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NCT00490139

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

Version 81 to 82 · Novartis Pharmaceuticals

Patch inspector

Version 81 to 82

55 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
arms_or_interventions_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:01:34+00
Raw hash
feaf04a216f7f50c1bb52aeeaf5c9d206b6afbb15dcb6560248303493c20f89c
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 2 ops
add /protocolSection/armsInterventionsModule/armGroups/2
Triage: High
Arm Intervention Change Operation 3
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "type": "EXPERIMENTAL",
  "label": "Arm 4: Lapatinib in combination with Trastuzumab",
  "interventionNames": [
    "Biological: Trastuzumab",
    "Drug: Lapatinib"
  ]
}
remove /protocolSection/armsInterventionsModule/armGroups/4
Triage: High
Arm Intervention Change Operation 4
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
{
  "type": "EXPERIMENTAL",
  "label": "Arm 4: Lapatinib in combination with Trastuzumab",
  "interventionNames": [
    "Biological: Trastuzumab",
    "Drug: Lapatinib"
  ]
}
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 51 ops
add /protocolSection/contactsLocationsModule/locations/24
Triage: Uncategorized
Uncategorized Operation 5
After
{
  "zip": "94040",
  "city": "Mountain View",
  "state": "California",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 37.38605,
    "lon": -122.08385
  }
}
remove /protocolSection/contactsLocationsModule/locations/26
Triage: Uncategorized
Uncategorized Operation 6
Before
{
  "zip": "94040",
  "city": "Mountain View",
  "state": "California",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 37.38605,
    "lon": -122.08385
  }
}
add /protocolSection/contactsLocationsModule/locations/32
Triage: Uncategorized
Uncategorized Operation 7
After
{
  "zip": "94588",
  "city": "Pleasanton",
  "state": "California",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 37.66243,
    "lon": -121.87468
  }
}
remove /protocolSection/contactsLocationsModule/locations/34
Triage: Uncategorized
Uncategorized Operation 8
Before
{
  "zip": "94588",
  "city": "Pleasanton",
  "state": "California",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 37.66243,
    "lon": -121.87468
  }
}
add /protocolSection/contactsLocationsModule/locations/46
Triage: Uncategorized
Uncategorized Operation 9
After
{
  "zip": "80218",
  "city": "Denver",
  "state": "Colorado",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 39.73915,
    "lon": -104.9847
  }
}
remove /protocolSection/contactsLocationsModule/locations/48
Triage: Uncategorized
Uncategorized Operation 10
Before
{
  "zip": "80218",
  "city": "Denver",
  "state": "Colorado",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 39.73915,
    "lon": -104.9847
  }
}
add /protocolSection/contactsLocationsModule/locations/89
Triage: Uncategorized
Uncategorized Operation 11
After
{
  "zip": "30342",
  "city": "Atlanta",
  "state": "Georgia",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 33.749,
    "lon": -84.38798
  }
}
remove /protocolSection/contactsLocationsModule/locations/91
Triage: Uncategorized
Uncategorized Operation 12
Before
{
  "zip": "30342",
  "city": "Atlanta",
  "state": "Georgia",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 33.749,
    "lon": -84.38798
  }
}
add /protocolSection/contactsLocationsModule/locations/102
Triage: Uncategorized
Uncategorized Operation 13
After
{
  "zip": "31405",
  "city": "Savannah",
  "state": "Georgia",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 32.08354,
    "lon": -81.09983
  }
}
remove /protocolSection/contactsLocationsModule/locations/104
Triage: Uncategorized
Uncategorized Operation 14
Before
{
  "zip": "31405",
  "city": "Savannah",
  "state": "Georgia",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 32.08354,
    "lon": -81.09983
  }
}
add /protocolSection/contactsLocationsModule/locations/144
Triage: Uncategorized
Uncategorized Operation 15
After
{
  "zip": "61350",
  "city": "Ottawa",
  "state": "Illinois",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 41.34559,
    "lon": -88.84258
  }
}
remove /protocolSection/contactsLocationsModule/locations/146
Triage: Uncategorized
Uncategorized Operation 16
Before
{
  "zip": "61350",
  "city": "Ottawa",
  "state": "Illinois",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 41.34559,
    "lon": -88.84258
  }
}
add /protocolSection/contactsLocationsModule/locations/175
Triage: Uncategorized
Uncategorized Operation 17
After
{
  "zip": "52722",
  "city": "Bettendorf",
  "state": "Iowa",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 41.52448,
    "lon": -90.51569
  }
}
replace /protocolSection/contactsLocationsModule/locations/177/city
Triage: Uncategorized
Uncategorized Operation 18
Before
Bettendorf
After
Cedar Rapids
replace /protocolSection/contactsLocationsModule/locations/177/zip
Triage: Uncategorized
Uncategorized Operation 19
Before
52722
After
52402
replace /protocolSection/contactsLocationsModule/locations/177/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 20
Before
41.52448
After
42.00833
replace /protocolSection/contactsLocationsModule/locations/177/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 21
Before
-90.51569
After
-91.64407
remove /protocolSection/contactsLocationsModule/locations/179
Triage: Uncategorized
