{ "schema_name": "soa2usdm-activity-inventory", "schema_version": "2.1", "collection": "misc_studies", "generated_at": "2026-10-03 19:23 UTC", "counts": { "protocols": 2, "activities": 91, "multi_table_activities": 0, "activities_with_wording_variants": 0, "redacted_activities": 0 }, "activities": [ { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-001", "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": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 3, "verbatim_name": "Eligibility Assessment", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-002", "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 Parameters", "table_type": "main_soa", "track_label": null, "row_position": 4, "verbatim_name": "Informed Consent", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-003", "activity_name": "Medical History & Assessment of Baseline Signs and 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": [ "Medical History & Assessment of Baseline Signs and Symptoms" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 5, "verbatim_name": "Medical History & Assessment of Baseline Signs and Symptoms", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-004", "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": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 6, "verbatim_name": "Physical Exam", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] }, { "marker": "b", "table_number": 1, "text": "≤ 7 days prior to the start of C1D1.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 1" ] }, { "marker": "c", "table_number": 1, "text": "+/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends, bad weather or other unforeseen circumstances will be permitted.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-005", "activity_name": "Concomitant Meds", "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 Meds" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 7, "verbatim_name": "Concomitant Meds", "has_schedule_data": true } ], "annotations": [ { "marker": "pr1", "table_number": 1, "text": "see Appendix C", "document_references": [ { "kind": "appendix", "target": "C" } ] }, { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] }, { "marker": "b", "table_number": 1, "text": "≤ 7 days prior to the start of C1D1.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 1" ] }, { "marker": "c", "table_number": 1, "text": "+/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends, bad weather or other unforeseen circumstances will be permitted.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-006", "activity_name": "Vital Signs (Blood Pressure, Heart Rate, Temperature) 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": [ "Vital Signs (Blood Pressure, Heart Rate, Temperature) and Weight" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 8, "verbatim_name": "Vital Signs (Blood Pressure, Heart Rate, Temperature) and Weight", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] }, { "marker": "b", "table_number": 1, "text": "≤ 7 days prior to the start of C1D1.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 1" ] }, { "marker": "c", "table_number": 1, "text": "+/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends, bad weather or other unforeseen circumstances will be permitted.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-007", "activity_name": "ECOG Performance 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": [ "ECOG Performance Status" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 9, "verbatim_name": "ECOG Performance Status", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] }, { "marker": "b", "table_number": 1, "text": "≤ 7 days prior to the start of C1D1.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 1" ] }, { "marker": "c", "table_number": 1, "text": "+/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends, bad weather or other unforeseen circumstances will be permitted.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-008", "activity_name": "Adverse Events Assessments", "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 Assessments" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 10, "verbatim_name": "Adverse Events Assessments", "has_schedule_data": true } ], "annotations": [ { "marker": "b", "table_number": 1, "text": "≤ 7 days prior to the start of C1D1.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 1" ] }, { "marker": "c", "table_number": 1, "text": "+/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends, bad weather or other unforeseen circumstances will be permitted.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle" ] }, { "marker": "j", "table_number": 1, "text": "Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or everolimus/placebo) or until ≤ grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last dose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo.", "columns": [ "End of Induction Phase End of Treatment", "Continuation Phase (until progression or unacceptable toxicity)", "Follow-Up Off Therapy (every 3 months for total of 3 yrs from date of randomization)" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-009", "activity_name": "Imaging Scans", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Imaging Scans" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 11, "verbatim_name": "Imaging Scans", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] }, { "marker": "i", "table_number": 1, "text": "Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week (every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be repeated once disease progression is documented.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study", "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Every 12 weeks", "End of Induction Phase End of Treatment", "Continuation Phase (until progression or unacceptable toxicity)", "Follow-Up Off Therapy (every 3 months for total of 3 yrs from date of randomization)" ] }, { "marker": "m", "table_number": 1, "text": "All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed during the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented progression.", "columns": [ "Follow-Up Off Therapy (every 3 months for total of 3 yrs from date of randomization)" ] }, { "marker": "o", "table_number": 1, "text": "Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented.", "columns": [ "Follow-Up Off Therapy (every 3 months for total of 3 yrs from date of randomization)" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-010", "activity_name": "PT with INR", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "PT with INR" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 12, "verbatim_name": "PT with INR", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-011", "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": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 13, "verbatim_name": "Urinalysis", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-012", "activity_name": "CBC with differentials, Platelets", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "CBC with differentials, Platelets" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 14, "verbatim_name": "CBC with differentials, Platelets", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] }, { "marker": "b", "table_number": 1, "text": "≤ 7 days prior to the start of C1D1.