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If re-enrolled, the participant must be re-consented and assigned a new participant number from IRT.", "display_markers": "T1:n1", "source_occurrences": [ { "table_num": 1, "marker": "n1", "annotation_id": "annot-001" } ], "referenced_xacts": [ "xact-002" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-002", "annotation_type": "footnote", "annotation_text": "Must be confirmed prior to treatment.\nSee Sections 6.1 and 6.2.", "display_markers": "T1:n2", "source_occurrences": [ { "table_num": 1, "marker": "n2", "annotation_id": "annot-002" } ], "referenced_xacts": [ "xact-003" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "6.1" }, { "kind": "section", "target": "6.2" } ] }, { "xannot_id": "xannot-003", "annotation_type": "footnote", "annotation_text": "All relevant medical history including smoking history, and prior anti-cancer therapies.", "display_markers": "T1:n3", "source_occurrences": [ { "table_num": 1, "marker": "n3", "annotation_id": "annot-003" } ], "referenced_xacts": [ "xact-004" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-004", "annotation_type": "footnote", "annotation_text": "Include vital signs (blood pressure, heart rate, and temperature) plus height, weight, and pulse oximetry within 14 days prior to treatment.", "display_markers": "T1:n4", "source_occurrences": [ { "table_num": 1, "marker": "n4", "annotation_id": "annot-004" } ], "referenced_xacts": [ "xact-006" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-005", "annotation_type": "footnote", "annotation_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).", "display_markers": "T1:n5", "source_occurrences": [ { "table_num": 1, "marker": "n5", "annotation_id": "annot-005" } ], "referenced_xacts": [ "xact-007" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "appendix", "target": "7" } ] }, { "xannot_id": "xannot-006", "annotation_type": "footnote", "annotation_text": "Must be collected within 14 days prior to treatment.\nVaccine use within 30 days prior to treatment must be collected.", "display_markers": "T1:n6", "source_occurrences": [ { "table_num": 1, "marker": "n6", "annotation_id": "annot-006" } ], "referenced_xacts": [ "xact-008" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-007", "annotation_type": "footnote", "annotation_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.", "display_markers": "T1:n7", "source_occurrences": [ { "table_num": 1, "marker": "n7", "annotation_id": "annot-007" } ], "referenced_xacts": [ "xact-009" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-008", "annotation_type": "footnote", "annotation_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).", "display_markers": "T1:n8", "source_occurrences": [ { "table_num": 1, "marker": "n8", "annotation_id": "annot-008" } ], "referenced_xacts": [ "xact-011" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.4.6" } ] }, { "xannot_id": "xannot-009", "annotation_type": "footnote", "annotation_text": "Within 14 days prior to treatment (see Section 9.4.3).", "display_markers": "T1:n9", "source_occurrences": [ { "table_num": 1, "marker": "n9", "annotation_id": "annot-009" } ], "referenced_xacts": [ "xact-012" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.4.3" } ] }, { "xannot_id": "xannot-010", "annotation_type": "footnote", "annotation_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.", "display_markers": "T1:n10", "source_occurrences": [ { "table_num": 1, "marker": "n10", "annotation_id": "annot-010" } ], "referenced_xacts": [ "xact-013" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-011", "annotation_type": "footnote", "annotation_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.", "display_markers": "T1:n11", "source_occurrences": [ { "table_num": 1, "marker": "n11", "annotation_id": "annot-011" } ], "referenced_xacts": [ "xact-014" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-012", "annotation_type": "footnote", "annotation_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.", "display_markers": "T1:n12", "source_occurrences": [ { "table_num": 1, "marker": "n12", "annotation_id": "annot-012" } ], "referenced_xacts": [ "xact-016" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1.1" } ] }, { "xannot_id": "xannot-013", "annotation_type": "footnote", "annotation_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.", "display_markers": "T1:n13", "source_occurrences": [ { "table_num": 1, "marker": "n13", "annotation_id": "annot-013" } ], "referenced_xacts": [ "xact-017" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1.1" } ] }, { "xannot_id": "xannot-014", "annotation_type": "footnote", "annotation_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]", "display_markers": "T1:n14", "source_occurrences": [ { "table_num": 1, "marker": "n14", "annotation_id": "annot-014" } ], "referenced_xacts": [ "xact-018" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1" } ] }, { "xannot_id": "xannot-015", "annotation_type": "footnote", "annotation_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]", "display_markers": "T1:n15", "source_occurrences": [ { "table_num": 1, "marker": "n15", "annotation_id": "annot-015" } ], "referenced_xacts": [ "xact-019" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1" } ] }, { "xannot_id": "xannot-016", "annotation_type": "footnote", "annotation_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]", "display_markers": "T1:n16", "source_occurrences": [ { "table_num": 1, "marker": "n16", "annotation_id": "annot-016" } ], "referenced_xacts": [ "xact-020" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1.2.5" } ] }, { "xannot_id": "xannot-017", "annotation_type": "footnote", "annotation_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]", "display_markers": "T1:n17", "source_occurrences": [ { "table_num": 1, "marker": "n17", "annotation_id": "annot-017" } ], "referenced_xacts": [ "xact-021" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1.2.5" } ] }, { "xannot_id": "xannot-018", "annotation_type": "footnote", "annotation_text": "Some of the assessments referred to in this section may not be captured as data in the electronic case report form. They are intended to be used as safety monitoring by the treating physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations.", "display_markers": "T1-2:a, T3:c", "source_occurrences": [ { "table_num": 1, "marker": "a", "annotation_id": "annot-018" }, { "table_num": 2, "marker": "a", "annotation_id": "annot-019" }, { "table_num": 3, "marker": "c", "annotation_id": "annot-015" } ], "referenced_xacts": [], "referenced_xcols": [ "xcol-001", "xcol-002", "xcol-003", "xcol-004", "xcol-005", "xcol-006", "xcol-007" ], "referenced_props": [], "cell_references": [], "occurrence_count": 3 }, { "xannot_id": "xannot-019", "annotation_type": "footnote", "annotation_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.", "display_markers": "T2:n1", "source_occurrences": [ { "table_num": 2, "marker": "n1", "annotation_id": "annot-001" } ], "referenced_xacts": [ "xact-022" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "appendix", "target": "7" } ] }, { "xannot_id": "xannot-020", "annotation_type": "footnote", "annotation_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", "display_markers": "T2:n2", "source_occurrences": [ { "table_num": 2, "marker": "n2", "annotation_id": "annot-002" } ], "referenced_xacts": [ "xact-023" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-021", "annotation_type": "footnote", "annotation_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).", "display_markers": "T2:n3", "source_occurrences": [ { "table_num": 2, "marker": "n3", "annotation_id": "annot-003" } ], "referenced_xacts": [ "xact-009" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "appendix", "target": "3" } ] }, { "xannot_id": "xannot-022", "annotation_type": "footnote", "annotation_text": "Record at each visit.", "display_markers": "T2:n4", "source_occurrences": [ { "table_num": 2, "marker": "n4", "annotation_id": "annot-004" } ], "referenced_xacts": [ "xact-024" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-023", "annotation_type": "footnote", "annotation_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.", "display_markers": "T2:n5", "source_occurrences": [ { "table_num": 2, "marker": "n5", "annotation_id": "annot-005" } ], "referenced_xacts": [ "xact-011" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.4.6" } ] }, { "xannot_id": "xannot-024", "annotation_type": "footnote", "annotation_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.", "display_markers": "T2:n6", "source_occurrences": [ { "table_num": 2, "marker": "n6", "annotation_id": "annot-006" } ], "referenced_xacts": [ "xact-014" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-025", "annotation_type": "footnote", "annotation_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.", "display_markers": "T2:n7", "source_occurrences": [ { "table_num": 2, "marker": "n7", "annotation_id": "annot-007" } ], "referenced_xacts": [ "xact-016" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1.1" }, { "kind": "section", "target": "8.1.2" } ] }, { "xannot_id": "xannot-026", "annotation_type": "footnote", "annotation_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.", "display_markers": "T2:n8", "source_occurrences": [ { "table_num": 2, "marker": "n8", "annotation_id": "annot-008" } ], "referenced_xacts": [ "xact-017" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1.1" } ] }, { "xannot_id": "xannot-027", "annotation_type": "footnote", "annotation_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]", "display_markers": "T2:n9", "source_occurrences": [ { "table_num": 2, "marker": "n9", "annotation_id": "annot-009" } ], "referenced_xacts": [ "xact-026" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1" } ] }, { "xannot_id": "xannot-028", "annotation_type": "footnote", "annotation_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]", "display_markers": "T2:n10", "source_occurrences": [ { "table_num": 2, "marker": "n10", "annotation_id": "annot-010" } ], "referenced_xacts": [ "xact-027" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1" } ] }, { "xannot_id": "xannot-029", "annotation_type": "footnote", "annotation_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]", "display_markers": "T2:n11", "source_occurrences": [ { "table_num": 2, "marker": "n11", "annotation_id": "annot-011" } ], "referenced_xacts": [ "xact-020" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1.2.5" } ] }, { "xannot_id": "xannot-030", "annotation_type": "footnote", "annotation_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]", "display_markers": "T2:n12", "source_occurrences": [ { "table_num": 2, "marker": "n12", "annotation_id": "annot-012" } ], "referenced_xacts": [ "xact-028" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-031", "annotation_type": "footnote", "annotation_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.", "display_markers": "T2:n13", "source_occurrences": [ { "table_num": 2, "marker": "n13", "annotation_id": "annot-013" } ], "referenced_xacts": [ "xact-034" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-032", "annotation_type": "source_note", "annotation_text": "See Figure 5.1-1, Figure 5.1-2 and Figure 5.1-3.", "display_markers": "T2:n14", "source_occurrences": [ { "table_num": 2, "marker": "n14", "annotation_id": "annot-014" } ], "referenced_xacts": [ "xact-036" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "figure", "target": "5.1-1" }, { "kind": "figure", "target": "5.1-2" }, { "kind": "figure", "target": "5.1-3" } ] }, { "xannot_id": "xannot-033", "annotation_type": "footnote", "annotation_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.", "display_markers": "T2:n15", "source_occurrences": [ { "table_num": 2, "marker": "n15", "annotation_id": "annot-015" } ], "referenced_xacts": [ "xact-037" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "7.1.1.1" } ] }, { "xannot_id": "xannot-034", "annotation_type": "source_note", "annotation_text": "See Section 7.1.1.1.", "display_markers": "T2:n16", "source_occurrences": [ { "table_num": 2, "marker": "n16", "annotation_id": "annot-016" } ], "referenced_xacts": [ "xact-039" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "7.1.1.1" } ] }, { "xannot_id": "xannot-035", "annotation_type": "footnote", "annotation_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.", "display_markers": "T2:n17", "source_occurrences": [ { "table_num": 2, "marker": "n17", "annotation_id": "annot-017" } ], "referenced_xacts": [ "xact-040" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "7.1.1.1" } ] }, { "xannot_id": "xannot-036", "annotation_type": "footnote", "annotation_text": "At Day 8 visits collect vital signs only.", "display_markers": "T2:*", "source_occurrences": [ { "table_num": 2, "marker": "*", "annotation_id": "annot-018" } ], "referenced_xacts": [ "xact-022" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [ { "xact_id": "xact-022", "xcol_id": "xcol-005" } ], "occurrence_count": 1 }, { "xannot_id": "xannot-037", "annotation_type": "footnote", "annotation_text": "If a dose is delayed, the procedures scheduled for that same time point, with the exception of the body/brain imaging, should also be delayed to coincide with when the time point’s dosing actually occurs.", "display_markers": "T2:b", "source_occurrences": [ { "table_num": 2, "marker": "b", "annotation_id": "annot-020" } ], "referenced_xacts": [], "referenced_xcols": [ "xcol-002", "xcol-003", "xcol-004", "xcol-005", "xcol-006", "xcol-007" ], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-038", "annotation_type": "footnote", "annotation_text": "For Cycle 5 only, participants will return for additional sample collection at Days 3 and 5. Refer to Section 9.5.1 (Table 9.5.1-1) for all details, including allowed windows.", "display_markers": "T2:c", "source_occurrences": [ { "table_num": 2, "marker": "c", "annotation_id": "annot-021" } ], "referenced_xacts": [], "referenced_xcols": [ "xcol-006", "xcol-007" ], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.5.1" }, { "kind": "table", "target": "9.5.1-1" } ] }, { "xannot_id": "xannot-039", "annotation_type": "footnote", "annotation_text": "Samples can be collected ± 3 hours. If participants are dosed on a Thursday, Day 3 samples may be collected on Day 2. If dosed on a Friday, Day 3 sample can be collected on Day 4.", "display_markers": "T2:d", "source_occurrences": [ { "table_num": 2, "marker": "d", "annotation_id": "annot-022" } ], "referenced_xacts": [], "referenced_xcols": [ "xcol-003" ], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-040", "annotation_type": "footnote", "annotation_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.", "display_markers": "T2:e", "source_occurrences": [ { "table_num": 2, "marker": "e", "annotation_id": "annot-023" } ], "referenced_xacts": [ "xact-029" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-041", "annotation_type": "footnote", "annotation_text": "Blood pressure, heart rate, temperature.", "display_markers": "T3:n1", "source_occurrences": [ { "table_num": 3, "marker": "n1", "annotation_id": "annot-001" } ], "referenced_xacts": [ "xact-041" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-042", "annotation_type": "footnote", "annotation_text": "Lansky play score for ≤ 16 years or Karnofsky performance score for > 16 years of age (Appendix 7).", "display_markers": "T3:n2", "source_occurrences": [ { "table_num": 3, "marker": "n2", "annotation_id": "annot-002" } ], "referenced_xacts": [ "xact-007" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "appendix", "target": "7" } ] }, { "xannot_id": "xannot-043", "annotation_type": "footnote", "annotation_text": "Participant should rest for 5 minutes prior to each ECG.", "display_markers": "T3:n3", "source_occurrences": [ { "table_num": 3, "marker": "n3", "annotation_id": "annot-003" } ], "referenced_xacts": [ "xact-042" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-044", "annotation_type": "footnote", "annotation_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.", "display_markers": "T3:n4", "source_occurrences": [ { "table_num": 3, "marker": "n4", "annotation_id": "annot-004" } ], "referenced_xacts": [ "xact-009" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.2.8" }, { "kind": "section", "target": "8.3" } ] }, { "xannot_id": "xannot-045", "annotation_type": "footnote", "annotation_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.", "display_markers": "T3:n5", "source_occurrences": [ { "table_num": 3, "marker": "n5", "annotation_id": "annot-005" } ], "referenced_xacts": [ "xact-044" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-046", "annotation_type": "source_note", "annotation_text": "See Section 9.4.6 for the list of laboratory tests.", "display_markers": "T3:n6", "source_occurrences": [ { "table_num": 3, "marker": "n6", "annotation_id": "annot-006" } ], "referenced_xacts": [ "xact-045" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.4.6" } ] }, { "xannot_id": "xannot-047", "annotation_type": "footnote", "annotation_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.", "display_markers": "T3:n7", "source_occurrences": [ { "table_num": 3, "marker": "n7", "annotation_id": "annot-007" } ], "referenced_xacts": [ "xact-014" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-048", "annotation_type": "source_note", "annotation_text": "See Section 9.1.1 for further details.", "display_markers": "T3:n8", "source_occurrences": [ { "table_num": 3, "marker": "n8", "annotation_id": "annot-008" } ], "referenced_xacts": [ "xact-016" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1.1" } ] }, { "xannot_id": "xannot-049", "annotation_type": "footnote", "annotation_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.", "display_markers": "T3:n9", "source_occurrences": [ { "table_num": 3, "marker": "n9", "annotation_id": "annot-009" } ], "referenced_xacts": [ "xact-017" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1.1" } ] }, { "xannot_id": "xannot-050", "annotation_type": "footnote", "annotation_text": "CSF