Uncategorized Operation 22
Before
{
  "zip": "52402",
  "city": "Cedar Rapids",
  "state": "Iowa",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 42.00833,
    "lon": -91.64407
  }
}
add /protocolSection/contactsLocationsModule/locations/216
Triage: Uncategorized
Uncategorized Operation 23
After
{
  "zip": "67214",
  "city": "Wichita",
  "state": "Kansas",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 37.69224,
    "lon": -97.33754
  }
}
remove /protocolSection/contactsLocationsModule/locations/218
Triage: Uncategorized
Uncategorized Operation 24
Before
{
  "zip": "67214",
  "city": "Wichita",
  "state": "Kansas",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 37.69224,
    "lon": -97.33754
  }
}
add /protocolSection/contactsLocationsModule/locations/227
Triage: Uncategorized
Uncategorized Operation 25
After
{
  "zip": "04074",
  "city": "Scarborough",
  "state": "Maine",
  "status": "COMPLETED",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 43.57814,
    "lon": -70.32172
  }
}
remove /protocolSection/contactsLocationsModule/locations/229
Triage: Uncategorized
Uncategorized Operation 26
Before
{
  "zip": "04074",
  "city": "Scarborough",
  "state": "Maine",
  "status": "COMPLETED",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 43.57814,
    "lon": -70.32172
  }
}
add /protocolSection/contactsLocationsModule/locations/274
Triage: Uncategorized
Uncategorized Operation 27
After
{
  "zip": "55805",
  "city": "Duluth",
  "state": "Minnesota",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 46.78327,
    "lon": -92.10658
  }
}
remove /protocolSection/contactsLocationsModule/locations/276
Triage: Uncategorized
Uncategorized Operation 28
Before
{
  "zip": "55805",
  "city": "Duluth",
  "state": "Minnesota",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 46.78327,
    "lon": -92.10658
  }
}
add /protocolSection/contactsLocationsModule/locations/288
Triage: Uncategorized
Uncategorized Operation 29
After
{
  "zip": "56303",
  "city": "Saint Cloud",
  "state": "Minnesota",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 45.5608,
    "lon": -94.16249
  }
}
remove /protocolSection/contactsLocationsModule/locations/290
Triage: Uncategorized
Uncategorized Operation 30
Before
{
  "zip": "56303",
  "city": "Saint Cloud",
  "state": "Minnesota",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 45.5608,
    "lon": -94.16249
  }
}
add /protocolSection/contactsLocationsModule/locations/362
Triage: Uncategorized
Uncategorized Operation 31
After
{
  "zip": "87106",
  "city": "Albuquerque",
  "state": "New Mexico",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 35.08449,
    "lon": -106.65114
  }
}
remove /protocolSection/contactsLocationsModule/locations/364
Triage: Uncategorized
Uncategorized Operation 32
Before
{
  "zip": "87106",
  "city": "Albuquerque",
  "state": "New Mexico",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 35.08449,
    "lon": -106.65114
  }
}
add /protocolSection/contactsLocationsModule/locations/372
Triage: Uncategorized
Uncategorized Operation 33
After
{
  "zip": "11030",
  "city": "Manhasset",
  "state": "New York",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 40.79788,
    "lon": -73.69957
  }
}
remove /protocolSection/contactsLocationsModule/locations/374
Triage: Uncategorized
Uncategorized Operation 34
Before
{
  "zip": "11030",
  "city": "Manhasset",
  "state": "New York",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 40.79788,
    "lon": -73.69957
  }
}
add /protocolSection/contactsLocationsModule/locations/400
Triage: Uncategorized
Uncategorized Operation 35
After
{
  "zip": "58501",
  "city": "Bismarck",
  "state": "North Dakota",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 46.80833,
    "lon": -100.78374
  }
}
remove /protocolSection/contactsLocationsModule/locations/402
Triage: Uncategorized
Uncategorized Operation 36
Before
{
  "zip": "58501",
  "city": "Bismarck",
  "state": "North Dakota",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 46.80833,
    "lon": -100.78374
  }
}
add /protocolSection/contactsLocationsModule/locations/438
Triage: Uncategorized
Uncategorized Operation 37
After
{
  "zip": "44857",
  "city": "Norwalk",
  "state": "Ohio",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 41.24255,
    "lon": -82.61573
  }
}
add /protocolSection/contactsLocationsModule/locations/449
Triage: Uncategorized
Uncategorized Operation 38
After
{
  "zip": "43623",
  "city": "Toledo",
  "state": "Ohio",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 41.66394,
    "lon": -83.55521
  }
}
remove /protocolSection/contactsLocationsModule/locations/451
Triage: Uncategorized
Uncategorized Operation 39
Before
{
  "zip": "43623",
  "city": "Toledo",
  "state": "Ohio",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 41.66394,
    "lon": -83.55521
  }
}
add /protocolSection/contactsLocationsModule/locations/565
Triage: Uncategorized
Uncategorized Operation 40
After
{
  "zip": "98122",
  "city": "Seattle",
  "state": "Washington",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 47.60621,
    "lon": -122.33207
  }
}
remove /protocolSection/contactsLocationsModule/locations/567
Triage: Uncategorized
Uncategorized Operation 41
Before
{
  "zip": "98122",
  "city": "Seattle",
  "state": "Washington",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 47.60621,
    "lon": -122.33207
  }
}
