evt_NCT04588246_v17_v18_5739cfa1d732

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  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT04588246_v17_v18_5739cfa1d732. ClinicalTrials.gov NCT04588246, versions 17-18. Evidence version 1.",
  "claims_not_supported": [
    "That the amendment was scientifically unjustified.",
    "That the change constitutes misconduct or wrongdoing.",
    "That sponsor intent can be inferred from this registry change.",
    "That the change caused or altered the trial's results.",
    "That the change was or was not disclosed in a manuscript.",
    "That TrialDiff determines regulatory compliance or non-compliance.",
    "That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.",
    "That event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 17 to version 18 for NCT04588246.",
    "The JSON Patch for this comparison has hash 2b2936afadfa8a087581443d0b36cd956af747ea3619d893cf9809057519f266.",
    "The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
    "The deterministic triage label was high; before timing adjustment it was high.",
    "The triage label is uncalibrated metadata, not a validated review-priority finding.",
    "The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting, secondary_outcome_removed_after_primary_completion.",
    "A registry field under an arm or intervention module changed between ClinicalTrials.gov versions 17 and 18.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: arms_or_interventions_change, eligibility_criteria_change, why_stopped_change.",
    "The changed JSON Pointer paths were: /protocolSection/identificationModule/secondaryIdInfos/1, /protocolSection/identificationModule/briefTitle, /protocolSection/identificationModule/officialTitle, /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/whyStopped, /protocolSection/statusModule/startDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/oversightModule/oversightHasDmc, /protocolSection/descriptionModule/briefSummary, /protocolSection/descriptionModule/detailedDescription, /protocolSection/conditionsModule/conditions/1, /protocolSection/conditionsModule/conditions/1, /protocolSection/conditionsModule/conditions/2, /protocolSection/conditionsModule/conditions/3, /protocolSection/conditionsModule/conditions/4, /protocolSection/conditionsModule/conditions/6, /protocolSection/conditionsModule/conditions/9, /protocolSection/conditionsModule/conditions/12, /protocolSection/conditionsModule/conditions/12, /protocolSection/armsInterventionsModule/armGroups/0/label, /protocolSection/armsInterventionsModule/armGroups/0/description, /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/6, /protocolSection/armsInterventionsModule/armGroups/1/label, /protocolSection/armsInterventionsModule/armGroups/1/description, /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2, /protocolSection/armsInterventionsModule/interventions/0/type, /protocolSection/armsInterventionsModule/interventions/0/name, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1, /protocolSection/armsInterventionsModule/interventions/0/otherNames, /protocolSection/armsInterventionsModule/interventions/1/type, /protocolSection/armsInterventionsModule/interventions/1/name, /protocolSection/armsInterventionsModule/interventions/1/description, /protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/1, /protocolSection/armsInterventionsModule/interventions/1/otherNames/0, /protocolSection/armsInterventionsModule/interventions/1/otherNames/1, /protocolSection/armsInterventionsModule/interventions/1/otherNames/2, /protocolSection/armsInterventionsModule/interventions/1/otherNames/3, /protocolSection/armsInterventionsModule/interventions/1/otherNames/4, /protocolSection/armsInterventionsModule/interventions/1/otherNames/5, /protocolSection/armsInterventionsModule/interventions/1/otherNames/6, /protocolSection/armsInterventionsModule/interventions/1/otherNames/7, /protocolSection/armsInterventionsModule/interventions/1/otherNames/8, /protocolSection/armsInterventionsModule/interventions/1/otherNames/9, /protocolSection/armsInterventionsModule/interventions/2/type, /protocolSection/armsInterventionsModule/interventions/2/name, /protocolSection/armsInterventionsModule/interventions/2/description, /protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/1, /protocolSection/armsInterventionsModule/interventions/2/otherNames, /protocolSection/armsInterventionsModule/interventions/3/type, /protocolSection/armsInterventionsModule/interventions/3/name, /protocolSection/armsInterventionsModule/interventions/3/description, /protocolSection/armsInterventionsModule/interventions/3/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/3/armGroupLabels/1, /protocolSection/armsInterventionsModule/interventions/3/otherNames, /protocolSection/armsInterventionsModule/interventions/4/type, /protocolSection/armsInterventionsModule/interventions/4/name, /protocolSection/armsInterventionsModule/interventions/4/description, /protocolSection/armsInterventionsModule/interventions/4/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/4/armGroupLabels/1, /protocolSection/armsInterventionsModule/interventions/4/otherNames/0, /protocolSection/armsInterventionsModule/interventions/4/otherNames/1, /protocolSection/armsInterventionsModule/interventions/5, /protocolSection/armsInterventionsModule/interventions/6, /protocolSection/armsInterventionsModule/interventions/7, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/6, /protocolSection/eligibilityModule/eligibilityCriteria, /protocolSection/contactsLocationsModule/locations/2/zip, /protocolSection/contactsLocationsModule/locations/9, /protocolSection/contactsLocationsModule/locations/39/facility, /protocolSection/contactsLocationsModule/locations/41/facility, /protocolSection/contactsLocationsModule/locations/52, /protocolSection/contactsLocationsModule/locations/53, /protocolSection/contactsLocationsModule/locations/74/facility, /protocolSection/contactsLocationsModule/locations/79, /protocolSection/contactsLocationsModule/locations/80, /annotationSection, /hasResults, /resultsSection, /documentSection.",
    "The timeline value moved by 233 days.",
    "An outcome path changed between versions 17 and 18 in a patch that also carried a hasResults or resultsSection co-occurrence signal.",
    "The JSON Patch removed a whole secondary outcome item after primary completion between versions 17 and 18; when a TO-version outcome list is available, reindex-only removals are excluded.",
    "The changed paths include the ClinicalTrials.gov whyStopped field, a stopped-trial explanation field relevant to 42 CFR 11.64 when applicable."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "arm_intervention_change",
      "status_termination",
      "eligibility_change",
      "timeline_actual_date_correction",
      "results_reconciliation"
    ],
    "category": "arm_intervention_change",
    "deterministic_rules": [
      "arms_or_interventions_change",
      "eligibility_criteria_change",
      "why_stopped_change"
    ],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting",
      "secondary_outcome_removed_after_primary_completion"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "severity": "high",
    "severity_pre_timing": "high",
    "timing_context": "post_recruitment",
    "triage_label": "high",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "timeline_actual_date_correction",
        "date_struct": "startDateStruct",
        "delta_days": 233,
        "direction": "later",
        "new_precision": "day",
        "new_type": "ACTUAL",
        "new_value": "2021-08-05",
        "old_precision": "day",
        "old_type": "ACTUAL",
        "old_value": "2020-12-15",
        "path": "/protocolSection/statusModule/startDateStruct/date",
        "severity": "low",
        "signal": "timeline_actual_date_correction"
      },
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/0/description",
          "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/6"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT04588246_v17_v18_5739cfa1d732",