cytopathology should be obtained in any participant with a previously positive CSF as part of response assessment. See Section 9.1", "display_markers": "T3:n10", "source_occurrences": [ { "table_num": 3, "marker": "n10", "annotation_id": "annot-010" } ], "referenced_xacts": [ "xact-046" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1" } ] }, { "xannot_id": "xannot-051", "annotation_type": "footnote", "annotation_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.", "display_markers": "T3:n11", "source_occurrences": [ { "table_num": 3, "marker": "n11", "annotation_id": "annot-011" } ], "referenced_xacts": [ "xact-047" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "9.1" } ] }, { "xannot_id": "xannot-052", "annotation_type": "footnote", "annotation_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.", "display_markers": "T3:n12", "source_occurrences": [ { "table_num": 3, "marker": "n12", "annotation_id": "annot-012" } ], "referenced_xacts": [ "xact-048" ], "referenced_xcols": [], "referenced_props": [], "cell_references": [], "occurrence_count": 1, "document_references": [ { "kind": "section", "target": "5.1.4" } ] }, { "xannot_id": "xannot-053", "annotation_type": "footnote", "annotation_text": "Participants must be followed for at least 150 days after last dose of study treatment. Follow-up Visit 1 should occur 30 days from the last dose (± 7) days or can be performed on the date of discontinuation if that date is greater than 42 days from last dose. Follow-up Visit 2 occurs approximately 100 days (± 7 days) from last dose of study drug. Follow-up Visit 3 occurs approximately 150 days (± 7 days) from last dose of study drug. All 3 follow-up visits should be conducted in person.", "display_markers": "T3:a", "source_occurrences": [ { "table_num": 3, "marker": "a", "annotation_id": "annot-013" } ], "referenced_xacts": [], "referenced_xcols": [ "xcol-008", "xcol-009", "xcol-010" ], "referenced_props": [], "cell_references": [], "occurrence_count": 1 }, { "xannot_id": "xannot-054", "annotation_type": "footnote", "annotation_text": "Survival follow-up visits to occur every 3 months subsequent to Follow-up Visit 3. Survival visits may be conducted in person or by telephone. Bristol-Myers Squibb may request that survival data be collected on all treated participants outside of the 3 month specified window. At the time of this request, each participant will be contacted to determine their survival status unless the participant has withdrawn consent for all contact.", "display_markers": "T3:b", "source_occurrences": [ { "table_num": 3, "marker": "b", "annotation_id": "annot-014" } ], "referenced_xacts": [], "referenced_xcols": [ "xcol-011" ], "referenced_props": [], "cell_references": [], "occurrence_count": 1 } ], "review_items": [ { "table_number": 2, "id": "D1", "severity": "high", "location": { "page": 31, "row_position": 4, "column_position": 5, "annotation_marker": "*" }, "call_made": "The last line of the Notes cell for Targeted Physical Examination ('*At Day 8 visits collect vital signs only.') is emitted as its own annotation '*' bound to the Day 8 cell that carries 'X*'; the rest of the Notes cell is annotation n1 bound to the activity.", "alternative": "Keep the whole Notes cell, including the '*' line, as one activity-level annotation n1 and leave '*' only as a cell marker, so the Day 8 restriction is read as part of the general row note.", "report_section": "3.3" }, { "table_number": 2, "id": "D2", "severity": "high", "location": { "page": 37, "row_position": 29, "column_position": 4 }, "call_made": "The Oral Hydration Follow-up mark 'X (Day 3-5)' is recorded only in the Cycle 1 Day 5 column (position 4), where it is printed; the rule line between Day 3 and Day 5 is present in that row, so it is not a merged cell. The qualifier is kept literally in the cell value.", "alternative": "Read '(Day 3-5)' as naming the Cycle 1 Day 3 and Day 5 columns and distribute the X across positions 3:4 with source_range '3:4'.", "report_section": "3.2" }, { "table_number": 2, "id": "D3", "severity": "low", "location": { "page": 31, "row_positions": [ 1, 2 ] }, "call_made": "The cycle-length lines ('Cycle = 3 wks', 'Each cycle = 3 wks') and the visit windows ('± 1 day', '- 1 day') are kept inside the cycle and day header cells, giving two header properties (cycle, study_day).", "alternative": "Split them into separate header properties (an 'other' cycle-length row and a 'window' row) so windows are machine-readable per column.", "report_section": "3.1" } ] }