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NCT00490139

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

Version 41 to 42 · Novartis Pharmaceuticals

Patch inspector

Version 41 to 42

24 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
secondary_outcome_any_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:01:13+00
Raw hash
2c7b1a849df51197f2591945d405ee274e029fae80e23e601e586aa247e225cb
Payload
Source URL
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 1 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 3
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Overall survival
After
Overall Survival
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 21 ops
add /protocolSection/contactsLocationsModule/locations/40
Triage: Uncategorized
Uncategorized Operation 4
After
{
  "zip": "32207",
  "city": "Jacksonville",
  "state": "Florida",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Troy Guthrie",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 30.33218,
    "lon": -81.65565
  }
}
add /protocolSection/contactsLocationsModule/locations/49
Triage: Uncategorized
Uncategorized Operation 5
After
{
  "zip": "30309",
  "city": "Atlanta",
  "state": "Georgia",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Thomas Seay",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 33.749,
    "lon": -84.38798
  }
}
add /protocolSection/contactsLocationsModule/locations/50
Triage: Uncategorized
Uncategorized Operation 6
After
{
  "zip": "30342",
  "city": "Atlanta",
  "state": "Georgia",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Thomas Seay",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 33.749,
    "lon": -84.38798
  }
}
add /protocolSection/contactsLocationsModule/locations/51
Triage: Uncategorized
Uncategorized Operation 7
After
{
  "zip": "30106",
  "city": "Austell",
  "state": "Georgia",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Thomas Seay",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 33.81261,
    "lon": -84.63438
  }
}
add /protocolSection/contactsLocationsModule/locations/53
Triage: Uncategorized
Uncategorized Operation 8
After
{
  "zip": "30033",
  "city": "Decatur",
  "state": "Georgia",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Thomas Seay",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 33.77483,
    "lon": -84.29631
  }
}
add /protocolSection/contactsLocationsModule/locations/55
Triage: Uncategorized
Uncategorized Operation 9
After
{
  "zip": "30045",
  "city": "Lawrenceville",
  "state": "Georgia",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Thomas Seay",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 33.95621,
    "lon": -83.98796
  }
}
add /protocolSection/contactsLocationsModule/locations/56
Triage: Uncategorized
Uncategorized Operation 10
After
{
  "zip": "30060",
  "city": "Marietta",
  "state": "Georgia",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Thomas Seay",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 33.9526,
    "lon": -84.54993
  }
}
add /protocolSection/contactsLocationsModule/locations/57
Triage: Uncategorized
Uncategorized Operation 11
After
{
  "zip": "30274",
  "city": "Riverdale",
  "state": "Georgia",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Thomas Seay",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 33.57261,
    "lon": -84.41326
  }
}
add /protocolSection/contactsLocationsModule/locations/143
Triage: Uncategorized
Uncategorized Operation 12
After
{
  "zip": "49221",
  "city": "Adrian",
  "state": "Michigan",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Paul Schaefer",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 41.89755,
    "lon": -84.03717
  }
}
add /protocolSection/contactsLocationsModule/locations/151
Triage: Uncategorized
Uncategorized Operation 13
After
{
  "zip": "49085",
  "city": "Saint Joseph",
  "state": "Michigan",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Eric Lester",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 42.10976,
    "lon": -86.48002
  }
}
remove /protocolSection/contactsLocationsModule/locations/153
Triage: Uncategorized
Uncategorized Operation 14
Before
{
  "zip": "49085",
  "city": "Saint Joseph",
  "state": "Michigan",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Eric Lester",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 42.10976,
    "lon": -86.48002
  }
}
add /protocolSection/contactsLocationsModule/locations/216
Triage: Uncategorized
Uncategorized Operation 15
After
{
  "zip": "07871",
  "city": "Sparta",
  "state": "New Jersey",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Richard Cantor",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 41.03343,
    "lon": -74.63849
  }
}
add /protocolSection/contactsLocationsModule/locations/226
Triage: Uncategorized
Uncategorized Operation 16
After
{
  "zip": "10011",
  "city": "New York",
  "state": "New York",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Paula Klein",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 40.71427,
    "lon": -74.00597
  }
}
add /protocolSection/contactsLocationsModule/locations/236
Triage: Uncategorized
Uncategorized Operation 17
After
{
  "zip": "28139",
  "city": "Rutherfordton",
  "state": "North Carolina",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "James Bearden",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 35.36929,
    "lon": -81.95677
  }
}
add /protocolSection/contactsLocationsModule/locations/303
Triage: Uncategorized
Uncategorized Operation 18
After
{
  "zip": "19111",
  "city": "Philadelphia",
  "state": "Pennsylvania",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Lori Goldstein",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 39.95238,