  "evidence_version": 1,
  "patch": [
    {
      "op": "add",
      "path": "/protocolSection/identificationModule/secondaryIdInfos/1",
      "value": {
        "id": "NRG-BN009"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/identificationModule/briefTitle",
      "value": "Comparing Whole Brain Radiotherapy Using a Technique That Avoids the Hippocampus to Stereotactic Radiosurgery in Patients With Cancer That Has Spread to the Brain and Come Back in Other Areas of the Brain After Earlier Stereotactic Radiosurgery"
    },
    {
      "op": "replace",
      "path": "/protocolSection/identificationModule/officialTitle",
      "value": "Phase III Trial of Stereotactic Radiosurgery (SRS) or Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for Distant Brain Relapse With Brain Metastasis Velocity >/= 4 Brain Metastases/Year"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2025-04"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/whyStopped",
      "value": "Inadequate accrual rate"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/startDateStruct/date",
      "value": "2021-08-05"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-06-05"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-06-06"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
      "value": "2025-04-25"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
      "value": "2025-06-05"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
      "value": {
        "date": "2025-06-06",
        "type": "ACTUAL"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/oversightModule/oversightHasDmc",
      "value": false
    },
    {
      "op": "replace",
      "path": "/protocolSection/descriptionModule/briefSummary",
      "value": "This phase III trial compares the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery.\nHippocampus avoidance during whole-brain radiation therapy decreases the amount of radiation that is delivered to the hippocampus, which is a brain structure that is important for memory.\nThe medicine memantine is also often given with whole brain radiation therapy because it may decrease the risk of side effects of radiation on neurocognitive function (including thinking and memory).\nStereotactic radiosurgery delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue.\nAdding whole brain radiotherapy with hippocampal avoidance and memantine may be effective in reducing the size of the cancer or keeping the cancer the same size when it has spread to the brain and/or come back in other areas of the brain compared to stereotactic radiosurgery."
    },
    {
      "op": "replace",
      "path": "/protocolSection/descriptionModule/detailedDescription",
      "value": "<p>PRIMARY OBJECTIVE:</p><p>I. To determine if hippocampal-avoidant plus whole brain radiotherapy (HA-WBRT) in patients with distant brain failure with brain metastasis velocity &gt;= 4 new brain metastases&#x2F;year prolongs time to neurologic death as compared to stereotactic radiosurgery (SRS).</p><p>SECONDARY OBJECTIVES:</p><p>I. To determine if HA-WBRT in patients with distant brain failure with brain metastasis velocity &gt;= 4 new brain metastases&#x2F;year prolongs overall survival as compared to SRS.</p><p>II.\nTo evaluate if HA-WBRT in patients with distant brain failure with brain metastasis velocity &gt;= 4 new brain metastases&#x2F;year prolongs intracranial progression-free survival as compared to SRS.</p><p>III.\nTo evaluate if HA-WBRT in patients with distant brain failure with brain metastasis velocity &gt;= 4 new brain metastases&#x2F;year improves brain metastasis velocity at subsequent relapse as compared to SRS.</p><p>IV.\nTo assess perceived difficulties in cognitive abilities, symptom burden and health status after HA-WBRT, as compared to SRS, in patients with distant brain failure with brain metastasis velocity &gt;= 4 new brain metastases&#x2F;year.</p><p>V. To compare neurocognitive function outcomes following HA-WBRT, as compared to SRS, in patients with distant brain failure with brain metastasis velocity &gt;= 4 new brain metastases&#x2F;year.</p><p>VI.\nTo tabulate and descriptively compare the adverse events associated with the interventions.</p><p>VII.\nTo tabulate and descriptively compare the number of salvage procedures used to manage recurrent intracranial disease following the interventions.</p><p>EXPLORATORY OBJECTIVES:</p><p>I. To collect serum, plasma, and whole blood for translational research analyses.</p><p>II.\nTo collect baseline and all follow-up magnetic resonance (MR) imaging for hippocampal volume, memory center substructures, axial T2 volumes, and quantitative texture analysis.</p><p>III.\nTo collect baseline and follow-up MR imaging to extract whole brain volume, white matter volume and volume of metastatic disease to correlate with cognitive change at 4 months.</p><p>IV.\nTo evaluate dose-volume histogram parameters to correlate with radiation toxicity.</p><p>V. To assess in patients receiving immunotherapy or targeted therapy, if HA-WBRT in patients with distant brain failure with brain metastasis velocity &gt;= 4 new brain metastases&#x2F;year at time improves brain metastasis velocity and&#x2F;or overall survival at subsequent relapse as compared to SRS.</p><p>VI.\nTo compare the estimated cost of brain-related therapies and quality-adjusted life years in patients who receive HA-WBRT, as compared to SRS, in patients with distant brain failure with metastasis velocity &gt;= 4 new brain metastases&#x2F;year.</p><p>OUTLINE: Patients are randomized to 1 of 2 arms.</p><p>ARM I: Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total of 10 fractions in the absence of disease progression or unacceptable toxicity.\nPrior to HA-WBRT or no later than the 4th treatment, patients also receive memantine orally (PO) once daily (QD) or twice daily (BID) for 24 weeks in the absence of disease progression or unacceptable toxicity.\nPatients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) and may undergo blood sample collection throughout the trial.</p><p>ARM II: Patients undergo single fraction SRS or fractionated SRS (fSRS) on study.\nPatients also undergo CT and MRI and may undergo blood sample collection throughout the trial.</p><p>Patients are followed up at 2, 4, 6, 9, and 12 months from the start of SRS&#x2F;fSFS or HA-WBRT and then every 6 months after month 12 and within 21 days after patient death.</p>"
    },
    {
      "op": "remove",
      "path": "/protocolSection/conditionsModule/conditions/1"
    },
    {
      "op": "remove",
      "path": "/protocolSection/conditionsModule/conditions/1"
    },
    {
      "op": "add",
      "path": "/protocolSection/conditionsModule/conditions/2",
      "value": "Metastatic Lung Small Cell Carcinoma"
    },
    {
      "op": "add",
      "path": "/protocolSection/conditionsModule/conditions/3",
      "value": "Metastatic Malignant Breast Neoplasm"
    },
    {
      "op": "add",
      "path": "/protocolSection/conditionsModule/conditions/4",
      "value": "Metastatic Malignant Digestive System Neoplasm"
    },
    {
      "op": "add",
      "path": "/protocolSection/conditionsModule/conditions/6",
      "value": "Metastatic Malignant Solid Neoplasm"
    },
    {
      "op": "remove",
      "path": "/protocolSection/conditionsModule/conditions/9"
    },
    {
      "op": "remove",
      "path": "/protocolSection/conditionsModule/conditions/12"
    },
    {
      "op": "remove",
      "path": "/protocolSection/conditionsModule/conditions/12"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
      "value": "Arm I (memantine, HA-WBRT)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
      "value": "Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total of 10 fractions in the absence of disease progression or unacceptable toxicity.\nPrior to HA-WBRT or no later than the 4th treatment, patients also receive memantine PO QD or BID for 24 weeks in the absence of disease progression or unacceptable toxicity.\nPatients also undergo CT and MRI and may undergo blood sample collection throughout the trial."