add /protocolSection/contactsLocationsModule/locations/571
Triage: Uncategorized
Uncategorized Operation 42
After
{
  "zip": "98405",
  "city": "Tacoma",
  "state": "Washington",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 47.25288,
    "lon": -122.44429
  }
}
remove /protocolSection/contactsLocationsModule/locations/573
Triage: Uncategorized
Uncategorized Operation 43
Before
{
  "zip": "98405",
  "city": "Tacoma",
  "state": "Washington",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 47.25288,
    "lon": -122.44429
  }
}
add /protocolSection/contactsLocationsModule/locations/594
Triage: Uncategorized
Uncategorized Operation 44
After
{
  "zip": "53233",
  "city": "Milwaukee",
  "state": "Wisconsin",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 43.0389,
    "lon": -87.90647
  }
}
remove /protocolSection/contactsLocationsModule/locations/596
Triage: Uncategorized
Uncategorized Operation 45
Before
{
  "zip": "53233",
  "city": "Milwaukee",
  "state": "Wisconsin",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "facility": "GSK Investigational Site",
  "geoPoint": {
    "lat": 43.0389,
    "lon": -87.90647
  }
}
replace /protocolSection/contactsLocationsModule/locations/657/status
Triage: Uncategorized
Uncategorized Operation 46
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/675/status
Triage: Uncategorized
Uncategorized Operation 47
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/698/status
Triage: Uncategorized
Uncategorized Operation 48
Before
RECRUITING
After
COMPLETED
replace /protocolSection/contactsLocationsModule/locations/712/status
Triage: Uncategorized
Uncategorized Operation 49
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/722/status
Triage: Uncategorized
Uncategorized Operation 50
Before
NOT_YET_RECRUITING
After
COMPLETED
replace /protocolSection/contactsLocationsModule/locations/739/zip
Triage: Uncategorized
Uncategorized Operation 51
Before
140 00
After
140 59
replace /protocolSection/contactsLocationsModule/locations/754/status
Triage: Uncategorized
Uncategorized Operation 52
Before
RECRUITING
After
COMPLETED
replace /protocolSection/contactsLocationsModule/locations/778/status
Triage: Uncategorized
Uncategorized Operation 53
Before
RECRUITING
After
ACTIVE_NOT_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/1157/status
Triage: Uncategorized
Uncategorized Operation 54
Before
RECRUITING
After
ACTIVE_NOT_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/1161/status
Triage: Uncategorized
Uncategorized Operation 55
Before
NOT_YET_RECRUITING
After
RECRUITING
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 2 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2010-02-12
After
2010-02-18
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 2
Before
2010-02-17
After
2010-02-22
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2010-02-18"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2010-02-22"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2",
    "value": {
      "type": "EXPERIMENTAL",
      "label": "Arm 4: Lapatinib in combination with Trastuzumab",
      "interventionNames": [
        "Biological: Trastuzumab",
        "Drug: Lapatinib"
      ]
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/4"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/24",
    "value": {
      "zip": "94040",
      "city": "Mountain View",
      "state": "California",
      "status": "RECRUITING",
      "country": "United States",
      "facility": "GSK Investigational Site",
      "geoPoint": {
        "lat": 37.38605,
        "lon": -122.08385
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/26"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/32",
    "value": {
      "zip": "94588",
      "city": "Pleasanton",
      "state": "California",
      "status": "RECRUITING",
      "country": "United States",
      "facility": "GSK Investigational Site",
      "geoPoint": {
        "lat": 37.66243,
        "lon": -121.87468
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/34"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/46",
    "value": {
      "zip": "80218",
      "city": "Denver",
      "state": "Colorado",
      "status": "RECRUITING",
      "country": "United States",
      "facility": "GSK Investigational Site",
      "geoPoint": {
        "lat": 39.73915,
        "lon": -104.9847
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/48"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/89",
    "value": {
      "zip": "30342",
      "city": "Atlanta",
      "state": "Georgia",
      "status": "RECRUITING",
      "country": "United States",
      "facility": "GSK Investigational Site",
      "geoPoint": {
        "lat": 33.749,
        "lon": -84.38798
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/91"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/102",
    "value": {
      "zip": "31405",
      "city": "Savannah",
      "state": "Georgia",
      "status": "NOT_YET_RECRUITING",
      "country": "United States",
      "facility": "GSK Investigational Site",
      "geoPoint": {
        "lat": 32.08354,
        "lon": -81.09983
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/104"
  },
  {
    "op": "add",
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/177/zip",
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    "op": "replace",
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]