evt_NCT05243641_v15_v16_20841cc192d8

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
    "/protocolSection/outcomesModule/primaryOutcomes/1/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/2/lowerLimit",
    "/resultsSection/baselineCharacteristicsModule/measures/0/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/1",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/2",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/3",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/4",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/5",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/0/value",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/1",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/2",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/3",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/4",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/5",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/paramType",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/dispersionType",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/unitOfMeasure",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/0/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/1",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/2",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/3",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/4",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/5",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/0/value",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/1",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/2",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/3",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/4",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/5",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/paramType",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/unitOfMeasure",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/0/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/1",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/2",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/3",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/4",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/0/value",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/1",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/2",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/3",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/4",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/paramType",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/dispersionType",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/unitOfMeasure",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/0/title",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/1",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/2",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/3",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/4",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/5",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/0/value",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/1",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/2",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/3",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/4",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/5",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/paramType",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/unitOfMeasure",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes",
    "/resultsSection/adverseEventsModule/timeFrame",
    "/resultsSection/adverseEventsModule/description",
    "/resultsSection/adverseEventsModule/allCauseMortalityReviewUnit",
    "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT05243641_v15_v16_20841cc192d8. ClinicalTrials.gov NCT05243641, versions 15-16. 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 15 to version 16 for NCT05243641.",
    "The JSON Patch for this comparison has hash 15fc843ce689bc79268be01909de636b7c27a4581c1c301d582bb0af0c16ae42.",
    "The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
    "The deterministic triage label was low; before timing adjustment it was low.",
    "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.",
    "The timing context for the from-version record was post_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/2/lowerLimit, /resultsSection/baselineCharacteristicsModule/measures/0/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/1, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/3, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/4, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/5, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/0/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/1, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/3, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/4, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/5, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/paramType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/dispersionType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/unitOfMeasure, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/0/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/1, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/3, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/4, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/5, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/0/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/1, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/3, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/4, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/5, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/paramType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/unitOfMeasure, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/0/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/1, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/3, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/4, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/0/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/1, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/3, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/4, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/paramType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/dispersionType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/unitOfMeasure, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/0/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/1, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/3, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/4, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/5, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/0/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/1, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/3, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/4, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/5, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/paramType, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/unitOfMeasure, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes, /resultsSection/adverseEventsModule/timeFrame, /resultsSection/adverseEventsModule/description, /resultsSection/adverseEventsModule/allCauseMortalityReviewUnit, /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date.",
    "An outcome path changed between versions 15 and 16 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "results_reconciliation"
    ],
    "category": "results_reconciliation",
    "deterministic_rules": [],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "severity": "low",
    "severity_pre_timing": "low",
    "timing_context": "post_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/1/description",
          "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/description"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT05243641_v15_v16_20841cc192d8",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2025-03"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-03-24"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-04-09"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
      "value": "To Determine Overall Response Rate"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
      "value": "The overall response rate (ORR) for patients treated at the MTD in Phase II was assessed.\nORR was defined as the proportion of patients who achieved a partial response or complete response as their best response.\nAll tumor responses were evaluated according to RECIST 1.1 criteria and measured using the QIAC system."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "value": "Adverse events (AEs) graded using CTCAE version 5.0: ≥ Grade 2 for non-hematological and ≥ Grade 3 for hematological AEs observed after the first protocol intervention."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "value": "Clinical benefit rate (CBR) is defined as the proportion of patients achieving complete response, partial response, or stable disease for ≥24 weeks, was summarized by frequency and percentage with Wilson 95% confidence intervals, overall and by dose level."
