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      "row_position": 13,
      "column_position": 3,
      "cell_value": "• Participants in brain tumor-related cohorts and those with a history of brain metastasis or symptoms should undergo MRI of the brain without and with contrast every 9 weeks (± 7 days) from start of treatment up to 54 weeks, and then approximately every 12 weeks (± 7 days), or sooner if clinically indicated. Tumor assessment schedule should be maintained regardless of dose delays. Cerebrospinal fluid (CSF), if clinically indicated, should be followed as per Response Assessment in Pediatric Neuro-Oncology guidelines.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 13,
      "column_position": 4,
      "cell_value": "• Participants in brain tumor-related cohorts and those with a history of brain metastasis or symptoms should undergo MRI of the brain without and with contrast every 9 weeks (± 7 days) from start of treatment up to 54 weeks, and then approximately every 12 weeks (± 7 days), or sooner if clinically indicated. Tumor assessment schedule should be maintained regardless of dose delays. Cerebrospinal fluid (CSF), if clinically indicated, should be followed as per Response Assessment in Pediatric Neuro-Oncology guidelines.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 13,
      "column_position": 5,
      "cell_value": "• Participants in brain tumor-related cohorts and those with a history of brain metastasis or symptoms should undergo MRI of the brain without and with contrast every 9 weeks (± 7 days) from start of treatment up to 54 weeks, and then approximately every 12 weeks (± 7 days), or sooner if clinically indicated. Tumor assessment schedule should be maintained regardless of dose delays. Cerebrospinal fluid (CSF), if clinically indicated, should be followed as per Response Assessment in Pediatric Neuro-Oncology guidelines.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 13,
      "column_position": 6,
      "cell_value": "• Participants in brain tumor-related cohorts and those with a history of brain metastasis or symptoms should undergo MRI of the brain without and with contrast every 9 weeks (± 7 days) from start of treatment up to 54 weeks, and then approximately every 12 weeks (± 7 days), or sooner if clinically indicated. Tumor assessment schedule should be maintained regardless of dose delays. Cerebrospinal fluid (CSF), if clinically indicated, should be followed as per Response Assessment in Pediatric Neuro-Oncology guidelines.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 13,
      "column_position": 7,
      "cell_value": "• Participants in brain tumor-related cohorts and those with a history of brain metastasis or symptoms should undergo MRI of the brain without and with contrast every 9 weeks (± 7 days) from start of treatment up to 54 weeks, and then approximately every 12 weeks (± 7 days), or sooner if clinically indicated. Tumor assessment schedule should be maintained regardless of dose delays. Cerebrospinal fluid (CSF), if clinically indicated, should be followed as per Response Assessment in Pediatric Neuro-Oncology guidelines.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 14,
      "column_position": 3,
      "cell_value": "Performed at time of imaging assessments for disease response as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 14,
      "column_position": 4,
      "cell_value": "Performed at time of imaging assessments for disease response as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 14,
      "column_position": 5,
      "cell_value": "Performed at time of imaging assessments for disease response as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 14,
      "column_position": 6,
      "cell_value": "Performed at time of imaging assessments for disease response as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 14,
      "column_position": 7,
      "cell_value": "Performed at time of imaging assessments for disease response as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 15,
      "column_position": 3,
      "cell_value": "Performed at time of imaging assessments for disease response as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 15,
      "column_position": 4,
      "cell_value": "Performed at time of imaging assessments for disease response as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 15,
      "column_position": 5,
      "cell_value": "Performed at time of imaging assessments for disease response as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 15,
      "column_position": 6,
      "cell_value": "Performed at time of imaging assessments for disease response as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 15,
      "column_position": 7,
      "cell_value": "Performed at time of imaging assessments for disease response as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 16,
      "column_position": 3,
      "cell_value": "Performed as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 16,
      "column_position": 4,
      "cell_value": "Performed as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 16,
      "column_position": 5,
      "cell_value": "Performed as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 16,
      "column_position": 6,
      "cell_value": "Performed as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 16,
      "column_position": 7,
      "cell_value": "Performed as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 17,
      "column_position": 3,
      "cell_value": "Performed as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 17,
      "column_position": 4,
      "cell_value": "Performed as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 17,
      "column_position": 5,
      "cell_value": "Performed as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 17,
      "column_position": 6,
      "cell_value": "Performed as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 17,
      "column_position": 7,
      "cell_value": "Performed as clinically indicated.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 19,
      "column_position": 3,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 19,
      "column_position": 4,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 19,
      "column_position": 5,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 19,
      "column_position": 6,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 19,
      "column_position": 7,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 20,
      "column_position": 3,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 20,
      "column_position": 4,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 20,
