evt_NCT01818063_v12_v13_879a74480ccb

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/overallStatus",
    "/protocolSection/statusModule/whyStopped",
    "/protocolSection/statusModule/startDateStruct/date",
    "/protocolSection/statusModule/startDateStruct/type",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/type",
    "/protocolSection/statusModule/completionDateStruct",
    "/protocolSection/designModule/enrollmentInfo/count",
    "/protocolSection/designModule/enrollmentInfo/type"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT01818063_v12_v13_879a74480ccb. ClinicalTrials.gov NCT01818063, versions 12-13. 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 12 to version 13 for NCT01818063.",
    "The JSON Patch for this comparison has hash 48a2ab7e7522c4c18794a6ca6c0c8e5228583d2f0d3051fd00a0836e7ca949c8.",
    "The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
    "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 12 and 13.",
    "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/startDateStruct/date, /protocolSection/statusModule/startDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/lastUpdatePostDateStruct/type, /protocolSection/statusModule/completionDateStruct, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type.",
    "The whyStopped value was empty or removed in the changed registry record.",
    "The timeline value moved by 24 days.",
    "A timeline value changed and was classified by TrialDiff's timeline signal rules.",
    "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 12 and 13.",
    "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",
      "timeline_shift",
      "timeline_minor_adjustment"
    ],
    "category": "status_termination",
    "deterministic_rules": [
      "enrollment_count_change",
      "enrollment_type_change",
      "why_stopped_change"
    ],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "why_stopped_removed_in_terminal_context"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "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": "timeline_minor_adjustment",
        "date_struct": "startDateStruct",
        "delta_days": 24,
        "direction": "later",
        "new_precision": "day",
        "new_type": "ACTUAL",
        "new_value": "2013-04-25",
        "old_precision": "month",
        "old_type": null,
        "old_value": "2013-04",
        "path": "/protocolSection/statusModule/startDateStruct/date",
        "severity": "low",
        "signal": "timeline_minor_adjustment"
      },
      {
        "category": "timeline_shift",
        "date_struct": "completionDateStruct",
        "direction": "unknown",
        "new_type": "ESTIMATED",
        "new_value": "2019-01",
        "old_type": null,
        "old_value": null,
        "path": "/protocolSection/statusModule/completionDateStruct",
        "reason": "date_unparsed_or_missing",
        "severity": "medium",
        "signal": "timeline_shift"
      },
      {
        "category": "enrollment_change",
        "new_value": 9,
        "old_value": 80,
        "path": "/protocolSection/designModule/enrollmentInfo/count",
        "pct_change": 0.8875,
        "severity": "high",
        "signal": "enrollment_count_change_ge_20pct"
      }
    ]
  },
  "event_id": "evt_NCT01818063_v12_v13_879a74480ccb",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2017-05"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/overallStatus",
      "value": "ACTIVE_NOT_RECRUITING"
    },
    {
      "op": "remove",
      "path": "/protocolSection/statusModule/whyStopped"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/startDateStruct/date",
      "value": "2013-04-25"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/startDateStruct/type",
      "value": "ACTUAL"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2017-05-10"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2017-05-11"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/type",
      "value": "ACTUAL"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/completionDateStruct",
      "value": {
        "date": "2019-01",
        "type": "ESTIMATED"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/designModule/enrollmentInfo/count",
      "value": 9
    },
    {
      "op": "replace",
      "path": "/protocolSection/designModule/enrollmentInfo/type",
      "value": "ACTUAL"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "4d9865d2fd856fe2ce9b853f9ee46aca24df462421bf494008811f2e0fadaa84",
    "materiality_event_hash": "4ff750c979204cd0993624a142cd26f9a8ec548616db7f3ec365c8a7523caa57",
    "patch_hash": "48a2ab7e7522c4c18794a6ca6c0c8e5228583d2f0d3051fd00a0836e7ca949c8",
    "patch_raw_hash": "940b6bcf139ca21599b682e3de269c5cfafff6b239701f40033ccdedce82d537",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT01818063/history/12?patchToVersion=13",
    "to_snapshot_hash": "105dd02827fe671a97d5fb7df220a595da3dc0102fb6fed0bda1cfc0675e93ad"
  },
  "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/NCT01818063",
    "nct_id": "NCT01818063"
  },
  "versions": {
    "from_version": 12,
    "submitted_date": "2017-05-10",
    "to_version": 13
  }
}