evt_NCT01818063_v15_v16_a94208113f2c

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/descriptionModule/detailedDescription",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/resultsSection/baselineCharacteristicsModule/measures/4/paramType",
    "/resultsSection/baselineCharacteristicsModule/measures/4/unitOfMeasure",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT01818063_v15_v16_a94208113f2c. ClinicalTrials.gov NCT01818063, versions 15-16. 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 co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.",
    "That event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 15 to version 16 for NCT01818063.",
    "The JSON Patch for this comparison has hash 3c71eceb8db5d519bdc3ed2079b534e4ad6ae0958c48089bf106a94ab4032711.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "The deterministic triage label was low; before timing adjustment it was low.",
    "The triage label is uncalibrated metadata, not a validated review-priority finding.",
    "The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.",
    "The timing context for the from-version record was late_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/descriptionModule/detailedDescription, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /resultsSection/baselineCharacteristicsModule/measures/4/paramType, /resultsSection/baselineCharacteristicsModule/measures/4/unitOfMeasure, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame.",
    "An outcome path changed between versions 15 and 16 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "results_reconciliation"
    ],
    "category": "results_reconciliation",
    "deterministic_rules": [],
    "event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "low",
    "severity_pre_timing": "low",
    "timing_context": "late_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT01818063_v15_v16_a94208113f2c",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2018-01"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2018-01-16"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2018-02-13"
    },
    {
      "op": "replace",
      "path": "/protocolSection/descriptionModule/detailedDescription",
      "value": "<p>PRIMARY OBJECTIVE:</p><p>1) To compare the pathologic complete response (path CR) in patients with stage IIB or stage III triple negative breast cancer treated with neoadjuvant paclitaxel and carboplatin to the path CR of patients treated with paclitaxel, carboplatin, and veliparib.</p><p>SECONDARY OBJECTIVES:</p><ol><li>Relapse free survival (follow-up period of 36 months).</li><li>Overall clinical response to neoadjuvant therapy.</li></ol><p>OUTLINE: Patients are randomized to 1 of 2 treatment arms.</p><p>ARM I: Patients receive paclitaxel intravenously (IV) and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>ARM II: Patients receive veliparib orally (PO) twice daily (BID) on days 1-5.\nPatients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12).\nTreatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity.\nBeginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1.\nTreatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.</p><p>After completion of study treatment, patients are followed up every 3 months for 36 months.</p>"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "36 months following surgery"
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/4/paramType",
      "value": "COUNT_OF_PARTICIPANTS"
    },
    {
      "op": "replace",
      "path": "/resultsSection/baselineCharacteristicsModule/measures/4/unitOfMeasure",
      "value": "Participants"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
      "value": "36 months following surgery"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "5533a5710a87296df798572e29262c3d74af0c24441d1907929efa0bf7a027af",
    "materiality_event_hash": "c5f0f8cccf33ec9489122fee326f1dcf6ae946911abf4151e9e5e403e8730d88",
    "patch_hash": "3c71eceb8db5d519bdc3ed2079b534e4ad6ae0958c48089bf106a94ab4032711",
    "patch_raw_hash": "e3b369ea735788fc9ca968e448e3569bef419b298509d5a9edf84dc9a3a61cfd",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT01818063/history/15?patchToVersion=16",
    "to_snapshot_hash": "bab3e1616f37a361182a6f20b5c1e0107a99d858e016f1b8c200c288cd037a2a"
  },
  "review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
  "schema": "trialdiff.evidence_record",
  "trial": {
    "clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT01818063",
    "nct_id": "NCT01818063"
  },
  "versions": {
    "from_version": 15,
    "submitted_date": "2018-01-16",
    "to_version": 16
  }
}