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
      "value": "Procedure: Biospecimen Collection"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1",
      "value": "Procedure: Computed Tomography"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2",
      "value": "Procedure: Magnetic Resonance Imaging"
    },
    {
      "op": "remove",
      "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/6"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
      "value": "Arm II (SRS&#x2F;fSRS)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
      "value": "Patients undergo single fraction SRS or fSRS on study.\nPatients also undergo CT and MRI and may undergo blood sample collection throughout the trial."
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0",
      "value": "Procedure: Biospecimen Collection"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1",
      "value": "Procedure: Computed Tomography"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2",
      "value": "Procedure: Magnetic Resonance Imaging"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/type",
      "value": "PROCEDURE"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/name",
      "value": "Biospecimen Collection"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
      "value": "Undergo blood sample collection"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
      "value": "Arm I (memantine, HA-WBRT)"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1",
      "value": "Arm II (SRS&#x2F;fSRS)"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames",
      "value": [
        "Biological Sample Collection",
        "Biospecimen Collected",
        "Specimen Collection"
      ]
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/type",
      "value": "PROCEDURE"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/name",
      "value": "Computed Tomography"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/description",
      "value": "Undergo CT"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0",
      "value": "Arm I (memantine, HA-WBRT)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/1",
      "value": "Arm II (SRS&#x2F;fSRS)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/0",
      "value": "CAT"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/1",
      "value": "CAT Scan"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/2",
      "value": "Computed Axial Tomography"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/3",
      "value": "Computerized Axial Tomography"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/4",
      "value": "Computerized axial tomography (procedure)"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/5",
      "value": "Computerized Tomography"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/6",
      "value": "Computerized Tomography (CT) scan"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/7",
      "value": "CT"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/8",
      "value": "CT Scan"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/9",
      "value": "tomography"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/2/type",
      "value": "PROCEDURE"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/2/name",
      "value": "Magnetic Resonance Imaging"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/2/description",
      "value": "Undergo MRI"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/0",
      "value": "Arm I (memantine, HA-WBRT)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/1",
      "value": "Arm II (SRS&#x2F;fSRS)"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/2/otherNames",
      "value": [
        "Magnetic Resonance",
        "Magnetic Resonance Imaging (MRI)",
        "Magnetic resonance imaging (procedure)",
        "Magnetic Resonance Imaging Scan",
        "Medical Imaging, Magnetic Resonance &#x2F; Nuclear Magnetic Resonance",
        "MR",
        "MR Imaging",
        "MRI",
        "MRI Scan",
        "MRIs",
        "NMR Imaging",
        "NMRI",
        "Nuclear Magnetic Resonance Imaging",
        "sMRI",
        "Structural MRI"
      ]
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/3/type",
      "value": "DRUG"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/3/name",
      "value": "Memantine"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/3/description",
      "value": "Given PO"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/3/armGroupLabels/0",
      "value": "Arm I (memantine, HA-WBRT)"
    },
    {
      "op": "remove",
      "path": "/protocolSection/armsInterventionsModule/interventions/3/armGroupLabels/1"
    },
    {
      "op": "remove",
      "path": "/protocolSection/armsInterventionsModule/interventions/3/otherNames"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/4/type",
      "value": "OTHER"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/4/name",
      "value": "Quality-of-Life Assessment"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/4/description",
      "value": "Ancillary studies"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/4/armGroupLabels/0",
      "value": "Arm I (memantine, HA-WBRT)"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/4/armGroupLabels/1",
      "value": "Arm II (SRS&#x2F;fSRS)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/4/otherNames/0",
      "value": "Quality of Life Assessment"
    },
    {
      "op": "remove",
      "path": "/protocolSection/armsInterventionsModule/interventions/4/otherNames/1"
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/5",
      "value": {
        "armGroupLabels": [
          "Arm I (memantine, HA-WBRT)",
          "Arm II (SRS&#x2F;fSRS)"
        ],
        "description": "Ancillary studies",
        "name": "Questionnaire Administration",
        "type": "OTHER"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/6",
      "value": {
        "armGroupLabels": [
          "Arm II (SRS&#x2F;fSRS)"
        ],
        "description": "Undergo SRS&#x2F;fSRS",
        "name": "Stereotactic Radiosurgery",
        "otherNames": [
          "SRS",
          "Stereotactic External Beam Irradiation",
          "stereotactic external-beam radiation therapy",
          "Stereotactic Radiation Therapy",
          "Stereotactic Radiotherapy",
          "stereotaxic radiation therapy",
          "stereotaxic radiosurgery"
        ],
        "type": "RADIATION"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/interventions/7",
      "value": {
        "armGroupLabels": [
          "Arm I (memantine, HA-WBRT)"
        ],
        "description": "Undergo HA-WBRT",
        "name": "Whole-Brain Radiotherapy",
        "otherNames": [
          "WBRT",
          "whole-brain radiation therapy"
        ],
        "type": "RADIATION"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "value": "Percentage of Participants With Neurologic Death"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "Neurologic death defined as 1) Progressive neurologic decline or new neurologic symptoms&#x2F;signs at time of death irrespective of status of extracranial disease OR 2) Death from inter-current disease in patients with severe neurologic dysfunction.\nNeurologic death rates were to be estimated using the cumulative incidence method, treating non-neurologic deaths as competing risks, and otherwise censoring participants alive at time of analysis.\nAnalysis was to occur after 127 neurologic death events overall.\nThe primary comparison of treatment arms would be a one-sided 0.05-level test for cause-specific hazard ratio (CHR) in a Cox proportional hazards model.\nGiven the small number of participants due to early study closure, only the number of patients with neurologic death is reported and no statistical testing was done."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "From baseline to neurologic death or last follow-up. Maximum follow-up at time of study termination was 29.7 months."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "value": "Overall Survival"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "value": "Survival rates were to be estimated using the Kaplan-Meier method and the treatment arms were to be compared using a stratified log-rank test.\nGiven the small number of participants due to early study closure, only the number of patients alive at time of study termination is reported, and no statistical testing was done."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
      "value": "Baseline to death or last follow-up. Maximum follow-up at time of study termination was 29.7 months."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "value": "IPFS rates were to be estimated using the Kaplan-Meier method and the treatment arms were to be compared using a stratified log-rank test.\nGiven the small number of participants due to early study closure, only the number of patients with alive without intracranial progression is reported, and no statistical testing was done.\nPer the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria, intracranial progression is defined as local progression of lesions treated with prior radiation or distant progression&#x2F;development of a new brain lesion.\nGiven the small number of participants due to early study closure, only the number of patients alive without intracranial progression is reported and no statistical testing was done."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "value": "Baseline to intracranial progression, death, or last follow-up. Maximum follow-up at time of study termination was 29.7 months."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
