evt_NCT00165256_v7_v8_54cd6306925b

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/overallStatus",
    "/protocolSection/statusModule/whyStopped",
    "/protocolSection/statusModule/completionDateStruct/date",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/type",
    "/protocolSection/designModule/studyType",
    "/protocolSection/designModule/patientRegistry",
    "/protocolSection/designModule/designInfo/observationalModel",
    "/protocolSection/designModule/designInfo/timePerspective",
    "/protocolSection/designModule/designInfo/allocation",
    "/protocolSection/designModule/designInfo/interventionModel",
    "/protocolSection/designModule/designInfo/primaryPurpose",
    "/protocolSection/designModule/designInfo/maskingInfo",
    "/protocolSection/designModule/phases",
    "/protocolSection/armsInterventionsModule/armGroups/0/type"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT00165256_v7_v8_54cd6306925b. ClinicalTrials.gov NCT00165256, versions 7-8. 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 7 to version 8 for NCT00165256.",
    "The JSON Patch for this comparison has hash 22ae109b1766acd909fdfa9e98ee18d0d5ae92a0ec2554237e789ddc28f9a91a.",
    "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 7 and 8.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: arms_or_interventions_change, design_info_change, phase_change, why_stopped_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/whyStopped, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/lastUpdatePostDateStruct/type, /protocolSection/designModule/studyType, /protocolSection/designModule/patientRegistry, /protocolSection/designModule/designInfo/observationalModel, /protocolSection/designModule/designInfo/timePerspective, /protocolSection/designModule/designInfo/allocation, /protocolSection/designModule/designInfo/interventionModel, /protocolSection/designModule/designInfo/primaryPurpose, /protocolSection/designModule/designInfo/maskingInfo, /protocolSection/designModule/phases, /protocolSection/armsInterventionsModule/armGroups/0/type.",
    "The whyStopped value was empty or removed in the changed registry record.",
    "The timeline value moved by 944 days.",
    "The whyStopped field changed from nonempty to empty or absent in a terminal-status context between versions 7 and 8.",
    "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": [
      "design_change",
      "arm_intervention_change",
      "status_termination",
      "timeline_major_slip"
    ],
    "category": "status_termination",
    "deterministic_rules": [
      "arms_or_interventions_change",
      "design_info_change",
      "phase_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_major_slip",
        "date_struct": "completionDateStruct",
        "delta_days": 944,
        "direction": "later",
        "new_precision": "month",
        "new_type": "ESTIMATED",
        "new_value": "2019-11",
        "old_precision": "month",
        "old_type": "ESTIMATED",
        "old_value": "2017-04",
        "path": "/protocolSection/statusModule/completionDateStruct/date",
        "severity": "high",
        "signal": "timeline_major_slip"
      }
    ]
  },
  "event_id": "evt_NCT00165256_v7_v8_54cd6306925b",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2018-11"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/overallStatus",
      "value": "ACTIVE_NOT_RECRUITING"
    },
    {
      "op": "remove",
      "path": "/protocolSection/statusModule/whyStopped"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/completionDateStruct/date",
      "value": "2019-11"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2018-11-02"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2018-11-05"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/type",
      "value": "ACTUAL"
    },
    {
      "op": "replace",
      "path": "/protocolSection/designModule/studyType",
      "value": "INTERVENTIONAL"
    },
    {
      "op": "remove",
      "path": "/protocolSection/designModule/patientRegistry"
    },
    {
      "op": "remove",
      "path": "/protocolSection/designModule/designInfo/observationalModel"
    },
    {
      "op": "remove",
      "path": "/protocolSection/designModule/designInfo/timePerspective"
    },
    {
      "op": "add",
      "path": "/protocolSection/designModule/designInfo/allocation",
      "value": "NA"
    },
    {
      "op": "add",
      "path": "/protocolSection/designModule/designInfo/interventionModel",
      "value": "SINGLE_GROUP"
    },
    {
      "op": "add",
      "path": "/protocolSection/designModule/designInfo/primaryPurpose",
      "value": "OTHER"
    },
    {
      "op": "add",
      "path": "/protocolSection/designModule/designInfo/maskingInfo",
      "value": {
        "masking": "NONE"
      }
    },
    {
      "op": "add",
      "path": "/protocolSection/designModule/phases",
      "value": [
        "PHASE2"
      ]
    },
    {
      "op": "add",
      "path": "/protocolSection/armsInterventionsModule/armGroups/0/type",
      "value": "EXPERIMENTAL"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "380dc1d5d49b637e8b99ffe0bec2b93a82f47451642e58644e2613389318fab4",
    "materiality_event_hash": "e7aa785cd4117134b52345ce8e9b30ccda12dc3ef865c0727c1590223d91732f",
    "patch_hash": "22ae109b1766acd909fdfa9e98ee18d0d5ae92a0ec2554237e789ddc28f9a91a",
    "patch_raw_hash": "6baad01ff0e88261b21d799435501a2ebf5ddaffe8f18b0cf0c504a82a201b57",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT00165256/history/7?patchToVersion=8",
    "to_snapshot_hash": "6c6694e4d17d289a270bae4a88480064fa899485aa0a02cd18c8cbf0353f54dc"
  },
  "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/NCT00165256",
    "nct_id": "NCT00165256"
  },
  "versions": {
    "from_version": 7,
    "submitted_date": "2018-11-02",
    "to_version": 8
  }
}