evt_NCT01147016_v16_v17_ca258d9e35de

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/overallStatus",
    "/protocolSection/statusModule/whyStopped",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/designModule/enrollmentInfo/count",
    "/protocolSection/designModule/enrollmentInfo/type"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT01147016_v16_v17_ca258d9e35de. ClinicalTrials.gov NCT01147016, versions 16-17. 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 TrialDiff determines whether the stopped-trial explanation satisfies 42 CFR 11.64.",
    "That event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 16 to version 17 for NCT01147016.",
    "The JSON Patch for this comparison has hash b621ed8855becc6d2f95a76123dc481ba1eb9e9849820273565d5941b41aa41c.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "The deterministic triage label was critical; before timing adjustment it was critical.",
    "The triage label is uncalibrated metadata, not a validated review-priority finding.",
    "The patch satisfied these deterministic event-class predicates: why_stopped_removed_in_terminal_context.",
    "A registry field under the status or stopped-trial explanation module changed between ClinicalTrials.gov versions 16 and 17.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: enrollment_count_change, enrollment_type_change, why_stopped_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/whyStopped, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type.",
    "The whyStopped value was empty or removed in the changed registry record.",
    "The enrollment count changed by at least 20 percent.",
    "The whyStopped field changed from nonempty to empty or absent in a terminal-status context between versions 16 and 17.",
    "The changed paths include the ClinicalTrials.gov whyStopped field, a stopped-trial explanation field relevant to 42 CFR 11.64 when applicable."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "status_termination",
      "enrollment_change"
    ],
    "category": "status_termination",
    "deterministic_rules": [
      "enrollment_count_change",
      "enrollment_type_change",
      "why_stopped_change"
    ],
    "event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
    "event_classes": [
      "why_stopped_removed_in_terminal_context"
    ],
    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "critical",
    "severity_pre_timing": "critical",
    "timing_context": "post_recruitment",
    "triage_label": "critical",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "status_termination",
        "path": "/protocolSection/statusModule/whyStopped",
        "severity": "critical",
        "signal": "why_stopped_empty"
      },
      {
        "category": "enrollment_change",
        "new_value": 8,
        "old_value": 32,
        "path": "/protocolSection/designModule/enrollmentInfo/count",
        "pct_change": 0.75,
        "severity": "high",
        "signal": "enrollment_count_change_ge_20pct"
      }
    ]
  },
  "event_id": "evt_NCT01147016_v16_v17_ca258d9e35de",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2016-12"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/overallStatus",
      "value": "ACTIVE_NOT_RECRUITING"
    },
    {
      "op": "remove",
      "path": "/protocolSection/statusModule/whyStopped"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2016-12-05"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2016-12-07"
    },
    {
      "op": "replace",
      "path": "/protocolSection/designModule/enrollmentInfo/count",
      "value": 8
    },
    {
      "op": "replace",
      "path": "/protocolSection/designModule/enrollmentInfo/type",
      "value": "ACTUAL"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "66c5f600580b7bc8d89e672cb11b2fe29ca64d3903848080313b33b61db5b22e",
    "materiality_event_hash": "48d2abe3670f3687eea8e9458fa001c6817463a806cc7f6a00285f991ae351e1",
    "patch_hash": "b621ed8855becc6d2f95a76123dc481ba1eb9e9849820273565d5941b41aa41c",
    "patch_raw_hash": "733e8ad5bf9f2e452ef060a199a26fd3650e7a6b1e58da35d88869c40af810f6",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT01147016/history/16?patchToVersion=17",
    "to_snapshot_hash": "acc6d2a9df0f220d24e62a62ab3f4e95fc0d6f7da4fe206feb1ec4b0e876564c"
  },
  "review_question": "Does the public registry record give a specific explanation for the stopped or terminal status?",
  "schema": "trialdiff.evidence_record",
  "trial": {
    "clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT01147016",
    "nct_id": "NCT01147016"
  },
  "versions": {
    "from_version": 16,
    "submitted_date": "2016-12-05",
    "to_version": 17
  }
}