      "value": "Brain Metastasis Velocity at Subsequent Relapse (BMVs)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
      "value": "BMVs = [total number of new brain metastases since on-study SRS&#x2F;HA-WBRT] &#x2F; (years since on-study SRS&#x2F;HA-WBRT).\nBMVs is calculated at the time of distant brain relapse.\nHigher BMVs is associated with lower rates of survival and higher rates of neurologic death."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "value": "Baseline to death or last follow-up. Maximum follow-up at time of study termination was 29.7 months."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
      "value": "Change From Baseline in the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
      "value": "The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the presence and severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors.\nEach item ranges from 0 (&quot;not present&quot;) to 10 (&quot;as bad as you can imagine&quot;) and is rated as the worst occurrence in the last 24 hours.\nThe Symptom Severity subscale score is the average of the symptom severity items, ranging from 0 (best) to 10 (worst).\nChange from baseline is calculated as score at 4 months minus score at baseline.\nA negative change value indicates improvement in symptom severity, while a positive change value indicates worsening."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
      "value": "Baseline and 4 months from treatment start"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
      "value": "Number of Participants With a Grade 3 or Higher Adverse Event"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
      "value": "Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event.\nAdverse events reported as possibly, probably, or definitely related to treatment are considered to be treatment-related adverse events.\nSummary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
      "value": "Baseline to last follow-up. Maximum follow-up at time of study termination was 29.7 months."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
      "value": "Number of Participants Who Received Salvage Procedures"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
      "value": "Salvage procedures are defined as procedures for the purpose of managing recurrent intracranial disease following protocol treatment."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
      "value": "Baseline to last follow-up. Maximum follow-up at time of study termination was 29.7 months."
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/6"
    },
    {
      "op": "replace",
      "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
      "value": "<p>Inclusion Criteria:</p><ul><li><p>Patients must have developed their distant brain relapse(s) at least 8 weeks after last SRS and within 21 days prior to randomization</p><ul><li>Distant brain relapse lesions to be treated must measure =&lt; 3.0 cm in maximal extent and total volume of distant brain relapses to be treated must measure &lt; 30 mL on the contrast-enhanced diagnostic MRI brain scan obtained within 21 days prior to randomization</li><li>&quot;last SRS&quot; refers to the most recent SRS procedure that the patient received prior to enrollment on this study</li><li><p>Distant brain relapse lesions must be diagnosed on MRI, which will include the following elements:</p><ul><li><p>REQUIRED MRI ELEMENTS</p><ul><li>Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR).\nAcceptable 3D SPGR sequences include magnetization-prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (brain volume imaging) or 3D fast FE (field echo).\nThe T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm</li><li>Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged)</li><li>A minimum of one axial T2 fluid attenuated inversion recovery (FLAIR) (preferred) or T2 sequence is required.\nThis can be acquired as a 2D or 3D image.\nIf 2D, the images should be obtained in the axial plane</li></ul></li><li><p>ADDITIONAL RECOMMENDATIONS</p><ul><li>Recommendation is that an axial T2 FLAIR (preferred) sequence be performed instead of a T2 sequence</li><li>Recommendation is that that pre-contrast 3D T1 be performed with the same parameters as the post-contrast 3D T1</li><li>Recommendation is that imaging be performed on a 3 Tesla (3T) MRI</li><li>Recommendation is that the study participants be scanned on the same MRI instrument at each time point</li><li>Recommendation is that if additional sequences are obtained, these should meet the criteria outlined in Kaufmann et al., 2020</li><li>If additional sequences are obtained, total imaging time should not exceed 60 minutes</li></ul></li></ul></li></ul></li><li>Brain metastasis velocity (BMV) since last SRS must be &gt;= 4 brain metastases&#x2F;year</li><li>The patient or a legally authorized representative must provide study-specific informed consent prior to study entry</li><li><p>Pathologically (histologically or cytologically) proven diagnosis of small cell cancer, non-small cell lung cancer, melanoma, breast cancer, renal cell carcinoma, or gastrointestinal cancer within 10 years prior to randomization.\nIf the original histologic proof of malignancy is greater than 10 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)</p><ul><li>Other histologies are not permitted</li></ul></li><li>History and physical examination within 28 days prior to randomization</li><li>Age &gt;= 18</li><li>Karnofsky performance status of &gt;= 70 within 28 days prior to randomization</li><li>Calculated creatinine clearance (CrCl) &gt;= 30 ml&#x2F;min (within 28 days prior to randomization)</li><li>Blood urea nitrogen (BUN) within 1.5 times the institutional upper limit of normal (ULN) (e.g., if the ULN is 20 mg&#x2F;dL, then BUN up to 30 mg&#x2F;dL is permitted) (within 28 days prior to randomization)</li><li>Negative urine or serum pregnancy test (in women of childbearing potential) within 14 days prior to randomization</li></ul><p>Exclusion Criteria:</p><ul><li><p>BMV &gt;= 4 brain metastases&#x2F;year at time of any SRS prior to enrollment.</p><ul><li>Patients are permitted to have undergone multiple SRS treatments to different brain metastases so long as prior BMV has been less than 4 brain metastases&#x2F;year</li></ul></li><li>Prior WBRT or prophylactic cranial irradiation</li><li>Local relapse of metastasis previously treated with upfront SRS (i.e., relapse outside previously SRS-treated metastases is allowed)</li><li>Brain metastases from primary germ cell tumor or lymphoma</li><li>Definitive leptomeningeal metastasis</li><li>Planned cytotoxic chemotherapy on the same day as SRS or HA-WBRT; concurrent immunotherapy is permitted</li><li>Radiographic evidence of enlargement or other architectural distortion of the lateral ventricles, including placement of external ventricular drain or ventriculoperitoneal shunt</li><li>Known history of demyelinating disease such as multiple sclerosis</li><li>Inability to swallow pills</li><li>Contraindication to MR imaging such as non-MR conditional implanted metal devices or unknown metallic foreign bodies, or contraindication to gadolinium contrast administration during MR imaging, such as anaphylactic allergy that cannot be adequately addressed with pre-contrast medications or acute kidney injury</li><li><p>Contraindications to memantine, including:</p><ul><li>Allergy, including prior allergic reaction to memantine</li><li>Intractable seizures on adequate anticonvulsive therapy-more than 1 seizure per month for the past 2 months</li><li>Current use of N-methyl-D-asparatate (NMDA) agonist</li><li>Current alcohol or drug abuse, which can exacerbate lethargy&#x2F;dizziness with memantine</li></ul></li><li><p>Severe, active co-morbidity defined as follows:</p><ul><li>Unstable angina and&#x2F;or congestive heart failure requiring hospitalization within the last 6 months</li><li>Transmural myocardial infarction within the last 6 months</li><li>Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization</li><li>Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization</li><li>Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease</li><li>Renal tubular acidosis or metabolic acidosis</li><li>Human immunodeficiency virus (HIV) positive with CD4 count &lt; 200 cells&#x2F;microliter.\nNote that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count &gt;= 200 cells&#x2F;microliter within 30 days prior to randomization.\nNote also that HIV testing is not required for eligibility for this protocol</li></ul></li><li>Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing&#x2F;able to use medically acceptable forms of contraception; this exclusion is necessary because the medication and radiation involved in this study has unknown effects on the unborn fetus</li></ul>"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/2/zip",
      "value": "92882"
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/9",
      "value": {
        "city": "San Francisco",
        "country": "United States",
        "facility": "California Pacific Medical Center-Pacific Campus",
        "geoPoint": {
          "lat": 37.77493,
          "lon": -122.41942
        },
        "state": "California",
        "zip": "94115"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/39/facility",
