evt_NCT03152929_v3_v4_6b7b4c687f1b

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "/protocolSection/designModule/enrollmentInfo/count",
    "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit",
    "/annotationSection",
    "/reviewUnit"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03152929_v3_v4_6b7b4c687f1b. ClinicalTrials.gov NCT03152929, versions 3-4. 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 3 to version 4 for NCT03152929.",
    "The JSON Patch for this comparison has hash 34a95e3aa5b1ee22418eed3354f34ebf2bf3556c2400e76b8dee7d0d0052b47c.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "The deterministic triage label was high; before timing adjustment it was high.",
    "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.",
    "A registry field under enrollment changed between ClinicalTrials.gov versions 3 and 4.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: enrollment_count_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit, /annotationSection, /reviewUnit.",
    "An outcome path changed between versions 3 and 4 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "enrollment_change",
      "results_reconciliation"
    ],
    "category": "enrollment_change",
    "deterministic_rules": [
      "enrollment_count_change"
    ],
    "event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "high",
    "severity_pre_timing": "high",
    "timing_context": "post_recruitment",
    "triage_label": "high",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit",
          "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT03152929_v3_v4_6b7b4c687f1b",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2023-06"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2023-06-05"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2023-06-06"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
      "value": "2023-06-05"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
      "value": {
        "date": "2023-06-06",
        "type": "ACTUAL"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/designModule/enrollmentInfo/count",
      "value": 89
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
      "value": "in PACU, generally 1-3 hours"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
      "value": "in PACU, generally 1-3 hours"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit"
    },
    {
      "op": "remove",
      "path": "/annotationSection"
    },
    {
      "op": "remove",
      "path": "/reviewUnit"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "a366cc536e3ac74a7dacee1559bea6c870691848ff972fa5a9b90df219f04f54",
    "materiality_event_hash": "193bddb7344d45c84a0680100cb88bfb5ba0fac4aa977636316ec94ef4895edb",
    "patch_hash": "34a95e3aa5b1ee22418eed3354f34ebf2bf3556c2400e76b8dee7d0d0052b47c",
    "patch_raw_hash": "005c8359efe4b159322e4ab9d31386e26bdf406aaf2aacf9f0d47ee2062455f5",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT03152929/history/3?patchToVersion=4",
    "to_snapshot_hash": null
  },
  "review_question": "What explains the enrollment change, and does the change affect interpretation of trial feasibility or power?",
  "schema": "trialdiff.evidence_record",
  "trial": {
    "clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT03152929",
    "nct_id": "NCT03152929"
  },
  "versions": {
    "from_version": 3,
    "submitted_date": "2023-06-05",
    "to_version": 4
  }
}