -2" ] } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-022", "activity_name": "Serum FSH (female only)", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Serum FSH (female only)" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 10, "verbatim_name": "Serum FSH (female only)", "has_schedule_data": true } ], "annotations": [ { "marker": "g", "table_number": 2, "text": "Luteinizing hormone and estradiol levels may additionally be collected if deemed necessary for confirmation of postmenopausal status as described in exclusion criteria section 4.2.4", "document_references": [ { "kind": "section", "target": "4.2.4" } ] }, { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-023", "activity_name": "Breath Alcohol Screen", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Breath Alcohol Screen" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 11, "verbatim_name": "Breath Alcohol Screen", "has_schedule_data": true } ], "annotations": [ { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-024", "activity_name": "HIV, Hep C Ab, HBsAg", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "HIV, Hep C Ab, HBsAg" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 12, "verbatim_name": "HIV, Hep C Ab, HBsAg", "has_schedule_data": true } ], "annotations": [ { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-025", "activity_name": "iPTH", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "iPTH" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 13, "verbatim_name": "iPTH", "has_schedule_data": true } ], "annotations": [ { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" }, { "marker": "b", "table_number": 2, "text": "If screening albumin, phosphorus, cCa, pregnancy, and iPTH tests occur within 7 days prior to start of IP, then Day -2 lab tests can be waived", "columns": [ "Study Visit (Day) / -2" ] } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-026", "activity_name": "25(OH) vitamin D", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "25(OH) vitamin D" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 14, "verbatim_name": "25(OH) vitamin D", "has_schedule_data": true } ], "annotations": [ { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-027", "activity_name": "Kt/V or URR", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Kt/V or URR" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 15, "verbatim_name": "Kt/V or URR", "has_schedule_data": true } ], "annotations": [ { "marker": "e", "table_number": 2, "text": "Perform Kt/V or URR assessment at screening unless a qualifying Kt/V or URR measurement from within 4 weeks prior to screening assessments is available." }, { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-028", "activity_name": "Anti-drug antibodies", "parent_name": "Laboratory Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Anti-drug antibodies" ], "occurrences": [ { "table_number": 2, "table_title": "Table 1b. Schedule of Laboratory Assessments", "table_type": "domain", "track_label": null, "row_position": 16, "verbatim_name": "Anti-drug antibodies", "has_schedule_data": true } ], "annotations": [ { "marker": "f", "table_number": 2, "text": "Serum samples for anti-drug antibodies will be collected predialysis on days 1, 29, and 55. Any subjects with positive titers for antibodies to AMG 416 may be asked to return to the clinical research unit to provide additional serum samples." }, { "marker": "t1", "table_number": 2, "text": "Time: Pre HD" } ] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-029", "activity_name": "Central Laboratory", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": false, "variants": [ "Central Laboratory" ], "occurrences": [ { "table_number": 3, "table_title": "Table 1c. Schedule of Pharmacokinetic Assessments", "table_type": "domain", "track_label": null, "row_position": 3, "verbatim_name": "Central Laboratory", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-030", "activity_name": "PK (Pre HD)", "parent_name": "Central Laboratory", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "PK (Pre HD)" ], "occurrences": [ { "table_number": 3, "table_title": "Table 1c. Schedule of Pharmacokinetic Assessments", "table_type": "domain", "track_label": null, "row_position": 4, "verbatim_name": "PK (Pre HD)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-031", "activity_name": "PK (SDA + 10 min)", "parent_name": "Central Laboratory", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "PK (SDA + 10 min)" ], "occurrences": [ { "table_number": 3, "table_title": "Table 1c. Schedule of Pharmacokinetic Assessments", "table_type": "domain", "track_label": null, "row_position": 5, "verbatim_name": "PK (SDA + 10 min)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-032", "activity_name": "PK (SDA + 30 min)", "parent_name": "Central Laboratory", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "PK (SDA + 30 min)" ], "occurrences": [ { "table_number": 3, "table_title": "Table 1c. Schedule of Pharmacokinetic Assessments", "table_type": "domain", "track_label": null, "row_position": 6, "verbatim_name": "PK (SDA + 30 min)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-033", "activity_name": "PK (SDA + 60 min)", "parent_name": "Central Laboratory", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "PK (SDA + 60 min)" ], "occurrences": [ { "table_number": 3, "table_title": "Table 1c. Schedule of Pharmacokinetic Assessments", "table_type": "domain", "track_label": null, "row_position": 7, "verbatim_name": "PK (SDA + 60 min)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-034", "activity_name": "PK (SDA + 90 min)", "parent_name": "Central Laboratory", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "PK (SDA + 90 min)" ], "occurrences": [ { "table_number": 3, "table_title": "Table 1c. Schedule of Pharmacokinetic Assessments", "table_type": "domain", "track_label": null, "row_position": 8, "verbatim_name": "PK (SDA + 90 min)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03283098", "sponsor": "Amgen", "d4k_folder": "Amgen_NCT03283098_Kidney", "therapeutic_area": "Kidney", "xact_id": "xact-035", "activity_name": "PK (SDA + 18 to 30 hr)", "parent_name": "Central Laboratory", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "PK (SDA + 18 to 30 hr)" ], "occurrences": [ { "table_number": 3, "table_title": "Table 1c. Schedule of Pharmacokinetic Assessments", "table_type": "domain", "track_label": null, "row_position": 9, "verbatim_name": "PK (SDA + 18 to 30 hr)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-001", "activity_name": "Informed consent", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed consent" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 2, "verbatim_name": "Informed consent", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-002", "activity_name": "IVRS/IWRS unique patient number obtained", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "IVRS/IWRS unique patient number obtained" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 3, "verbatim_name": "IVRS/IWRS unique patient number obtained", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-003", "activity_name": "Demographics", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Demographics" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Demographics", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-004", "activity_name": "Medical and surgical history", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Medical and surgical history" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Medical and surgical history", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-005", "activity_name": "Prior cancer therapies including radiotherapy, best response to prior chemotherapy regimen", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Prior cancer therapies including radiotherapy, best response to prior chemotherapy regimen" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Prior cancer therapies including radiotherapy, best response to prior chemotherapy regimen", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-006", "activity_name": "History of blood transfusions", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "History of blood transfusions" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "History of blood transfusions", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "Include history of blood transfusion within previous 120 days from start of study treatment and the reasons, e.g., bleeding or myelosuppression." } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-007", "activity_name": "Inclusion/exclusion criteria", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Inclusion/exclusion criteria" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Inclusion/exclusion criteria", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-008", "activity_name": "ECOG performance status", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "ECOG performance status" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "ECOG performance status", "has_schedule_data": true }, { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "ECOG performance status", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-009", "activity_name": "Physical examination", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Physical examination" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Physical examination", "has_schedule_data": true }, { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Physical examination", "has_schedule_data": true } ], "annotations": [ { "marker": "c", "table_number": 2, "text": "To be additionally performed if clinically indicated at any other time." }, { "marker": "b", "table_number": 2, "text": "If assessed within 7 days before first dose and meets the stated eligibility criteria (if applicable), it does not need to be repeated on Day 1 of study treatment unless Investigator believes that it is likely to have changed significantly.", "columns": [ "2 / 1 / 0" ] } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-010", "activity_name": "Vital signs (includes blood pressure, pulse and temperature), body weight", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "decision", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Vital signs (includes blood pressure, pulse and temperature), body weight", "Vital signs, body weight (includes blood pressure, pulse and temperature)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Vital signs (includes blood pressure, pulse and temperature), body weight", "has_schedule_data": true }, { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Vital signs, body weight (includes blood pressure, pulse and temperature)", "has_schedule_data": true } ], "annotations": [ { "marker": "c", "table_number": 2, "text": "To be additionally performed if clinically indicated at any other time." }, { "marker": "b", "table_number": 2, "text": "If assessed within 7 days before first dose and meets the stated eligibility criteria (if applicable), it does not need to be repeated on Day 1 of study treatment unless Investigator believes that it is likely to have changed significantly.", "columns": [ "2 / 1 / 0" ] } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-011", "activity_name": "Haematology / clinical chemistry", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Haematology / clinical chemistry" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Haematology / clinical chemistry", "has_schedule_data": true }, { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Haematology / clinical chemistry", "has_schedule_data": true } ], "annotations": [ { "marker": "b", "table_number": 1, "text": "Coagulation test should be performed if clinically indicated. For a list of all required laboratory tests please refer to Section 5.2.1.", "document_references": [ { "kind": "section", "target": "5.2.1" } ] }, { "marker": "f", "table_number": 1, "text": "These measurements may be repeated within the screening period if abnormalities are found which are the only reason for screen failing the patient and which can reasonably be expected to have return to the acceptable range" }, { "marker": "d", "table_number": 2, "text": "All samples should be taken prior to first dose. Coagulation test should be performed if clinically indicated. For a list of all required laboratory tests please refer to Section 5.2.1.", "document_references": [ { "kind": "section", "target": "5.2.1" } ] }, { "marker": "b", "table_number": 2, "text": "If assessed within 7 days before first dose and meets the stated eligibility criteria (if applicable), it does not need to be repeated on Day 1 of study treatment unless Investigator believes that it is likely to have changed significantly.", "columns": [ "2 / 1 / 0" ] } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-012", "activity_name": "Urinalysis", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Urinalysis" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Urinalysis", "has_schedule_data": true }, { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Urinalysis", "has_schedule_data": true } ], "annotations": [ { "marker": "c", "table_number": 2, "text": "To be additionally performed if clinically indicated at any other time." }, { "marker": "b", "table_number": 2, "text": "If assessed within 7 days before first dose and meets the stated eligibility criteria (if applicable), it does not need to be repeated on Day 1 of study treatment unless Investigator believes that it is likely to have changed significantly.", "columns": [ "2 / 1 / 0" ] } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-013", "activity_name": "Pregnancy test for women of childbearing potential", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "decision", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Pregnancy test for women of childbearing potential", "Pregnancy test" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Pregnancy test for women of childbearing potential", "has_schedule_data": true }, { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Pregnancy test", "has_schedule_data": true } ], "annotations": [ { "marker": "c", "table_number": 1, "text": "Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to starting treatment and a confirmatory test before treatment on Day 1. If results are positive, the patient is ineligible/must be discontinued from the study." }, { "marker": "e", "table_number": 2, "text": "Pregnancy tests on blood or urine samples will be performed for women of childbearing potential within 28 days prior to the start of study treatment, on Day 1 of the study prior to commencing treatment, at the time points shown in Table 2 during study treatment and at the 30-day follow-up visit. If results are positive the patient is ineligible/must be discontinued from study treatment immediately.", "document_references": [ { "kind": "table", "target": "2" } ] } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-014", "activity_name": "Confirmed as having non-Germline BRCA Mutated ovarian cancer", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Confirmed as having non-Germline BRCA Mutated ovarian cancer" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Confirmed as having non-Germline BRCA Mutated ovarian cancer", "has_schedule_data": true } ], "annotations": [ { "marker": "d", "table_number": 1, "text": "Patients must be non-germline BRCA mutated to be enrolled into the study. Patients for whom their gBRCA status is already known should be consented to the study within 28 days prior to Day 1 of study treatment. Patients who do not know their mutation status will need BRCA1/2 mutation screening (see Section 4.1.1 and Appendix F).", "document_references": [ { "kind": "section", "target": "4.1.1" }, { "kind": "appendix", "target": "F" } ] } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-015", "activity_name": "Tumour assessment", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Tumour assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Tumour assessment", "has_schedule_data": true }, { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Tumour assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "e", "table_number": 1, "text": "Includes CA-125 measurement where required (Refer to Inclusion Criterion 6). RECIST assessment should be performed no more than 28 days before the start of study treatment, and ideally should be performed as close as possible to the start of study treatment." }, { "marker": "n1", "table_number": 1, "text": "Note: MRI/ CT scan more than 28 days prior to Day 1 may be acceptable, please consult with AstraZeneca." }, { "marker": "f", "table_number": 2, "text": "Visit 4 onwards: Subsequent tumour assessments will be conducted every 8 weeks (±7 days) for the first 12 months and then every 12 weeks (± 7 days) until documented disease progression." } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-016", "activity_name": "AEs (from time of consent)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "AEs (from time of consent)", "AEs" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "AEs (from time of consent)", "has_schedule_data": true }, { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "AEs", "has_schedule_data": true } ], "annotations": [ { "marker": "h", "table_number": 2, "text": "All ongoing AEs/SAEs and any new AEs/SAEs identified during the 30 calendar days follow-up period after last dose of study medication must be followed to resolution." } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-017", "activity_name": "Concomitant medications", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Concomitant medications" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Concomitant medications", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-018", "activity_name": "Archival or fresh tumour biopsy sample for post treatment analysis confirmation of HRD status", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Archival or fresh tumour biopsy sample for post treatment analysis confirmation of HRD status" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule – Screening (Visit 1)", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Archival or fresh tumour biopsy sample for post treatment analysis confirmation of HRD status", "has_schedule_data": true } ], "annotations": [ { "marker": "g", "table_number": 1, "text": "All patients are required to submit either an archival tumour sample, or a fresh biopsy if an archival sample is not available, for retrospective testing of their genetic status. If archival tissue, the presence of adequate tissue needs to be confirmed prior to screening, but it will not be shipped to the central lab before Day1. If fresh, the biopsy should be taken after the baseline scan has been performed. Samples should be submitted as paraffin blocks, alternatively, sections mounted on glass slides prepared from the block can be provided. Please refer to the laboratory manual for further details regarding tissue collection, shipping and storage." } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-019", "activity_name": "Blood sample for ctDNA", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Blood sample for ctDNA" ], "occurrences": [ { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Blood sample for ctDNA", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-020", "activity_name": "Blood sample for restrospective gBRCA test", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Blood sample for restrospective gBRCA test" ], "occurrences": [ { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Blood sample for restrospective gBRCA test", "has_schedule_data": true } ], "annotations": [ { "marker": "g", "table_number": 2, "text": "Unless patient was tested at Myriad as part of screening. All patients are required to provide a 9 ml blood sample for confirmation of gBRCA status. Please refer to the laboratory manual for further details regarding blood sample collection,shipping and storage." } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-021", "activity_name": "FACT-O and EQ-5D-5L questionnaires", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "FACT-O and EQ-5D-5L questionnaires" ], "occurrences": [ { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "FACT-O and EQ-5D-5L questionnaires", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-022", "activity_name": "Concomitant medications including blood transfusions", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Concomitant medications including blood transfusions" ], "occurrences": [ { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Concomitant medications including blood transfusions", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-023", "activity_name": "Olaparib dispensed/returned", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Olaparib dispensed/returned" ], "occurrences": [ { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Olaparib dispensed/returned", "has_schedule_data": true } ], "annotations": [ { "marker": "j", "table_number": 2, "text": "+/- 2 days visit window allowed for the dispensing. Sufficient study treatment should be dispensed for at least each treatment period plus overage; however, additional treatment can be dispensed to patients to last longer if required.", "columns": [ "3 / 29 / ±3d", "Visit No. 4 and subsequent tumour assessment visits / On the first day of next visit period (V4 = Day 57 and thereafter every 8 weeks for the first 12 months; every 12 weeks thereafter) / ±7d" ] } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-024", "activity_name": "Subsequent cancer therapy following discontinuation of study treatment", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Subsequent cancer therapy following discontinuation of study treatment" ], "occurrences": [ { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Subsequent cancer therapy following discontinuation of study treatment", "has_schedule_data": true } ], "annotations": [ { "marker": "k", "table_number": 2, "text": "Start date of the first anticancer treatments (including, but not limited to, chemotherapy and targeted agents), following discontinuation from study treatment must be recorded." } ] }, { "protocol_id": "NCT03402841", "sponsor": "AZ", "d4k_folder": "AZ_NCT03402841_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-025", "activity_name": "Time to subsequent therapy and Survival", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Time to subsequent therapy and Survival" ], "occurrences": [ { "table_number": 2, "table_title": "Study Plan Detailing the Procedures", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Time to subsequent therapy and Survival", "has_schedule_data": true } ], "annotations": [ { "marker": "l", "table_number": 2, "text": "Patient will be followed (can be by phone or email) regularly until start of subsequent therapy; survival will be followed at approximately 12 weekly intervals thereafter." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-001", "activity_name": "Clinical Assessments", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Clinical Assessments" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 3, "verbatim_name": "Clinical Assessments", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-002", "activity_name": "Informed Consent", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed Consent" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Informed Consent", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-003", "activity_name": "Randomization", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Randomization" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Randomization", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-004", "activity_name": "Admission to CRU", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Admission to CRU" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Admission to CRU", "has_schedule_data": true } ], "annotations": [ { "marker": "c1", "table_number": 1, "text": "Admission can be rescheduled if PG level is not 90 to 250 mg/dL on Day 1." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-005", "activity_name": "Discharge from CRU", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Discharge from CRU" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Discharge from CRU", "has_schedule_data": true } ], "annotations": [ { "marker": "c2", "table_number": 1, "text": "Patient may be discharged 6 hours after glucagon administration. A patient may remain inpatient at the CRU at the discretion of the investigator." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-006", "activity_name": "Medical History", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Medical History" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Medical History", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-007", "activity_name": "Collect Pre-existing Conditions and Adverse Events", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Collect Pre-existing Conditions and Adverse Events" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Collect Pre-existing Conditions and Adverse Events", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-008", "activity_name": "Physical Exam", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Physical Exam" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Physical Exam", "has_schedule_data": true } ], "annotations": [ { "marker": "c3", "table_number": 1, "text": "After screening, medical assessment only performed to include medical review and targeted examination, as appropriate." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-009", "activity_name": "Height and Weight", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Height and Weight" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Height and Weight", "has_schedule_data": true } ], "annotations": [ { "marker": "c4", "table_number": 1, "text": "Height is at screening only. Weight on Day 1 will be collected before the start of the procedure to induce hypoglycemia." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-010", "activity_name": "Collect Hypoglycemic Events", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Collect Hypoglycemic Events" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Collect Hypoglycemic Events", "has_schedule_data": true } ], "annotations": [ { "marker": "c5", "table_number": 1, "text": "Refer to Section 9.5.5.1.", "document_references": [ { "kind": "section", "target": "9.5.5.1" } ] } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-011", "activity_name": "Collect Concomitant Medications", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Collect Concomitant Medications" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Collect Concomitant Medications", "has_schedule_data": true } ], "annotations": [ { "marker": "c6", "table_number": 1, "text": "Review patients’ insulin regimens to confirm acceptability to undergo the procedure to induce hypoglycemia." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-012", "activity_name": "Meal", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Meal" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Meal", "has_schedule_data": true } ], "annotations": [ { "marker": "c7", "table_number": 1, "text": "After completion of all PK sampling, patients will be provided a carbohydrate-rich meal. The investigator will ensure the patient’s PG is stable. A prandial insulin dose will be administered if needed." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-013", "activity_name": "Insulin infusion to Induce Hypoglycemia", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Insulin infusion to Induce Hypoglycemia" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Insulin infusion to Induce Hypoglycemia", "has_schedule_data": true } ], "annotations": [ { "marker": "c8", "table_number": 1, "text": "Procedures in Period 2 will occur at approximately the same time as those in Period 1. Insulin infusion is stopped once bedside PG is <60 mg/dL." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-014", "activity_name": "Bedside PG Monitoring for Safety", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Bedside PG Monitoring for Safety" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Bedside PG Monitoring for Safety", "has_schedule_data": true } ], "annotations": [ { "marker": "c9", "table_number": 1, "text": "Samples will be collected during the hypoglycemia induction procedure and post study treatment (up to 120 mins). Bedside PG monitoring will be conducted no more than 10 minutes apart while bedside PG is ≥90 mg/dL and no more than 5 minutes apart when bedside PG is <90 mg/dL." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-015", "activity_name": "Study Treatment Administration", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Study Treatment Administration" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Study Treatment Administration", "has_schedule_data": true } ], "annotations": [ { "marker": "c10", "table_number": 1, "text": "Once bedside PG reaches <60 mg/dL, the insulin infusion is stopped and approximately 5 minutes later study drug is administered. Indicates Time = 0 min." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-016", "activity_name": "Injection-Site Assessment", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Injection-Site Assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Injection-Site Assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "c11", "table_number": 1, "text": "Injection-site assessment for IMG only." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-017", "activity_name": "Nasal Inspection", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Nasal Inspection" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Nasal Inspection", "has_schedule_data": true } ], "annotations": [ { "marker": "c12", "table_number": 1, "text": "Nasal inspection both for IMG and LY900018." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-018", "activity_name": "Vital Signs (Supine Blood Pressure, Pulse Rate, and Body Temperature)", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Vital Signs (Supine Blood Pressure, Pulse Rate, and Body Temperature)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Vital Signs (Supine Blood Pressure, Pulse Rate, and Body Temperature)", "has_schedule_data": true } ], "annotations": [ { "marker": "c13", "table_number": 1, "text": "Time points may be added for each period if warranted and agreed upon between Lilly and the investigator. Predose time point will be between insulin infusion stop and study treatment." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-019", "activity_name": "Single 12-lead ECG (Local)", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Single 12-lead ECG (Local)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Single 12-lead ECG (Local)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-020", "activity_name": "Triplicate 12-lead ECG (Central)", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Triplicate 12-lead ECG (Central)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "Triplicate 12-lead ECG (Central)", "has_schedule_data": true } ], "annotations": [ { "marker": "c14", "table_number": 1, "text": "Time points may be added for Period 1 and Period 2 if warranted and agreed upon between Lilly and the investigator. Predose time point will be between insulin infusion stop and study treatment." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-021", "activity_name": "Laboratory Tests", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Laboratory Tests" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 23, "verbatim_name": "Laboratory Tests", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-022", "activity_name": "Clinical Serology Tests", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Clinical Serology Tests" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "Clinical Serology Tests", "has_schedule_data": true } ], "annotations": [ { "marker": "c15", "table_number": 1, "text": "See Appendix 2, Clinical Laboratory Tests, for details.", "document_references": [ { "kind": "appendix", "target": "2" } ] } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-023", "activity_name": "Clinical Lab Tests (Hematology, Clinical Chemistry, and Urinalysis)", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Clinical Lab Tests (Hematology, Clinical Chemistry, and Urinalysis)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 25, "verbatim_name": "Clinical Lab Tests (Hematology, Clinical Chemistry, and Urinalysis)", "has_schedule_data": true } ], "annotations": [ { "marker": "c16", "table_number": 1, "text": "See Appendix 2, Clinical Laboratory Tests, for details. Patients do not need to fast for samples at screening or follow-up. At Periods 1 and 2, samples should be collected from patients who have fasted at least 8 hours before any study procedures.", "document_references": [ { "kind": "appendix", "target": "2" } ] } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-024", "activity_name": "HbA1c", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "HbA1c" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 26, "verbatim_name": "HbA1c", "has_schedule_data": true } ], "annotations": [ { "marker": "c15", "table_number": 1, "text": "See Appendix 2, Clinical Laboratory Tests, for details.", "document_references": [ { "kind": "appendix", "target": "2" } ] } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-025", "activity_name": "Pregnancy Test (Female patients of childbearing potential only)", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Pregnancy Test (Female patients of childbearing potential only)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 27, "verbatim_name": "Pregnancy Test (Female patients of childbearing potential only)", "has_schedule_data": true } ], "annotations": [ { "marker": "c17", "table_number": 1, "text": "Serum pregnancy test will be performed at screening. Urine pregnancy test will be performed at every admission period and follow-up visit if applicable." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-026", "activity_name": "FSH (Female patients only)", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "FSH (Female patients only)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 28, "verbatim_name": "FSH (Female patients only)", "has_schedule_data": true } ], "annotations": [ { "marker": "c18", "table_number": 1, "text": "When needed to confirm postmenopausal status." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-027", "activity_name": "Ethanol Testing", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Ethanol Testing" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 29, "verbatim_name": "Ethanol Testing", "has_schedule_data": true } ], "annotations": [ { "marker": "c19", "table_number": 1, "text": "Additional tests can be done at the discretion of the investigator." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-028", "activity_name": "Urine Drug Screen", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Urine Drug Screen" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 30, "verbatim_name": "Urine Drug Screen", "has_schedule_data": true } ], "annotations": [ { "marker": "c19", "table_number": 1, "text": "Additional tests can be done at the discretion of the investigator." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-029", "activity_name": "PK (Glucagon)", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "PK (Glucagon)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 31, "verbatim_name": "PK (Glucagon)", "has_schedule_data": true } ], "annotations": [ { "marker": "c20", "table_number": 1, "text": "Sampling times are relative to the time of study treatment administration (0 min). Predose time point will be between insulin infusion stop and study treatment." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-030", "activity_name": "Plasma Glucose for PD", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Plasma Glucose for PD" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 32, "verbatim_name": "Plasma Glucose for PD", "has_schedule_data": true } ], "annotations": [ { "marker": "c21", "table_number": 1, "text": "-5 mins = stop insulin infusion. Sampling times are relative to the time of study treatment administration (0 min). Predose time point will be between insulin infusion stop and study treatment." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-031", "activity_name": "Genetic Sample (Stored)", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Genetic Sample (Stored)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 33, "verbatim_name": "Genetic Sample (Stored)", "has_schedule_data": true } ], "annotations": [ { "marker": "c22", "table_number": 1, "text": "Single sample for pharmacogenetic analysis taken prior to/on Period 1 Day -1." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-032", "activity_name": "Anti-glucagon Antibodies", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Anti-glucagon Antibodies" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 34, "verbatim_name": "Anti-glucagon Antibodies", "has_schedule_data": true } ], "annotations": [ { "marker": "c23", "table_number": 1, "text": "In the event of drug hypersensitivity reactions (immediate or non-immediate), samples will be collected as close to event onset as possible, at event resolution, and 30 days following the event. Patients with TE ADA at follow-up/ED will undergo additional follow-up. Refer to Section 9.7.1 for details.", "document_references": [ { "kind": "section", "target": "9.7.1" } ] } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-033", "activity_name": "Health Outcome Instruments", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Health Outcome Instruments" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 35, "verbatim_name": "Health Outcome Instruments", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-034", "activity_name": "Clarke Hypoglycemia Awareness Survey", "parent_name": "Health Outcome Instruments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Clarke Hypoglycemia Awareness Survey" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 36, "verbatim_name": "Clarke Hypoglycemia Awareness Survey", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-035", "activity_name": "Nasal and Non-nasal Score Questionnaire", "parent_name": "Health Outcome Instruments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Nasal and Non-nasal Score Questionnaire" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 37, "verbatim_name": "Nasal and Non-nasal Score Questionnaire", "has_schedule_data": true } ], "annotations": [ { "marker": "c24", "table_number": 1, "text": "Sampling times are relative to the time of study treatment administration (0 min). Questionnaire will be collected in both LY900018 and IMG treatment groups in both periods." } ] }, { "protocol_id": "NCT03421379", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT03421379_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-036", "activity_name": "Edinburgh Hypoglycemia Scale: Experimental Hypoglycemia", "parent_name": "Health Outcome Instruments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Edinburgh Hypoglycemia Scale: Experimental Hypoglycemia" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8R-JE-IGBJ", "table_type": "main_soa", "track_label": null, "row_position": 38, "verbatim_name": "Edinburgh Hypoglycemia Scale: Experimental Hypoglycemia", "has_schedule_data": true } ], "annotations": [ { "marker": "c25", "table_number": 1, "text": "Sampling times are relative to the time of study treatment administration (0 min). During hypoglycemia induction will be when PG ≤75 mg/dL. Predose time point will be between insulin infusion stop and study treatment." } ] }, { "protocol_id": "NCT03548935", "sponsor": "Novo", "d4k_folder": "Novo_NCT03548935_Obesity", "therapeutic_area": "Obesity", "xact_id": "xact-001", "activity_name": "SUBJECT RELATED INFORMATION AND ASSESSMENTS", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "SUBJECT RELATED INFORMATION AND ASSESSMENTS" ], "occurrences": [ { "table_number": 1, "table_title": "Flowchart", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "SUBJECT RELATED INFORMATION AND ASSESSMENTS", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT03548935", "sponsor": "Novo", "d4k_folder": "Novo_NCT03548935_Obesity", "therapeutic_area": "Obesity", "xact_id": "xact-002", "activity_name": "Informed consent and Demography", "parent_name": "SUBJECT 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"protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-023", "activity_name": "AE/SAE Assessment", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "AE/SAE Assessment" ], "occurrences": [ { "table_number": 1, "table_title": "SCHEDULE OF ACTIVITIES (SOA)", "table_type": "main_soa", "track_label": null, "row_position": 26, "verbatim_name": "AE/SAE Assessment", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-024", "activity_name": "Prior/Concomitant Medication", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Prior/Concomitant Medication" ], "occurrences": [ { "table_number": 1, "table_title": "SCHEDULE OF ACTIVITIES (SOA)", "table_type": "main_soa", "track_label": null, "row_position": 27, "verbatim_name": "Prior/Concomitant Medication", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-025", "activity_name": "PK", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "PK" ], "occurrences": [ { "table_number": 1, "table_title": "SCHEDULE OF ACTIVITIES (SOA)", "table_type": "main_soa", "track_label": null, "row_position": 28, "verbatim_name": "PK", "has_schedule_data": false } ], "annotations": [ { "marker": "pr7", "table_number": 1, "text": "See Pharmacokinetics and immunogenicity Flow Chart" } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-026", "activity_name": "ADA", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "ADA" ], "occurrences": [ { "table_number": 1, "table_title": "SCHEDULE OF ACTIVITIES (SOA)", "table_type": "main_soa", "track_label": null, "row_position": 29, "verbatim_name": "ADA", "has_schedule_data": false } ], "annotations": [ { "marker": "pr7", "table_number": 1, "text": "See Pharmacokinetics and immunogenicity Flow Chart" } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-027", "activity_name": "Tumor Biopsy, Archival Tumor Tissue Collection, Biomarker Blood Draw", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Tumor Biopsy, Archival Tumor Tissue Collection, Biomarker Blood Draw" ], "occurrences": [ { "table_number": 1, "table_title": "SCHEDULE OF ACTIVITIES (SOA)", "table_type": "main_soa", "track_label": null, "row_position": 30, "verbatim_name": "Tumor Biopsy, Archival Tumor Tissue Collection, Biomarker Blood Draw", "has_schedule_data": false } ], "annotations": [ { "marker": "pr8", "table_number": 1, "text": "See Biomarker Flow Chart" } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-028", "activity_name": "Subsequent Anticancer Therapy Status", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Subsequent Anticancer Therapy Status" ], "occurrences": [ { "table_number": 1, "table_title": "SCHEDULE OF ACTIVITIES (SOA)", "table_type": "main_soa", "track_label": null, "row_position": 31, "verbatim_name": "Subsequent Anticancer Therapy Status", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-029", "activity_name": "Survival Status", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Survival Status" ], "occurrences": [ { "table_number": 1, "table_title": "SCHEDULE OF ACTIVITIES (SOA)", "table_type": "main_soa", "track_label": null, "row_position": 32, "verbatim_name": "Survival Status", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-030", "activity_name": "IMP administration (IV infusion)", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": false, "variants": [ "IMP administration (IV infusion)" ], "occurrences": [ { "table_number": 2, "table_title": "PHARMACOKINETICS AND IMMUNOGENICITY FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 8, "verbatim_name": "IMP administration (IV infusion)", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-031", "activity_name": "Atezolizumab", "parent_name": "IMP administration (IV infusion)", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Atezolizumab" ], "occurrences": [ { "table_number": 2, "table_title": "PHARMACOKINETICS AND IMMUNOGENICITY FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 9, "verbatim_name": "Atezolizumab", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-032", "activity_name": "Isatuximab", "parent_name": "IMP administration (IV infusion)", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Isatuximab" ], "occurrences": [ { "table_number": 2, "table_title": "PHARMACOKINETICS AND IMMUNOGENICITY FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 10, "verbatim_name": "Isatuximab", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-033", "activity_name": "Pharmacokinetics", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": false, "variants": [ "Pharmacokinetics" ], "occurrences": [ { "table_number": 2, "table_title": "PHARMACOKINETICS AND IMMUNOGENICITY FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 11, "verbatim_name": "Pharmacokinetics", "has_schedule_data": false } ], "annotations": [ { "marker": "a", "table_number": 2, "text": "Refer to the laboratory manual for sample collection, processing and shipping." }, { "marker": "i", "table_number": 2, "text": "Isatuximab PK and ADA samples to be collected each cycle until the last study treatment for PK and until FUP 90(±7) days after last IMP administration for ADA or at the cut-off date, whichever comes first. However, collection can be reduced or stopped earlier upon notification from the Sponsor based on the updated knowledge of isatuximab on PK/ADA." } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-034", "activity_name": "Atezolizumab Sample ID", "parent_name": "Pharmacokinetics", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Atezolizumab Sample ID" ], "occurrences": [ { "table_number": 2, "table_title": "PHARMACOKINETICS AND IMMUNOGENICITY FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 12, "verbatim_name": "Atezolizumab Sample ID", "has_schedule_data": true } ], "annotations": [ { "marker": "j", "table_number": 2, "text": "For subsequent cycles, atezolizumab PK and ADA samples (pre-dose) are to be collected at Cycle 8 Day 1 and Cycle 16 Day 1 only." }, { "marker": "c", "table_number": 2, "text": "Atezolizumab sample collected strictly before the start of atezolizumab infusion (during treatment phase).", "columns": [ "Treatment Phase / Cycle 2 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Cycle 3 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Cycle 4 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Subsequent Cycles / D1 / SOI / [-24h, SOI] / SOI" ] } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-035", "activity_name": "Isatuximab Sample ID", "parent_name": "Pharmacokinetics", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Isatuximab Sample ID" ], "occurrences": [ { "table_number": 2, "table_title": "PHARMACOKINETICS AND IMMUNOGENICITY FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 13, "verbatim_name": "Isatuximab Sample ID", "has_schedule_data": true } ], "annotations": [ { "marker": "i", "table_number": 2, "text": "Isatuximab PK and ADA samples to be collected each cycle until the last study treatment for PK and until FUP 90(±7) days after last IMP administration for ADA or at the cut-off date, whichever comes first. However, collection can be reduced or stopped earlier upon notification from the Sponsor based on the updated knowledge of isatuximab on PK/ADA." }, { "marker": "b", "table_number": 2, "text": "Isatuximab PK or ADA predose samples should be collected before isatuximab administration and at the same time as atezolizumab predose samples when applicable.", "columns": [ "Treatment Phase / Cycle 1 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Cycle 2 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Cycle 3 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Cycle 4 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Subsequent Cycles / D1 / SOI / [-24h, SOI] / SOI" ] }, { "marker": "f", "table_number": 2, "text": "Sample collected just before actual end of infusion of isatuximab.", "columns": [ "Treatment Phase / Cycle 1 / D1 / EOI / ±10 min", "Treatment Phase / Cycle 1 / D15 / EOI / ±10 min", "Treatment Phase / Cycle 2 / D1 / EOI / ±10 min", "Treatment Phase / Cycle 4 / D1 / EOI / ±10 min" ] }, { "marker": "d", "table_number": 2, "text": "P04 sample must be collected even if the participant withdraws the study without receiving the second administration of isatuximab.", "columns": [ "Treatment Phase / Cycle 1 / D1 / 168h (SOI of Day 8) / [-24h, SOI]" ] }, { "marker": "g", "table_number": 2, "text": "Isatuximab sample collected strictly before the start of isatuximab infusion (during treatment phase).", "columns": [ "Treatment Phase / Cycle 1 / D1 / 168h (SOI of Day 8) / [-24h, SOI]", "Treatment Phase / Cycle 1 / D15 / SOI / [-24h, SOI]", "Treatment Phase / Cycle 2 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Cycle 3 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Cycle 4 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Subsequent Cycles / D1 / SOI / [-24h, SOI] / SOI" ] } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-036", "activity_name": "Immunogenicity (ADA)", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": false, "variants": [ "Immunogenicity (ADA)" ], "occurrences": [ { "table_number": 2, "table_title": "PHARMACOKINETICS AND IMMUNOGENICITY FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 14, "verbatim_name": "Immunogenicity (ADA)", "has_schedule_data": false } ], "annotations": [ { "marker": "a", "table_number": 2, "text": "Refer to the laboratory manual for sample collection, processing and shipping." }, { "marker": "e", "table_number": 2, "text": "After start of study treatment, if 1 drug is prematurely discontinued, ADA samples for this drug will be collected and tested on Day 1 of the 2 next cycles. The ADA sample collection for other drug should be done as planned." }, { "marker": "i", "table_number": 2, "text": "Isatuximab PK and ADA samples to be collected each cycle until the last study treatment for PK and until FUP 90(±7) days after last IMP administration for ADA or at the cut-off date, whichever comes first. However, collection can be reduced or stopped earlier upon notification from the Sponsor based on the updated knowledge of isatuximab on PK/ADA." } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-037", "activity_name": "Atezolizumab", "parent_name": "Immunogenicity (ADA)", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Atezolizumab" ], "occurrences": [ { "table_number": 2, "table_title": "PHARMACOKINETICS AND IMMUNOGENICITY FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 15, "verbatim_name": "Atezolizumab", "has_schedule_data": true } ], "annotations": [ { "marker": "c", "table_number": 2, "text": "Atezolizumab sample collected strictly before the start of atezolizumab infusion (during treatment phase)." }, { "marker": "j", "table_number": 2, "text": "For subsequent cycles, atezolizumab PK and ADA samples (pre-dose) are to be collected at Cycle 8 Day 1 and Cycle 16 Day 1 only." } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-038", "activity_name": "Isatuximab", "parent_name": "Immunogenicity (ADA)", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Isatuximab" ], "occurrences": [ { "table_number": 2, "table_title": "PHARMACOKINETICS AND IMMUNOGENICITY FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 16, "verbatim_name": "Isatuximab", "has_schedule_data": true } ], "annotations": [ { "marker": "g", "table_number": 2, "text": "Isatuximab sample collected strictly before the start of isatuximab infusion (during treatment phase)." }, { "marker": "h", "table_number": 2, "text": "After FUP 90(±7) days after last isatuximab administration no further ADA will be sampled even if the status is positive or inconclusive." }, { "marker": "i", "table_number": 2, "text": "Isatuximab PK and ADA samples to be collected each cycle until the last study treatment for PK and until FUP 90(±7) days after last IMP administration for ADA or at the cut-off date, whichever comes first. However, collection can be reduced or stopped earlier upon notification from the Sponsor based on the updated knowledge of isatuximab on PK/ADA." }, { "marker": "b", "table_number": 2, "text": "Isatuximab PK or ADA predose samples should be collected before isatuximab administration and at the same time as atezolizumab predose samples when applicable.", "columns": [ "Treatment Phase / Cycle 1 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Cycle 2 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Cycle 3 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Cycle 4 / D1 / SOI / [-24h, SOI] / SOI", "Treatment Phase / Subsequent Cycles / D1 / SOI / [-24h, SOI] / SOI" ] } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-039", "activity_name": "Peripheral Blood", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": false, "variants": [ "Peripheral Blood" ], "occurrences": [ { "table_number": 3, "table_title": "EXPLORATORY BIOMARKER FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 4, "verbatim_name": "Peripheral Blood", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-040", "activity_name": "Immune genetic markers", "parent_name": "Peripheral Blood", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Immune genetic markers" ], "occurrences": [ { "table_number": 3, "table_title": "EXPLORATORY BIOMARKER FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 5, "verbatim_name": "Immune genetic markers", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-041", "activity_name": "Tumor mutational profile (plasma cell free DNA)", "parent_name": "Peripheral Blood", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Tumor mutational profile (plasma cell free DNA)" ], "occurrences": [ { "table_number": 3, "table_title": "EXPLORATORY BIOMARKER FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 6, "verbatim_name": "Tumor mutational profile (plasma cell free DNA)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-042", "activity_name": "Immunophenotyping", "parent_name": "Peripheral Blood", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Immunophenotyping" ], "occurrences": [ { "table_number": 3, "table_title": "EXPLORATORY BIOMARKER FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 7, "verbatim_name": "Immunophenotyping", "has_schedule_data": true } ], "annotations": [ { "marker": "n1", "table_number": 3, "text": "Only for Phase 2 Stage 2 participants" } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-043", "activity_name": "Plasma or serum cytokines", "parent_name": "Peripheral Blood", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Plasma or serum cytokines" ], "occurrences": [ { "table_number": 3, "table_title": "EXPLORATORY BIOMARKER FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 8, "verbatim_name": "Plasma or serum cytokines", "has_schedule_data": true } ], "annotations": [ { "marker": "n1", "table_number": 3, "text": "Only for Phase 2 Stage 2 participants" } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-044", "activity_name": "Adaptive immunity", "parent_name": "Peripheral Blood", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Adaptive immunity" ], "occurrences": [ { "table_number": 3, "table_title": "EXPLORATORY BIOMARKER FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 9, "verbatim_name": "Adaptive immunity", "has_schedule_data": true } ], "annotations": [ { "marker": "n2", "table_number": 3, "text": "Only Phase 2 Stage 2 participants, if sufficient clinical response is observable in Phase 1 and Phase 2 Stage 1 participants" } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-045", "activity_name": "Plasma or serum Metabolites", "parent_name": "Peripheral Blood", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Plasma or serum Metabolites" ], "occurrences": [ { "table_number": 3, "table_title": "EXPLORATORY BIOMARKER FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 10, "verbatim_name": "Plasma or serum Metabolites", "has_schedule_data": true } ], "annotations": [ { "marker": "n2", "table_number": 3, "text": "Only Phase 2 Stage 2 participants, if sufficient clinical response is observable in Phase 1 and Phase 2 Stage 1 participants" } ] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-046", "activity_name": "Archival Pre-Treatment Tumor Tissue Collection (for HCC, SCCHN, EOC and GBM)", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": false, "variants": [ "Archival Pre-Treatment Tumor Tissue Collection (for HCC, SCCHN, EOC and GBM)" ], "occurrences": [ { "table_number": 3, "table_title": "EXPLORATORY BIOMARKER FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 11, "verbatim_name": "Archival Pre-Treatment Tumor Tissue Collection (for HCC, SCCHN, EOC and GBM)", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT03637764", "sponsor": "Sanofi", "d4k_folder": "Sanofi_NCT03637764_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-047", "activity_name": "If feasible, biomarker analyses listed below for “Baseline or on treatment tumor biopsy core”", "parent_name": "Archival Pre-Treatment Tumor Tissue Collection (for HCC, SCCHN, EOC and GBM)", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "If feasible, biomarker analyses listed below for “Baseline or on treatment tumor biopsy core”" ], "occurrences": [ { "table_number": 3, "table_title": "EXPLORATORY BIOMARKER FLOW CHART", "table_type": "subsidiary", "track_label": null, "row_position": 12, "verbatim_name": "If feasible, biomarker analyses listed below for “Baseline or on treatment tumor biopsy core”", "has_schedule_data": true } ], "annotations": [ { "marker": "n3", "table_number": 3, "text": "Mandatory for all GBM participants. 