evt_NCT05243641_v17_v18_e624c50b11cc

{
  "changed_paths": [
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reviewUnit",
    "/resultsSection/adverseEventsModule/timeFrame",
    "/resultsSection/adverseEventsModule/reviewUnit",
    "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT05243641_v17_v18_e624c50b11cc. ClinicalTrials.gov NCT05243641, 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 NCT05243641.",
    "The JSON Patch for this comparison has hash 6604e68e30c5cd06708dc86076c0d033f79b6a6ab95de41599529a23a1feb8fd.",
    "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/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reviewUnit, /resultsSection/adverseEventsModule/timeFrame, /resultsSection/adverseEventsModule/reviewUnit, /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date.",
    "An outcome path changed between versions 17 and 18 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/secondaryOutcomes/1/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT05243641_v17_v18_e624c50b11cc",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-04-29"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-05-01"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
      "value": {
        "resetReasons": [
          "The Time Frame appears inconsistent with information provided here or in other parts of the record."
        ]
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit",
      "value": {
        "resetReasons": [
          "The Time Frame appears inconsistent with information provided here or in other parts of the record."
        ]
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit",
      "value": {
        "resetReasons": [
          "The Time Frame appears inconsistent with information provided here or in other parts of the record."
        ]
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit",
      "value": {
        "resetReasons": [
          "The Time Frame appears inconsistent with information provided here or in other parts of the record."
        ]
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit",
      "value": {
        "resetReasons": [
          "The Time Frame appears inconsistent with information provided here or in other parts of the record."
        ]
      }
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reviewUnit",
      "value": {
        "resetReasons": [
          "The Time Frame appears inconsistent with information provided here or in other parts of the record."
        ]
      }
    },
    {
      "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 27 months."
    },
    {
      "op": "remove",
      "path": "/resultsSection/adverseEventsModule/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
      "value": "2025-04-30"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "fd105e8b90b6b313e06fae311fb2c92d44efb188bae352b0cf535b5d7eed9957",
    "materiality_event_hash": "27a3744911e571f3731a8cab39189b42d76309f7fb1f8c1e97249d5580aa1520",
    "patch_hash": "6604e68e30c5cd06708dc86076c0d033f79b6a6ab95de41599529a23a1feb8fd",
    "patch_raw_hash": "26e78af52a7f18808f6235fb84f1d3d986ef3c881f4f73b8360a3c21bbee7bbf",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT05243641/history/17?patchToVersion=18",
    "to_snapshot_hash": "4bce221b78fc3005f1924281fb2332708054de7451839ceb3bf4f00b333673c5"
  },
  "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": 17,
    "submitted_date": "2025-04-29",
    "to_version": 18
  }
}