evt_NCT03025035_v21_v22_59cd215bd319

{
  "changed_paths": [
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
    "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
    "/reviewUnit/resetReasons/0"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03025035_v21_v22_59cd215bd319. ClinicalTrials.gov NCT03025035, versions 21-22. 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 21 to version 22 for NCT03025035.",
    "The JSON Patch for this comparison has hash f02a7cb19ae786ce59a9c37eed40f56a22700d237b009a95f26958050371fed8.",
    "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/outcomesModule/primaryOutcomes/0/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame, /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date, /reviewUnit/resetReasons/0.",
    "An outcome path changed between versions 21 and 22 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/timeFrame"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT03025035_v21_v22_59cd215bd319",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-05-23"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-05-28"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "assessment every 9 weeks during the first year and while on the study drug, and every 12 weeks thereafter until all patients off study"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
      "value": "assessment every 9 weeks during the first year and while on the study drug, and every 12 weeks thereafter until all patients off study"
    },
    {
      "op": "replace",
      "path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
      "value": "2025-05-27"
    },
    {
      "op": "replace",
      "path": "/reviewUnit/resetReasons/0",
      "value": "Issues noted on a previous submission of this record do not appear to have been addressed."
    }
  ],
  "provenance": {
    "from_snapshot_hash": "9cc52e41cc66d07a05e822a084883cf472757b8259f061a9ff81f4291d269679",
    "materiality_event_hash": "b5e3612f63c0d9c5f36ca49b0aba86253b4a200b73b3e4af37916e183fa059d4",
    "patch_hash": "f02a7cb19ae786ce59a9c37eed40f56a22700d237b009a95f26958050371fed8",
    "patch_raw_hash": "10f7bffe224154418011f94a08570a1361a32c00f15dfd7811ea1256e81711c9",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT03025035/history/21?patchToVersion=22",
    "to_snapshot_hash": "5d6366f795c72dc7103517da8612d31f4ad5c192d16129cc87f1af84ff1ad4db"
  },
  "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": 21,
    "submitted_date": "2025-05-23",
    "to_version": 22
  }
}