evt_NCT04224272_v17_v18_bdec83904802

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "/protocolSection/outcomesModule/primaryOutcomes/2/description",
    "/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame",
    "/protocolSection/outcomesModule/primaryOutcomes/2/reviewUnit",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
    "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit",
    "/annotationSection"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT04224272_v17_v18_bdec83904802. ClinicalTrials.gov NCT04224272, versions 17-18. 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 17 to version 18 for NCT04224272.",
    "The JSON Patch for this comparison has hash f99a80f22c04de6d6019e0e9d723ac73375af7a7ac419fdd4b0afcbbfb60322a.",
    "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/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/2/description, /protocolSection/outcomesModule/primaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/2/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit, /annotationSection.",
    "An outcome path changed between versions 17 and 18 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/2/description",
          "/protocolSection/outcomesModule/primaryOutcomes/2/reviewUnit",
          "/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT04224272_v17_v18_bdec83904802",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2024-08"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2024-08-13"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2024-08-14"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
      "value": "2024-08-13"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
      "value": {
        "date": "2024-08-14",
        "type": "ACTUAL"
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/2/description",
      "value": "The progression-free survival at 6 months (PFS6) is a binary endpoint variable based on the progression-free survival (PFS) time, defined as the proportion of participants having PFS time greater than or equal to 24 weeks (168 days)."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame",
      "value": "6 months from first dose of any study drug to the date of documented disease progression or death"
    },
    {
      "op": "remove",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/2/reviewUnit"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description",
      "value": "The progression-free survival at 6 months (PFS6) is a binary endpoint variable based on the progression-free survival (PFS) time, defined as the proportion of participants having PFS time greater than or equal to 24 weeks (168 days)."
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
      "value": "6 months from first dose of any study drug to the date of documented disease progression or death"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit"
    },
    {
      "op": "remove",
      "path": "/annotationSection"
    }
  ],
  "provenance": {
    "from_snapshot_hash": "0a05389475c64483d67a86b9f1c4b0fc058b0014a8f94ddff08ba22edacf89d1",
    "materiality_event_hash": "85296b856c52f0363ae7c8431dc2f1abc897a9f041d139d89c644541753e9a40",
    "patch_hash": "f99a80f22c04de6d6019e0e9d723ac73375af7a7ac419fdd4b0afcbbfb60322a",
    "patch_raw_hash": "3e5b164f2bbe030a40523ea7f9e60d0f38fb18c627fae6b754d9390c497ad356",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT04224272/history/17?patchToVersion=18",
    "to_snapshot_hash": "c16c64eda947731126cdab68508086f896196634cc7baeb9e8dc9347d2febb47"
  },
  "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/NCT04224272",
    "nct_id": "NCT04224272"
  },
  "versions": {
    "from_version": 17,
    "submitted_date": "2024-08-13",
    "to_version": 18
  }
}