Back to trial

NCT03025035

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

Version 22 to 23 · Yuan Yuan

Patch inspector

Version 22 to 23

10 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/reviewUnit",
      "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:43+00
Raw hash
b514077033769c96098b8e4e7fb410ba1ad890367cda39690c5709b1fe0cd8a6
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 2 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 5
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
assessment every 9 weeks during the first year and while on the study drug, and every 12 weeks thereafter until all patients off study
After
Up to 2 Years
remove /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit
Triage: Critical
Primary Outcome Change Operation 6
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
{
  "resetReasons": [
    "There does not appear to be sufficient information to understand the Time Frame."
  ]
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 6 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2025-05-23
After
2025-05-28
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 2
Before
2025-05-28
After
2025-05-29
add /protocolSection/statusModule/resultsFirstSubmitQcDate
Triage: Uncategorized
Uncategorized Operation 3
After
2025-05-28
add /protocolSection/statusModule/resultsFirstPostDateStruct
Triage: Uncategorized
Uncategorized Operation 4
After
{
  "date": "2025-05-29",
  "type": "ACTUAL"
}
remove /annotationSection
Triage: Uncategorized
Uncategorized Operation 9
Before
{
  "annotationModule": {
    "unpostedAnnotation": {
      "unpostedEvents": [
        {
          "date": "2025-05-27",
          "type": "RESET"
        }
      ],
      "unpostedResponsibleParty": "Yuan Yuan, Director, Breast Oncology, Cedars-Sinai Medical Center"
    }
  }
}
remove /reviewUnit
Triage: Uncategorized
Uncategorized Operation 10
Before
{
  "resetReasons": [
    "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 2 ops
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame
Triage: Uncategorized
Uncategorized Operation 7
Before
assessment every 9 weeks during the first year and while on the study drug, and every 12 weeks thereafter until all patients off study
After
Up to 2 Years
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit
Triage: Uncategorized
Uncategorized Operation 8
Before
{
  "resetReasons": [
    "There does not appear to be sufficient information to understand the Time Frame."
  ]
}
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2025-05-28"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2025-05-29"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "value": "2025-05-28"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "value": {
      "date": "2025-05-29",
      "type": "ACTUAL"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "Up to 2 Years"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
    "value": "Up to 2 Years"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit"
  },
  {
    "op": "remove",
    "path": "/annotationSection"
  },
  {
    "op": "remove",
    "path": "/reviewUnit"
  }
]