evt_NCT06975085_v0_v1_bbdf26e8b022

{
  "changed_paths": [
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/designModule/phases/1",
    "/protocolSection/outcomesModule/primaryOutcomes/2/description"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT06975085_v0_v1_bbdf26e8b022. ClinicalTrials.gov NCT06975085, versions 0-1. 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 the outcome change was inconsistent with the protocol or statistical analysis plan.",
    "That event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 0 to version 1 for NCT06975085.",
    "The JSON Patch for this comparison has hash 427f7fcdd917009bb72583adabbea5fae809ac8cab45a55368dbd4ff712c98de.",
    "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: primary_endpoint_changed_after_primary_completion_without_results_reconciliation.",
    "A registry field under the primary outcome module changed between ClinicalTrials.gov versions 0 and 1.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: phase_change, primary_outcome_any_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/designModule/phases/1, /protocolSection/outcomesModule/primaryOutcomes/2/description.",
    "A primary outcome definition field changed after primary completion between versions 0 and 1, without a results-posting co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "primary_outcome_change",
      "design_change"
    ],
    "category": "primary_outcome_change",
    "deterministic_rules": [
      "phase_change",
      "primary_outcome_any_change"
    ],
    "event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
    "event_classes": [
      "primary_endpoint_changed_after_primary_completion_without_results_reconciliation"
    ],
    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "critical",
    "severity_pre_timing": "critical",
    "timing_context": "post_recruitment",
    "triage_label": "critical",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": []
  },
  "event_id": "evt_NCT06975085_v0_v1_bbdf26e8b022",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-05-15"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-05-21"
    },
    {
      "op": "remove",
      "path": "/protocolSection/designModule/phases/1"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/2/description",
      "value": "Participants are asked: In the next 12 months, do you plan to get a mammogram?\nThe question is answered on a 5-point will-will not Likert scale.\n1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "6a65865fddd4b4537958923ac38afe49e313a6283c4c53f014c94f92f333b4be",
    "materiality_event_hash": "a47f62d4a47be34928129ea6b55e7c6632039a686c48879a06b41f7b24a96484",
    "patch_hash": "427f7fcdd917009bb72583adabbea5fae809ac8cab45a55368dbd4ff712c98de",
    "patch_raw_hash": "5aaa2b30ff75062b18f1c93e207a1b8f7140b0bc61cd515a1217654ae80b6590",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT06975085/history/0?patchToVersion=1",
    "to_snapshot_hash": "7908e3f8285439231a3cfcd2a140f9775af041bd63245dfd078c0a1fc1867d8e"
  },
  "review_question": "What did the primary outcome field say before and after the amendment, and is there a public protocol, statistical analysis plan, or manuscript explaining the change?",
  "schema": "trialdiff.evidence_record",
  "trial": {
    "clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT06975085",
    "nct_id": "NCT06975085"
  },
  "versions": {
    "from_version": 0,
    "submitted_date": "2025-05-15",
    "to_version": 1
  }
}