evt_NCT04756765_v9_v10_d388a0f50e56

{
  "changed_paths": [
    "/protocolSection/identificationModule/secondaryIdInfos/1",
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/overallStatus",
    "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "/protocolSection/statusModule/completionDateStruct/date",
    "/protocolSection/statusModule/completionDateStruct/type",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/whyStopped",
    "/protocolSection/designModule/enrollmentInfo/count",
    "/protocolSection/designModule/enrollmentInfo/type",
    "/protocolSection/contactsLocationsModule/centralContacts",
    "/protocolSection/contactsLocationsModule/locations/0/status",
    "/protocolSection/contactsLocationsModule/locations/0/contacts"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT04756765_v9_v10_d388a0f50e56. ClinicalTrials.gov NCT04756765, versions 9-10. 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 event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 9 to version 10 for NCT04756765.",
    "The JSON Patch for this comparison has hash a5a8b4d76ef160f5445b79920f3ec2bf1812d13d35eed2d302c1e1c98c7d9696.",
    "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: enrollment_changed_to_zero.",
    "A registry field under enrollment changed between ClinicalTrials.gov versions 9 and 10.",
    "The timing context for the from-version record was early_recruitment.",
    "The deterministic rules that fired were: contact_admin_change, enrollment_count_change, enrollment_type_change, terminal_status_change, why_stopped_change.",
    "The changed JSON Pointer paths were: /protocolSection/identificationModule/secondaryIdInfos/1, /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/primaryCompletionDateStruct/type, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/completionDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/whyStopped, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type, /protocolSection/contactsLocationsModule/centralContacts, /protocolSection/contactsLocationsModule/locations/0/status, /protocolSection/contactsLocationsModule/locations/0/contacts.",
    "The timeline value moved by 73 days.",
    "The enrollment count changed from a positive value to zero.",
    "The enrollment count changed from a positive value to zero between versions 9 and 10.",
    "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_actualized_earlier",
      "administrative_contact_change"
    ],
    "category": "enrollment_change",
    "deterministic_rules": [
      "contact_admin_change",
      "enrollment_count_change",
      "enrollment_type_change",
      "terminal_status_change",
      "why_stopped_change"
    ],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "enrollment_changed_to_zero"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "severity": "critical",
    "severity_pre_timing": "critical",
    "timing_context": "early_recruitment",
    "triage_label": "critical",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "timeline_actualized_earlier",
        "date_struct": "primaryCompletionDateStruct",
        "delta_days": 73,
        "direction": "earlier",
        "new_precision": "day",
        "new_type": "ACTUAL",
        "new_value": "2024-12-18",
        "old_precision": "month",
        "old_type": "ESTIMATED",
        "old_value": "2025-03",
        "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
        "severity": "low",
        "signal": "timeline_actualized_earlier"
      },
      {
        "category": "timeline_actualized_earlier",
        "date_struct": "completionDateStruct",
        "delta_days": 73,
        "direction": "earlier",
        "new_precision": "day",
        "new_type": "ACTUAL",
        "new_value": "2024-12-18",
        "old_precision": "month",
        "old_type": "ESTIMATED",
        "old_value": "2025-03",
        "path": "/protocolSection/statusModule/completionDateStruct/date",
        "severity": "low",
        "signal": "timeline_actualized_earlier"
      },
      {
        "category": "enrollment_change",
        "new_value": 0,
        "old_value": 30,
        "path": "/protocolSection/designModule/enrollmentInfo/count",
        "pct_change": 1,
        "severity": "critical",
        "signal": "enrollment_zeroed"
      }
    ]
  },
  "event_id": "evt_NCT04756765_v9_v10_d388a0f50e56",
  "evidence_version": 1,
  "patch": [
    {
      "op": "add",
      "path": "/protocolSection/identificationModule/secondaryIdInfos/1",
      "value": {
        "domain": "National Cancer Institute: Clinical Trials Reporting Program",
        "id": "NCI-2023-01961",
        "type": "REGISTRY"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2025-08"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/overallStatus",
      "value": "WITHDRAWN"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
      "value": "2024-12-18"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
      "value": "ACTUAL"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/completionDateStruct/date",
      "value": "2024-12-18"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/completionDateStruct/type",
      "value": "ACTUAL"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-08-13"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-08-17"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/whyStopped",
      "value": "Due to changes in the treatment landscape, the study faced significant recruitment challenges.\nAs no patients were enrolled, the sponsor requested study closure"
    },
    {
      "op": "replace",
      "path": "/protocolSection/designModule/enrollmentInfo/count",
      "value": 0
    },
    {
      "op": "replace",
      "path": "/protocolSection/designModule/enrollmentInfo/type",
      "value": "ACTUAL"
    },
    {
      "op": "remove",
      "path": "/protocolSection/contactsLocationsModule/centralContacts"
    },
    {
      "op": "remove",
      "path": "/protocolSection/contactsLocationsModule/locations/0/status"
    },
    {
      "op": "remove",
      "path": "/protocolSection/contactsLocationsModule/locations/0/contacts"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "c712810e7d3e88c3b3f5aadb24436dbbaffcf2da15a71cb92aaad83caed8da6c",
    "materiality_event_hash": "94839945c87403421b9360d281e26e9787f1339e4be3beb4b0f67a12e03ffbd6",
    "patch_hash": "a5a8b4d76ef160f5445b79920f3ec2bf1812d13d35eed2d302c1e1c98c7d9696",
    "patch_raw_hash": "8b807468de0e253ef83f5fda8c590fef89b460e3814bea3f2c6781d002c48ed9",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT04756765/history/9?patchToVersion=10",
    "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/NCT04756765",
    "nct_id": "NCT04756765"
  },
  "versions": {
    "from_version": 9,
    "submitted_date": "2025-08-13",
    "to_version": 10
  }
}