evt_NCT00165256_v13_v14_4e07ab9ea9cf

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/description"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT00165256_v13_v14_4e07ab9ea9cf. ClinicalTrials.gov NCT00165256, versions 13-14. 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 13 to version 14 for NCT00165256.",
    "The JSON Patch for this comparison has hash 391f8aeb57e2cfce3c59d17e8cb56de6b41b6373471cb6425ea069c0d8106049.",
    "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: primary_endpoint_changed_after_primary_completion_without_results_reconciliation.",
    "A registry field under the primary outcome module changed between ClinicalTrials.gov versions 13 and 14.",
    "The timing context for the from-version record was late_recruitment.",
    "The deterministic rules that fired were: primary_outcome_any_change, secondary_outcome_any_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/description.",
    "A primary outcome definition field changed after primary completion between versions 13 and 14, without a results-posting co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "primary_outcome_change",
      "secondary_outcome_change"
    ],
    "category": "primary_outcome_change",
    "deterministic_rules": [
      "primary_outcome_any_change",
      "secondary_outcome_any_change"
    ],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "primary_endpoint_changed_after_primary_completion_without_results_reconciliation"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "severity": "critical",
    "severity_pre_timing": "critical",
    "timing_context": "late_recruitment",
    "triage_label": "critical",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": []
  },
  "event_id": "evt_NCT00165256_v13_v14_4e07ab9ea9cf",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2023-05"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2023-05-02"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2023-05-06"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "Using information gathered from follow-up physical examinations and mammography to check for recurrence (DCIS or invasive carcinoma in the breast), DCIS patients treated with wide excision alone will be evaluated."
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "value": "Using information gathered from follow-up physical examinations and mammography, the exploration of breast recurrences between grade 2 DCIS and grade 1 DCIS patients will be evaluated."
    }
  ],
  "provenance": {
    "from_snapshot_hash": "4213555e20dc675eea5f233f0acbb5032155466483e7e42b79febf4c2680af87",
    "materiality_event_hash": "a4f890b8f078fa9a13a0bbfeebe85fb6a8323bae464bb288429a6d0b38e58ac5",
    "patch_hash": "391f8aeb57e2cfce3c59d17e8cb56de6b41b6373471cb6425ea069c0d8106049",
    "patch_raw_hash": "ebe56772545148129c277d5abdc3c8cf91fe479b20d62be345d91dc0cb9b2b60",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT00165256/history/13?patchToVersion=14",
    "to_snapshot_hash": "78be174f6a7782912beec35270b0ce0ac4c287a5199b990deda71edb4dcf60e2"
  },
  "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/NCT00165256",
    "nct_id": "NCT00165256"
  },
  "versions": {
    "from_version": 13,
    "submitted_date": "2023-05-02",
    "to_version": 14
  }
}