evt_NCT05243641_v16_v17_ef58571baddf

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/0/value",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/value",
    "/resultsSection/adverseEventsModule/timeFrame",
    "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected",
    "/resultsSection/adverseEventsModule/eventGroups/3/deathsNumAffected",
    "/resultsSection/adverseEventsModule/reviewUnit/resetReasons/0",
    "/resultsSection/adverseEventsModule/allCauseMortalityReviewUnit",
    "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
    "/reviewUnit/resetReasons/0"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT05243641_v16_v17_ef58571baddf. ClinicalTrials.gov NCT05243641, versions 16-17. 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 16 to version 17 for NCT05243641.",
    "The JSON Patch for this comparison has hash a275cf8e2d6ce77c50c72755e6829356201d2b3f66e4886c922fb03614860a88.",
    "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.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: adverse_event_group_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/0/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/value, /resultsSection/adverseEventsModule/timeFrame, /resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected, /resultsSection/adverseEventsModule/eventGroups/3/deathsNumAffected, /resultsSection/adverseEventsModule/reviewUnit/resetReasons/0, /resultsSection/adverseEventsModule/allCauseMortalityReviewUnit, /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date, /reviewUnit/resetReasons/0.",
    "An outcome path changed between versions 16 and 17 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "adverse_event_group_change",
      "results_reconciliation"
    ],
    "category": "adverse_event_group_change",
    "deterministic_rules": [
      "adverse_event_group_change"
    ],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "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": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/secondaryOutcomes/0/description"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT05243641_v16_v17_ef58571baddf",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2025-04"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-04-08"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-04-25"
    },
    {
      "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 for phase II patients."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
      "value": "Patients treated at the MTD in phase II were intended to be evaluated.\nHowever, due to the study's termination during Phase Ib, no patients were analyzed for this objective."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit"
    },
    {
      "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 for phase II patients."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
      "value": "Patients treated at the MTD in phase II were intended to be evaluated.\nHowever, due to the study's termination during Phase Ib, no patients were analyzed for this objective."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/measureCategoriesReviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/0/value",
      "value": "14.3"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/value",
      "value": "33.3"
    },
    {
      "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, up to 3 years."
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected",
      "value": 6
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/3/deathsNumAffected",
      "value": 2
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/reviewUnit/resetReasons/0",
      "value": "The Time Frame appears inconsistent with information provided here or in other parts of the record."
    },
    {
      "op": "remove",
      "path": "/resultsSection/adverseEventsModule/allCauseMortalityReviewUnit"
    },
    {
      "op": "replace",
      "path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
      "value": "2025-04-24"
    },
    {
      "op": "replace",
      "path": "/reviewUnit/resetReasons/0",
      "value": "This record has new issues that must be addressed."
    }
  ],
  "provenance": {
    "from_snapshot_hash": "8dcd2d13da5b547d887f57bdda4fa18bb9edd5f74fc115c2a8bd93a98f9ba672",
    "materiality_event_hash": "458765315a39371f10127db489814725efd82501102234c816de25097457336e",
    "patch_hash": "a275cf8e2d6ce77c50c72755e6829356201d2b3f66e4886c922fb03614860a88",
    "patch_raw_hash": "71ad179f14a058d67e4e87a3f54eceefbd44f6b62f32e8f136e8c5788f777e9f",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT05243641/history/16?patchToVersion=17",
    "to_snapshot_hash": "fd105e8b90b6b313e06fae311fb2c92d44efb188bae352b0cf535b5d7eed9957"
  },
  "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": 16,
    "submitted_date": "2025-04-08",
    "to_version": 17
  }
}