      "value": "Trinity Health Saint Joseph Mercy Hospital Ann Arbor"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/41/facility",
      "value": "Chelsea Hospital"
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/52",
      "value": {
        "city": "Syracuse",
        "country": "United States",
        "facility": "State University of New York Upstate Medical University",
        "geoPoint": {
          "lat": 43.04812,
          "lon": -76.14742
        },
        "state": "New York",
        "zip": "13210"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/53",
      "value": {
        "city": "Verona",
        "country": "United States",
        "facility": "Upstate Cancer Center at Verona",
        "geoPoint": {
          "lat": 43.13812,
          "lon": -75.57073
        },
        "state": "New York",
        "zip": "13478"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/74/facility",
      "value": "University of Wisconsin Carbone Cancer Center - University Hospital"
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/79",
      "value": {
        "city": "Montreal",
        "country": "Canada",
        "facility": "CHUM - Centre Hospitalier de l&#x27;Universite de Montreal",
        "geoPoint": {
          "lat": 45.50884,
          "lon": -73.58781
        },
        "state": "Quebec",
        "zip": "H2X 3E4"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/contactsLocationsModule/locations/80",
      "value": {
        "city": "Chai Wan",
        "country": "Hong Kong",
        "facility": "Pamela Youde Nethersole Eastern Hospital",
        "geoPoint": {
          "lat": 22.26718,
          "lon": 114.24051
        }
      }
    },
    {
      "op": "remove",
      "path": "/annotationSection"
    },
    {
      "op": "replace",
      "path": "/hasResults",
      "value": true
    },
    {
      "op": "add",
      "path": "/resultsSection",
      "value": {
        "adverseEventsModule": {
          "description": "All-cause mortality was assessed in eligible participants.\nAdverse events were assessed in eligible participants who started protocol treatment.",
          "eventGroups": [
            {
              "deathsNumAffected": 5,
              "deathsNumAtRisk": 10,
              "description": "Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total 30 Gy in 10 fractions in the absence of disease progression or unacceptable toxicity.\nConsolidative SRS boost following HA-WBRT is permitted during the follow-up period before progression.\nPrior to HA-WBRT or no later than the 4th treatment, patients also receive memantine target BID dose 20 mg&#x2F;day or target extended-release dose 28mg&#x2F;day in the absence of disease progression or unacceptable toxicity.",
              "id": "EG000",
              "otherNumAffected": 6,
              "otherNumAtRisk": 8,
              "seriousNumAffected": 4,
              "seriousNumAtRisk": 8,
              "title": "Arm I (Memantine, HA-WBRT)"
            },
            {
              "deathsNumAffected": 4,
              "deathsNumAtRisk": 9,
              "description": "Patients undergo salvage SRS or fSRS.",
              "id": "EG001",
              "otherNumAffected": 6,
              "otherNumAtRisk": 8,
              "seriousNumAffected": 1,
              "seriousNumAtRisk": 8,
              "title": "Arm II (SRS&#x2F;Fractionated Stereotactic Radiosurgery(fSRS))"
            }
          ],
          "frequencyThreshold": "0",
          "otherEvents": [
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Atrial fibrillation"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Sinus tachycardia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Ear and labyrinth disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Hearing impaired"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Endocrine disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Hypothyroidism"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Eye disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Blurred vision"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Eye disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Eye pain"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Eye disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Floaters"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Abdominal pain"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Constipation"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 8
                }
              ],
              "term": "Diarrhea"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Dry mouth"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 8
                }
              ],
              "term": "Nausea"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Vomiting"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Edema limbs"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 4,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 3,
                  "numAtRisk": 8
                }
              ],
              "term": "Fatigue"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Fever"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Gait disturbance"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Urinary tract infection"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Dermatitis radiation"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Fall"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 8
                }
              ],
              "term": "Weight loss"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Anorexia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Hypokalemia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Hyponatremia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Arthralgia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Back pain"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Bone pain"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 2,
                  "numAtRisk": 8
                }
              ],
              "term": "Generalized muscle weakness"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Neck pain"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Dizziness"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Dysgeusia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Facial nerve disorder"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 3,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Headache"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 4,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Memory impairment"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Muscle weakness left-sided"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Paresthesia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Seizure"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Psychiatric disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Confusion"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Psychiatric disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Depression"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Psychiatric disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Insomnia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Renal and urinary disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Chronic kidney disease"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Renal and urinary disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Urinary incontinence"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Renal and urinary disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Urinary urgency"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Cough"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 3,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Dyspnea"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Hypoxia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Pleural effusion"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Alopecia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Dry skin"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Skin ulceration"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Hypertension"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Thromboembolic event"
            }
          ],
          "seriousEvents": [
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Blood and lymphatic system disorders - Other"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Leukocytosis"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Small intestinal obstruction"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Fatigue"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 0,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Lung infection"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Fall"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 1,
                  "numAtRisk": 8
                }
              ],
              "term": "Generalized muscle weakness"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Encephalopathy"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "sourceVocabulary": "CTCAE (5.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 8
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 8
                }
              ],
              "term": "Memory impairment"
            }
          ],
          "timeFrame": "Baseline to last follow-up. Maximum follow-up was 29.7 months."