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 1" ] }, { "marker": "d", "table_number": 1, "text": "In the event of grade 3 or 4 hematologic toxicity, CBC with differential and platelet count will be obtained every 1-3 days until there is evidence of hematologic recovery.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 15", "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle", "End of Induction Phase End of Treatment" ] }, { "marker": "c", "table_number": 1, "text": "+/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends, bad weather or other unforeseen circumstances will be permitted.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle" ] }, { "marker": "k", "table_number": 1, "text": "CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone. Patients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per labeling guidelines.", "columns": [ "Continuation Phase (until progression or unacceptable toxicity)" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-013", "activity_name": "Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.", "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 Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid." ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 15, "verbatim_name": "Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] }, { "marker": "b", "table_number": 1, "text": "≤ 7 days prior to the start of C1D1.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 1" ] }, { "marker": "c", "table_number": 1, "text": "+/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends, bad weather or other unforeseen circumstances will be permitted.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle" ] }, { "marker": "k", "table_number": 1, "text": "CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone. Patients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per labeling guidelines.", "columns": [ "Continuation Phase (until progression or unacceptable toxicity)" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-014", "activity_name": "Fasting Glucose", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Fasting Glucose" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Fasting Glucose", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] }, { "marker": "b", "table_number": 1, "text": "≤ 7 days prior to the start of C1D1.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 1" ] }, { "marker": "e", "table_number": 1, "text": "+/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of treatment.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle", "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Every 12 weeks", "End of Induction Phase End of Treatment" ] }, { "marker": "k", "table_number": 1, "text": "CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone. Patients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per labeling guidelines.", "columns": [ "Continuation Phase (until progression or unacceptable toxicity)" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-015", "activity_name": "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] }, { "marker": "b", "table_number": 1, "text": "≤ 7 days prior to the start of C1D1.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 1" ] }, { "marker": "e", "table_number": 1, "text": "+/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of treatment.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle", "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Every 12 weeks", "End of Induction Phase End of Treatment" ] }, { "marker": "k", "table_number": 1, "text": "CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone. Patients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per labeling guidelines.", "columns": [ "Continuation Phase (until progression or unacceptable toxicity)" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-016", "activity_name": "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV-RNA-PCR", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV-RNA-PCR" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV-RNA-PCR", "has_schedule_data": true } ], "annotations": [ { "marker": "a", "table_number": 1, "text": "≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ] }, { "marker": "f", "table_number": 1, "text": "All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a positive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or HBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment should continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Pre-Study" ], "document_references": [ { "kind": "section", "target": "7.1.1" }, { "kind": "table", "target": "5-3" } ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-017", "activity_name": "HBV DNA", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "HBV DNA" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 19, "verbatim_name": "HBV DNA", "has_schedule_data": true } ], "annotations": [ { "marker": "f", "table_number": 1, "text": "All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a positive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or HBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). 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See Table 5-4 for reactivation instructions.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 1", "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle" ], "document_references": [ { "kind": "table", "target": "5-4" } ] }, { "marker": "k", "table_number": 1, "text": "CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone. Patients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per labeling guidelines.", "columns": [ "Continuation Phase (until progression or unacceptable toxicity)" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-018", "activity_name": "HCV RNA-PCR", "parent_name": "", "hierarchy_level": 0, "is_section_header": false, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": true, "variants": [ "HCV RNA-PCR" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "HCV RNA-PCR", "has_schedule_data": true } ], "annotations": [ { "marker": "f", "table_number": 1, "text": "All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a positive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or HBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment should continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 1", "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle" ], "document_references": [ { "kind": "section", "target": "7.1.1" }, { "kind": "table", "target": "5-3" } ] }, { "marker": "h", "table_number": 1, "text": "Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered ‘cured’) should have HCV RNA-PCR testing performed on ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be discontinued if HCV flare is confirmed according to the guidance in Table 