evt_NCT03094169_v12_v13_d55a0526cf21

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  "citation_text": "TrialDiff Evidence Record evt_NCT03094169_v12_v13_d55a0526cf21. ClinicalTrials.gov NCT03094169, versions 12-13. 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."
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    "TrialDiff compared ClinicalTrials.gov record version 12 to version 13 for NCT03094169.",
    "The JSON Patch for this comparison has hash 9604949fcbf88d5fe8c63abc2aab36fc8d325cf7a750a78da87940c147716505.",
    "The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
    "The deterministic triage label was low; before timing adjustment it was low.",
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    "The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.",
    "The timing context for the from-version record was post_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2, /resultsSection/adverseEventsModule/timeFrame, /resultsSection/adverseEventsModule/reviewUnit, /annotationSection, /reviewUnit.",
    "An outcome path changed between versions 12 and 13 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
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  "event_id": "evt_NCT03094169_v12_v13_d55a0526cf21",
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    "patch_raw_hash": "e0ccf98d50c5349c6045b8348fd5e771a5d53a6f824955f5b3d668bbd18b3753",
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  "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/NCT03094169",
    "nct_id": "NCT03094169"
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}