evt_NCT03584009_v23_v24_6fcc63eabc17

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/comment",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame",
    "/resultsSection/adverseEventsModule/timeFrame",
    "/resultsSection/adverseEventsModule/reviewUnit",
    "/annotationSection"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03584009_v23_v24_6fcc63eabc17. ClinicalTrials.gov NCT03584009, versions 23-24. 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 23 to version 24 for NCT03584009.",
    "The JSON Patch for this comparison has hash 0352c51df29d43f19e0c8ce176c4692de737d7d45ebc48df89f07f7ca98860ff.",
    "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 post_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/comment, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame, /resultsSection/adverseEventsModule/timeFrame, /resultsSection/adverseEventsModule/reviewUnit, /annotationSection.",
    "An outcome path changed between versions 23 and 24 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": "post_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
          "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT03584009_v23_v24_6fcc63eabc17",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2021-08"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2021-08-31"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2021-09-27"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
      "value": "2021-08-31"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
      "value": {
        "date": "2021-09-27",
        "type": "ACTUAL"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)."
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
      "value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)."
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "value": "Time from first occurrence of a documented objective response to the first documented disease progression or death from any cause, whichever occurs first, until 6 months after the last participant is enrolled in the study (up to approximately 23 months)."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
      "value": "Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later) (up to approximately 23 months)."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
      "value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
      "value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
      "value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
      "value": "Time from first occurrence of a documented objective response to the first documented disease progression or death from any cause, whichever occurs first, until 6 months after the last participant is enrolled in the study (up to approximately 23 months)."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/comment",
      "value": "Insufficient number of participants meant that Median, Lower Limit and Upper Limit values could not be estimated."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame",
      "value": "Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later) (up to approximately 23 months)."
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/timeFrame",
      "value": "Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later) (up to approximately 23 months)."
    },
    {
      "op": "remove",
      "path": "/resultsSection/adverseEventsModule/reviewUnit"
    },
    {
      "op": "remove",
      "path": "/annotationSection"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "d90013009571884d9f307aed5af127502c4d2d0fc7770953e56dc5be29688f0e",
    "materiality_event_hash": "603a0a3e88531d5bb482dca65ec8faea10967caa87563ead317e61a1861c72b0",
    "patch_hash": "0352c51df29d43f19e0c8ce176c4692de737d7d45ebc48df89f07f7ca98860ff",
    "patch_raw_hash": "3d385a2649bcfa49670e1fd74f817dc5e2e3eb28b05d0b31f4adcf8d000c13ae",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT03584009/history/23?patchToVersion=24",
    "to_snapshot_hash": "489849bdc5e036be4e3e88e538b058529e074abce779b79e62635d6121377c7a"
  },
  "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/NCT03584009",
    "nct_id": "NCT03584009"
  },
  "versions": {
    "from_version": 23,
    "submitted_date": "2021-08-31",
    "to_version": 24
  }
}