5-5.", "columns": [ "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Cycle 1 Day 1", "Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) / Day 1 Each Subsequent Cycle" ], "document_references": [ { "kind": "table", "target": "5-5" } ] }, { "marker": "k", "table_number": 1, "text": "CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone. Patients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per labeling guidelines.", "columns": [ "Continuation Phase (until progression or unacceptable toxicity)" ] } ] }, { "protocol_id": "NCT01797120", "sponsor": "PrECOG, LLC.", "d4k_folder": "", "therapeutic_area": "Breast Cancer", "xact_id": "xact-019", "activity_name": "Study Drug Compliance (Pill 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": [ "Study Drug Compliance (Pill Diary)" ], "occurrences": [ { "table_number": 1, "table_title": "Study Parameters", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Study Drug Compliance (Pill Diary)", "has_schedule_data": true } ], "annotations": [ { "marker": "l", "table_number": 1, "text": "Study Drug Compliance (Pill Diary) 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Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-010", "activity_name": "Height", "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": [ "Height" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 16, "verbatim_name": "Height", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05051579", "sponsor": "Eli Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-011", "activity_name": "Weight", "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": [ "Weight" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 17, "verbatim_name": "Weight", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05051579", "sponsor": "Eli Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-012", "activity_name": "Waist circumference", "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": [ "Waist circumference" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 18, "verbatim_name": "Waist circumference", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05051579", "sponsor": "Eli Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-013", "activity_name": "Vital signs (2 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Vital sign measurements should be collected after participant has been sitting for at least 5 minutes and before obtaining an ECG tracing and before collection of blood samples for laboratory testing (see Section 10.7).", "document_references": [ { "kind": "section", "target": "10.7" } ] } ] }, { "protocol_id": "NCT05051579", "sponsor": "Eli Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-014", "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": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 20, "verbatim_name": "Physical examination", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05051579", "sponsor": "Eli Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-015", "activity_name": "Symptom-directed 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": [ "Symptom-directed physical examination" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 21, "verbatim_name": "Symptom-directed physical examination", "has_schedule_data": true } ], "annotations": [ { "marker": "n3", "table_number": 1, "text": "As indicated based on participant status and standard of care. May be performed by qualified personnel per local regulations." } ] }, { "protocol_id": "NCT05051579", "sponsor": "Eli Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-016", "activity_name": "12-Lead ECG", "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": [ "12-Lead ECG" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 22, "verbatim_name": "12-Lead ECG", "has_schedule_data": true } ], "annotations": [ { "marker": "n4", "table_number": 1, "text": "Single central ECGs will be performed at screening and early termination. Central ECGs should be collected in triplicate at all other visits. ECG should be collected prior to collection of blood samples, including PK samples. ECG measurements should be obtained per the instructions in Section 8.2.3.", "document_references": [ { "kind": "section", "target": "8.2.3" } ] } ] }, { "protocol_id": "NCT05051579", "sponsor": "Eli Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-017", "activity_name": "ABPM training", "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": [ "ABPM training" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 23, "verbatim_name": "ABPM training", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05051579", "sponsor": "Eli Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-018", "activity_name": "Initiate ABPM device", "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": [ "Initiate ABPM device" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 24, "verbatim_name": "Initiate ABPM device", "has_schedule_data": true } ], "annotations": [] }, { "protocol_id": "NCT05051579", "sponsor": "Eli Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-019", "activity_name": "Return ABPM device", "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": [ "Return ABPM device" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 25, "verbatim_name": "Return ABPM device", "has_schedule_data": true } ], "annotations": [ { "marker": "n5", "table_number": 1, "text": "Participants should return the ABPM device at the conclusion of the 24- to 27-hour monitoring period." } ] }, { "protocol_id": "NCT05051579", "sponsor": "Eli Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-020", "activity_name": "Record ABPM measurements", "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": [ "Record ABPM measurements" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 26, "verbatim_name": "Record ABPM measurements", "has_schedule_data": true } ], "annotations": [ { "marker": "n6", "table_number": 1, "text": "At the time participant visit data are uploaded by the site, the ABPM Data Validity Report will be generated and should be reviewed to ensure ≥70% of readings are valid. If <70% of readings are valid, the 24-hour monitoring session should be repeated within the visit window." } ] }, { "protocol_id": "NCT05051579", "sponsor": "Eli Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-021", "activity_name": "Participant Education", "parent_name": "", "hierarchy_level": 0, "is_section_header": true, "is_redacted": false, "match_status": "new", "table_count": 1, "tables": [ 1 ], "any_marks": false, "variants": [ "Participant Education" ], "occurrences": [ { "table_number": 1, "table_title": "Schedule of Activities (SoA)", "table_type": "main_soa", "track_label": null, "row_position": 27, "verbatim_name": "Participant Education", "has_schedule_data": false } ], "annotations": [] }, { "protocol_id": "NCT05051579", "sponsor": "Eli Lilly and Company", "d4k_folder": "", "therapeutic_area": "Obesity", "xact_id": "xact-022", "activity_name": "Explain diet and physical activity plan", "parent_name": "Participant Education", 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