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NCT01033032

Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer

Version 9 to 10 · SCRI Development Innovations, LLC

Patch inspector

Version 9 to 10

8 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
design_info_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2010-12",
    "old_value": "2012-07",
    "delta_days": 578,
    "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": "2013-12",
    "old_value": "2012-12",
    "delta_days": 365,
    "date_struct": "completionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:42+00
Raw hash
12dd5edb3427804d8c7381601edffa4acaf1489c5dc852e50ebd01f2fab4f8d5
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 1 ops
replace /protocolSection/designModule/designInfo/allocation
Triage: High
Design Change Operation 7
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
Before
NON_RANDOMIZED
After
NA
Timeline Start, primary completion, and completion date movement. Triage: Medium 3 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2012-07
After
2010-12
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2012-12
After
2013-12
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 1 ops
replace /protocolSection/contactsLocationsModule/locations/13/zip
Triage: Uncategorized
Uncategorized Operation 8
Before
37023
After
37203
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2012-06
After
2013-06
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
Before
2012-06-05
After
2013-06-26
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 6
Before
2012-06-07
After
2013-06-27
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2013-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2010-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2013-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2013-06-26"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2013-06-27"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/designInfo/allocation",
    "value": "NA"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/13/zip",
    "value": "37203"
  }
]