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/2/lowerLimit",
      "value": "34"
    },
    {
      "op": "remove",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/0/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/title",
      "value": "To Determine Overall Response Rate"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
      "value": "The overall response rate (ORR) for patients treated at the MTD in Phase II was assessed.\nORR was defined as the proportion of patients who achieved a partial response or complete response as their best response.\nAll tumor responses were evaluated according to RECIST 1.1 criteria and measured using the QIAC system."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
      "value": "Patients treated at the MTD in Phase II."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
      "value": "Adverse events (AEs) graded using CTCAE version 5.0: ≥ Grade 2 for non-hematological and ≥ Grade 3 for hematological AEs observed after the first protocol intervention."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
      "value": "Patients treated at the MTD in Phase II."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description",
      "value": "Clinical benefit rate (CBR) is defined as the proportion of patients achieving complete response, partial response, or stable disease for ≥24 weeks, was summarized by frequency and percentage with Wilson 95% confidence intervals, overall and by dose level."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/populationDescription",
      "value": "The baseline analysis population included all treated participants.\nHowever, patients who discontinued the study due to toxicities before completing Cycle 2 and without a RECIST assessment after therapy were excluded."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/title",
      "value": "Phase Ib: Dose Level 1"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/description",
      "value": "Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/1",
      "value": {
        "description": "Neratinib 120 mg Dose 1-7,160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily",
        "id": "OG001",
        "title": "Phase Ib: Dose Level 2"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/2",
      "value": {
        "description": "Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily",
        "id": "OG002",
        "title": "Phase Ib: Dose Level 3"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/3",
      "value": {
        "description": "Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily",
        "id": "OG003",
        "title": "Phase Ib: Dose Level-1"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/4",
      "value": {
        "description": "Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily",
        "id": "OG004",
        "title": "Phase Ib: Dose Level-2"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/5",
      "value": {
        "description": "Subjects receive neratinib and capmatinib.\nThe MTD determined during Phase Ib will be used.",
        "id": "OG005",
        "title": "Phase II"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/0/value",
      "value": "5"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/1",
      "value": {
        "groupId": "OG001",
        "value": "0"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/2",
      "value": {
        "groupId": "OG002",
        "value": "0"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/3",
      "value": {
        "groupId": "OG003",
        "value": "2"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/4",
      "value": {
        "groupId": "OG004",
        "value": "0"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/5",
      "value": {
        "groupId": "OG005",
        "value": "0"
      }
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/paramType",
      "value": "NUMBER"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/dispersionType",
      "value": "95% Confidence Interval"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/unitOfMeasure",
      "value": "percentage"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes",
      "value": [
        {
          "categories": [
            {
              "measurements": [
                {
                  "groupId": "OG000",
                  "lowerLimit": "3.6",
                  "upperLimit": "62.4",
                  "value": "20.0"
                },
                {
                  "groupId": "OG003",
                  "lowerLimit": "0.0",
                  "upperLimit": "65.8",
                  "value": "0.0"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription",
      "value": "Baseline analysis population included all participants treated."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/0/title",
      "value": "Phase Ib: Dose Level 1"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/0/description",
      "value": "Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/1",
      "value": {
        "description": "Neratinib 120 mg Dose 1-7,160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily",
        "id": "OG001",
        "title": "Phase Ib: Dose Level 2"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/2",
      "value": {
        "description": "Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily",
        "id": "OG002",
        "title": "Phase Ib: Dose Level 3"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/3",
      "value": {
        "description": "Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily",
        "id": "OG003",
        "title": "Phase Ib: Dose Level-1"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/4",
      "value": {
        "description": "Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily",
        "id": "OG004",
        "title": "Phase Ib: Dose Level-2"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/5",
      "value": {
        "description": "Subjects receive neratinib and capmatinib.\nThe MTD determined during Phase Ib will be used.",
        "id": "OG005",
        "title": "Phase II"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/0/value",
      "value": "7"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/1",
      "value": {
        "groupId": "OG001",
        "value": "0"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/2",
      "value": {
        "groupId": "OG002",
        "value": "0"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/3",
      "value": {
        "groupId": "OG003",
        "value": "3"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/4",
      "value": {
        "groupId": "OG004",
        "value": "0"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms/0/counts/5",
      "value": {
        "groupId": "OG005",
        "value": "0"
      }
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/paramType",
      "value": "NUMBER"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/unitOfMeasure",
      "value": "Months"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/classes",
      "value": [
        {
          "categories": [
            {
              "measurements": [
                {
                  "comment": "No patient experienced partial response nor complete response, so duration of response is not estimable.",
                  "groupId": "OG000",
                  "value": "NA"
                },
                {
                  "comment": "No patient experienced partial response nor complete response, so duration of response is not estimable.",