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Record abnormalities observed at baseline on the General Medical History and Baseline Conditions eCRF. At subsequent visits, record new or worsened clinically significant abnormalities on the Adverse Event eCRF." } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-007", "activity_name": "Weight", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Weight" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Weight", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-008", "activity_name": "Height", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Height" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Height", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-009", "activity_name": "ECG", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "ECG" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "ECG", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-010", "activity_name": "LVEF (echocardiography or MUGA scan)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "LVEF (echocardiography or MUGA scan)" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "LVEF (echocardiography or MUGA scan)", "has_schedule_data": true } ], "annotations": [ { "marker": "z", "table_number": 1, "text": "LVEF required for patients who receive CHOP only." } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-011", "activity_name": "Complete physical examination", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Complete physical examination" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Complete physical examination", "has_schedule_data": true } ], "annotations": [ { "marker": "h", "table_number": 1, "text": "Includes evaluation of the head, eyes, ears, nose, and throat, and the cardiovascular, dermatologic, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurologic systems. Record abnormalities observed at baseline on the General Medical History and Baseline Conditions eCRF. At subsequent visits, record new or worsened clinically significant abnormalities on the Adverse Event eCRF." }, { "marker": "i", "table_number": 1, "text": "As part of tumor assessment, the physical examination should include evaluation for the presence of enlarged nodes, palpable hepatomegaly, and splenomegaly. This information will be recorded on the appropriate tumor assessment eCRF." } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-012", "activity_name": "Targeted physical examination", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Targeted physical examination" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Targeted physical examination", "has_schedule_data": true } ], "annotations": [ { "marker": "j", "table_number": 1, "text": "Includes systems of primary relevance (e.g., cardiovascular and respiratory systems), systems associated with symptoms (newly emergent or monitored from baseline), and areas associated with tumor assessment (lymph nodes, liver, spleen, and any other areas identified at baseline). Record new or worsened clinically significant abnormalities on the Adverse Event eCRF." }, { "marker": "k", "table_number": 1, "text": "Perform at the same time as tumor assessments after the end of induction treatment." } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-013", "activity_name": "B symptoms", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "B symptoms" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "B symptoms", "has_schedule_data": true } ], "annotations": [ { "marker": "l", "table_number": 1, "text": "Unexplained fever >38ºC, night sweats, unexplained weight loss >10% of body weight over 6 months." } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-014", "activity_name": "Hematology", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Hematology" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Hematology", "has_schedule_data": true } ], "annotations": [ { "marker": "m", "table_number": 1, "text": "Hematology includes WBC count, RBC count, hemoglobin, hematocrit, platelet count, and differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes, other cells)." } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-015", "activity_name": "Chemistry", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Chemistry" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Chemistry", "has_schedule_data": true } ], "annotations": [ { "marker": "n", "table_number": 1, "text": "Chemistry panel (serum or plasma) includes bicarbonate or total carbon dioxide (if considered standard of care for the region), sodium, potassium, chloride, glucose, BUN or urea, creatinine, total protein, albumin, phosphate, calcium, total and direct bilirubin, ALP, ALT, AST, urate, beta-2 microglobulin (at screening and EOI only) and LDH." } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-016", "activity_name": "Pregnancy test", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Pregnancy test" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Pregnancy test", "has_schedule_data": true } ], "annotations": [ { "marker": "o", "table_number": 1, "text": "All women of childbearing potential will have a serum pregnancy test at screening." } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-017", "activity_name": "Coagulation INR, aPTT or PTT and PT", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Coagulation INR, aPTT or PTT and PT" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Coagulation INR, aPTT or PTT and PT", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-018", "activity_name": "Urinalysis", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Urinalysis" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "Urinalysis", "has_schedule_data": true } ], "annotations": [ { "marker": "p", "table_number": 1, "text": "Includes dipstick (pH, specific gravity, glucose, protein, ketones, blood) and microscopic examination if routinely performed (sediment, RBCs, WBCs, casts, crystals, epithelial cells, bacteria)." } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-019", "activity_name": "HIV, HTLV-1, Hep B / C testing", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "HIV, HTLV-1, Hep B / C testing" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 23, "verbatim_name": "HIV, HTLV-1, Hep B / C testing", "has_schedule_data": true } ], "annotations": [ { "marker": "q", "table_number": 1, "text": "To include assessment of HBV/HCV DNA PCR in patients with resolved HBV/HCV infection at baseline. HBV DNA PCR testing at least every 3 months should also be conducted (during the study and for at least 1 year after completion of lymphoma treatment) for patients with prior HBV infection or who are carriers of HBV. HTLV-1 testing will be performed at baseline in patients from endemic countries only. HIV testing will be performed at baseline if required by local regulations." } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-020", "activity_name": "Study drug administration", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Study drug administration" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "Study drug administration", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-021", "activity_name": "obinutuzumab", "parent_name": "Study drug administration", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "obinutuzumab" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 25, "verbatim_name": "obinutuzumab", "has_schedule_data": true } ], "annotations": [ { "marker": "r", "table_number": 1, "text": "Obinutuzumab administered on Days, 1, 8 and 15 of cycle 1 and Day 1 of subsequent cycles." }, { "marker": "c", "table_number": 1, "text": "Obinutuzumab administered according to the regular infusion rate (see Table 1, Section 3.1).", "columns": [ "Treatment / Induction (6–8 cycles) / Cycle 1 / D1", "Treatment / Induction (6–8 cycles) / Cycle 1 / D8", "Treatment / Induction (6–8 cycles) / Cycle 1 / D15" ], "document_references": [ { "kind": "section", "target": "3.1" }, { "kind": "table", "target": "1" } ] }, { "marker": "d", "table_number": 1, "text": "Obinutuzumab administered according a 90-minute short duration infusion (see Table 1, Section 3.1) for patients who do not experience any Grade ≥3 IRRs during the first or previous cycle. If a patient experiences any Grade 3 IRRs during any SDI administrations of obinutuzumab (i.e. after Cycle 1, Day 1), the next dose of obinutuzumab will be administered at the regular infusion rate. If the patient experiences a second occurrence of a Grade 3 IRR, the obinutuzumab infusion must be stopped and the therapy must be permanently discontinued.", "columns": [ "Treatment / Induction (6–8 cycles) / Cycle 2 / D1", "Treatment / Induction (6–8 cycles) / Cycles 3–6/8 / D1", "Treatment / Maintenance (every 8 weeks ± 10 days)" ], "document_references": [ { "kind": "section", "target": "3.1" }, { "kind": "table", "target": "1" } ] } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-022", "activity_name": "chemotherapy", "parent_name": "Study drug administration", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "chemotherapy" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 26, "verbatim_name": "chemotherapy", "has_schedule_data": true } ], "annotations": [ { "marker": "s", "table_number": 1, "text": "Chemotherapy comprises either bendamustine (Days 1 and 2, Cycles 1–6; 28-day cycles), CHOP (Days 1–5, Cycles 1–6; 21-day cycles; followed by 2 cycles of obinutuzumab alone), or CVP (Days 1–5, Cycles 1–8; 21-day cycles). See Section 4.3.2.2 Combination chemotherapy.", "document_references": [ { "kind": "section", "target": "4.3.2.2" } ] } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-023", "activity_name": "Tumor assessment", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Tumor assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 27, "verbatim_name": "Tumor assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "t", "table_number": 1, "text": "By the investigator according to local practice and according to the guidelines used at the site (Lugano [Cheson et al 2014], Cheson et al 2007, or Cheson et al 1999). Including bone marrow where applicable. If bone marrow data are available in the patient’s medical record that were obtained within 3 months prior to study inclusion, these data can be used instead, and the patient does not need to undergo a new bone marrow biopsy with or without aspirate at screening." } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-024", "activity_name": "Concomitant medications", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Concomitant medications" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 28, "verbatim_name": "Concomitant medications", "has_schedule_data": true } ], "annotations": [ { "marker": "u", "table_number": 1, "text": "Medication (e.g., prescription drugs, over-the-counter drugs, vaccines, herbal or homeopathic remedies, nutritional supplements) used by a patient in addition to protocol-mandated treatment from 7 days prior to study entry until 3 months after the final dose of study drug." }, { "marker": "v", "table_number": 1, "text": "Concomitant medications and adverse events will be collected throughout the study." } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-025", "activity_name": "Adverse events", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Adverse events" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 29, "verbatim_name": "Adverse events", "has_schedule_data": true } ], "annotations": [ { "marker": "w", "table_number": 1, "text": "After informed consent has been obtained but prior to initiation of study drug, only serious adverse events caused by a protocol-mandated intervention should be reported. After initiation of study drug, all adverse events will be reported until 3 months (90 days (± 10 days)) after the final dose of study drug. After this period, the Sponsor should be notified if the investigator becomes aware of any serious adverse event that is believed to be related to prior study treatment (see Section 5.6). An exception is made for Grade 3–4 infections (related and unrelated), which should be reported until resolution or until up to 2 years after the last dose of obinutuzumab and secondary malignancies should be reported indefinitely. The investigator should follow each adverse event until the event has resolved to baseline grade or better, the event is assessed as stable by the investigator, the patient is lost to follow-up, or the patient withdraws consent.", "document_references": [ { "kind": "section", "target": "5.6" } ] } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-026", "activity_name": "Provider-reported measures", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Provider-reported measures" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 30, "verbatim_name": "Provider-reported measures", "has_schedule_data": true } ], "annotations": [ { "marker": "x", "table_number": 1, "text": "After administration of SDI at Cycle 4 Day 1, providers will complete the evaluation of site experience questionnaire.", "columns": [ "Treatment / Induction (6–8 cycles) / Cycles 3–6/8 / D1" ] } ] }, { "protocol_id": "NCT03817853", "sponsor": "Roche", "d4k_folder": "Roche_NCT03817853_Lymphoma", "therapeutic_area": "Lymphoma", "xact_id": "xact-027", "activity_name": "Patient-reported measures", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Patient-reported measures" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 31, "verbatim_name": "Patient-reported measures", "has_schedule_data": true } ], "annotations": [ { "marker": "y", "table_number": 1, "text": "Before administration of treatment at Day 1 of Cycles 1–6, at the end of induction, during maintenance, at end of maintenance, and at end of study, patients will complete the MDASI. The MDASI will be self-administered before the patient receives any information on disease status, prior to the performance of non-PRO assessments, and prior to the administration of study treatment." } ] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-001", "activity_name": "Informed Consent", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed Consent" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 3, "verbatim_name": "Informed Consent", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-002", "activity_name": "Subject Admission to CRU", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Subject Admission to CRU" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Subject Admission to CRU", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-003", "activity_name": "Tirzepatide Dosing", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Tirzepatide Dosing" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Tirzepatide Dosing", "has_schedule_data": true } ], "annotations": [ { "marker": "n1", "table_number": 1, "text": "Study drug will be administered after an overnight fast of at least 8 hours." } ] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-004", "activity_name": "Subject Discharge from CRU", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Subject Discharge from CRU" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Subject Discharge from CRU", "has_schedule_data": true } ], "annotations": [ { "marker": "n2", "table_number": 1, "text": "Subjects’ CRU stay may be extended at the investigator’s discretion for safety monitoring." } ] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-005", "activity_name": "Outpatient Visit", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Outpatient Visit" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Outpatient Visit", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-006", "activity_name": "Medical History and Demographics", "parent_name": "", "hierarchy_level": 0, 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"main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Physical Examination /Medical Assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "n3", "table_number": 1, "text": "Physical examination at screening. Thereafter, targeted reviews and medical assessments as appropriate." } ] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-008", "activity_name": "Weight", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Weight" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Weight", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-009", "activity_name": "Height", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Height" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Height", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-010", "activity_name": "Temperature", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Temperature" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Temperature", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-011", "activity_name": "Safety 12-lead ECG", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Safety 12-lead ECG" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Safety 12-lead ECG", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "Specified times are approximate, and actual times will be recorded. Actual sampling time should not exceed 1 hour prior to dosing for the predose sample." }, { "marker": "n4", "table_number": 1, "text": "Single safety ECG will be collected. ECGs must be recorded before collecting any blood samples at each timepoint. Subjects must be supine for approximately 5 to 10 minutes before ECG collection, and remain supine but awake during ECG collection." } ] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-012", "activity_name": "Supine Vital Signs (hours)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Supine Vital Signs (hours)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Supine Vital Signs (hours)", "has_schedule_data": true } ], "annotations": [ { "marker": "n5", "table_number": 1, "text": "Additional time points may be added, if warranted and agreed upon between Lilly and the investigator." } ] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-013", "activity_name": "Clinical Laboratory Tests", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Clinical Laboratory Tests" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Clinical Laboratory Tests", "has_schedule_data": true } ], "annotations": [ { "marker": "n6", "table_number": 1, "text": "See Appendix 2 for details. Day 1 predose sample is for baseline only.", "document_references": [ { "kind": "appendix", "target": "2" } ] } ] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-014", "activity_name": "Pregnancy Test", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Pregnancy Test" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Pregnancy Test", "has_schedule_data": true } ], "annotations": [ { "marker": "n7", "table_number": 1, "text": "Female subjects only. Serum pregnancy test will be performed at screening and urine pregnancy tests at subsequent visits." } ] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-015", "activity_name": "FSH test, if applicable", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "FSH test, if applicable" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "FSH test, if applicable", "has_schedule_data": true } ], "annotations": [ { "marker": "n8", "table_number": 1, "text": "Female subjects considered to be postmenopausal only. Women with confirmed nonchildbearing potential status can be exempted from further pregnancy tests during the study after screening." } ] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-016", "activity_name": "AEs/Concomitant Medications", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "AEs/Concomitant Medications" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "AEs/Concomitant Medications", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-017", "activity_name": "Pharmacogenetic Sample", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Pharmacogenetic Sample" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Pharmacogenetic Sample", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "Specified times are approximate, and actual times will be recorded. Actual sampling time should not exceed 1 hour prior to dosing for the predose sample." }, { "marker": "n9", "table_number": 1, "text": "Single sample in Period 1 only." } ] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-018", "activity_name": "Immunogenicity", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Immunogenicity" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Immunogenicity", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "Specified times are approximate, and actual times will be recorded. Actual sampling time should not exceed 1 hour prior to dosing for the predose sample." }, { "marker": "n10", "table_number": 1, "text": "Where applicable, collection times should match with PK sampling time points. In the event of immediate or non-immediate drug hypersensitivity reactions, unscheduled samples will be collected as detailed in Section 9.4.6. Subjects with TE ADA at follow-up/ED will undergo additional follow-up as detailed in Section 9.7.", "document_references": [ { "kind": "section", "target": "9.4.6" }, { "kind": "section", "target": "9.7" } ] } ] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-019", "activity_name": "Blood glucose monitoring (hours)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Blood glucose monitoring (hours)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Blood glucose monitoring (hours)", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "Specified times are approximate, and actual times will be recorded. Actual sampling time should not exceed 1 hour prior to dosing for the predose sample." }, { "marker": "n11", "table_number": 1, "text": "Performed using a bedside glucose monitor. Additional unscheduled measurements may be taken at the discretion of the investigator where clinically indicated." } ] }, { "protocol_id": "NCT04004988", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04004988_Device", "therapeutic_area": "Device", "xact_id": "xact-020", "activity_name": "PK Sampling (hours)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "PK Sampling (hours)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Schedule Protocol I8F-MC-GPGS", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "PK Sampling (hours)", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "Specified times are approximate, and actual times will be recorded. Actual sampling time should not exceed 1 hour prior to dosing for the predose sample." }, { "marker": "n12", "table_number": 1, "text": "Up to a 10% deviation from the nominal collection time is permissible as long as actual sampling time is recorded." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-001", "activity_name": "Informed consent", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed consent" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Informed consent", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-002", "activity_name": "Randomization", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Randomization" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Randomization", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-003", "activity_name": "Register study visit in IWRS", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Register study visit in IWRS" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Register study visit in IWRS", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 6, "verbatim_name": "Register study visit in IWRS", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-004", "activity_name": "Clinical Assessments", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": false, 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"variants": [ "Medical history" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Medical history", "has_schedule_data": true } ], "annotations": [ { "marker": "n7", "table_number": 1, "text": "Medical history includes assessment of preexisting conditions (for example, history of gallbladder disease, cardiovascular disease, and medullary thyroid carcinoma) and substance usage (such as alcohol and tobacco)." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-006", "activity_name": "Physical examination", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Physical examination" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Physical examination", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-007", "activity_name": "Height", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Height" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Height", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-008", "activity_name": "Weight", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Weight" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Weight", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 8, "verbatim_name": "Weight", "has_schedule_data": true } ], "annotations": [ { "marker": "n8", "table_number": 1, "text": "Weight measurements should be obtained per the instructions in Section 10.7. Body weight must be measured in fasting state. If the participant is not fasting, the participant should be called in for a new visit within the visit window to have the fasting body weight measured.", "document_references": [ { "kind": "section", "target": "10.7" } ] } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-009", "activity_name": "Waist circumference", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Waist circumference" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Waist circumference", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 9, "verbatim_name": "Waist circumference", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-010", "activity_name": "Electrocardiogram", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Electrocardiogram" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Electrocardiogram", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 10, "verbatim_name": "Electrocardiogram", "has_schedule_data": true } ], "annotations": [ { "marker": "n9", "table_number": 1, "text": "ECG measurements should be obtained per the instructions in Section 10.7. ECGs will be performed in triplicate at Weeks 0 and 36. All other ECGs will be single measurements. ECGs should be collected at least 30 minutes prior to collection of blood samples for laboratory testing, including PK samples.", "document_references": [ { "kind": "section", "target": "10.7" } ] } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-011", "activity_name": "Vital signs (3 sitting BP and HR)", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Vital signs (3 sitting BP and HR)" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Vital signs (3 sitting BP and HR)", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 11, "verbatim_name": "Vital signs (3 sitting BP and HR)", "has_schedule_data": true } ], "annotations": [ { "marker": "n10", "table_number": 1, "text": "Vital-sign measurements should be taken before obtaining an ECG tracing and before collection of blood samples for laboratory testing, per the instruction in Section 10.7.", "document_references": [ { "kind": "section", "target": "10.7" } ] } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-012", "activity_name": "Adverse events and product complaints", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Adverse events and product complaints", "Adverse events/Product Complaints" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Adverse events and product complaints", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 12, "verbatim_name": "Adverse events/Product Complaints", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-013", "activity_name": "Concomitant medications", "parent_name": "Clinical Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Concomitant medications" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Concomitant medications", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 13, "verbatim_name": "Concomitant medications", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-014", "activity_name": "Participant Education and Assessment", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": false, "variants": [ "Participant Education and Assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Participant Education and Assessment", "has_schedule_data": false }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 14, "verbatim_name": "Participant Education and Assessment", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-015", "activity_name": "Hand out diary, instruct in use", "parent_name": "Participant Education and Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Hand out diary, instruct in use" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Hand out diary, instruct in use", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 15, "verbatim_name": "Hand out diary, instruct in use", "has_schedule_data": true } ], "annotations": [ { "marker": "n11", "table_number": 1, "text": "All training should be repeated as needed to ensure participant compliance." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-016", "activity_name": "Review study participant diary, including study-drug compliance", "parent_name": "Participant Education and Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Review study participant diary, including study-drug compliance", "Review study participant diary, including study drug compliance" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Review study participant diary, including study-drug compliance", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 16, "verbatim_name": "Review study participant diary, including study drug compliance", "has_schedule_data": true } ], "annotations": [ { "marker": "n12", "table_number": 1, "text": "Data from diary, as well as study drug compliance, should be reviewed." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-017", "activity_name": "Lifestyle Program instructions", "parent_name": "Participant Education and Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Lifestyle Program instructions" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "Lifestyle Program instructions", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 17, "verbatim_name": "Lifestyle Program instructions", "has_schedule_data": true } ], "annotations": [ { "marker": "n13", "table_number": 1, "text": "Counselling on diet and exercise, to be performed by a dietician or equivalent qualified delegate, to include calculation of individualized energy requirement and methods to change dietary composition and amount of physical activity. The Lifestyle Program Instruction may be delivered on a separate day from the rest of that visit’s study procedures but must occur within the visit window. Beginning at Week 8, the Lifestyle Program Instruction may be delivered by phone." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-018", "activity_name": "Review diet and exercise goals", "parent_name": "Participant Education and Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Review diet and exercise goals" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 23, "verbatim_name": "Review diet and exercise goals", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 18, "verbatim_name": "Review diet and exercise goals", "has_schedule_data": true } ], "annotations": [ { "marker": "n14", "table_number": 1, "text": "All training should be repeated as needed to ensure participant compliance. Study personnel to provide reinforcement and encouragement for lifestyle modifications." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-019", "activity_name": "Injection training with autoinjector demonstration device", "parent_name": "Participant Education and Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Injection training with autoinjector demonstration device" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "Injection training with autoinjector demonstration device", "has_schedule_data": true } ], "annotations": [ { "marker": "n15", "table_number": 1, "text": "All training should be repeated as needed to ensure participant compliance" } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-020", "activity_name": "Dispense study drug", "parent_name": "Participant Education and Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Dispense study drug" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 25, "verbatim_name": "Dispense study drug", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 19, "verbatim_name": "Dispense study drug", "has_schedule_data": true } ], "annotations": [ { "marker": "n16", "table_number": 1, "text": "This applies only to those participants going into the additional 2-year treatment period for participants with prediabetes at randomization.", "columns": [ "21 / 72 / ±7 / X" ] } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-021", "activity_name": "Observe participant administer study drug", "parent_name": "Participant Education and Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Observe participant administer study drug" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 26, "verbatim_name": "Observe participant administer study drug", "has_schedule_data": true } ], "annotations": [ { "marker": "n17", "table_number": 1, "text": "Participants should administer their first dose of study drug at the end of the Visit 3, after other study procedures are completed" } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-022", "activity_name": "Participant returns study drugs and injection supplies", "parent_name": "Participant Education and Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Participant returns study drugs and injection supplies" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 27, "verbatim_name": "Participant returns study drugs and injection supplies", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 20, "verbatim_name": "Participant returns study drugs and injection supplies", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-023", "activity_name": "Laboratory Tests", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": false, "variants": [ "Laboratory Tests" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 28, "verbatim_name": "Laboratory Tests", "has_schedule_data": false }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 21, "verbatim_name": "Laboratory Tests", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-024", "activity_name": "Serum pregnancy test", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Serum pregnancy test" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 29, "verbatim_name": "Serum pregnancy test", "has_schedule_data": true } ], "annotations": [ { "marker": "n18", "table_number": 1, "text": "A serum pregnancy test will be performed at Visit 1 for women of childbearing potential only." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-025", "activity_name": "Urine pregnancy test", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Urine pregnancy test" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 30, "verbatim_name": "Urine pregnancy test", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 22, "verbatim_name": "Urine pregnancy test", "has_schedule_data": true } ], "annotations": [ { "marker": "n19", "table_number": 1, "text": "A urine pregnancy test must be performed at Visit 3 with the result available prior to randomization and first injection of study drug(s) for women of childbearing potential only. Additional pregnancy tests (beyond those required per the Schedule of Activities) should be performed at any time during the trial if a menstrual period is missed, there is clinical suspicion of pregnancy, or as required by local law or regulation." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-026", "activity_name": "Follicle-stimulating hormone test", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Follicle-stimulating hormone test" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 31, "verbatim_name": "Follicle-stimulating hormone test", "has_schedule_data": true } ], "annotations": [ { "marker": "n20", "table_number": 1, "text": "Follicle-stimulating hormone test performed at Visit 1 for postmenopausal women at least 40 years of age with an intact uterus, not on hormone therapy, and who have had spontaneous amenorrhea for more than 1 year without an alternative medical cause." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-027", "activity_name": "2-hour oral glucose tolerance test (includes glucose, insulin, c-peptide at each timepoint)", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "2-hour oral glucose tolerance test (includes glucose, insulin, c-peptide at each timepoint)", "2 hour oral glucose tolerance test (includes glucose, insulin, c-peptide)" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 32, "verbatim_name": "2-hour oral glucose tolerance test (includes glucose, insulin, c-peptide at each timepoint)", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 23, "verbatim_name": "2 hour oral glucose tolerance test (includes glucose, insulin, c-peptide)", "has_schedule_data": true } ], "annotations": [ { "marker": "n21", "table_number": 1, "text": "2-hour OGTT testing should be omitted at visits following a protocol-defined diabetes diagnosis." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-028", "activity_name": "Chemistry panel (include Cr for eGFR calculation and glucose)", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Chemistry panel (include Cr for eGFR calculation and glucose)", "Chemistry panel (includes Cr for eGFR calculation and glucose)" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 33, "verbatim_name": "Chemistry panel (include Cr for eGFR calculation and glucose)", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 24, "verbatim_name": "Chemistry panel (includes Cr for eGFR calculation and glucose)", "has_schedule_data": true } ], "annotations": [ { "marker": "n23", "table_number": 1, "text": "The CKD-EPI equation will be used by the central lab to estimate and report eGFR." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-029", "activity_name": "Lipid panel", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Lipid panel" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 34, "verbatim_name": "Lipid panel", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 25, "verbatim_name": "Lipid panel", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-030", "activity_name": "Fasting insulin", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Fasting insulin" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 35, "verbatim_name": "Fasting insulin", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-031", "activity_name": "C-peptide", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "C-peptide" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 36, "verbatim_name": "C-peptide", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-032", "activity_name": "Free fatty acids", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Free fatty acids" ], "occurrences": [ { "table_number": 1, "table_title": 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"occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 38, "verbatim_name": "Urinary albumin/creatinine", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 27, "verbatim_name": "Urinary albumin/creatinine ratio", "has_schedule_data": true } ], "annotations": [ { "marker": "n22", "table_number": 1, "text": "Screening visit assessment will be used to confirm eligibility. If calcitonin results are not available, a final review of eligibility will occur at Visit 3 before randomization can proceed.", "columns": [ "1 / -2 / X" ] } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-034", "activity_name": "Cystatin-c", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Cystatin-c" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 39, "verbatim_name": "Cystatin-c", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 28, "verbatim_name": "Cystatin-c", "has_schedule_data": true } ], "annotations": [ { "marker": "n22", "table_number": 1, "text": "Screening visit assessment will be used to confirm eligibility. If calcitonin results are not available, a final review of eligibility will occur at Visit 3 before randomization can proceed.", "columns": [ "1 / -2 / X" ] } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-035", "activity_name": "Calcitonin", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Calcitonin" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 40, "verbatim_name": "Calcitonin", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 29, "verbatim_name": "Calcitonin", "has_schedule_data": true } ], "annotations": [ { "marker": "n22", "table_number": 1, "text": "Screening visit assessment will be used to confirm eligibility. If calcitonin results are not available, a final review of eligibility will occur at Visit 3 before randomization can proceed.", "columns": [ "1 / -2 / X" ] } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-036", "activity_name": "Hematology", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Hematology" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 41, "verbatim_name": "Hematology", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 30, "verbatim_name": "Hematology", "has_schedule_data": true } ], "annotations": [ { "marker": "n22", "table_number": 1, "text": "Screening visit assessment will be used to confirm eligibility. If calcitonin results are not available, a final review of eligibility will occur at Visit 3 before randomization can proceed.", "columns": [ "1 / -2 / X" ] } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-037", "activity_name": "HbA1c", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "HbA1c" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 42, "verbatim_name": "HbA1c", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 31, "verbatim_name": "HbA1c", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-038", "activity_name": "Pancreatic amylase, lipase", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Pancreatic amylase, lipase" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 43, "verbatim_name": "Pancreatic amylase, lipase", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 32, "verbatim_name": "Pancreatic amylase, lipase", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-039", "activity_name": "Thyroid-stimulating hormone", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Thyroid-stimulating hormone" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 44, "verbatim_name": "Thyroid-stimulating hormone", "has_schedule_data": true } ], "annotations": [ { "marker": "n22", "table_number": 1, "text": "Screening visit assessment will be used to confirm eligibility. If calcitonin results are not available, a final review of eligibility will occur at Visit 3 before randomization can proceed.", "columns": [ "1 / -2 / X" ] } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-040", "activity_name": "Immunogenicity (includes PK sample)", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Immunogenicity (includes PK sample)" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 45, "verbatim_name": "Immunogenicity (includes PK sample)", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 33, "verbatim_name": "Immunogenicity (includes PK sample)", "has_schedule_data": true } ], "annotations": [ { "marker": "n24", "table_number": 1, "text": "PK samples for immunogenicity must be taken prior to drug administration at these visits. In the event of systemic drug hypersensitivity reactions (immediate or nonimmediate), additional blood samples will be collected including ADA, PK, and exploratory biomarker samples." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-041", "activity_name": "TZP PK", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "TZP PK" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 46, "verbatim_name": "TZP PK", "has_schedule_data": true } ], "annotations": [ { "marker": "n25", "table_number": 1, "text": "PK samples will be collected at these visits at time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post dose, as assigned by IWRS at randomization. Dependent on the time windows to which a participant is assigned, they may be required to come to site for PK-specific visits." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-042", "activity_name": "Pharmacogenetic stored sample", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Pharmacogenetic stored sample" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 47, "verbatim_name": "Pharmacogenetic stored sample", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-043", "activity_name": "Nonpharmacogenetic stored sample", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Nonpharmacogenetic stored sample" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 48, "verbatim_name": "Nonpharmacogenetic stored sample", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 34, "verbatim_name": "Nonpharmacogenetic stored sample", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-044", "activity_name": "Mental Health Questionnaires", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": false, "variants": [ "Mental Health Questionnaires" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 49, "verbatim_name": "Mental Health Questionnaires", "has_schedule_data": false }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 35, "verbatim_name": "Mental Health Questionnaires", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-045", "activity_name": "PHQ-9", "parent_name": "Mental Health Questionnaires", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "PHQ-9" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 50, "verbatim_name": "PHQ-9", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 36, "verbatim_name": "PHQ-9", "has_schedule_data": true } ], "annotations": [ { "marker": "n26", "table_number": 1, "text": "The C-SSRS, Self-Harm Supplement Form and PHQ-9 should be administered after assessment of adverse events. For this study, the C-SSRS is adapted for the assessment of the ideation and behavior categories only. The Intensity of Ideation and Lethality of Behavior sections are removed." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-046", "activity_name": "C-SSRS (Baseline/Screening) Version)", "parent_name": "Mental Health Questionnaires", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "C-SSRS (Baseline/Screening) Version)" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 51, "verbatim_name": "C-SSRS (Baseline/Screening) Version)", "has_schedule_data": true } ], "annotations": [ { "marker": "n26", "table_number": 1, "text": "The C-SSRS, Self-Harm Supplement Form and PHQ-9 should be administered after assessment of adverse events. For this study, the C-SSRS is adapted for the assessment of the ideation and behavior categories only. The Intensity of Ideation and Lethality of Behavior sections are removed." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-047", "activity_name": "C-SSRS (Since Last Visit Version)", "parent_name": "Mental Health Questionnaires", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "C-SSRS (Since Last Visit Version)" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 52, "verbatim_name": "C-SSRS (Since Last Visit Version)", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 37, "verbatim_name": "C-SSRS (Since Last Visit Version)", "has_schedule_data": true } ], "annotations": [ { "marker": "n26", "table_number": 1, "text": "The C-SSRS, Self-Harm Supplement Form and PHQ-9 should be administered after assessment of adverse events. For this study, the C-SSRS is adapted for the assessment of the ideation and behavior categories only. The Intensity of Ideation and Lethality of Behavior sections are removed." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-048", "activity_name": "Self-Harm Supplement Form", "parent_name": "Mental Health Questionnaires", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Self-Harm Supplement Form" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 53, "verbatim_name": "Self-Harm Supplement Form", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 38, "verbatim_name": "Self-Harm Supplement Form", "has_schedule_data": true } ], "annotations": [ { "marker": "n26", "table_number": 1, "text": "The C-SSRS, Self-Harm Supplement Form and PHQ-9 should be administered after assessment of adverse events. For this study, the C-SSRS is adapted for the assessment of the ideation and behavior categories only. The Intensity of Ideation and Lethality of Behavior sections are removed." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-049", "activity_name": "Self-Harm Follow-up Form", "parent_name": "Mental Health Questionnaires", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Self-Harm Follow-up Form" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 54, "verbatim_name": "Self-Harm Follow-up Form", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 39, "verbatim_name": "Self-Harm Follow-up Form", "has_schedule_data": true } ], "annotations": [ { "marker": "n27", "table_number": 1, "text": "Self-Harm Follow-up Form is only required if triggered by the Self-Harm Supplement Form, per instructions in the form." } ] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-050", "activity_name": "Patient Reported Outcomes", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Patient Reported Outcomes" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 55, "verbatim_name": "Patient Reported Outcomes", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-051", "activity_name": "PGIS", "parent_name": "Patient Reported Outcomes", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "PGIS" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 56, "verbatim_name": "PGIS", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 41, "verbatim_name": "PGIS", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-052", "activity_name": "SF-36, version 2, acute form", "parent_name": "Patient Reported Outcomes / PROs", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_cross_parent", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "SF-36, version 2, acute form", "SF-36, version 2 acute" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 57, "verbatim_name": "SF-36, version 2, acute form", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 42, "verbatim_name": "SF-36, version 2 acute", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-053", "activity_name": "IWQOL-Lite CT", "parent_name": "Patient Reported Outcomes / PROs", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_cross_parent", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "IWQOL-Lite CT", "IWQOL-Lite -CT" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 58, "verbatim_name": "IWQOL-Lite CT", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 43, "verbatim_name": "IWQOL-Lite -CT", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-054", "activity_name": "EQ-5D-5L", "parent_name": "Patient Reported Outcomes", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "EQ-5D-5L" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities covering visits to primary study endpoint", "table_type": "main_soa", "track_label": null, "row_position": 59, "verbatim_name": "EQ-5D-5L", "has_schedule_data": true }, { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 44, "verbatim_name": "EQ-5D-5L", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04184622", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04184622_Diabetes", "therapeutic_area": "Diabetes", "xact_id": "xact-055", "activity_name": "PROs", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": false, "variants": [ "PROs" ], "occurrences": [ { "table_number": 2, "table_title": "Schedule of Activities for additional 2-year treatment period for participants with prediabetes at randomization", "table_type": "track", "track_label": "Prediabetes", "row_position": 40, "verbatim_name": "PROs", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-001", "activity_name": "Informed consent", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed consent" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Informed consent", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-002", "activity_name": "Inclusion/exclusion criteria", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Inclusion/exclusion criteria" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Inclusion/exclusion criteria", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-003", "activity_name": "Demographic data", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Demographic data" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Demographic data", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-004", "activity_name": "Randomization", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Randomization" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Randomization", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-005", "activity_name": "Medical history", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Medical history" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Medical history", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-006", "activity_name": "Complete physical examination", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Complete physical examination" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Complete physical examination", "has_schedule_data": true } ], "annotations": [ { "marker": "c", "table_number": 1, "text": "A complete physical examination, performed at screening and per the investigator’s discretion during the study, includes an evaluation of the head, eyes, ears, nose, and throat, and the cardiovascular, dermatologic, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurologic systems. Any abnormality identified at screening should be recorded on the General Medical History and Baseline Conditions eCRF. New or worsened clinically significant abnormalities identified during the study should be reported as adverse events." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-007", "activity_name": "Weight", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Weight" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Weight", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-008", "activity_name": "COVID-19 diagnosis", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "COVID-19 diagnosis" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "COVID-19 diagnosis", "has_schedule_data": true } ], "annotations": [ { "marker": "d", "table_number": 1, "text": "COVID-19 test (SARS-CoV2 PCR) to confirm diagnosis should be performed within 7 days of randomization." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-009", "activity_name": "Chest X-ray/CT scan", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Chest X-ray/CT scan" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Chest X-ray/CT scan", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 3, "verbatim_name": "Chest X-ray/CT scan", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 3, "verbatim_name": "Chest X-ray/CT scan", "has_schedule_data": true } ], "annotations": [ { "marker": "e", "table_number": 1, "text": "Screening chest X-ray or CT scans should be performed within 48 hours prior to randomization. If additional chest X-rays/CT scans are taken per local practice during the study, this information should be provided in the eCRF." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-010", "activity_name": "ECG", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "ECG" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "ECG", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-011", "activity_name": "Pregnancy test", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Pregnancy test" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Pregnancy test", "has_schedule_data": true } ], "annotations": [ { "marker": "f", "table_number": 1, "text": "For women of childbearing potential, including those who have had a tubal ligation, positive urine test results will be confirmed with a serum pregnancy test. Study drug infusion must not be administered unless the serum pregnancy test result is negative." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-012", "activity_name": "PaO2/FiO2", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "PaO2/FiO2" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "PaO2/FiO2", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "PaO2/FiO2", "has_schedule_data": true } ], "annotations": [ { "marker": "g", "table_number": 1, "text": "If arterial blood gases are measured." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-013", "activity_name": "SpO2", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "SpO2" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "SpO2", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "SpO2", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "SpO2", "has_schedule_data": true } ], "annotations": [ { "marker": "h", "table_number": 1, "text": "All vital sign measurements (i.e., respiratory rate, pulse rate, systolic and diastolic blood pressures, and body temperature), oxygen saturation and NEWS2-specific assessments (i.e., consciousness and presence or absence of oxygen support) should be recorded together twice daily with approximately 12 hours in between while the patient remains hospitalized. If measured more than once during a 12-hour period, the worst values (highest temperature, respiratory rate, and heart rate; lowest blood pressure, oxygen saturation, and consciousness level) during that period should be recorded on the eCRF." }, { "marker": "b", "table_number": 2, "text": "All vital sign measurements (i.e., respiratory rate, pulse rate, systolic and diastolic blood pressures, and body temperature), oxygen saturation and NEWS2-specific assessments (i.e., consciousness and presence or absence of oxygen support) should be recorded together twice daily with approximately 12 hours in between while the patient remains hospitalized. If measured more than once during a 12-hour period, the worst values (highest temperature, respiratory rate, and heart rate; lowest blood pressure, oxygen saturation, and consciousness level) during that period should be recorded on the eCRF. Following hospital discharge these parameters should be recorded once at each return visit to the clinic. Vital signs and oxygen saturation will not be recorded if follow-up visits are conducted by telephone." }, { "marker": "c", "table_number": 3, "text": "For patients who remain in hospital, vital sign measurements and NEWS2-specific assessments should be conducted twice daily. Following hospital discharge, these parameters should be recorded once at each return visit to the clinic. Vital signs and oxygen saturation will not be recorded if follow-up visits are conducted by telephone." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-014", "activity_name": "Vital signs", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Vital signs" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Vital signs", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Vital signs", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Vital signs", "has_schedule_data": true } ], "annotations": [ { "marker": "h", "table_number": 1, "text": "All vital sign measurements (i.e., respiratory rate, pulse rate, systolic and diastolic blood pressures, and body temperature), oxygen saturation and NEWS2-specific assessments (i.e., consciousness and presence or absence of oxygen support) should be recorded together twice daily with approximately 12 hours in between while the patient remains hospitalized. If measured more than once during a 12-hour period, the worst values (highest temperature, respiratory rate, and heart rate; lowest blood pressure, oxygen saturation, and consciousness level) during that period should be recorded on the eCRF." }, { "marker": "b", "table_number": 2, "text": "All vital sign measurements (i.e., respiratory rate, pulse rate, systolic and diastolic blood pressures, and body temperature), oxygen saturation and NEWS2-specific assessments (i.e., consciousness and presence or absence of oxygen support) should be recorded together twice daily with approximately 12 hours in between while the patient remains hospitalized. If measured more than once during a 12-hour period, the worst values (highest temperature, respiratory rate, and heart rate; lowest blood pressure, oxygen saturation, and consciousness level) during that period should be recorded on the eCRF. Following hospital discharge these parameters should be recorded once at each return visit to the clinic. Vital signs and oxygen saturation will not be recorded if follow-up visits are conducted by telephone." }, { "marker": "c", "table_number": 3, "text": "For patients who remain in hospital, vital sign measurements and NEWS2-specific assessments should be conducted twice daily. Following hospital discharge, these parameters should be recorded once at each return visit to the clinic. Vital signs and oxygen saturation will not be recorded if follow-up visits are conducted by telephone." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-015", "activity_name": "Ordinal scoring", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Ordinal scoring" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Ordinal scoring", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Ordinal scoring", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Ordinal scoring", "has_schedule_data": true } ], "annotations": [ { "marker": "i", "table_number": 1, "text": "Assessment of clinical status using the ordinal scale should be recorded at baseline on Day 1/Visit 1 then again daily every morning (between 8 am and 12 pm) for patients who remain hospitalized." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-016", "activity_name": "Adverse events", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Adverse events" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Adverse events", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Adverse events", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Adverse events", "has_schedule_data": true } ], "annotations": [ { "marker": "j", "table_number": 1, "text": "After informed consent has been obtained but prior to initiation of study drug, only serious adverse events caused by a protocol-mandated intervention should be reported. After initiation of study drug, all adverse events will be reported until 60 days after the final dose of study drug. After this period, the Sponsor should be notified if the investigator becomes aware of any serious adverse event that is believed to be related to prior study drug treatment (see Section 5.6).", "document_references": [ { "kind": "section", "target": "5.6" } ] } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-017", "activity_name": "Concomitant medications", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Concomitant medications" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Concomitant medications", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Concomitant medications", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Concomitant medications", "has_schedule_data": true } ], "annotations": [ { "marker": "k", "table_number": 1, "text": "Medication (e.g., prescription drugs, over-the-counter drugs, vaccines, herbal or homeopathic remedies, nutritional supplements) used by a patient in addition to protocol-mandated treatment from 7 days prior to initiation of study drug to the study completion/discontinuation visit." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-018", "activity_name": "Hematology", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Hematology" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Hematology", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Hematology", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Hematology", "has_schedule_data": true } ], "annotations": [ { "marker": "l", "table_number": 1, "text": "Hematology includes WBC count, RBC count, hemoglobin, hematocrit, platelet count, differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes), and lymphocyte subsets (T cells, B cells, and NK cells; if the test is available at the site)." }, { "marker": "g", "table_number": 3, "text": "Hematology includes WBC count, RBC count, hemoglobin, hematocrit, platelet count, differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes), and lymphocyte subsets (T cells, B cells, and NK cells). Hematology labs will not be performed if follow-up visits are conducted by telephone." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-019", "activity_name": "Chemistry", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Chemistry" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "Chemistry", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Chemistry", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Chemistry", "has_schedule_data": true } ], "annotations": [ { "marker": "m", "table_number": 1, "text": "Chemistry panel (serum or plasma) includes bicarbonate or total carbon dioxide (if considered standard of care for the region), sodium, potassium, chloride, glucose, BUN or urea, creatinine, total protein, albumin, phosphorus, calcium, total bilirubin, ALP, ALT, and/or AST, uric acid, LDH, ferritin, and D-dimer." }, { "marker": "h", "table_number": 3, "text": "Chemistry panel (serum or plasma) includes bicarbonate or total carbon dioxide (if considered standard of care for the region), sodium, potassium, chloride, glucose, BUN or urea, creatinine, total protein, albumin, phosphorus, calcium, total bilirubin, ALP, ALT, and/or AST, uric acid, LDH, ferritin, and D-dimer. Chemistry labs will not be performed if follow-up visits are conducted by telephone." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-020", "activity_name": "Study drug administration", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Study drug administration" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 23, "verbatim_name": "Study drug administration", "has_schedule_data": true } ], "annotations": [ { "marker": "n", "table_number": 1, "text": "Study drug should be administered after collection of all samples for pharmacodynamic and exploratory biomarker analyses. The initial study drug infusion should be given within 4 hours of randomization. If the clinical signs or symptoms worsen or do not improve (reflected by sustained fever or at least a one-category worsening on the 7-category ordinal scale of clinical status), one additional infusion of blinded treatment of TCZ or placebo can be given, 8–24 hours after the initial infusion." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-021", "activity_name": "Central Labs", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": false, "variants": [ "Central Labs" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "Central Labs", "has_schedule_data": false }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Central Labs", "has_schedule_data": false }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Central Labs", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-022", "activity_name": "Serum PD (CRP, IL-6, sIL-6R)", "parent_name": "Central Labs", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Serum PD (CRP, IL-6, sIL-6R)" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 25, "verbatim_name": "Serum PD (CRP, IL-6, sIL-6R)", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Serum PD (CRP, IL-6, sIL-6R)", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Serum PD (CRP, IL-6, sIL-6R)", "has_schedule_data": true } ], "annotations": [ { "marker": "o", "table_number": 1, "text": "On Day 1, CRP, IL-6, and sIL-6R samples should be drawn 0–4 hours before the start of infusion and then within 15 minutes (to 1 hour) after the end of the infusion, on the opposite arm as the infusion. Patents receiving a second infusion of study drug should provide extra samples for CRP, IL-6, and sIL-6R prior to and 15 minutes after the end of the infusion, on the opposite arm as the infusion.", "columns": [ "Baseline / 1 / 0 Pre-dose (−4 hrs)", "1 / 15 min After end of infusion (+1 hr)" ] } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-023", "activity_name": "Serum PK", "parent_name": "Central Labs", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Serum PK" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 26, "verbatim_name": "Serum PK", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Serum PK", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Serum PK", "has_schedule_data": true } ], "annotations": [ { "marker": "p", "table_number": 1, "text": "Patents receiving a second infusion of study drug should provide an extra PK sample prior to and 15 minutes (to 1 hour) after the end of the infusion, on the opposite arm as the infusion." }, { "marker": "q", "table_number": 1, "text": "On Day 1, PK samples should be drawn 0–4 hours before the start of infusion and then within 15 minutes (to 1 hour) after the end of the infusion, on the opposite arm as the infusion.", "columns": [ "Baseline / 1 / 0 Pre-dose (−4 hrs)", "1 / 15 min After end of infusion (+1 hr)" ] } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-024", "activity_name": "Serum sample for exploratory biomarkers", "parent_name": "Central Labs", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Serum sample for exploratory biomarkers" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 27, "verbatim_name": "Serum sample for exploratory biomarkers", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Serum sample for exploratory biomarkers", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Serum sample for exploratory biomarkers", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-025", "activity_name": "SARS-CoV-2 viral load", "parent_name": "Central Labs", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "SARS-CoV-2 viral load" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 28, "verbatim_name": "SARS-CoV-2 viral load", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "SARS-CoV-2 viral load", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "SARS-CoV-2 viral load", "has_schedule_data": true } ], "annotations": [ { "marker": "r", "table_number": 1, "text": "Viral load will be assessed by nasopharyngeal swab. Patients who are intubated and undergo bronchoalveolar lavage will have samples taken for virological assessment. It may only be possible to access one nostril if a patient has a nasogastric tube in place, in which case sites may collect a sample from one nostril only and where possible the same nostril should be used." }, { "marker": "b", "table_number": 3, "text": "Patients who remain in hospital will have viral load assessed by nasopharyngeal swabs; these will be done if there is evidence of on-going infection." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-026", "activity_name": "Serum SARS-CoV-2 antibody titer", "parent_name": "Central Labs", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Serum SARS-CoV-2 antibody titer", "Serum SARS-Cov-2 antibody titer" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 29, "verbatim_name": "Serum SARS-CoV-2 antibody titer", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Serum SARS-CoV-2 antibody titer", "has_schedule_data": true }, { "table_number": 3, "table_title": "Appendix 3 Schedule of Activities: After Day 28", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Serum SARS-Cov-2 antibody titer", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-027", "activity_name": "Cryopreserved PBMCs", "parent_name": "Central Labs", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Cryopreserved PBMCs" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 30, "verbatim_name": "Cryopreserved PBMCs", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Cryopreserved PBMCs", "has_schedule_data": true } ], "annotations": [ { "marker": "s", "table_number": 1, "text": "For sites capable of sample collection for analysis of T cells by high-dimensional cytometry." } ] }, { "protocol_id": "NCT04320615", "sponsor": "Roche", "d4k_folder": "Roche_NCT04320615_COVID", "therapeutic_area": "COVID", "xact_id": "xact-028", "activity_name": "Whole blood in PAXgene® tubes for RNA analyses", "parent_name": "Central Labs", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Whole blood in PAXgene® tubes for RNA analyses" ], "occurrences": [ { "table_number": 1, "table_title": "Appendix 1 Schedule of Activities: Days 1 and 2", "table_type": "main_soa", "track_label": null, "row_position": 31, "verbatim_name": "Whole blood in PAXgene® tubes for RNA analyses", "has_schedule_data": true }, { "table_number": 2, "table_title": "Appendix 2 Schedule of Activities: Days 3–28", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Whole blood in PAXgene® tubes for RNA analyses", "has_schedule_data": true } ], "annotations": [ { "marker": "t", "table_number": 1, "text": "The first draw of blood should not be for PAXgene® tubes to avoid contact with RNA preservation reagent inside the tube." } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-001", "activity_name": "Informed consent", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed consent" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Informed consent", "has_schedule_data": true } ], "annotations": [ { "marker": "i2", "table_number": 1, "text": "ICF must be signed before any protocol-specific procedures are performed" } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-002", "activity_name": "Inclusion/Exclusion criteria", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Inclusion/Exclusion criteria" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Inclusion/Exclusion criteria", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-003", "activity_name": "Medical history", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Medical history" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Medical history", "has_schedule_data": true } ], "annotations": [ { "marker": "i3", "table_number": 1, "text": "Including assessment of preexisting conditions, historical illnesses, and habits (such as tobacco and alcohol use)." } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-004", "activity_name": "Cancer treatment history", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Cancer treatment history" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Cancer treatment history", "has_schedule_data": true } ], "annotations": [ { "marker": "i4", "table_number": 1, "text": "Record prior anti-cancer therapy" } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-005", "activity_name": "Concomitant medication", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Concomitant medication" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Concomitant medication", "has_schedule_data": true } ], "annotations": [ { "marker": "i5", "table_number": 1, "text": "• At baseline, record prior and concurrent medications.\n• Record all premedication, supportive care, and concomitant medication continuously at every visit and throughout the study." } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-006", "activity_name": "Physical examination", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Physical examination" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Physical examination", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-007", "activity_name": "Vital signs", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Vital signs" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Vital signs", "has_schedule_data": true } ], "annotations": [ { "marker": "i6", "table_number": 1, "text": "Measure vital signs (height [at baseline], weight, temperature, blood pressure, pulse rate, and respiration rate).\nOn days with concurrent ECGs, vital signs, and/or PK sampling, these measurements should occur at approximately the same time.\nVital sign measurements will be obtained:\n• Day 1 at predose (prior to SC ramucirumab dose, but within 90 minutes prior to predose blood draw)\n• C1D2 (24 hours postdose)\n• C1D8\n• C1D15\n• Any time for other specified visits, but prior to SC ramucirumab dose at same visit." } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-008", "activity_name": "AE collection", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "AE collection", "AE Collection" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "AE collection", "has_schedule_data": true }, { "table_number": 2, "table_title": "Continued Access Schedule of Activities", "table_type": "track", "track_label": "Continued Access", "row_position": 5, "verbatim_name": "AE Collection", "has_schedule_data": true } ], "annotations": [ { "marker": "i7", "table_number": 1, "text": "• Collect continuously at every visit and throughout the study.\n• CTCAE Version 5.0\n• See Section 10.3 for AE grading for lab investigations.", "document_references": [ { "kind": "section", "target": "10.3" } ] }, { "marker": "i1", "table_number": 2, "text": "Grading via CTCAE, Version 5.0. As part of AE collection, monitor vital signs and perform standard laboratory tests (hematology, chemistry, urinalysis, and pregnancy testing) at the same frequency as during the study treatment period. See Section 10.3 for AE grading for lab investigations. All laboratory tests during the continued access period will be performed in the local laboratories only.", "document_references": [ { "kind": "section", "target": "10.3" } ] } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-009", "activity_name": "ECOG PS", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "ECOG PS" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "ECOG PS", "has_schedule_data": true } ], "annotations": [ { "marker": "i8", "table_number": 1, "text": "During study treatment, perform ≤3 days prior to treatment." } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-010", "activity_name": "ECG", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "ECG" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "ECG", "has_schedule_data": true } ], "annotations": [ { "marker": "i9", "table_number": 1, "text": "Single, local.\nOn days with concurrent measurements, see vital sign row for more details. Times are referenced to the end of dosing.\nECGs will be obtained:\n• C1D1 at predose.\n• Every 6 weeks thereafter, predose.\n• Any other time as clinically indicated." } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-011", "activity_name": "Hematology", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Hematology" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Hematology", "has_schedule_data": true } ], "annotations": [ { "marker": "i10", "table_number": 1, "text": "See Appendix 2.", "document_references": [ { "kind": "appendix", "target": "2" } ] } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-012", "activity_name": "Coagulation", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Coagulation" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Coagulation", "has_schedule_data": true } ], "annotations": [ { "marker": "i11", "table_number": 1, "text": "See Appendix 2. Perform at baseline, C2D1, D1 of every other cycle afterwards (C4D1, C6D1, etc.), and as clinically indicated.", "document_references": [ { "kind": "appendix", "target": "2" } ] } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-013", "activity_name": "Clinical chemistry", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Clinical chemistry" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Clinical chemistry", "has_schedule_data": true } ], "annotations": [ { "marker": "i10", "table_number": 1, "text": "See Appendix 2.", "document_references": [ { "kind": "appendix", "target": "2" } ] } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-014", "activity_name": "Urinalysis", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Urinalysis" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Urinalysis", "has_schedule_data": true } ], "annotations": [ { "marker": "i12", "table_number": 1, "text": "See Appendix 2. In addition, perform as clinically indicated.", "document_references": [ { "kind": "appendix", "target": "2" } ] } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-015", "activity_name": "Pregnancy test", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Pregnancy test" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "Pregnancy test", "has_schedule_data": true } ], "annotations": [ { "marker": "i13", "table_number": 1, "text": "• Applies only to women of childbearing potential.\n• Note: During study treatment, perform monthly or as required per local regulations and/or institutional guidelines.\nSee Appendix 2.", "document_references": [ { "kind": "appendix", "target": "2" } ] } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-016", "activity_name": "Thyroid panel", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Thyroid panel" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 23, "verbatim_name": "Thyroid panel", "has_schedule_data": true } ], "annotations": [ { "marker": "i14", "table_number": 1, "text": "See Appendix 2. Starting C1D1, then every 3 months thereafter.", "document_references": [ { "kind": "appendix", "target": "2" } ] } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-017", "activity_name": "Radiologic imaging and measurement of palpable or visible lesions", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Radiologic imaging and measurement of palpable or visible lesions" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "Radiologic imaging and measurement of palpable or visible lesions", "has_schedule_data": true } ], "annotations": [ { "marker": "i15", "table_number": 1, "text": "• Perform according to RECIST 1.1, by the same method used at baseline, every 8 weeks (±7 days) for the first 6 months after C1D1 and every 12 weeks (±7 days) thereafter until radiographic disease progression, death, or study completion, whichever occurs first.\nPerform as scheduled, even if study treatment is delayed or omitted." } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-018", "activity_name": "Injection site assessments (solicited)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Injection site assessments (solicited)" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 25, "verbatim_name": "Injection site assessments (solicited)", "has_schedule_data": true } ], "annotations": [ { "marker": "i16", "table_number": 1, "text": "Prior to each injection and at the designated timepoints, the investigator/investigator designee will ask the participant if they have any injection site concerns and record the participant’s response.\n1.Cycle 1 collection:\na.C1D1: 5-15 min after injection is complete and 60 min after injection is complete\nb.C1D2 (approximately 24 hr after injection)\nc.C1D4 (± 1 day)\nd.C1D8: 5-15 min after injection and 60 min after injection\ne.C1D15: 5-15 min after injection and 60 min after injection\n2.Cycle 2-n collection:\na.5-15 min after injection and 60 min after injection\nThe findings from the assessment are recorded on the ISR questionnaire. All positive responses of pain require an additional assessment using the participant-completed Pain VAS. If there are ≥2 injections, the ISR questionnaire will be filled out separately for each site, after all injections have been administered. See Section 8.2.5 for details.", "document_references": [ { "kind": "section", "target": "8.2.5" } ] } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-019", "activity_name": "Injection site assessments (spontaneous)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Injection site assessments (spontaneous)" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 26, "verbatim_name": "Injection site assessments (spontaneous)", "has_schedule_data": true } ], "annotations": [ { "marker": "i17", "table_number": 1, "text": "1. ISR questionnaire completed outside of solicited assessment schedule.\n2. May be triggered by participant anytime during the cycle based on diary.\n3. If the participant indicates presence of pain during spontaneous ISR reporting, no VAS assessment is required." } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-020", "activity_name": "Participant diary", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Participant diary" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 27, "verbatim_name": "Participant diary", "has_schedule_data": true } ], "annotations": [ { "marker": "i18", "table_number": 1, "text": "• Participant will assess injection site(s) daily. If any ISR symptoms present, the participant should contact the investigator.\n• Diary should be returned to the investigator at each weekly visit." } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-021", "activity_name": "Sample collection", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Sample collection" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 28, "verbatim_name": "Sample collection", "has_schedule_data": false } ], "annotations": [ { "marker": "i19", "table_number": 1, "text": "See Section 1.3.1 for PK and IG.", "document_references": [ { "kind": "section", "target": "1.3.1" } ] } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-022", "activity_name": "PK", "parent_name": "Sample collection", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "PK" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 29, "verbatim_name": "PK", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-023", "activity_name": "IG", "parent_name": "Sample collection", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "IG" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 30, "verbatim_name": "IG", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-024", "activity_name": "Administer ramucirumab", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Administer ramucirumab" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 31, "verbatim_name": "Administer ramucirumab", "has_schedule_data": true }, { "table_number": 2, "table_title": "Continued Access Schedule of Activities", "table_type": "track", "track_label": "Continued Access", "row_position": 7, "verbatim_name": "Administer ramucirumab", "has_schedule_data": true } ], "annotations": [ { "marker": "i20", "table_number": 1, "text": "See Section 6.1. Participants must be closely monitored for a 1-hour observation period following the administration of SC ramucirumab (see Section 6.1).", "document_references": [ { "kind": "section", "target": "6.1" } ] }, { "marker": "i3", "table_number": 2, "text": "See Section 6.1. Participants must be closely monitored for a 1-hour observation period following the ramucirumab injection (see Section 6.1).", "document_references": [ { "kind": "section", "target": "6.1" } ] } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-025", "activity_name": "Administer combination medications, if applicable (Cohorts B and C only)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Administer combination medications, if applicable (Cohorts B and C only)" ], "occurrences": [ { "table_number": 1, "table_title": "Screening, On-Study, and Post-Treatment Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 32, "verbatim_name": "Administer combination medications, if applicable (Cohorts B and C only)", "has_schedule_data": true } ], "annotations": [ { "marker": "i21", "table_number": 1, "text": "Begin Combination anti-cancer therapies along with weekly SC ramucirumab at Cycle-2. See details in Section 6.1. Erlotinib (1L EGFR+ NSCLC), docetaxel (2L NSCLC), paclitaxel (2L gastric), FOLFIRI (2L CRC).", "document_references": [ { "kind": "section", "target": "6.1" } ] } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-026", "activity_name": "PK, IG, and exploratory hypersensitivity", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": false, "variants": [ "PK, IG, and exploratory hypersensitivity" ], "occurrences": [ { "table_number": 2, "table_title": "Continued Access Schedule of Activities", "table_type": "track", "track_label": "Continued Access", "row_position": 6, "verbatim_name": "PK, IG, and exploratory hypersensitivity", "has_schedule_data": false } ], "annotations": [ { "marker": "i2", "table_number": 2, "text": "In the event of hypersensitivity, blood samples will be collected for PK, IG, and exploratory hypersensitivity analyses at the following time points, as close as possible to: (i) the onset of the hypersensitivity, (ii) the resolution of the hypersensitivity, and (iii) 30 (±3) days following the hypersensitivity." } ] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-027", "activity_name": "Sample 1", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Sample 1" ], "occurrences": [ { "table_number": 3, "table_title": "Pharmacokinetic Sampling Schedule", "table_type": "subsidiary", "track_label": null, "row_position": 2, "verbatim_name": "Sample 1", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-028", "activity_name": "Sample 2", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Sample 2" ], "occurrences": [ { "table_number": 3, "table_title": "Pharmacokinetic Sampling Schedule", "table_type": "subsidiary", "track_label": null, "row_position": 3, "verbatim_name": "Sample 2", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-029", "activity_name": "Sample 3", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Sample 3" ], "occurrences": [ { "table_number": 3, "table_title": "Pharmacokinetic Sampling Schedule", "table_type": "subsidiary", "track_label": null, "row_position": 4, "verbatim_name": "Sample 3", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-030", "activity_name": "Sample 4", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Sample 4" ], "occurrences": [ { "table_number": 3, "table_title": "Pharmacokinetic Sampling Schedule", "table_type": "subsidiary", "track_label": null, "row_position": 5, "verbatim_name": "Sample 4", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04557384", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04557384_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-031", "activity_name": "Sample 5", "parent_name": "", "hierarchy_level": 0, 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Race and ethnicity will be collected where permitted by local regulations." } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-014", "activity_name": "WD history", "parent_name": "Study Administration", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "WD history" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "WD history", "has_schedule_data": true } ], "annotations": [ { "marker": "j", "table_number": 1, "text": "Wilson disease history will include diagnosis date, method of diagnosis, history of cirrhosis, details of any previous liver biopsies performed, and treatment received." } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-015", "activity_name": "Prior WD treatment", "parent_name": "Study Administration", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Prior WD treatment" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Prior WD treatment", "has_schedule_data": true } ], "annotations": [ { "marker": "j", "table_number": 1, "text": "Wilson disease history will include diagnosis date, method of diagnosis, history of cirrhosis, details of any previous liver biopsies performed, and treatment received." } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-016", "activity_name": "Physical examination", "parent_name": "Study Administration", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Physical examination" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Physical examination", "has_schedule_data": true } ], "annotations": [ { "marker": "k", "table_number": 1, "text": "A full physical examination will be performed at Screening, at check-in for the study, and at the End of the study/Early Termination Visit. A physical examination should also be performed on any participants with ongoing adverse events prior to discharge from the unit. Otherwise, a symptom-driven physical examination may be performed at other times, at the Principal Investigator’s discretion." } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-017", "activity_name": "Height, weight, and BMI", "parent_name": "Study Administration", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Height, weight, and BMI" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Height, weight, and BMI", "has_schedule_data": true } ], "annotations": [ { "marker": "l", "table_number": 1, "text": "Height at screening only." } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-018", "activity_name": "Enrollment", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Enrollment" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Enrollment", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-019", "activity_name": "Enrollment/inclusion", "parent_name": "Enrollment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Enrollment/inclusion" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "Enrollment/inclusion", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-020", "activity_name": "Discontinue chelation therapy", "parent_name": "Enrollment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Discontinue chelation therapy" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 23, "verbatim_name": "Discontinue chelation therapy", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-021", "activity_name": "Discontinue zinc therapy", "parent_name": "Enrollment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Discontinue zinc therapy" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "Discontinue zinc therapy", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-022", "activity_name": "Administration of Study Intervention", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Administration of Study Intervention" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 25, "verbatim_name": "Administration of Study Intervention", "has_schedule_data": false } ], "annotations": [ { "marker": "m", "table_number": 1, "text": "While in the CRU, study intervention will be administered after an overnight fast (ie, at least 10 hours) at the same time every morning; drug is to be administered with 240 mL of water and meals should be delayed a minimum of 2 hours after dosing. As an outpatient, participants are expected to take ALXN1840 at approximately the same time daily (+/-1 hour). Participants should take the medication with a glass of water on an empty stomach; meals should be delayed a minimum of 2 hours after dosing." } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-023", "activity_name": "ALXN1840 15 mg/day", "parent_name": "Administration of Study Intervention", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "ALXN1840 15 mg/day" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 26, "verbatim_name": "ALXN1840 15 mg/day", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-024", "activity_name": "ALXN1840 30 mg/day", "parent_name": "Administration of Study Intervention", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "ALXN1840 30 mg/day" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 27, "verbatim_name": "ALXN1840 30 mg/day", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-025", "activity_name": "Study intervention compliance", "parent_name": "Administration of Study Intervention", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Study intervention compliance" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 28, "verbatim_name": "Study intervention compliance", "has_schedule_data": true } ], "annotations": [ { "marker": "n", "table_number": 1, "text": "During the outpatient period, participants will use SMS text messaging to confirm study intervention administration.", "columns": [ "OP / 10-22" ] } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-026", "activity_name": "PK/PD Analyses", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "PK/PD