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NCT03025035

Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer

Version 21 to 22 · Yuan Yuan

Patch inspector

Version 21 to 22

6 operations 3 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired

None recorded.

Value signals
[
  {
    "paths": [
      "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:42+00
Raw hash
10f7bffe224154418011f94a08570a1361a32c00f15dfd7811ea1256e81711c9
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 1 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 3
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
until all patients off study
After
assessment every 9 weeks during the first year and while on the study drug, and every 12 weeks thereafter until all patients off study
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2025-05-08
After
2025-05-23
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 2
Before
2025-05-23
After
2025-05-28
replace /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2025-05-22
After
2025-05-27
replace /reviewUnit/resetReasons/0
Triage: Uncategorized
Uncategorized Operation 6
Before
This record has new issues that must be addressed.
After
Issues noted on a previous submission of this record do not appear to have been addressed.
Results outcome measures Posted result outcome measures and result-level endpoint data. Triage: Uncategorized 1 ops
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame
Triage: Uncategorized
Uncategorized Operation 4
Before
until all patients off study
After
assessment every 9 weeks during the first year and while on the study drug, and every 12 weeks thereafter until all patients off study
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2025-05-23"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2025-05-28"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "assessment every 9 weeks during the first year and while on the study drug, and every 12 weeks thereafter until all patients off study"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
    "value": "assessment every 9 weeks during the first year and while on the study drug, and every 12 weeks thereafter until all patients off study"
  },
  {
    "op": "replace",
    "path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
    "value": "2025-05-27"
  },
  {
    "op": "replace",
    "path": "/reviewUnit/resetReasons/0",
    "value": "Issues noted on a previous submission of this record do not appear to have been addressed."
  }
]