        },
        "baselineCharacteristicsModule": {
          "denoms": [
            {
              "counts": [
                {
                  "groupId": "BG000",
                  "value": "10"
                },
                {
                  "groupId": "BG001",
                  "value": "9"
                },
                {
                  "groupId": "BG002",
                  "value": "19"
                }
              ],
              "units": "Participants"
            }
          ],
          "groups": [
            {
              "description": "Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total 30 Gy in 10 fractions in the absence of disease progression or unacceptable toxicity.\nConsolidative SRS boost following HA-WBRT is permitted during the follow-up period before progression.\nPrior to HA-WBRT or no later than the 4th treatment, patients also receive memantine target BID dose 20 mg&#x2F;day or target extended-release dose 28mg&#x2F;day in the absence of disease progression or unacceptable toxicity.",
              "id": "BG000",
              "title": "Arm I (Memantine, HA-WBRT)"
            },
            {
              "description": "Patients undergo salvage SRS or fSRS.",
              "id": "BG001",
              "title": "Arm II (SRS&#x2F;fSRS)"
            },
            {
              "description": "Total of all reporting groups",
              "id": "BG002",
              "title": "Total"
            }
          ],
          "measures": [
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "lowerLimit": "52",
                          "upperLimit": "75",
                          "value": "63.5"
                        },
                        {
                          "groupId": "BG001",
                          "lowerLimit": "56",
                          "upperLimit": "75",
                          "value": "60"
                        },
                        {
                          "groupId": "BG002",
                          "lowerLimit": "52",
                          "upperLimit": "75",
                          "value": "63"
                        }
                      ]
                    }
                  ]
                }
              ],
              "dispersionType": "FULL_RANGE",
              "paramType": "MEDIAN",
              "title": "Age, Continuous",
              "unitOfMeasure": "years"
            },
            {
              "calculatePct": false,
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "6"
                        },
                        {
                          "groupId": "BG001",
                          "value": "8"
                        },
                        {
                          "groupId": "BG002",
                          "value": "14"
                        }
                      ],
                      "title": "Female"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "4"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "5"
                        }
                      ],
                      "title": "Male"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Sex: Female, Male",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "1"
                        }
                      ],
                      "title": "Hispanic or Latino"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "9"
                        },
                        {
                          "groupId": "BG001",
                          "value": "9"
                        },
                        {
                          "groupId": "BG002",
                          "value": "18"
                        }
                      ],
                      "title": "Not Hispanic or Latino"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "Unknown or Not Reported"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Ethnicity (NIH&#x2F;OMB)",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "American Indian or Alaska Native"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "Asian"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "Native Hawaiian or Other Pacific Islander"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "3"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "3"
                        }
                      ],
                      "title": "Black or African American"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "7"
                        },
                        {
                          "groupId": "BG001",
                          "value": "9"
                        },
                        {
                          "groupId": "BG002",
                          "value": "16"
                        }
                      ],
                      "title": "White"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "More than one race"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "Unknown or Not Reported"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Race (NIH&#x2F;OMB)",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "3"
                        },
                        {
                          "groupId": "BG001",
                          "value": "2"
                        },
                        {
                          "groupId": "BG002",
                          "value": "5"
                        }
                      ],
                      "title": "70"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "3"
                        },
                        {
                          "groupId": "BG001",
                          "value": "4"
                        },
                        {
                          "groupId": "BG002",
                          "value": "7"
                        }
                      ],
                      "title": "80"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "4"
                        },
                        {
                          "groupId": "BG001",
                          "value": "3"
                        },
                        {
                          "groupId": "BG002",
                          "value": "7"
                        }
                      ],
                      "title": "90"
                    }
                  ]
                }
              ],
              "description": "70 = Cares for self, unable to carry on normal activity or to do active work; 80 = Normal activity with effort, some signs or symptoms of disease; 90 = Able to carry on normal activity, minor signs or symptoms of disease; 100 = Normal no complaints, no evidence of disease.",
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Karnofsky performance status",
              "unitOfMeasure": "Participants"
            },
            {
              "calculatePct": false,
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "2"
                        },
                        {
                          "groupId": "BG001",
                          "value": "4"
                        },
                        {
                          "groupId": "BG002",
                          "value": "6"
                        }
                      ],
                      "title": "4 - 13"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "8"
                        },
                        {
                          "groupId": "BG001",
                          "value": "5"
                        },
                        {
                          "groupId": "BG002",
                          "value": "13"
                        }
                      ],
                      "title": "&gt;13"
                    }
                  ]
                }
              ],
              "description": "BMV = [Total number of new brain metastases since last SRS]&#x2F;[Time interval (in years) since upfront SRS].\n&quot;Last SRS&quot; refers to the most recent SRS procedure that the participant received prior to enrollment on this study.\nIt is calculated at the time of distant brain relapse after SRS.\nHigher BMV is associated with lower rates of survival and higher rates of neurologic death.",
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Brain Metastasis Velocity (BMV)",
              "unitOfMeasure": "Participants"
            },
            {
              "calculatePct": false,
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "8"
                        },
                        {
                          "groupId": "BG001",
                          "value": "8"
                        },
                        {
                          "groupId": "BG002",
                          "value": "16"
                        }
                      ],
                      "title": "No"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "2"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "3"
                        }
                      ],
                      "title": "Yes"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Is participant receiving immunotherapy?",
              "unitOfMeasure": "Participants"
            },
            {
              "calculatePct": false,
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "9"
                        },
                        {
                          "groupId": "BG001",
                          "value": "6"
                        },
                        {
                          "groupId": "BG002",
                          "value": "15"
                        }
                      ],
                      "title": "0-2"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1"
                        },
                        {
                          "groupId": "BG001",
                          "value": "3"
                        },
                        {
                          "groupId": "BG002",
                          "value": "4"
                        }
                      ],
                      "title": "3-4"
                    }
                  ]
                }
              ],
              "description": "A tool used by healthcare professionals to estimate the survival of patients with brain metastases based on the prognostic factors of the primary cancer.\nIt provides a score ranging from 0 (worst prognosis) to 4 (best prognosis).",
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Diagnosis-specific graded prognostic assessment (DS-GPA)",
              "unitOfMeasure": "Participants"
            }
          ],
          "populationDescription": "Randomized participants"
        },
        "moreInfoModule": {
          "certainAgreement": {
            "otherDetails": "PI&#x27;s are required to abide by the sponsor&#x27;s publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.",
            "piSponsorEmployee": false,
            "restrictionType": "OTHER",
            "restrictiveAgreement": true
          },
          "limitationsAndCaveats": {
            "description": "This study stopped accrual and data collection early due to unmet targeted accrual goals, with 19 participants enrolled out of 350 planned."