Analyses" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 29, "verbatim_name": "PK/PD Analyses", "has_schedule_data": false } ], "annotations": [ { "marker": "o", "table_number": 1, "text": "Blood sampling for PK/PD will occur before ALXN1840 administration and represents a predose trough. See Table 2 for PK/PD sampling on Days 1, 25, 29, and 39.", "document_references": [ { "kind": "table", "target": "2" } ] } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-027", "activity_name": "Blood sampling for PK: Plasma total Mo and PUF-Mo", "parent_name": "PK/PD Analyses", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Blood sampling for PK: Plasma total Mo and PUF-Mo" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 30, "verbatim_name": "Blood sampling for PK: Plasma total Mo and PUF-Mo", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2: Schedule of Pharmacokinetic and Pharmacodynamic Assessments on Days 1, 25, 29, and 39", "table_type": "subsidiary", "track_label": null, "row_position": 2, "verbatim_name": "Blood sampling for PK: Plasma total Mo and PUF-Mo", "has_schedule_data": true } ], "annotations": [ { "marker": "p", "table_number": 1, "text": "PK/PD collection will include timepoints described in the schedule of PK/PD assessment for Days 1, 25, 29, and 39 (Table 2).", "columns": [ "Inpatient Period 1 / 1", "Inpatient Period 2 / 25", "Inpatient Period 2 / 29", "Inpatient Period 2 / 39" ], "document_references": [ { "kind": "table", "target": "2" } ] }, { "marker": "b", "table_number": 2, "text": "Hour 24 PK/PD sampling is to occur just prior to the next-day dose of ALXN1840.", "columns": [ "24" ] } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-028", "activity_name": "PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu", "parent_name": "PK/PD Analyses", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 31, "verbatim_name": "PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu", "has_schedule_data": false }, { "table_number": 2, "table_title": "Table 2: Schedule of Pharmacokinetic and Pharmacodynamic Assessments on Days 1, 25, 29, and 39", "table_type": "subsidiary", "track_label": null, "row_position": 3, "verbatim_name": "PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu", "has_schedule_data": true } ], "annotations": [ { "marker": "n1", "table_number": 1, "text": "Reviewer note, not source content: this row prints with no marks at the top of page 15. Table 2 (page 17) prints 'Blood sampling for PK: Plasma total Mo and PUF-Mo' and 'PD: Plasma total and PUF-Cu, LBC, ceruloplasmin, ceruloplasmin-bound Cu' in one cell with one set of marks, so this row is probably the continuation of the PK row above (row 30, page 14), split by the page break. Not asserted: Table 2 covers only Days 1, 25, 29 and 39, so the PD sampling days are not stated for Table 1." }, { "marker": "b", "table_number": 2, "text": "Hour 24 PK/PD sampling is to occur just prior to the next-day dose of ALXN1840.", "columns": [ "24" ] } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-029", "activity_name": "Safety Assessments / Laboratory Analyses", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Safety Assessments / Laboratory Analyses" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 32, "verbatim_name": "Safety Assessments / Laboratory Analyses", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-030", "activity_name": "Chemistry, hematology, Coagulation", "parent_name": "Safety Assessments / Laboratory Analyses", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Chemistry, hematology, Coagulation" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 33, "verbatim_name": "Chemistry, hematology, Coagulation", "has_schedule_data": true } ], "annotations": [ { "marker": "q", "table_number": 1, "text": "Samples for serum chemistry will be obtained following a fast of at least 8 hours at the Screening Visit and at check-in. In case of rechecks, and postdose serum chemistry, participants may not have fasted for 6 or 8 hours before the serum chemistry sample is taken." }, { "marker": "r", "table_number": 1, "text": "Laboratory assessment including chemistry, hematology, and coagulation parameters should be performed on Days -8, -1, 8, 23, and 28 only.", "columns": [ "Inpatient Period 1 / -4 through -1", "Inpatient Period 2 / 26-28" ] }, { "marker": "g", "table_number": 1, "text": "A single outpatient visit or phone call and safety laboratory assessment should occur between Day 14 and Day 18. A phone call may take place on a different day than the blood draw within the Day 14 through Day 18 period.", "columns": [ "OP / 10-22" ] } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-031", "activity_name": "Urinalysis", "parent_name": "Safety Assessments / Laboratory Analyses", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Urinalysis" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 34, "verbatim_name": "Urinalysis", "has_schedule_data": true } ], "annotations": [ { "marker": "g", "table_number": 1, "text": "A single outpatient visit or phone call and safety laboratory assessment should occur between Day 14 and Day 18. A phone call may take place on a different day than the blood draw within the Day 14 through Day 18 period.", "columns": [ "OP / 10-22" ] } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-032", "activity_name": "Urine/serum pregnancy test", "parent_name": "Safety Assessments / Laboratory Analyses", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Urine/serum pregnancy test" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 35, "verbatim_name": "Urine/serum pregnancy test", "has_schedule_data": true } ], "annotations": [ { "marker": "s", "table_number": 1, "text": "Menstruation check is for women only; women of childbearing potential should only be enrolled after a negative serum pregnancy test result at Screening. Additional urine pregnancy testing will be standard for the protocol unless serum testing is required by site policies, local regulation, or Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) (Section 10.2). In addition to pregnancy tests detailed at the visits in the SoA, females of childbearing potential will be required to perform urine pregnancy tests at least every 4 weeks at their home or the study site throughout their time in the study.", "document_references": [ { "kind": "section", "target": "10.2" } ] } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-033", "activity_name": "Retained serum sample (safety)", "parent_name": "Safety Assessments / Laboratory Analyses", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Retained serum sample (safety)" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 36, "verbatim_name": "Retained serum sample (safety)", "has_schedule_data": true } ], "annotations": [ { "marker": "t", "table_number": 1, "text": "A single 15 mL serum sample will be retained for evaluation in the event of an unexpected safety finding; retained samples may be destroyed after completion of the clinical study report." } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-034", "activity_name": "Vitals sign measurements", "parent_name": "Safety Assessments / Laboratory Analyses", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Vitals sign measurements" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 37, "verbatim_name": "Vitals sign measurements", "has_schedule_data": true } ], "annotations": [ { "marker": "u", "table_number": 1, "text": "Vital signs measurements and ECGs should be performed predose, unless otherwise specified. Vitals signs include body temperature, heart rate, respiratory rate, and systolic and diastolic blood pressure." } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-035", "activity_name": "12-lead ECG (triplicate)", "parent_name": "Safety Assessments / Laboratory Analyses", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "12-lead ECG (triplicate)" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 38, "verbatim_name": "12-lead ECG (triplicate)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-036", "activity_name": "Adverse events", "parent_name": "Safety Assessments / Laboratory Analyses", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Adverse events" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 39, "verbatim_name": "Adverse events", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-037", "activity_name": "Balance assessments", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Balance assessments" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 40, "verbatim_name": "Balance assessments", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-038", "activity_name": "Cu/Mo-controlled meals", "parent_name": "Balance assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Cu/Mo-controlled meals" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 41, "verbatim_name": "Cu/Mo-controlled meals", "has_schedule_data": true } ], "annotations": [ { "marker": "v", "table_number": 1, "text": "Copper- and molybdenum-controlled diet will be initiated after registration/inclusion. Participants will remain on a copper/molybdenum controlled diet throughout both the inpatient Period 1 (Day -8 to Day 9) and inpatient Period 2 (Day 23 to Day 40); during this time participants will be strongly encouraged to complete all meals. While not in the CRU, participants will be encouraged to adhere to their usual copper-controlled diet." } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-039", "activity_name": "Light exercise regimen", "parent_name": "Balance assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Light exercise regimen" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 42, "verbatim_name": "Light exercise regimen", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-040", "activity_name": "Urination and bowel movement monitoring, menstruation check", "parent_name": "Balance assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Urination and bowel movement monitoring, menstruation check" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 43, "verbatim_name": "Urination and bowel movement monitoring, menstruation check", "has_schedule_data": true } ], "annotations": [ { "marker": "s", "table_number": 1, "text": "Menstruation check is for women only; women of childbearing potential should only be enrolled after a negative serum pregnancy test result at Screening. Additional urine pregnancy testing will be standard for the protocol unless serum testing is required by site policies, local regulation, or Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) (Section 10.2). In addition to pregnancy tests detailed at the visits in the SoA, females of childbearing potential will be required to perform urine pregnancy tests at least every 4 weeks at their home or the study site throughout their time in the study.", "document_references": [ { "kind": "section", "target": "10.2" } ] } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-041", "activity_name": "24-hour urine for Cu and Mo", "parent_name": "Balance assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "24-hour urine for Cu and Mo" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 44, "verbatim_name": "24-hour urine for Cu and Mo", "has_schedule_data": true } ], "annotations": [ { "marker": "w", "table_number": 1, "text": "For each input/output balance period, 24-hour urine samples are to be collected for measurement of copper and molybdenum." } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-042", "activity_name": "Feces for Cu and Mo", "parent_name": "Balance assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Feces for Cu and Mo" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 45, "verbatim_name": "Feces for Cu and Mo", "has_schedule_data": true } ], "annotations": [ { "marker": "x", "table_number": 1, "text": "For fecal samples, each individual sample will be independently collected with record of date, time, and weight of the sample." } ] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-043", "activity_name": "Other", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Other" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 46, "verbatim_name": "Other", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04573309", "sponsor": "Alexion", "d4k_folder": "Alexion_NCT04573309_Wilsons", "therapeutic_area": "Wilsons", "xact_id": "xact-044", "activity_name": "Concomitant medication and non-pharmacologic therapy/procedure", "parent_name": "Other", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Concomitant medication and non-pharmacologic therapy/procedure" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1: Schedule of Activities", "table_type": "main_soa", "track_label": null, "row_position": 47, "verbatim_name": "Concomitant medication and non-pharmacologic therapy/procedure", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-001", "activity_name": "Informed consent", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed consent" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Informed consent", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-002", "activity_name": "Site staff explains, participant reports remission/normal stool frequency", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Site staff explains, participant reports remission/normal stool frequency" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. 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Errors in the response cannot be corrected after the participant saves and confirms the response." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-003", "activity_name": "Inclusion and exclusion criteria, review and confirm", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Inclusion and exclusion criteria, review and confirm" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. 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Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Demographics", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-005", "activity_name": "Preexisting conditions and medical history", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Preexisting conditions and medical history" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Preexisting conditions and medical history", "has_schedule_data": true } ], "annotations": [ { "marker": "c2", "table_number": 1, "text": "Includes relevant surgical history." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-006", "activity_name": "Prespecified medical history", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Prespecified medical history" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Prespecified medical history", "has_schedule_data": true } ], "annotations": [ { "marker": "c3", "table_number": 1, "text": "Indication and history of interest." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-007", "activity_name": "Prior treatments for indication", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Prior treatments for indication" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Prior treatments for indication", "has_schedule_data": true } ], "annotations": [ { "marker": "c4", "table_number": 1, "text": "Includes all UC-specific therapies since date of diagnosis." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-008", "activity_name": "Concomitant medications", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "Concomitant medications" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Concomitant medications", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 6, "verbatim_name": "Concomitant medications", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 6, "verbatim_name": "Concomitant medications", "has_schedule_data": true }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 6, "verbatim_name": "Concomitant medications", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-009", "activity_name": "Adverse events", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "Adverse events" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Adverse events", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 7, "verbatim_name": "Adverse events", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 7, "verbatim_name": "Adverse events", "has_schedule_data": true }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 7, "verbatim_name": "Adverse events", "has_schedule_data": true } ], "annotations": [ { "marker": "c5", "table_number": 1, "text": "For AESIs, additional data are collected (Section 8.3.6).", "document_references": [ { "kind": "section", "target": "8.3.6" } ] } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-010", "activity_name": "Review modified Mayo score (MMS)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "Review modified Mayo score (MMS)" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. 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Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 8, "verbatim_name": "Review modified Mayo score (MMS)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-011", "activity_name": "Tobacco use", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "Tobacco use" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. 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Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 9, "verbatim_name": "Tobacco use", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-012", "activity_name": "Alcohol and caffeine use", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Alcohol and caffeine use" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. 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Vital signs should be measured after participant has been sitting for at least 5 minutes." }, { "marker": "c15", "table_number": 4, "text": "V997: Vital signs collection is optional.", "columns": [ "V997" ] } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-017", "activity_name": "Physical examination", "parent_name": "Physical Evaluation", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Physical examination" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. 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See Section 8.2.2.", "document_references": [ { "kind": "section", "target": "8.2.2" } ] } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-018", "activity_name": "Symptom-directed physical examination, including assessment for signs and symptoms of tuberculosis (TB), including peripheral lymph nodes", "parent_name": "Physical Evaluation", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "Symptom-directed physical examination, including assessment for signs and symptoms of tuberculosis (TB), including peripheral lymph nodes" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. 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Locally performed." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-022", "activity_name": "Patient Diary (Electronic)", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": false, "variants": [ "Patient Diary (Electronic)" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 27, "verbatim_name": "Patient Diary (Electronic)", "has_schedule_data": false }, { "table_number": 2, "table_title": "Table 2. 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Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 27, "verbatim_name": "Lipid panel", "has_schedule_data": true } ], "annotations": [ { "marker": "c15", "table_number": 1, "text": "Fasting samples are preferred, but if participant is non fasting at time of collection, this is not a protocol deviation." }, { "marker": "c15", "table_number": 2, "text": "Fasting samples are preferred, but if participant is nonfasting at time of collection, this is not a protocol deviation." }, { "marker": "c7", "table_number": 4, "text": "Fasting is not required for the lipid panel at ETV.", "columns": [ "ETV" ] } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-038", "activity_name": "Urinalysis", "parent_name": "Laboratory Tests and Sample Collections", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "Urinalysis" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. 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Pregnancy testing may be performed more frequently than designated on the SoA if local laws or regulations require more frequent testing." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-041", "activity_name": "Follicle-stimulating hormone (FSH)", "parent_name": "Laboratory Tests and Sample Collections", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Follicle-stimulating hormone (FSH)" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. 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Collect additional samples at specified times relative to onset of hypersensitivity events." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-043", "activity_name": "Tuberculosis (TB) test", "parent_name": "Laboratory Tests and Sample Collections", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Tuberculosis (TB) test" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. 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A local laboratory must be qualified by local regulations." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-044", "activity_name": "Human immunodeficiency virus (HIV) screening tests", "parent_name": "Laboratory Tests and Sample Collections", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Human immunodeficiency virus (HIV) screening tests" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 49, "verbatim_name": "Human immunodeficiency virus (HIV) screening tests", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-045", "activity_name": "Hepatitis C virus (HCV) screening tests", "parent_name": "Laboratory Tests and Sample Collections", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Hepatitis C virus (HCV) screening tests" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 50, "verbatim_name": "Hepatitis C virus (HCV) screening tests", "has_schedule_data": true } ], "annotations": [ { "marker": "c20", "table_number": 1, "text": "HCV RNA will be measured to confirm positive hepatitis C virus antibody." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-046", "activity_name": "Hepatitis B virus (HBV) screening tests", "parent_name": "Laboratory Tests and Sample Collections", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Hepatitis B virus (HBV) screening tests" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 51, "verbatim_name": "Hepatitis B virus (HBV) screening tests", "has_schedule_data": true } ], "annotations": [ { "marker": "c21", "table_number": 1, "text": "Includes testing for HBsAg and anti-HBc." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-047", "activity_name": "HBV DNA", "parent_name": "Laboratory Tests and Sample Collections", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "HBV DNA" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 52, "verbatim_name": "HBV DNA", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 32, "verbatim_name": "HBV DNA", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 32, "verbatim_name": "HBV DNA", "has_schedule_data": true }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 31, "verbatim_name": "HBV DNA", "has_schedule_data": true } ], "annotations": [ { "marker": "c22", "table_number": 1, "text": "Only for participants who are positive for anti-HBc at screening." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-048", "activity_name": "Pharmacokinetic (PK) samples", "parent_name": "Laboratory Tests and Sample Collections", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "Pharmacokinetic (PK) samples" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 53, "verbatim_name": "Pharmacokinetic (PK) samples", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 33, "verbatim_name": "Pharmacokinetic (PK) samples", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 33, "verbatim_name": "Pharmacokinetic (PK) samples", "has_schedule_data": true }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 32, "verbatim_name": "Pharmacokinetic (PK) samples", "has_schedule_data": true } ], "annotations": [ { "marker": "c23", "table_number": 1, "text": "Collect samples before dosing, if dosing is scheduled. Collect additional samples at specified times relative to onset of hypersensitivity events." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-049", "activity_name": "CCI", "parent_name": "Laboratory Tests and Sample Collections", "hierarchy_level": 1, "is_section_header": false, "is_redacted": true, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "CCI" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 54, "verbatim_name": "CCI", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 37, "verbatim_name": "CCI", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 37, "verbatim_name": "CCI", "has_schedule_data": true }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 36, "verbatim_name": "CCI", "has_schedule_data": true } ], "annotations": [ { "marker": "c23", "table_number": 1, "text": "Collect samples before dosing, if dosing is scheduled. Collect additional samples at specified times relative to onset of hypersensitivity events." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-050", "activity_name": "Flow cytometry panel", "parent_name": "Laboratory Tests and Sample Collections", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "Flow cytometry panel" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 55, "verbatim_name": "Flow cytometry panel", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 35, "verbatim_name": "Flow cytometry panel", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 35, "verbatim_name": "Flow cytometry panel", "has_schedule_data": true }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 34, "verbatim_name": "Flow cytometry panel", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-051", "activity_name": "Genetics sample", "parent_name": "Laboratory Tests and Sample Collections", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "Genetics sample" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 56, "verbatim_name": "Genetics sample", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 36, "verbatim_name": "Genetics sample", "has_schedule_data": false }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 36, "verbatim_name": "Genetics sample", "has_schedule_data": false }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 35, "verbatim_name": "Genetics sample", "has_schedule_data": false } ], "annotations": [ { "marker": "c24", "table_number": 1, "text": "Blood sample for DNA pharmacogenetics can be obtained any time at or after V2." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-052", "activity_name": "CCI", "parent_name": "Laboratory Tests and Sample Collections", "hierarchy_level": 1, "is_section_header": false, "is_redacted": true, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "CCI" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 57, "verbatim_name": "CCI", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 31, "verbatim_name": "CCI", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 31, "verbatim_name": "CCI", "has_schedule_data": true }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 30, "verbatim_name": "CCI", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-053", "activity_name": "Endoscopic Procedure", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": false, "variants": [ "Endoscopic Procedure" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 58, "verbatim_name": "Endoscopic Procedure", "has_schedule_data": false }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 38, "verbatim_name": "Endoscopic Procedure", "has_schedule_data": false }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 38, "verbatim_name": "Endoscopic Procedure", "has_schedule_data": false }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 37, "verbatim_name": "Endoscopic Procedure", "has_schedule_data": false } ], "annotations": [ { "marker": "c30", "table_number": 2, "text": "Not applicable for responders during the time period of V10 through V19" } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-054", "activity_name": "Endoscopy", "parent_name": "Endoscopic Procedure", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "Endoscopy" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 59, "verbatim_name": "Endoscopy", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 39, "verbatim_name": "Endoscopy", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 39, "verbatim_name": "Endoscopy", "has_schedule_data": true }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 38, "verbatim_name": "Endoscopy", "has_schedule_data": true } ], "annotations": [ { "marker": "c25", "table_number": 1, "text": "Screening endoscopy must occur ≤14 days prior to randomization. At screening, perform only for participants who are eligible for the study by all other study entry criteria." }, { "marker": "c12", "table_number": 4, "text": "Recommended at ETV based on judgment of the investigator and after discussion with the sponsor’s medical monitor. If not performed at ETV, this will not be considered a protocol deviation.", "columns": [ "ETV" ] } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-055", "activity_name": "Colon biopsy sample collection", "parent_name": "Endoscopic Procedure", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "Colon biopsy sample collection" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 60, "verbatim_name": "Colon biopsy sample collection", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 40, "verbatim_name": "Colon biopsy sample collection", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 40, "verbatim_name": "Colon biopsy sample collection", "has_schedule_data": true }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 39, "verbatim_name": "Colon biopsy sample collection", "has_schedule_data": true } ], "annotations": [ { "marker": "c26", "table_number": 1, "text": "Performed at time of endoscopy. Instructions for collection are provided in the lab manual. Flexible sigmoidoscopy is recommended, except for protocol-specified reasons when a colonoscopy should be performed." }, { "marker": "c16", "table_number": 4, "text": "Instructions for collection are provided in the lab manual. Flexible sigmoidoscopy is recommended, except for protocol-specified reasons when a colonoscopy should be performed." }, { "marker": "c13", "table_number": 4, "text": "Recommended at ETV based on judgment of the investigator and after discussion with the sponsor’s medical monitor.", "columns": [ "ETV" ] }, { "marker": "c17", "table_number": 4, "text": "If not performed at ETV, this will not be considered a protocol deviation.", "columns": [ "ETV" ] } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-056", "activity_name": "Stool Samples", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": false, "variants": [ "Stool Samples" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 61, "verbatim_name": "Stool Samples", "has_schedule_data": false }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 41, "verbatim_name": "Stool Samples", "has_schedule_data": false }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 41, "verbatim_name": "Stool Samples", "has_schedule_data": false }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 40, "verbatim_name": "Stool Samples", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-057", "activity_name": "Stool culture", "parent_name": "Stool Samples", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Stool culture" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 62, "verbatim_name": "Stool culture", "has_schedule_data": true } ], "annotations": [ { "marker": "c27", "table_number": 1, "text": "Additional local stool testing (for example, for ova and parasites) is allowed at the investigator’s discretion." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-058", "activity_name": "C. difficile testing", "parent_name": "Stool Samples", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "C. difficile testing" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 63, "verbatim_name": "C. difficile testing", "has_schedule_data": true } ], "annotations": [ { "marker": "c28", "table_number": 1, "text": "Additional C. difficile testing is allowed throughout the study at the investigator’s discretion." } ] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-059", "activity_name": "CCI", "parent_name": "Stool Samples", "hierarchy_level": 1, "is_section_header": false, "is_redacted": true, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "CCI" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 64, "verbatim_name": "CCI", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 43, "verbatim_name": "CCI", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 43, "verbatim_name": "CCI", "has_schedule_data": true }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 42, "verbatim_name": "CCI", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-060", "activity_name": "CCI", "parent_name": "Stool Samples", "hierarchy_level": 1, "is_section_header": false, "is_redacted": true, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "CCI" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 65, "verbatim_name": "CCI", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 42, "verbatim_name": "CCI", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 42, "verbatim_name": "CCI", "has_schedule_data": true }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 41, "verbatim_name": "CCI", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-061", "activity_name": "Randomization and Dosing", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": false, "variants": [ "Randomization and Dosing" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 66, "verbatim_name": "Randomization and Dosing", "has_schedule_data": false }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 44, "verbatim_name": "Randomization and Dosing", "has_schedule_data": false }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 44, "verbatim_name": "Randomization and Dosing", "has_schedule_data": false }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 43, "verbatim_name": "Randomization and Dosing", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-062", "activity_name": "Randomization", "parent_name": "Randomization and Dosing", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Randomization" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 67, "verbatim_name": "Randomization", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04677179", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT04677179", "therapeutic_area": "Ulcerative Colitis", "xact_id": "xact-063", "activity_name": "Dosing", "parent_name": "Randomization and Dosing", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 4, "tables": [ 1, 2, 3, 4 ], "any_marks": true, "variants": [ "Dosing" ], "occurrences": [ { "table_number": 1, "table_title": "Table 1. Schedule of Activities for the Screening and Induction Treatment Periods of Study J1P-MC-KFAH", "table_type": "main_soa", "track_label": null, "row_position": 68, "verbatim_name": "Dosing", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2. Schedule of Activities for the Maintenance Treatment Period of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Responders", "row_position": 45, "verbatim_name": "Dosing", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 3. Schedule of Activities for the Extension Induction and Extension Maintenance Treatment Periods of Study J1P-MC-KFAH", "table_type": "track", "track_label": "Nonresponders", "row_position": 45, "verbatim_name": "Dosing", "has_schedule_data": true }, { "table_number": 4, "table_title": "Table 4. Schedule of Activities for Early Termination, Unscheduled Visits, and Post-Treatment Follow-Up Period", "table_type": "track", "track_label": "Early Termination / Unscheduled / Post-Treatment", "row_position": 44, "verbatim_name": "Dosing", "has_schedule_data": false } ], "annotations": [ { "marker": "c29", "table_number": 1, "text": "No dosing at V3." }, { "marker": "c29", "table_number": 2, "text": "No dosing at V29." }, { "marker": "c14", "table_number": 4, "text": "No dosing at ETV, V997, or post-treatment follow-up visits." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-001", "activity_name": "Eligibility Assessments", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Eligibility Assessments" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 2, "verbatim_name": "Eligibility Assessments", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-002", "activity_name": "Informed Consent", "parent_name": "Eligibility Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed Consent" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 3, "verbatim_name": "Informed Consent", "has_schedule_data": true } ], "annotations": [ { "marker": "n1", "table_number": 1, "text": "Register in Interactive Response Technology (IRT) system to obtain participant number. The participant or legally authorized representative should sign the informed consent prior to any study-related assessment is performed.\nStudy allows for re-enrollment of a participant that is a pre-treatment failure and was not previously treated. If re-enrolled, the participant must be re-consented and assigned a new participant number from IRT." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-003", "activity_name": "Inclusion/Exclusion Criteria", "parent_name": "Eligibility Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Inclusion/Exclusion Criteria" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Inclusion/Exclusion Criteria", "has_schedule_data": true } ], "annotations": [ { "marker": "n2", "table_number": 1, "text": "Must be confirmed prior to treatment.\nSee Sections 6.1 and 6.2.", "document_references": [ { "kind": "section", "target": "6.1" }, { "kind": "section", "target": "6.2" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-004", "activity_name": "Medical History", "parent_name": "Eligibility Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Medical History" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Medical History", "has_schedule_data": true } ], "annotations": [ { "marker": "n3", "table_number": 1, "text": "All relevant medical history including smoking history, and prior anti-cancer therapies." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-005", "activity_name": "Safety Assessments", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": false, "variants": [ "Safety Assessments" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Safety Assessments", "has_schedule_data": false }, { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 3, "verbatim_name": "Safety Assessments", "has_schedule_data": false }, { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 2, "verbatim_name": "Safety Assessments", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-006", "activity_name": "Physical Examination", "parent_name": "Safety Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Physical Examination" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Physical Examination", "has_schedule_data": true } ], "annotations": [ { "marker": "n4", "table_number": 1, "text": "Include vital signs (blood pressure, heart rate, and temperature) plus height, weight, and pulse oximetry within 14 days prior to treatment." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-007", "activity_name": "Performance Status", "parent_name": "Safety Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 3 ], "any_marks": true, "variants": [ "Performance Status" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Performance Status", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Performance Status", "has_schedule_data": true } ], "annotations": [ { "marker": "n5", "table_number": 1, "text": "Within 14 days prior to treatment, collect Lansky play score for ≤ 16 years or Karnofsky performance score for > 16 years of age (Appendix 7).", "document_references": [ { "kind": "appendix", "target": "7" } ] }, { "marker": "n2", "table_number": 3, "text": "Lansky play score for ≤ 16 years or Karnofsky performance score for > 16 years of age (Appendix 7).", "document_references": [ { "kind": "appendix", "target": "7" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-008", "activity_name": "Prior and Concomitant Medication Use", "parent_name": "Safety Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Prior and Concomitant Medication Use" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Prior and Concomitant Medication Use", "has_schedule_data": true } ], "annotations": [ { "marker": "n6", "table_number": 1, "text": "Must be collected within 14 days prior to treatment.\nVaccine use within 30 days prior to treatment must be collected." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-009", "activity_name": "Serious Adverse Events (SAE) Assessment", "parent_name": "Safety Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Serious Adverse Events (SAE) Assessment", "Adverse Events Assessment (including Serious Adverse Events)", "Adverse Events and Serious Adverse Events (SAE) Assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Serious Adverse Events (SAE) Assessment", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Adverse Events Assessment (including Serious Adverse Events)", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Adverse Events and Serious Adverse Events (SAE) Assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "n7", "table_number": 1, "text": "SAEs collected and reported from time of consent.\nAll AEs (SAEs or non-serious AEs) related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection collected from time of consent." }, { "marker": "n3", "table_number": 2, "text": "Adverse events (AEs) will be graded according to the National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 5.\nRecord at each visit. All AEs (SAEs or non-serious AEs), including those associated with SARS-CoV-2 infection, must be collected continuously throughout the treatment period and for a minimum of 150 days after last dose of study treatment (Appendix 3).", "document_references": [ { "kind": "appendix", "target": "3" } ] }, { "marker": "n4", "table_number": 3, "text": "All SAEs and non-serious AEs should be collected continuously during the treatment period and for a minimum of 150 days following discontinuation of study treatment.\nParticipants will be followed for all SAEs, non-serious AEs of special interest (as defined in Section 9.2.8) and all AEs (SAEs and non-serious AEs) associated with confirmed or suspected SARS-CoV-2 infection until resolution, the condition stabilizes, the event is otherwise explained, the event is deemed irreversible, the participant is lost to follow-up (as defined in Section 8.3), or for suspected cases, until SARS-CoV-2 infection is ruled-out.", "document_references": [ { "kind": "section", "target": "9.2.8" }, { "kind": "section", "target": "8.3" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-022", "activity_name": "Targeted Physical Examination, Vital Signs, and Performance Status", "parent_name": "Safety Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Targeted Physical Examination, Vital Signs, and Performance Status" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Targeted Physical Examination, Vital Signs, and Performance Status", "has_schedule_data": true } ], "annotations": [ { "marker": "n1", "table_number": 2, "text": "Vital signs (blood pressure, heart rate, and temperature), weight, Lansky play score for ≤ 16 years or Karnofsky performance score for > 16 years of age (Appendix 7).\nMonitor and record vital signs at predose and within 30 minutes after administration of nivolumab.", "document_references": [ { "kind": "appendix", "target": "7" } ] }, { "marker": "*", "table_number": 2, "text": "At Day 8 visits collect vital signs only.", "columns": [ "Cycle 1 Only\nCycle = 3 wks / Day 8\n(- 1 day)" ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-023", "activity_name": "12-lead Electrocardiogram (ECG)", "parent_name": "Safety Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "12-lead Electrocardiogram (ECG)" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "12-lead Electrocardiogram (ECG)", "has_schedule_data": true } ], "annotations": [ { "marker": "n2", "table_number": 2, "text": "Pre-dose Day 1 of all cycles\nPre-PK blood draw on Cycle 1, Days 3,5, and 8\nPre-PK blood draw on Cycle 5, Days 3 and 5\nECG should be performed within 30 minutes prior to PK blood draw.\nParticipant should rest for 5 minutes prior to each ECG" } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-024", "activity_name": "Concomitant Medication Use", "parent_name": "Safety Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Concomitant Medication Use" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Concomitant Medication Use", "has_schedule_data": true } ], "annotations": [ { "marker": "n4", "table_number": 2, "text": "Record at each visit." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-041", "activity_name": "Vital Signs", "parent_name": "Safety Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Vital Signs" ], "occurrences": [ { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 3, "verbatim_name": "Vital Signs", "has_schedule_data": true } ], "annotations": [ { "marker": "n1", "table_number": 3, "text": "Blood pressure, heart rate, temperature." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-042", "activity_name": "12-lead ECG", "parent_name": "Safety Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "12-lead ECG" ], "occurrences": [ { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "12-lead ECG", "has_schedule_data": true } ], "annotations": [ { "marker": "n3", "table_number": 3, "text": "Participant should rest for 5 minutes prior to each ECG." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-043", "activity_name": "Subsequent Medications", "parent_name": "Safety Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Subsequent Medications" ], "occurrences": [ { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Subsequent Medications", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-044", "activity_name": "Review of Subsequent Anti-cancer Therapy", "parent_name": "Safety Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Review of Subsequent Anti-cancer Therapy" ], "occurrences": [ { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Review of Subsequent Anti-cancer Therapy", "has_schedule_data": true } ], "annotations": [ { "marker": "n5", "table_number": 3, "text": "Additional subsequent cancer therapy details such as regimen, setting of the regimen, line of therapy, start and end date of each regimen, best response to the regimen, and date of progression to subsequent anti-cancer therapies will be collected." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-010", "activity_name": "Laboratory Tests", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": false, "variants": [ "Laboratory Tests" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Laboratory Tests", "has_schedule_data": false }, { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Laboratory Tests", "has_schedule_data": false }, { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Laboratory Tests", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-011", "activity_name": "Clinical Laboratory Testing", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "Clinical Laboratory Testing" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Clinical Laboratory Testing", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Clinical Laboratory Testing", "has_schedule_data": true } ], "annotations": [ { "marker": "n8", "table_number": 1, "text": "All laboratory assessments to be performed within 14 days prior to treatment, except for viral testing, which, if clinically indicated, is to be completed within 28 days prior to treatment (see Section 9.4.6 for a list of laboratory tests to conduct).", "document_references": [ { "kind": "section", "target": "9.4.6" } ] }, { "marker": "n5", "table_number": 2, "text": "Hematology and chemistry assessments scheduled for the day of study drugs dosing must be available and assessed before dosing. Hematology and chemistry assessments can be drawn within 72 hours prior to treatment, though renal function (ie, serum creatinine) must be assessed within 24 hours prior to dosing with bempegaldesleukin or as soon as locally feasible.\nRefer to Section 9.4.6 for a list of laboratory tests to conduct.", "document_references": [ { "kind": "section", "target": "9.4.6" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-012", "activity_name": "Electrocardiogram", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Electrocardiogram" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Electrocardiogram", "has_schedule_data": true } ], "annotations": [ { "marker": "n9", "table_number": 1, "text": "Within 14 days prior to treatment (see Section 9.4.3).", "document_references": [ { "kind": "section", "target": "9.4.3" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-013", "activity_name": "Echocardiogram or Multigated Acquisition Scan (MUGA)", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Echocardiogram or Multigated Acquisition Scan (MUGA)" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Echocardiogram or Multigated Acquisition Scan (MUGA)", "has_schedule_data": true } ], "annotations": [ { "marker": "n10", "table_number": 1, "text": "Left ventricular ejection fraction > 45% within 60 days is required prior to treatment assignment.\nThe investigator should further evaluate participants with other significant abnormalities on echocardiogram/MUGA. Decision regarding treatment should be based on investigator’s best clinical judgment." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-014", "activity_name": "Pregnancy Test", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Pregnancy Test" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Pregnancy Test", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Pregnancy Test", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Pregnancy Test", "has_schedule_data": true } ], "annotations": [ { "marker": "n11", "table_number": 1, "text": "Women of childbearing potential only. Serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) to be done at screening visit and within 24 hours of first dose of study therapy." }, { "marker": "n6", "table_number": 2, "text": "Serum or urine pregnancy test (minimum sensitivity units 25 IU/L or equivalent units of human chorionic gonadotropin) is required within 24 hours prior to treatment in women of childbearing potential." }, { "marker": "n7", "table_number": 3, "text": "Women of childbearing potential only. Serum or urine pregnancy test (minimum sensitivity equivalent units 25 IU/L or equivalent units of human chorionic gonadotropin) is required." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-045", "activity_name": "Laboratory Tests (includes blood and urine samples)", "parent_name": "Laboratory Tests", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Laboratory Tests (includes blood and urine samples)" ], "occurrences": [ { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Laboratory Tests (includes blood and urine samples)", "has_schedule_data": true } ], "annotations": [ { "marker": "n6", "table_number": 3, "text": "See Section 9.4.6 for the list of laboratory tests.", "document_references": [ { "kind": "section", "target": "9.4.6" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-015", "activity_name": "Tumor Assessment", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Tumor Assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Tumor Assessment", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-016", "activity_name": "Body Imaging", "parent_name": "Tumor Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Body Imaging" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Body Imaging", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Body Imaging", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Body Imaging", "has_schedule_data": true } ], "annotations": [ { "marker": "n12", "table_number": 1, "text": "• Imaging to be performed within 28 days prior to treatment. See Section 9.1.1 for further details.\n• Not applicable to participants with leukemia.\n• Skull base to mid-thigh [18F]fluorodeoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) or PET-magnetic resonance imaging (PET-MRI); additional anatomy to include all sites of disease) for FDG-avid non-Hodgkin lymphoma.\n• Contrast-enhanced CT of the chest, contrast-enhanced CT/magnetic resonance imaging (MRI) of the abdomen, pelvis, and all other known and/or suspected sites of disease.\n• Participants with metaiodobenzylguanidine (MIBG)-avid neuroblastoma must also undergo MIBG scintigraphy in addition to CT/MRI as above.", "document_references": [ { "kind": "section", "target": "9.1.1" } ] }, { "marker": "n7", "table_number": 2, "text": "All study treatment decisions will be based on the investigator’s assessment of tumor images.\nSee Section 9.1.1 for additional details and to Section 8.1.2 for tumor assessment associated with treatment beyond progression.", "document_references": [ { "kind": "section", "target": "9.1.1" }, { "kind": "section", "target": "8.1.2" } ] }, { "marker": "n8", "table_number": 3, "text": "See Section 9.1.1 for further details.", "document_references": [ { "kind": "section", "target": "9.1.1" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-017", "activity_name": "Brain Imaging", "parent_name": "Tumor Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 3, "tables": [ 1, 2, 3 ], "any_marks": true, "variants": [ "Brain Imaging" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Brain Imaging", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Brain Imaging", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Brain Imaging", "has_schedule_data": true } ], "annotations": [ { "marker": "n13", "table_number": 1, "text": "MRI of the brain without and with contrast is required for participants at baseline in participants with a history of brain metastasis or symptoms. Except for glioma, medulloblastoma, ependymoma, and other central nervous system tumors in which an MRI is required, CT of the brain (without and with contrast) can be performed if MRI is contraindicated. Brain imaging must be done within 28 days prior to treatment. See Section 9.1.1 for further details.", "document_references": [ { "kind": "section", "target": "9.1.1" } ] }, { "marker": "n8", "table_number": 2, "text": "Except for glioma, medulloblastoma, ependymoma and other central nervous system tumors in which an MRI is required, CT of the brain (without and with contrast) can be performed if MRI is contraindicated.\nSee Section 9.1.1 for further details.", "document_references": [ { "kind": "section", "target": "9.1.1" } ] }, { "marker": "n9", "table_number": 3, "text": "Except for glioma, medulloblastoma, ependymoma, and other central nervous system tumors in which an MRI is required, CT of the brain without and with contrast can be performed if MRI is contraindicated.\nSee Section 9.1.1 for further details.", "document_references": [ { "kind": "section", "target": "9.1.1" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-018", "activity_name": "Cerebrospinal Fluid (CSF) - Solid Tumors", "parent_name": "Tumor Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Cerebrospinal Fluid (CSF) - Solid Tumors" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Cerebrospinal Fluid (CSF) - Solid Tumors", "has_schedule_data": true } ], "annotations": [ { "marker": "n14", "table_number": 1, "text": "CSF cytopathology should be obtained in any participant with a suspicion or high likelihood of CSF dissemination up to 7 days prior to treatment. This sample can be used as the Cycle 1 Day 1 sample. If initially positive, CSF cytopathology should be followed as part of response assessment. See Section 9.1. [remainder redacted in source]", "document_references": [ { "kind": "section", "target": "9.1" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-019", "activity_name": "Bone Marrow and Buccal Swab - Solid Tumors", "parent_name": "Tumor Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Bone Marrow and Buccal Swab - Solid Tumors" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Bone Marrow and Buccal Swab - Solid Tumors", "has_schedule_data": true } ], "annotations": [ { "marker": "n15", "table_number": 1, "text": "For participants with suspected bone marrow disease, bone marrow aspirate obtained where clinically indicated should be submitted along with buccal swab up to 28 days prior to treatment. If initially positive, bone marrow should be evaluated as part of response assessment. See Section 9.1. [remainder redacted in source]", "document_references": [ { "kind": "section", "target": "9.1" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-020", "activity_name": "CSF - Leukemia", "parent_name": "Tumor Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 1, 2 ], "any_marks": true, "variants": [ "CSF - Leukemia" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "CSF - Leukemia", "has_schedule_data": true }, { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "CSF - Leukemia", "has_schedule_data": true } ], "annotations": [ { "marker": "n16", "table_number": 1, "text": "Screening sample collected up to 7 days prior to treatment initiation can be used as Cycle 1 Day 1 pretreatment sample. See Section 9.1.2.5. [remainder redacted in source]", "document_references": [ { "kind": "section", "target": "9.1.2.5" } ] }, { "marker": "n11", "table_number": 2, "text": "CSF cytopathology should be obtained in any participant with a previously positive CSF as part of response assessment (see Section 9.1.2.5). [remainder redacted in source]", "document_references": [ { "kind": "section", "target": "9.1.2.5" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-021", "activity_name": "Bone Marrow and Buccal Swab - Leukemia", "parent_name": "Tumor Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Bone Marrow and Buccal Swab - Leukemia" ], "occurrences": [ { "table_number": 1, "table_title": "Table 2-1: Screening Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "Bone Marrow and Buccal Swab - Leukemia", "has_schedule_data": true } ], "annotations": [ { "marker": "n17", "table_number": 1, "text": "Bone marrow aspirate collected at screening and submitted along with buccal swab up to 28 days prior to treatment initiation can be used as Cycle 1 Day 1 pre-treatment sample. See Section 9.1.2.5. [remainder redacted in source]", "document_references": [ { "kind": "section", "target": "9.1.2.5" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-025", "activity_name": "Efficacy Assessments", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 2, 3 ], "any_marks": false, "variants": [ "Efficacy Assessments" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Efficacy Assessments", "has_schedule_data": false }, { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Efficacy Assessments", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-026", "activity_name": "CSF - Solid tumors", "parent_name": "Efficacy Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "CSF - Solid tumors" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "CSF - Solid tumors", "has_schedule_data": true } ], "annotations": [ { "marker": "n9", "table_number": 2, "text": "CSF cytopathology should be obtained in any participant with a previously positive CSF as part of response assessment (see Section 9.1). [remainder redacted in source]", "document_references": [ { "kind": "section", "target": "9.1" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-027", "activity_name": "Bone Marrow- Solid tumors", "parent_name": "Efficacy Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Bone Marrow- Solid tumors" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Bone Marrow- Solid tumors", "has_schedule_data": true } ], "annotations": [ { "marker": "n10", "table_number": 2, "text": "Bone marrow biopsy/aspirate should be obtained in any participant with a previously positive bone marrow aspirate as part of response assessment (see Section 9.1). [remainder redacted in source]", "document_references": [ { "kind": "section", "target": "9.1" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-028", "activity_name": "Bone Marrow - Leukemia", "parent_name": "Efficacy Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Bone Marrow - Leukemia" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Bone Marrow - Leukemia", "has_schedule_data": true } ], "annotations": [ { "marker": "n12", "table_number": 2, "text": "Bone marrow biopsy/aspirate should be obtained in any participant with a previously positive bone marrow aspirate as part of response assessment. [remainder redacted in source]" } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-046", "activity_name": "CSF - solid tumors and leukemia", "parent_name": "Efficacy Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "CSF - solid tumors and leukemia" ], "occurrences": [ { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "CSF - solid tumors and leukemia", "has_schedule_data": true } ], "annotations": [ { "marker": "n10", "table_number": 3, "text": "CSF cytopathology should be obtained in any participant with a previously positive CSF as part of response assessment. See Section 9.1", "document_references": [ { "kind": "section", "target": "9.1" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-047", "activity_name": "Bone marrow aspirate - solid tumors and leukemia", "parent_name": "Efficacy Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Bone marrow aspirate - solid tumors and leukemia" ], "occurrences": [ { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Bone marrow aspirate - solid tumors and leukemia", "has_schedule_data": true } ], "annotations": [ { "marker": "n11", "table_number": 3, "text": "Bone marrow aspirate should be obtained in any participant with a previously positive bone marrow aspirate as part of response assessment. See Section 9.1.", "document_references": [ { "kind": "section", "target": "9.1" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-048", "activity_name": "Survival Status", "parent_name": "Efficacy Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "Survival Status" ], "occurrences": [ { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Survival Status", "has_schedule_data": true } ], "annotations": [ { "marker": "n12", "table_number": 3, "text": "During safety follow-up and every 3 months (clinic visit or by telephone) thereafter and during survival phase. Include documentation of subsequent chemotherapy. See Section 5.1.4.", "document_references": [ { "kind": "section", "target": "5.1.4" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-029", "activity_name": "Pharmacokinetic (PK)/Immunogenicity Assessments", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "fuzzy_auto", "table_count": 2, "tables": [ 2, 3 ], "any_marks": false, "variants": [ "Pharmacokinetic (PK)/Immunogenicity Assessments", "Pharmacokinetics (PK)/Immunogenicity Assessment" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Pharmacokinetic (PK)/Immunogenicity Assessments", "has_schedule_data": false }, { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Pharmacokinetics (PK)/Immunogenicity Assessment", "has_schedule_data": false } ], "annotations": [ { "marker": "e", "table_number": 2, "text": "For participants who require blood draw volume modifications, blood collection volumes will be reduced per guidelines outlined in the laboratory manual. Omitted blood collection will likely be for [redacted in source] pharmacokinetic assessments, since all required safety assessments must be performed." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-030", "activity_name": "Bempegaldesleukin PK Plasma Samples", "parent_name": "Pharmacokinetic (PK)/Immunogenicity Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Bempegaldesleukin PK Plasma Samples" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Bempegaldesleukin PK Plasma Samples", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-031", "activity_name": "Nivolumab PK Serum Samples", "parent_name": "Pharmacokinetic (PK)/Immunogenicity Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Nivolumab PK Serum Samples" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Nivolumab PK Serum Samples", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-032", "activity_name": "Immunogenicity Samples", "parent_name": "Pharmacokinetic (PK)/Immunogenicity Assessments", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "exact", "table_count": 2, "tables": [ 2, 3 ], "any_marks": true, "variants": [ "Immunogenicity Samples" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Immunogenicity Samples", "has_schedule_data": true }, { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Immunogenicity Samples", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-033", "activity_name": "Health Outcomes", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": false, "variants": [ "Health 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CTCAE", "has_schedule_data": true } ], "annotations": [ { "marker": "n13", "table_number": 2, "text": "Questionnaire to be administered electronically in Part B only, on a weekly basis during the first 3 cycles of treatment, every cycle from Cycles 4 through 8, and then every other cycle (starting at Cycle 10) while on treatment until end of treatment.\nPRO-CTCAE™ for adults ≥18 years.\nPediatric (Ped-PRO-CTCAE) for children ≥7 to <18 years.\nPed-PRO-CTCAE [Caregiver] for children <7 years." } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-035", "activity_name": "Study Drug", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": false, "variants": [ "Study Drug" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "Study Drug", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-036", "activity_name": "Determine Dosing Schema", "parent_name": "Study Drug", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Determine Dosing Schema" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 25, "verbatim_name": "Determine Dosing Schema", "has_schedule_data": true } ], "annotations": [ { "marker": "n14", "table_number": 2, "text": "See Figure 5.1-1, Figure 5.1-2 and Figure 5.1-3.", "document_references": [ { "kind": "figure", "target": "5.1-1" }, { "kind": "figure", "target": "5.1-2" }, { "kind": "figure", "target": "5.1-3" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-037", "activity_name": "Administer Intravenous Fluids", "parent_name": "Study Drug", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Administer Intravenous Fluids" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 26, "verbatim_name": "Administer Intravenous Fluids", "has_schedule_data": true } ], "annotations": [ { "marker": "n15", "table_number": 2, "text": "May be withheld if deemed by the investigator to be in the best interest of the participant. Refer to Section 7.1.1.1 for additional information.", "document_references": [ { "kind": "section", "target": "7.1.1.1" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-038", "activity_name": "Administer Bempegaldesleukin + Nivolumab (Parts A and B)", "parent_name": "Study Drug", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Administer Bempegaldesleukin + Nivolumab (Parts A and B)" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 27, "verbatim_name": "Administer Bempegaldesleukin + Nivolumab (Parts A and B)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-039", "activity_name": "Review Hydration Guidelines with Participants", "parent_name": "Study Drug", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Review Hydration Guidelines with Participants" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 28, "verbatim_name": "Review Hydration Guidelines with Participants", "has_schedule_data": true } ], "annotations": [ { "marker": "n16", "table_number": 2, "text": "See Section 7.1.1.1.", "document_references": [ { "kind": "section", "target": "7.1.1.1" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-040", "activity_name": "Oral Hydration Follow-up", "parent_name": "Study Drug", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 2 ], "any_marks": true, "variants": [ "Oral Hydration Follow-up" ], "occurrences": [ { "table_number": 2, "table_title": "Table 2-2: On-treatment Procedural Outline (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 29, "verbatim_name": "Oral Hydration Follow-up", "has_schedule_data": true } ], "annotations": [ { "marker": "n17", "table_number": 2, "text": "For the first 2 doses of bempegaldesleukin, between Days 3 and 5 following infusion, site personnel must contact the participant (by telephone or clinic visit) to remind the participant of the oral hydration guidelines, to assess for any symptomatology and compliance with the guidelines, and document the results of the discussion. For subsequent administrations of bempegaldesleukin, the oral hydration follow-up should be conducted as clinically indicated for participants receiving bempegaldesleukin.\nSee Section 7.1.1.1 for details.", "document_references": [ { "kind": "section", "target": "7.1.1.1" } ] } ] }, { "protocol_id": "NCT04730349", "sponsor": "BMS", "d4k_folder": "BMS_NCT04730349_Oncology", "therapeutic_area": "Oncology", "xact_id": "xact-049", "activity_name": "PK Samples", "parent_name": "Pharmacokinetics (PK)/Immunogenicity Assessment", "hierarchy_level": 1, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 3 ], "any_marks": true, "variants": [ "PK Samples" ], "occurrences": [ { "table_number": 3, "table_title": "Table 2-3: Long-term Follow-up Period (CA045020)", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "PK Samples", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05176314", 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Serum pregnancy test at screening and urine pregnancy test at all other times." } ] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-012", "activity_name": "Urine drug screen (including cotinine)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Urine drug screen (including cotinine)" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Urine drug screen (including cotinine)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-013", "activity_name": "Ethanol test", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Ethanol test" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Ethanol test", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-014", "activity_name": "Supine vital signs (PR and BP)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Supine vital signs (PR and BP)" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Supine vital signs (PR and BP)", "has_schedule_data": true } ], "annotations": [ { "marker": "d", "table_number": 1, "text": "Definition not printed in the source: the footnote block on document page 12 lists a, b, c and e as text, while the positions where footnote 'd' would print are covered by redaction boxes labelled 'CCI'. [remainder redacted in source]" } ] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-015", "activity_name": "Oral body temperature", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Oral body temperature" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Oral body temperature", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-016", "activity_name": "12-lead ECG", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "12-lead ECG" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "12-lead ECG", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-017", "activity_name": "Clinical laboratory tests", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Clinical laboratory tests" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Clinical laboratory tests", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-018", "activity_name": "Physical examination", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Physical examination" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Physical examination", "has_schedule_data": true } ], "annotations": [ { "marker": "e", "table_number": 1, "text": "Complete physical examination at check-in, discharge from CRU, and follow-up. Additional symptom-driven physical examinations may be performed at the discretion of the investigator." } ] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-019", "activity_name": "Genetic blood sample for screening", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Genetic blood sample for screening" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Genetic blood sample for screening", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-020", "activity_name": "Rosuvastatin PK samples", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Rosuvastatin PK samples" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "Rosuvastatin PK samples", "has_schedule_data": true } ], "annotations": [ { "marker": "g", "table_number": 1, "text": "Definition not printed in the source: the footnote block on document page 12 lists a, b, c and e as text, while the positions where footnote 'g' would print are covered by redaction boxes labelled 'CCI'. [remainder redacted in source]" }, { "marker": "f", "table_number": 1, "text": "Definition not printed in the source: the footnote block on document page 12 lists a, b, c and e as text, while the positions where footnote 'f' would print are covered by redaction boxes labelled 'CCI'. [remainder redacted in source]", "columns": [ "Treatment Period (Study Days) / 6" ] } ] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-021", "activity_name": "Adverse event review", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Adverse event review" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 23, "verbatim_name": "Adverse event review", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-022", "activity_name": "Concomitant medication review", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Concomitant medication review" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "Concomitant medication review", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-023", "activity_name": "CCI", "parent_name": "Concomitant medication review", "hierarchy_level": 1, "is_section_header": false, "is_redacted": true, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "CCI" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 25, "verbatim_name": "CCI", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT05176314", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05176314", "therapeutic_area": "ClinPharm", "xact_id": "xact-024", "activity_name": "CCI", "parent_name": "Concomitant medication review", "hierarchy_level": 1, "is_section_header": false, "is_redacted": true, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "CCI" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 26, "verbatim_name": "CCI", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-001", "activity_name": "Informed Consent/Assent", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed Consent/Assent" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Informed Consent/Assent", "has_schedule_data": true } ], "annotations": [ { "marker": "f", "table_number": 1, "text": "Consent and assent may be collected through e-consent if allowed through country and site regulations." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-002", "activity_name": "Eligibility Assessment", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Eligibility Assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Eligibility Assessment", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-003", "activity_name": "HAE Diagnostic Lab Test", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "HAE Diagnostic Lab Test" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "HAE Diagnostic Lab Test", "has_schedule_data": true } ], "annotations": [ { "marker": "g", "table_number": 1, "text": "Diagnostic testing must be available for patients without genetic confirmation of HAE type I or II." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-004", "activity_name": "Medical History", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Medical History" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Medical History", "has_schedule_data": true } ], "annotations": [ { "marker": "h", "table_number": 1, "text": "Medical history includes any relevant previous and concurrent diseases, HAE disease history including the attack history and corresponding treatment for the past 3 months; therapies and supplements taken within the past 4 weeks; and previous participation in interventional clinical trials in the past 4 weeks." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-005", "activity_name": "12-lead ECG", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "12-lead ECG" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "12-lead ECG", "has_schedule_data": true } ], "annotations": [ { "marker": "i", "table_number": 1, "text": "ECG to be recorded after patient has rested supine for at least 5 minutes." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-006", "activity_name": "Demographics", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Demographics" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Demographics", "has_schedule_data": true } ], "annotations": [ { "marker": "j", "table_number": 1, "text": "Demographics: Year of birth; height (meters [m]; without shoes); weight (kilograms [kg]); race and ethnicity (if allowed); and sex." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-007", "activity_name": "Physical Examination", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Physical Examination" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Physical Examination", "has_schedule_data": true } ], "annotations": [ { "marker": "k", "table_number": 1, "text": "Complete physical examination at Screening only, all others will be symptom directed. In the case of a home health visit, the home healthcare nurse will conduct an abbreviated physical examination, and the Investigator will conduct the symptom-directed physical examination via televisit." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-008", "activity_name": "Vital Signs", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Vital Signs" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Vital Signs", "has_schedule_data": true } ], "annotations": [ { "marker": "l", "table_number": 1, "text": "Vital signs include pulse rate, respiratory rate, and systolic and diastolic blood pressure after patient has been resting at least 5 minutes." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-009", "activity_name": "Safety Laboratory", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Safety Laboratory" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Safety Laboratory", "has_schedule_data": true } ], "annotations": [ { "marker": "m", "table_number": 1, "text": "Laboratory assessments, including C1-INH functional level, performed by a central laboratory; repeat laboratory assessments may be performed." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-010", "activity_name": "Pregnancy Test", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Pregnancy Test" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Pregnancy Test", "has_schedule_data": true } ], "annotations": [ { "marker": "n", "table_number": 1, "text": "Serum pregnancy test will be performed on females of childbearing potential at Screening and at the Final/ET visit." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-011", "activity_name": "Randomize patient in RTSM", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Randomize patient in RTSM" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Randomize patient in RTSM", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-012", "activity_name": "Patient diary training", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Patient diary training" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Patient diary training", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-013", "activity_name": "Patient diary retraining", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Patient diary retraining" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Patient diary retraining", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-014", "activity_name": "Conventional on-demand treatment washout", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Conventional on-demand treatment washout" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Conventional on-demand treatment washout", "has_schedule_data": true } ], "annotations": [ { "marker": "o", "table_number": 1, "text": "If a patient takes conventional on-demand treatment during the trial, a 48-hour washout period is required prior to the subsequent dosing with IMP." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-015", "activity_name": "Dose", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Dose" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Dose", "has_schedule_data": true } ], "annotations": [ { "marker": "p", "table_number": 1, "text": "Eligible attacks should be treated with IMP as soon as possible after recognition of the start of the attack. A minimum 48-hour washout period is required between each eligible attack and last dose of IMP or conventional on-demand treatment. After the first dose of IMP and prior to the second dose or conventional on-demand treatment, patients will be required to call a designated Study Call Center to be reminded of the repeat dosing criteria. The Call Center staff will remind patients of the rules for re-dosing and the eDiary assessment requirements." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-016", "activity_name": "IMP dispensing/return/accountability", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "IMP dispensing/return/accountability" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "IMP dispensing/return/accountability", "has_schedule_data": true } ], "annotations": [ { "marker": "q", "table_number": 1, "text": "Arrangements will be made to dispense the assigned IMP. The IMP will be shipped to the patient via a courier service or will be dispensed at the trial clinic as required by local regulations or per the site’s local practice, as described in the Pharmacy Manual. Confirmation of dosing compliance will be performed at each of the HAE attack televisits. All unused IMP and packaging will be returned at the in-clinic Final Visit/ET Visit. If the Final Visit/ET Visit is performed by Home Health, arrangements will be made to return any unused IMP and packaging via courier." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-017", "activity_name": "PGI-S", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "PGI-S" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "PGI-S", "has_schedule_data": true } ], "annotations": [ { "marker": "r", "table_number": 1, "text": "Patients will complete timed assessments of HAE attack symptoms through 48 hours following first dose of IMP. Patient assessments will be performed as outlined in Table S1." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-018", "activity_name": "PGI-C", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "PGI-C" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "PGI-C", "has_schedule_data": true } ], "annotations": [ { "marker": "r", "table_number": 1, "text": "Patients will complete timed assessments of HAE attack symptoms through 48 hours following first dose of IMP. Patient assessments will be performed as outlined in Table S1." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-019", "activity_name": "VAS", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "VAS" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 23, "verbatim_name": "VAS", "has_schedule_data": true } ], "annotations": [ { "marker": "r", "table_number": 1, "text": "Patients will complete timed assessments of HAE attack symptoms through 48 hours following first dose of IMP. Patient assessments will be performed as outlined in Table S1." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-020", "activity_name": "GA-NRS", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "GA-NRS" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "GA-NRS", "has_schedule_data": true } ], "annotations": [ { "marker": "r", "table_number": 1, "text": "Patients will complete timed assessments of HAE attack symptoms through 48 hours following first dose of IMP. Patient assessments will be performed as outlined in Table S1." } ] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-021", "activity_name": "Concomitant Medication Review", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Concomitant Medication Review" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 25, "verbatim_name": "Concomitant Medication Review", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05259917", "sponsor": "KalVista", "d4k_folder": "KalVista_NCT05259917_Angioedema", "therapeutic_area": "Angioedema", "xact_id": "xact-022", "activity_name": "Adverse Event Review", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Adverse Event Review" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Events", "table_type": "main_soa", "track_label": null, "row_position": 26, "verbatim_name": "Adverse Event Review", "has_schedule_data": true } ], "annotations": [ { "marker": "s", "table_number": 1, "text": "Adverse events recorded from the first dose of KVD900 or placebo up to and including to Final Visit/ET. Serious AEs recorded from the time of signing the informed consent up to and including the Final Visit/ET." } ] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-001", "activity_name": "Informed consent", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Informed consent" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Informed consent", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-002", "activity_name": "Inclusion and exclusion criteria", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Inclusion and exclusion criteria" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Inclusion and exclusion criteria", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-003", "activity_name": "Demography", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Demography" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Demography", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-004", "activity_name": "Participant admission to CRU", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Participant admission to CRU" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Participant admission to CRU", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-005", "activity_name": "Participant discharge from CRU", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Participant discharge from CRU" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Participant discharge from CRU", "has_schedule_data": true } ], "annotations": [ { "marker": "cm1", "table_number": 1, "text": "A study participant may be required to stay later than Day 11 for management or monitoring of an AE or a clinically significant finding, at the discretion of the investigator." } ] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-006", "activity_name": "Outpatient visit", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Outpatient visit" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "Outpatient visit", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-007", "activity_name": "Medical history", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Medical history" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Medical history", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-008", "activity_name": "Medical assessment", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Medical assessment" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Medical assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "cm2", "table_number": 1, "text": "Full medical assessment to be performed at screening, and symptom driven examination to be done at other/any time point at physician’s discretion." } ] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-009", "activity_name": "Height and weight", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Height and weight" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "Height and weight", "has_schedule_data": true } ], "annotations": [ { "marker": "cm3", "table_number": 1, "text": "Height and weight to be measured at screening; weight only to be measured at Day 11 or ED as appropriate." } ] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-010", "activity_name": "Serum or urine pregnancy test (women of childbearing potential only)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Serum or urine pregnancy test (women of childbearing potential only)" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Serum or urine pregnancy test (women of childbearing potential only)", "has_schedule_data": true } ], "annotations": [ { "marker": "cm4", "table_number": 1, "text": "Serum pregnancy tests will be performed at screening and urine pregnancy test at all other time points" } ] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-011", "activity_name": "Follicle-stimulating hormone (women of non-childbearing potential only)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Follicle-stimulating hormone (women of non-childbearing potential only)" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "Follicle-stimulating hormone (women of non-childbearing potential only)", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-012", "activity_name": "Human immunodeficiency virus, hepatitis B and C screen", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Human immunodeficiency virus, hepatitis B and C screen" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Human immunodeficiency virus, hepatitis B and C screen", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-013", "activity_name": "12-lead ECG", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "12-lead ECG" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "12-lead ECG", "has_schedule_data": true } ], "annotations": [ { "marker": "cm5", "table_number": 1, "text": "Single ECGs are required." } ] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-014", "activity_name": "Vital signs (supine), pulse rate, and blood pressure", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Vital signs (supine), pulse rate, and blood pressure" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Vital signs (supine), pulse rate, and blood pressure", "has_schedule_data": true } ], "annotations": [ { "marker": "cm6", "table_number": 1, "text": "Time points may be added, if warranted and agreed upon between Lilly and the investigator." } ] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-015", "activity_name": "Clinical laboratory tests", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Clinical laboratory tests" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Clinical laboratory tests", "has_schedule_data": true } ], "annotations": [ { "marker": "cm7", "table_number": 1, "text": "See Appendix 10.2, Clinical Laboratory Tests, for details.", "document_references": [ { "kind": "appendix", "target": "10.2" } ] } ] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-016", "activity_name": "Genetic sample", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Genetic sample" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "Genetic sample", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": "ClinPharm", "xact_id": "xact-017", "activity_name": "Selpercatinib administration", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Selpercatinib administration" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Selpercatinib administration", "has_schedule_data": true } ], "annotations": [ { "marker": "cm8", "table_number": 1, "text": "Participant consumes high-fat meal within 30 minutes prior to dose based on randomization." } ] }, { "protocol_id": "NCT05324124", "sponsor": "EliLilly", "d4k_folder": "EliLilly_NCT05324124", "therapeutic_area": 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