      "column_position": 5,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 20,
      "column_position": 6,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 20,
      "column_position": 7,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 21,
      "column_position": 3,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 21,
      "column_position": 4,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 21,
      "column_position": 5,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 21,
      "column_position": 6,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 21,
      "column_position": 7,
      "cell_value": "See Section 9.5.1 for further details.",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 23,
      "column_position": 3,
      "cell_value": "See Notes",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 23,
      "column_position": 4,
      "cell_value": "See Notes",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 23,
      "column_position": 5,
      "cell_value": "See Notes",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 23,
      "column_position": 6,
      "cell_value": "See Notes",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 23,
      "column_position": 7,
      "cell_value": "See Notes",
      "source_range": "3:7"
    },
    {
      "table_number": 2,
      "row_position": 25,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 26,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 26,
      "column_position": 6,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 27,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 27,
      "column_position": 6,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 28,
      "column_position": 2,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 28,
      "column_position": 6,
      "cell_value": "X"
    },
    {
      "table_number": 2,
      "row_position": 29,
      "column_position": 4,
      "cell_value": "X (Day 3-5)"
    },
    {
      "table_number": 2,
      "row_position": 29,
      "column_position": 7,
      "cell_value": "X"
    }
  ],
  "annotations": [
    {
      "annotation_marker": "n1",
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 4,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n2",
      "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",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 5,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n3",
      "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).",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 6,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n4",
      "annotation_type": "footnote",
      "annotation_text": "Record at each visit.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 7,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n5",
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 9,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n6",
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 10,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n7",
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 12,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n8",
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 13,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n9",
      "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]",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 14,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n10",
      "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]",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 15,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n11",
      "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]",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 16,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n12",
      "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]",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 17,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n13",
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 23,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n14",
      "annotation_type": "source_note",
      "annotation_text": "See Figure 5.1-1, Figure 5.1-2 and Figure 5.1-3.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 25,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n15",
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 26,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n16",
      "annotation_type": "source_note",
      "annotation_text": "See Section 7.1.1.1.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 28,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "n17",
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 29,
          "method": "synthesized"
        }
      ]
    },
    {
      "annotation_marker": "*",
      "annotation_type": "footnote",
      "annotation_text": "At Day 8 visits collect vital signs only.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_cell",
          "row_position": 4,
          "column_position": 5
        }
      ]
    },
    {
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 2
        },
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 3
        },
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 4
        },
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 5
        },
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 6
        },
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 7
        }
      ]
    },
    {
      "annotation_marker": "b",
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 2
        },
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 3
        },
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 4
        },
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 5
        },
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 6
        },
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 7
        }
      ]
    },
    {
      "annotation_marker": "c",
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 6
        },
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 1,
          "column_position": 7
        }
      ]
    },
    {
      "annotation_marker": "d",
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "schedule_property",
          "row_position": 2,
          "column_position": 3
        }
      ]
    },
    {
      "annotation_marker": "e",
      "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.",
      "marker_locations": [
        {
          "table_number": 2,
          "location_type": "activity_name",
          "row_position": 18
        }
      ]
    }
  ],
  "review_items": [
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    }
  ]
}