evt_NCT05243641_v18_v19_571a3485cf50

{
  "changed_paths": [
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reviewUnit",
    "/annotationSection",
    "/reviewUnit"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT05243641_v18_v19_571a3485cf50. ClinicalTrials.gov NCT05243641, versions 18-19. 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 18 to version 19 for NCT05243641.",
    "The JSON Patch for this comparison has hash d72791c5cd3d74e5fb023ea279b9a9bbab8a6914ea7f951836714941c9638ab8.",
    "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 post_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reviewUnit, /annotationSection, /reviewUnit.",
    "An outcome path changed between versions 18 and 19 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": "post_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT05243641_v18_v19_571a3485cf50",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-04-30"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-05-15"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
      "value": "2025-04-30"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
      "value": {
        "date": "2025-05-15",
        "type": "ACTUAL"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "value": "Up to 27 months"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "value": "Up to 27 months"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
      "value": "Up to 27 months"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
      "value": "Up to 27 months"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame",
      "value": "Up to 27 months"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame",
      "value": "Up to 27 months"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reviewUnit"
    },
    {
      "op": "remove",
      "path": "/annotationSection"
    },
    {
      "op": "remove",
      "path": "/reviewUnit"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "4bce221b78fc3005f1924281fb2332708054de7451839ceb3bf4f00b333673c5",
    "materiality_event_hash": "df0fdf0290d871df41445940e5fe86ed0570a565455d9bebe1bf14b38933906b",
    "patch_hash": "d72791c5cd3d74e5fb023ea279b9a9bbab8a6914ea7f951836714941c9638ab8",
    "patch_raw_hash": "a006da8e77fd8fc9b449d74ea87549ac520718811cc663c736f743f25bed1f0b",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT05243641/history/18?patchToVersion=19",
    "to_snapshot_hash": "dbd3572c9c64845d2868fefa6f60f1b88ec1e4a065a5996f2566c0323e3534de"
  },
  "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": 18,
    "submitted_date": "2025-04-30",
    "to_version": 19
  }
}