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      ],
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          "kind": "section",
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        },
        {
          "kind": "section",
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      ]
    },
    {
      "annotation_id": "annot-003",
      "table_id": "table-001",
      "annotation_marker": "n3",
      "annotation_type": "footnote",
      "annotation_text": "All relevant medical history including smoking history, and prior anti-cancer therapies.",
      "annotation_scope": "activity",
      "referenced_elements": {
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        "activity_ids": [
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          "row_position": 5,
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        }
      ]
    },
    {
      "annotation_id": "annot-004",
      "table_id": "table-001",
      "annotation_marker": "n4",
      "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.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
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    },
    {
      "annotation_id": "annot-005",
      "table_id": "table-001",
      "annotation_marker": "n5",
      "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).",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
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        ],
        "cell_references": []
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          "method": "synthesized"
        }
      ],
      "document_references": [
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          "kind": "appendix",
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        }
      ]
    },
    {
      "annotation_id": "annot-006",
      "table_id": "table-001",
      "annotation_marker": "n6",
      "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.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
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      },
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          "location_type": "activity_name",
          "row_position": 9,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_id": "annot-007",
      "table_id": "table-001",
      "annotation_marker": "n7",
      "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.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
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      ]
    },
    {
      "annotation_id": "annot-008",
      "table_id": "table-001",
      "annotation_marker": "n8",
      "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).",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
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      },
      "marker_locations": [
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      ],
      "document_references": [
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      ]
    },
    {
      "annotation_id": "annot-009",
      "table_id": "table-001",
      "annotation_marker": "n9",
      "annotation_type": "footnote",
      "annotation_text": "Within 14 days prior to treatment (see Section 9.4.3).",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
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        ],
        "cell_references": []
      },
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          "method": "synthesized"
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      ],
      "document_references": [
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          "kind": "section",
          "target": "9.4.3"
        }
      ]
    },
    {
      "annotation_id": "annot-010",
      "table_id": "table-001",
      "annotation_marker": "n10",
      "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.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-013"
        ],
        "cell_references": []
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          "row_position": 14,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_id": "annot-011",
      "table_id": "table-001",
      "annotation_marker": "n11",
      "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.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-014"
        ],
        "cell_references": []
      },
      "marker_locations": [
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          "location_type": "activity_name",
          "row_position": 15,
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        }
      ]
    },
    {
      "annotation_id": "annot-012",
      "table_id": "table-001",
      "annotation_marker": "n12",
      "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.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
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        ],
        "cell_references": []
      },
      "marker_locations": [
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          "method": "synthesized"
        }
      ],
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          "kind": "section",
          "target": "9.1.1"
        }
      ]
    },
    {
      "annotation_id": "annot-013",
      "table_id": "table-001",
      "annotation_marker": "n13",
      "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.",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-017"
        ],
        "cell_references": []
      },
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      ]
    },
    {
      "annotation_id": "annot-014",
      "table_id": "table-001",
      "annotation_marker": "n14",
      "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]",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-018"
        ],
        "cell_references": []
      },
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          "method": "synthesized"
        }
      ],
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          "kind": "section",
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        }
      ]
    },
    {
      "annotation_id": "annot-015",
      "table_id": "table-001",
      "annotation_marker": "n15",
      "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]",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-019"
        ],
        "cell_references": []
      },
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          "kind": "section",
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        }
      ]
    },
    {
      "annotation_id": "annot-016",
      "table_id": "table-001",
      "annotation_marker": "n16",
      "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]",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
          "act-020"
        ],
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      },
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        }
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          "kind": "section",
          "target": "9.1.2.5"
        }
      ]
    },
    {
      "annotation_id": "annot-017",
      "table_id": "table-001",
      "annotation_marker": "n17",
      "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]",
      "annotation_scope": "activity",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [],
        "activity_ids": [
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        ],
        "cell_references": []
      },
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    },
    {
      "annotation_id": "annot-018",
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      "annotation_marker": "a",
      "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.",
      "annotation_scope": "column",
      "referenced_elements": {
        "property_ids": [],
        "column_ids": [
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        ],
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        "cell_references": []
      },
      "marker_locations": [
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          "location_type": "schedule_property",
          "row_position": 1,
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        }
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  "review_items": []
}