          },
          "pointOfContact": {
            "email": "seiferheldw@nrgoncology.org",
            "organization": "NRG Oncology",
            "phone": "215-574-3208",
            "title": "Wendy Seiferheld"
          }
        },
        "outcomeMeasuresModule": {
          "outcomeMeasures": [
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "3"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "10"
                    },
                    {
                      "groupId": "OG001",
                      "value": "9"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Neurologic death defined as 1) Progressive neurologic decline or new neurologic symptoms&#x2F;signs at time of death irrespective of status of extracranial disease OR 2) Death from inter-current disease in patients with severe neurologic dysfunction.\nNeurologic death rates were to be estimated using the cumulative incidence method, treating non-neurologic deaths as competing risks, and otherwise censoring participants alive at time of analysis.\nAnalysis was to occur after 127 neurologic death events overall.\nThe primary comparison of treatment arms would be a one-sided 0.05-level test for cause-specific hazard ratio (CHR) in a Cox proportional hazards model.\nGiven the small number of participants due to early study closure, only the number of patients with neurologic death is reported and no statistical testing was done.",
              "groups": [
                {
                  "description": "Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total 30 Gy in 10 fractions in the absence of disease progression or unacceptable toxicity.\nConsolidative SRS boost following HA-WBRT is permitted during the follow-up period before progression.\nPrior to HA-WBRT or no later than the 4th treatment, patients also receive memantine target BID dose 20 mg&#x2F;day or target extended-release dose 28mg&#x2F;day in the absence of disease progression or unacceptable toxicity.",
                  "id": "OG000",
                  "title": "Arm I (Memantine, HA-WBRT)"
                },
                {
                  "description": "Patients undergo salvage SRS or fSRS.",
                  "id": "OG001",
                  "title": "Arm II (SRS&#x2F;Fractionated Stereotactic Radiosurgery(fSRS))"
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "populationDescription": "Randomized participants",
              "reportingStatus": "POSTED",
              "timeFrame": "From baseline to neurologic death or last follow-up. Maximum follow-up at time of study termination was 29.7 months.",
              "title": "Percentage of Participants With Neurologic Death",
              "type": "PRIMARY",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "5"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "10"
                    },
                    {
                      "groupId": "OG001",
                      "value": "9"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Survival rates were to be estimated using the Kaplan-Meier method and the treatment arms were to be compared using a stratified log-rank test.\nGiven the small number of participants due to early study closure, only the number of patients alive at time of study termination is reported, and no statistical testing was done.",
              "groups": [
                {
                  "description": "Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total 30 Gy in 10 fractions in the absence of disease progression or unacceptable toxicity.\nConsolidative SRS boost following HA-WBRT is permitted during the follow-up period before progression.\nPrior to HA-WBRT or no later than the 4th treatment, patients also receive memantine target BID dose 20 mg&#x2F;day or target extended-release dose 28 mg&#x2F;day in the absence of disease progression or unacceptable toxicity.",
                  "id": "OG000",
                  "title": "Arm I (Memantine, HA-WBRT)"
                },
                {
                  "description": "Patients undergo salvage SRS or fSRS.",
                  "id": "OG001",
                  "title": "Arm II (SRS&#x2F;fSRS)"
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "populationDescription": "Randomized participants",
              "reportingStatus": "POSTED",
              "timeFrame": "Baseline to death or last follow-up. Maximum follow-up at time of study termination was 29.7 months.",
              "title": "Overall Survival",
              "type": "SECONDARY",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "5"
                        },
                        {
                          "groupId": "OG001",
                          "value": "2"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "10"
                    },
                    {
                      "groupId": "OG001",
                      "value": "9"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "IPFS rates were to be estimated using the Kaplan-Meier method and the treatment arms were to be compared using a stratified log-rank test.\nGiven the small number of participants due to early study closure, only the number of patients with alive without intracranial progression is reported, and no statistical testing was done.\nPer the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria, intracranial progression is defined as local progression of lesions treated with prior radiation or distant progression&#x2F;development of a new brain lesion.\nGiven the small number of participants due to early study closure, only the number of patients alive without intracranial progression is reported and no statistical testing was done.",
              "groups": [
                {
                  "description": "Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total 30 Gy in 10 fractions in the absence of disease progression or unacceptable toxicity.\nConsolidative SRS boost following HA-WBRT is permitted during the follow-up period before progression.\nPrior to HA-WBRT or no later than the 4th treatment, patients also receive memantine target BID dose 20 mg&#x2F;day or target extended-release dose 28 mg&#x2F;day in the absence of disease progression or unacceptable toxicity.",
                  "id": "OG000",
                  "title": "Arm I (Memantine, HA-WBRT)"
                },
                {
                  "description": "Patients undergo salvage SRS or fSRS.",
                  "id": "OG001",
                  "title": "Arm II (SRS&#x2F;fSRS)"
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "populationDescription": "Randomized participants",
              "reportingStatus": "POSTED",
              "timeFrame": "Baseline to intracranial progression, death, or last follow-up. Maximum follow-up at time of study termination was 29.7 months.",
              "title": "Intracranial Progression-Free Survival (IPFS)",
              "type": "SECONDARY",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG001",
                          "lowerLimit": "21.90",
                          "upperLimit": "104.29",
                          "value": "33.18"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "0"
                    },
                    {
                      "groupId": "OG001",
                      "value": "5"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "BMVs = [total number of new brain metastases since on-study SRS&#x2F;HA-WBRT] &#x2F; (years since on-study SRS&#x2F;HA-WBRT).\nBMVs is calculated at the time of distant brain relapse.\nHigher BMVs is associated with lower rates of survival and higher rates of neurologic death.",
              "dispersionType": "Full Range",
              "groups": [
                {
                  "description": "Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total 30 Gy in 10 fractions in the absence of disease progression or unacceptable toxicity.\nConsolidative SRS boost following HA-WBRT is permitted during the follow-up period before progression.\nPrior to HA-WBRT or no later than the 4th treatment, patients also receive memantine target BID dose 20 mg&#x2F;day or target extended-release dose 28 mg&#x2F;day in the absence of disease progression or unacceptable toxicity.",
                  "id": "OG000",
                  "title": "Arm I (Memantine, HA-WBRT)"
                },
                {
                  "description": "Patients undergo salvage SRS or fSRS.",
                  "id": "OG001",
                  "title": "Arm II (SRS&#x2F;fSRS)"
                }
              ],
              "paramType": "MEDIAN",
              "populationDescription": "Randomized participants who subsequently relapsed with new brain metastases",
              "reportingStatus": "POSTED",
              "timeFrame": "Baseline to death or last follow-up. Maximum follow-up at time of study termination was 29.7 months.",
              "title": "Brain Metastasis Velocity at Subsequent Relapse (BMVs)",
              "type": "SECONDARY",
              "unitOfMeasure": "brain metastases&#x2F;year"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "1.29",
                          "value": "-0.82"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "1.61",
                          "value": "0.53"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "5"
                    },
                    {
                      "groupId": "OG001",