                  "groupId": "OG003",
                  "value": "NA"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/populationDescription",
      "value": "Baseline analysis population included all participants treated."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/0/title",
      "value": "Phase Ib: Dose Level 1"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/0/description",
      "value": "Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/1",
      "value": {
        "description": "Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily",
        "id": "OG001",
        "title": "Phase Ib: Dose Level 2"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/2",
      "value": {
        "description": "Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily",
        "id": "OG002",
        "title": "Phase Ib: Dose Level 3"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/3",
      "value": {
        "description": "Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily",
        "id": "OG003",
        "title": "Phase Ib: Dose Level-2"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/4",
      "value": {
        "description": "Subjects receive neratinib and capmatinib.\nThe MTD determined during Phase Ib will be used.",
        "id": "OG004",
        "title": "Phase II"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/0/value",
      "value": "7"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/1",
      "value": {
        "groupId": "OG001",
        "value": "0"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/2",
      "value": {
        "groupId": "OG002",
        "value": "0"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/3",
      "value": {
        "groupId": "OG003",
        "value": "3"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms/0/counts/4",
      "value": {
        "groupId": "OG004",
        "value": "0"
      }
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/measureCategoriesReviewUnit"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/paramType",
      "value": "MEAN"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/dispersionType",
      "value": "95% Confidence Interval"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/unitOfMeasure",
      "value": "Months"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/classes",
      "value": [
        {
          "categories": [
            {
              "measurements": [
                {
                  "groupId": "OG000",
                  "lowerLimit": "2.13",
                  "upperLimit": "7.39",
                  "value": "4.76"
                },
                {
                  "groupId": "OG003",
                  "lowerLimit": "0.70",
                  "upperLimit": "8.38",
                  "value": "4.54"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/populationDescription",
      "value": "All patients who received at least one dose of the study medication."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/0/title",
      "value": "Phase Ib: Dose Level 1"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/0/description",
      "value": "Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 400 mg twice daily"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/1",
      "value": {
        "description": "Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 200 mg through end of treatment once daily + Capmatinib 400 mg twice daily",
        "id": "OG001",
        "title": "Phase Ib: Dose Level 2"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/2",
      "value": {
        "description": "Neratinib 120 mg Dose 1-7, 160 mg Dose 8-14, 240 mg through end of treatment once daily + Capmatinib 400 mg twice daily",
        "id": "OG002",
        "title": "Phase Ib: Dose Level 3"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/3",
      "value": {
        "description": "Neratinib 120 mg Dose 1-7, 160 mg through end of treatment once daily + Capmatinib 300 mg twice daily",
        "id": "OG003",
        "title": "Phase Ib: Dose Level-1"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/4",
      "value": {
        "description": "Neratinib 120 mg through end of treatment once daily + Capmatinib 200 mg twice daily",
        "id": "OG004",
        "title": "Phase Ib: Dose Level-2"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/5",
      "value": {
        "description": "Subjects receive neratinib and capmatinib.\nThe MTD determined during Phase Ib will be used.",
        "id": "OG005",
        "title": "Phase II"
      }
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/0/value",
      "value": "7"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/1",
      "value": {
        "groupId": "OG001",
        "value": "0"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/2",
      "value": {
        "groupId": "OG002",
        "value": "0"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/3",
      "value": {
        "groupId": "OG003",
        "value": "3"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/4",
      "value": {
        "groupId": "OG004",
        "value": "0"
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms/0/counts/5",
      "value": {
        "groupId": "OG005",
        "value": "0"
      }
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/measureCategoriesReviewUnit"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/paramType",
      "value": "NUMBER"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/unitOfMeasure",
      "value": "Percentage"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes",
      "value": [
        {
          "categories": [
            {
              "measurements": [
                {
                  "groupId": "OG000",
                  "value": "85.7"
                },
                {
                  "groupId": "OG003",
                  "value": "66.7"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/timeFrame",
      "value": "From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug."
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/description",
      "value": "Adverse events were evaluated based on the CTCAE version 5.0.\nAll study participants who received neratinib and capmatinib combination therapy were included in the safety analysis."
    },
    {
      "op": "add",
      "path": "/resultsSection/adverseEventsModule/allCauseMortalityReviewUnit",
      "value": {
        "resetReasons": [
          "Information in other parts of the record suggests that adverse events were collected that are not reported here."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
      "value": "2025-04-08"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "649f00a9e565cc060c3c6c8d277dee9546a914898571e9b70e032ee7a750c9d9",
    "materiality_event_hash": "4bd019445d38a4f4529d1d5b96e5518cba502be3bccf8c0a8c32d73107cfbc4c",
    "patch_hash": "15fc843ce689bc79268be01909de636b7c27a4581c1c301d582bb0af0c16ae42",
    "patch_raw_hash": "e39456f4a88718b016f86e1771c0049fba4e1e1a3e8481e9d27fc067a485243d",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT05243641/history/15?patchToVersion=16",
    "to_snapshot_hash": "8dcd2d13da5b547d887f57bdda4fa18bb9edd5f74fc115c2a8bd93a98f9ba672"
  },
  "review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
  "schema": "trialdiff.evidence_record",
  "trial": {
    "clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT05243641",
    "nct_id": "NCT05243641"
  },
  "versions": {
    "from_version": 15,
    "submitted_date": "2025-03-24",
    "to_version": 16
  }
}