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NCT00490139

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

Version 198 to 199 · Novartis Pharmaceuticals

Patch inspector

Version 198 to 199

16 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
enrollment_count_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:02:36+00
Raw hash
265f9635e64b29bf7cbf9919ad9142961fea80bed5d930f381354a6759d1d15e
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 1 ops
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 4
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
8381
After
8382
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 8 ops
remove /protocolSection/contactsLocationsModule/locations/896
Triage: Uncategorized
Uncategorized Operation 5
Before
{
  "zip": "84028",
  "city": "Landshut",
  "state": "Bavaria",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 48.52961,
    "lon": 12.16179
  }
}
add /protocolSection/contactsLocationsModule/locations/897
Triage: Uncategorized
Uncategorized Operation 6
After
{
  "zip": "84036",
  "city": "Landshut",
  "state": "Bavaria",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 48.52961,
    "lon": 12.16179
  }
}
remove /protocolSection/contactsLocationsModule/locations/1076
Triage: Uncategorized
Uncategorized Operation 7
Before
{
  "zip": "1122",
  "city": "Budapest",
  "country": "Hungary",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 47.49835,
    "lon": 19.04045
  }
}
add /protocolSection/contactsLocationsModule/locations/1077
Triage: Uncategorized
Uncategorized Operation 8
After
{
  "zip": "H-1122",
  "city": "Budapest",
  "country": "Hungary",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 47.49835,
    "lon": 19.04045
  }
}
replace /protocolSection/contactsLocationsModule/locations/1114/zip
Triage: Uncategorized
Uncategorized Operation 9
Before
48121
After
48100
replace /protocolSection/contactsLocationsModule/locations/1154/zip
Triage: Uncategorized
Uncategorized Operation 10
Before
57124
After
57123
add /protocolSection/contactsLocationsModule/locations/1259
Triage: Uncategorized
Uncategorized Operation 11
After
{
  "zip": "119074",
  "city": "Singapore",
  "country": "Singapore",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 1.28967,
    "lon": 103.85007
  }
}
remove /protocolSection/contactsLocationsModule/locations/1372
Triage: Uncategorized
Uncategorized Operation 12
Before
{
  "zip": "CH63 4JY",
  "city": "Bebington",
  "country": "United Kingdom",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.35,
    "lon": -3.01667
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2019-05
After
2019-08
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2019-05-14
After
2019-08-29
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2019-05-21
After
2019-09-10
replace /protocolSection/ipdSharingStatementModule/ipdSharing
Triage: Uncategorized
Uncategorized Operation 13
Before
UNDECIDED
After
YES
Results outcome measures Posted result outcome measures and result-level endpoint data. Triage: Uncategorized 3 ops
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/0/nonInferiorityType
Triage: Uncategorized
Uncategorized Operation 14
Before
SUPERIORITY_OR_OTHER
After
SUPERIORITY_OR_OTHER_LEGACY
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/nonInferiorityType
Triage: Uncategorized
Uncategorized Operation 15
Before
SUPERIORITY_OR_OTHER
After
SUPERIORITY_OR_OTHER_LEGACY
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/2/nonInferiorityType
Triage: Uncategorized
Uncategorized Operation 16
Before
SUPERIORITY_OR_OTHER
After
SUPERIORITY_OR_OTHER_LEGACY
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2019-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2019-08-29"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2019-09-10"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 8382
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/896"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/897",
    "value": {
      "zip": "84036",
      "city": "Landshut",
      "state": "Bavaria",
      "country": "Germany",
      "facility": "Novartis Investigative Site",
      "geoPoint": {
        "lat": 48.52961,
        "lon": 12.16179
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1076"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1077",
    "value": {
      "zip": "H-1122",
      "city": "Budapest",
      "country": "Hungary",
      "facility": "Novartis Investigative Site",
      "geoPoint": {
        "lat": 47.49835,
        "lon": 19.04045
      }
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/1114/zip",
    "value": "48100"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/1154/zip",
    "value": "57123"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1259",
    "value": {
      "zip": "119074",
      "city": "Singapore",
      "country": "Singapore",
      "facility": "Novartis Investigative Site",
      "geoPoint": {
        "lat": 1.28967,
        "lon": 103.85007
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1372"
  },
  {
    "op": "replace",
    "path": "/protocolSection/ipdSharingStatementModule/ipdSharing",
    "value": "YES"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/0/nonInferiorityType",
    "value": "SUPERIORITY_OR_OTHER_LEGACY"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/nonInferiorityType",
    "value": "SUPERIORITY_OR_OTHER_LEGACY"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/2/nonInferiorityType",
    "value": "SUPERIORITY_OR_OTHER_LEGACY"
  }
]