evt_NCT03152929_v2_v3_f33038eddc95

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
    "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit/resetReasons/0",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
    "/resultsSection/participantFlowModule/preAssignmentDetails",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit/resetReasons/0",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit",
    "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
    "/reviewUnit"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03152929_v2_v3_f33038eddc95. ClinicalTrials.gov NCT03152929, versions 2-3. 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 2 to version 3 for NCT03152929.",
    "The JSON Patch for this comparison has hash e6aff97423834b4adee5b2cf5c28a6cf8c09be56f807c5098822c2836f0efc67.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "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/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit/resetReasons/0, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit, /resultsSection/participantFlowModule/preAssignmentDetails, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit/resetReasons/0, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit, /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date, /reviewUnit.",
    "An outcome path changed between versions 2 and 3 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": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "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/0/reviewUnit",
          "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit/resetReasons/0",
          "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT03152929_v2_v3_f33038eddc95",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2023-05"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2023-05-03"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2023-06-02"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "intraoperatively, average of about 1 hour"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
      "value": "in PACU"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit/resetReasons/0",
      "value": "The Time Frame does not appear specific or in the correct format."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
      "value": "intraoperative"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "value": "intraoperative"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit"
    },
    {
      "op": "add",
      "path": "/resultsSection/participantFlowModule/preAssignmentDetails",
      "value": "enrollment was stopped prematurely as the Standard of Care changed due to rising evidence during the enrollment period."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
      "value": "intraoperatively, average of about 1 hour"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
      "value": "in PACU"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit/resetReasons/0",
      "value": "The Time Frame does not appear specific or in the correct format."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
      "value": "intraoperative"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame",
      "value": "intraoperative"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
      "value": "2023-06-01"
    },
    {
      "op": "add",
      "path": "/reviewUnit",
      "value": {
        "resetReasons": [
          "This record has new issues that must be addressed."
        ]
      }
    }
  ],
  "provenance": {
    "from_snapshot_hash": "277c1d27b1ed7ff1058fe9e4c9a91b2c6e1e50a38f60971f6b1cc2813f8e29ff",
    "materiality_event_hash": "a54182405241df6094f4dadfd90f8e8fc8e0823e21d884260e386cdb439a4d35",
    "patch_hash": "e6aff97423834b4adee5b2cf5c28a6cf8c09be56f807c5098822c2836f0efc67",
    "patch_raw_hash": "369ff7c50dae23fa05d52e23c66d0370d424ff3518953a36c2502bd3cb3f6394",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT03152929/history/2?patchToVersion=3",
    "to_snapshot_hash": "a366cc536e3ac74a7dacee1559bea6c870691848ff972fa5a9b90df219f04f54"
  },
  "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/NCT03152929",
    "nct_id": "NCT03152929"
  },
  "versions": {
    "from_version": 2,
    "submitted_date": "2023-05-03",
    "to_version": 3
  }
}