                      "value": "4"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the presence and severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors.\nEach item ranges from 0 (&quot;not present&quot;) to 10 (&quot;as bad as you can imagine&quot;) and is rated as the worst occurrence in the last 24 hours.\nThe Symptom Severity subscale score is the average of the symptom severity items, ranging from 0 (best) to 10 (worst).\nChange from baseline is calculated as score at 4 months minus score at baseline.\nA negative change value indicates improvement in symptom severity, while a positive change value indicates worsening.",
              "dispersionType": "Standard Deviation",
              "groups": [
                {
                  "description": "Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total 30 Gy in 10 fractions in the absence of disease progression or unacceptable toxicity.\nConsolidative SRS boost following HA-WBRT is permitted during the follow-up period before progression.\nPrior to HA-WBRT or no later than the 4th treatment, patients also receive memantine target BID dose 20 mg&#x2F;day or target extended-release dose 28 mg&#x2F;day in the absence of disease progression or unacceptable toxicity.",
                  "id": "OG000",
                  "title": "Arm I (Memantine, HA-WBRT)"
                },
                {
                  "description": "Patients undergo salvage SRS or fSRS.",
                  "id": "OG001",
                  "title": "Arm II (SRS&#x2F;fSRS)"
                }
              ],
              "paramType": "MEAN",
              "populationDescription": "Randomized participants with data at baseline and 4 months from start of treatment",
              "reportingStatus": "POSTED",
              "timeFrame": "Baseline and 4 months from treatment start",
              "title": "Change From Baseline in the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score",
              "type": "SECONDARY",
              "unitOfMeasure": "score on a scale"
            },
            {
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                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "4"
                        },
                        {
                          "groupId": "OG001",
                          "value": "3"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "8"
                    },
                    {
                      "groupId": "OG001",
                      "value": "8"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event.\nAdverse events reported as possibly, probably, or definitely related to treatment are considered to be treatment-related adverse events.\nSummary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.",
              "groups": [
                {
                  "description": "Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total 30 Gy in 10 fractions in the absence of disease progression or unacceptable toxicity.\nConsolidative SRS boost following HA-WBRT is permitted during the follow-up period before progression.\nPrior to HA-WBRT or no later than the 4th treatment, patients also receive memantine target BID dose 20 mg&#x2F;day or target extended-release dose 28 mg&#x2F;day in the absence of disease progression or unacceptable toxicity.",
                  "id": "OG000",
                  "title": "Arm I (Memantine, HA-WBRT)"
                },
                {
                  "description": "Patients undergo salvage SRS or fSRS.",
                  "id": "OG001",
                  "title": "Arm II (SRS&#x2F;fSRS)"
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "populationDescription": "Randomized participants who started treatment",
              "reportingStatus": "POSTED",
              "timeFrame": "Baseline to last follow-up. Maximum follow-up at time of study termination was 29.7 months.",
              "title": "Number of Participants With a Grade 3 or Higher Adverse Event",
              "type": "SECONDARY",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "2"
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                          "groupId": "OG001",
                          "value": "1"
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              "denoms": [
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                      "value": "8"
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                    {
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                      "value": "8"
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                  "units": "Participants"
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              "description": "Salvage procedures are defined as procedures for the purpose of managing recurrent intracranial disease following protocol treatment.",
              "groups": [
                {
                  "description": "Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total 30 Gy in 10 fractions in the absence of disease progression or unacceptable toxicity.\nConsolidative SRS boost following HA-WBRT is permitted during the follow-up period before progression.\nPrior to HA-WBRT or no later than the 4th treatment, patients also receive memantine target BID dose 20 mg&#x2F;day or target extended-release dose 28 mg&#x2F;day in the absence of disease progression or unacceptable toxicity.",
                  "id": "OG000",
                  "title": "Arm I (Memantine, HA-WBRT)"
                },
                {
                  "description": "Patients undergo salvage SRS or fSRS.",
                  "id": "OG001",
                  "title": "Arm II (SRS&#x2F;fSRS)"
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "populationDescription": "Randomized participants who started treatment",
              "reportingStatus": "POSTED",
              "timeFrame": "Baseline to last follow-up. Maximum follow-up at time of study termination was 29.7 months.",
              "title": "Number of Participants Who Received Salvage Procedures",
              "type": "SECONDARY",
              "unitOfMeasure": "Participants"
            }
          ]
        },
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          "groups": [
            {
              "description": "Patients undergo hippocampal-avoidant whole brain radiotherapy (HA-WBRT) daily (5 times weekly) for 2 weeks for a total 30 Gy in 10 fractions in the absence of disease progression or unacceptable toxicity.\nConsolidative stereotactic radiosurgery (SRS) boost following HA-WBRT is permitted during the follow-up period before progression.\nPrior to HA-WBRT or no later than the 4th treatment, patients also receive memantine target twice daily (BID) dose 20 mg&#x2F;day or target extended-release dose 28 mg&#x2F;day in the absence of disease progression or unacceptable toxicity.",
              "id": "FG000",
              "title": "Arm I (Memantine, HA-WBRT)"
            },
            {
              "description": "Patients undergo salvage SRS or fractionated stereotactic radiosurgery(fSRS).",
              "id": "FG001",
              "title": "Arm II (SRS&#x2F;fSRS)"
            }
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                      "numSubjects": "10"
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                      "numSubjects": "9"
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                  "comment": "Randomized",
                  "type": "STARTED"
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                      "numSubjects": "10"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "9"
                    }
                  ],
                  "comment": "Participants contributing data to results are considered to have completed the study.",
                  "type": "COMPLETED"
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                    {
                      "groupId": "FG000",
                      "numSubjects": "0"
                    },
                    {
                      "groupId": "FG001",
                      "numSubjects": "0"
                    }
                  ],
                  "type": "NOT COMPLETED"
                }
              ],
              "title": "Overall Study"
            }
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              "hasSap": true,
              "label": "Study Protocol and Statistical Analysis Plan",
              "size": 994755,
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              "uploadDate": "2025-04-24T10:38"
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              "date": "2023-04-06",
              "filename": "ICF_001.pdf",
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              "hasProtocol": false,
              "hasSap": false,
              "label": "Informed Consent Form",
              "size": 274620,
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    "materiality_event_hash": "284e790803f01b3218af88b10c44e06aa70a5a4712ef8aa96eb0358bba2ecb62",
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    "patch_raw_hash": "ce38fc1d29b02170eecb6a978a6ed44d1ed5c4d5fef97fc731a23db0e07aab37",
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  "review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
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  "versions": {
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}