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NCT03025035

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

Version 9 to 10 · Yuan Yuan

Patch inspector

Version 9 to 10

12 operations 4 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
contact_admin_changewhy_stopped_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/whyStopped",
    "signal": "why_stopped_empty",
    "category": "status_termination",
    "severity": "critical"
  },
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_significant_shift",
    "category": "timeline_significant_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2023-11",
    "old_value": "2023-04",
    "delta_days": 214,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_significant_shift",
    "category": "timeline_significant_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2025-11",
    "old_value": "2025-04",
    "delta_days": 214,
    "date_struct": "completionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:40+00
Raw hash
61ea373818648f6b09071e39f4309cbc1e914afbab68713fe189a4d6931b3cac
Payload
Source URL
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: High 2 ops
replace /protocolSection/statusModule/overallStatus
Triage: Uncategorized
Uncategorized Operation 2
Before
SUSPENDED
After
RECRUITING
remove /protocolSection/statusModule/whyStopped
Triage: High
Status Termination Operation 3
Matched rules
  • why_stopped_change Why-stopped changes explain discontinuation and need review.
Before
pending amendment
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2023-04
After
2023-11
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2025-04
After
2025-11
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 3 ops
add /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 8
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/0/contacts
Triage: Uncategorized
Uncategorized Operation 9
After
[
  {
    "name": "Parisa Mirzadehgan, MPH",
    "role": "CONTACT",
    "email": "Parisa.Mirzadehgan@cshs.org",
    "phone": "310-967-4387"
  },
  {
    "name": "Monica Mita, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  },
  {
    "name": "Philomena McAndrew, MD",
    "role": "SUB_INVESTIGATOR"
  },
  {
    "name": "Heather McArthur, MD",
    "role": "SUB_INVESTIGATOR"
  },
  {
    "name": "Dorothy Park, MD",
    "role": "SUB_INVESTIGATOR"
  },
  {
    "name": "Alain Mita, MD",
    "role": "SUB_INVESTIGATOR"
  },
  {
    "name": "Reva Basho, MD",
    "role": "SUB_INVESTIGATOR"
  },
  {
    "name": "Bobbie Rimel, MD",
    "role": "SUB_INVESTIGATOR"
  }
]
add /protocolSection/contactsLocationsModule/centralContacts
Triage: Low
Administrative Contact Change Operation 10
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
After
[
  {
    "name": "Parisa Mirzadehgan",
    "role": "CONTACT",
    "email": "Parisa.Mirzadehgan@cshs.org",
    "phone": "3109674387"
  }
]
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 5 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2020-10
After
2020-11
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 6
Before
2020-10-01
After
2020-11-02
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 7
Before
2020-10-05
After
2020-11-04
replace /protocolSection/ipdSharingStatementModule/ipdSharing
Triage: Uncategorized
Uncategorized Operation 11
Before
UNDECIDED
After
NO
remove /protocolSection/ipdSharingStatementModule/description
Triage: Uncategorized
Uncategorized Operation 12
Before
Undecided
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2020-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "RECRUITING"
  },
  {
    "op": "remove",
    "path": "/protocolSection/statusModule/whyStopped"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2023-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2025-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2020-11-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2020-11-04"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/0/contacts",
    "value": [
      {
        "name": "Parisa Mirzadehgan, MPH",
        "role": "CONTACT",
        "email": "Parisa.Mirzadehgan@cshs.org",
        "phone": "310-967-4387"
      },
      {
        "name": "Monica Mita, MD",
        "role": "PRINCIPAL_INVESTIGATOR"
      },
      {
        "name": "Philomena McAndrew, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Heather McArthur, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Dorothy Park, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Alain Mita, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Reva Basho, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Bobbie Rimel, MD",
        "role": "SUB_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/centralContacts",
    "value": [
      {
        "name": "Parisa Mirzadehgan",
        "role": "CONTACT",
        "email": "Parisa.Mirzadehgan@cshs.org",
        "phone": "3109674387"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/ipdSharingStatementModule/ipdSharing",
    "value": "NO"
  },
  {
    "op": "remove",
    "path": "/protocolSection/ipdSharingStatementModule/description"
  }
]