evt_NCT03025035_v22_v23_eafc339d2463

{
  "changed_paths": [
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit",
    "/annotationSection",
    "/reviewUnit"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03025035_v22_v23_eafc339d2463. ClinicalTrials.gov NCT03025035, versions 22-23. 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 22 to version 23 for NCT03025035.",
    "The JSON Patch for this comparison has hash 5a09d66fb6dea4c081e28531dacee2c856d40af7ebc629c36350960e890e555a.",
    "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 late_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit, /annotationSection, /reviewUnit.",
    "An outcome path changed between versions 22 and 23 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": "late_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"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT03025035_v22_v23_eafc339d2463",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-05-28"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-05-29"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
      "value": "2025-05-28"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
      "value": {
        "date": "2025-05-29",
        "type": "ACTUAL"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "Up to 2 Years"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
      "value": "Up to 2 Years"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit"
    },
    {
      "op": "remove",
      "path": "/annotationSection"
    },
    {
      "op": "remove",
      "path": "/reviewUnit"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "5d6366f795c72dc7103517da8612d31f4ad5c192d16129cc87f1af84ff1ad4db",
    "materiality_event_hash": "da1eb386d9ffe1e33871a22b8efe8e652b1a944a1340abc97e661dcb29d8ca87",
    "patch_hash": "5a09d66fb6dea4c081e28531dacee2c856d40af7ebc629c36350960e890e555a",
    "patch_raw_hash": "b514077033769c96098b8e4e7fb410ba1ad890367cda39690c5709b1fe0cd8a6",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT03025035/history/22?patchToVersion=23",
    "to_snapshot_hash": "f1e8bab37e3fa1450ad6316e1d62005b1f6f63926e29abeff972f619ea2f4728"
  },
  "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/NCT03025035",
    "nct_id": "NCT03025035"
  },
  "versions": {
    "from_version": 22,
    "submitted_date": "2025-05-28",
    "to_version": 23
  }
}