    "lon": -75.16362
  }
}
add /protocolSection/contactsLocationsModule/locations/306
Triage: Uncategorized
Uncategorized Operation 19
After
{
  "zip": "18508",
  "city": "Scranton",
  "state": "Pennsylvania",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Richard Cantor",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 41.40916,
    "lon": -75.6649
  }
}
add /protocolSection/contactsLocationsModule/locations/313
Triage: Uncategorized
Uncategorized Operation 20
After
{
  "zip": "29621",
  "city": "Anderson",
  "state": "South Carolina",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "James Bearden",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 34.50344,
    "lon": -82.65013
  }
}
add /protocolSection/contactsLocationsModule/locations/315
Triage: Uncategorized
Uncategorized Operation 21
After
{
  "zip": "29303",
  "city": "Spartanburg",
  "state": "South Carolina",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "James Bearden",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 34.94957,
    "lon": -81.93205
  }
}
add /protocolSection/contactsLocationsModule/locations/316
Triage: Uncategorized
Uncategorized Operation 22
After
{
  "zip": "57701",
  "city": "Rapid City",
  "state": "South Dakota",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Richard Tenglin",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 44.08054,
    "lon": -103.23101
  }
}
add /protocolSection/contactsLocationsModule/locations/325
Triage: Uncategorized
Uncategorized Operation 23
After
{
  "zip": "84112",
  "city": "Salt Lake City",
  "state": "Utah",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Theresa Werner",
      "role": "CONTACT",
      "phone": "877-379-3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Center",
  "geoPoint": {
    "lat": 40.76078,
    "lon": -111.89105
  }
}
remove /protocolSection/contactsLocationsModule/locations/930
Triage: Uncategorized
Uncategorized Operation 24
Before
{
  "zip": "01120",
  "city": "Mexico City",
  "status": "NOT_YET_RECRUITING",
  "country": "Mexico",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 19.42847,
    "lon": -99.12766
  }
}
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
2008-09-09
After
2008-09-12
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 2
Before
2008-09-10
After
2008-09-16
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2008-09-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2008-09-16"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "Overall Survival"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/40",
    "value": {
      "zip": "32207",
      "city": "Jacksonville",
      "state": "Florida",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Troy Guthrie",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 30.33218,
        "lon": -81.65565
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/49",
    "value": {
      "zip": "30309",
      "city": "Atlanta",
      "state": "Georgia",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Thomas Seay",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 33.749,
        "lon": -84.38798
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/50",
    "value": {
      "zip": "30342",
      "city": "Atlanta",
      "state": "Georgia",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Thomas Seay",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 33.749,
        "lon": -84.38798
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/51",
    "value": {
      "zip": "30106",
      "city": "Austell",
      "state": "Georgia",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Thomas Seay",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 33.81261,
        "lon": -84.63438
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/53",
    "value": {
      "zip": "30033",
      "city": "Decatur",
      "state": "Georgia",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Thomas Seay",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 33.77483,
        "lon": -84.29631
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/55",
    "value": {
      "zip": "30045",
      "city": "Lawrenceville",
      "state": "Georgia",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Thomas Seay",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 33.95621,
        "lon": -83.98796
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/56",
    "value": {
      "zip": "30060",
      "city": "Marietta",
      "state": "Georgia",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Thomas Seay",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 33.9526,
        "lon": -84.54993
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/57",
    "value": {
      "zip": "30274",
      "city": "Riverdale",
      "state": "Georgia",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Thomas Seay",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 33.57261,
        "lon": -84.41326
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/143",
    "value": {
      "zip": "49221",
      "city": "Adrian",
      "state": "Michigan",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Paul Schaefer",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 41.89755,
        "lon": -84.03717
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/151",
    "value": {
      "zip": "49085",
      "city": "Saint Joseph",
      "state": "Michigan",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Eric Lester",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 42.10976,
        "lon": -86.48002
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/153"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/216",
    "value": {
      "zip": "07871",
      "city": "Sparta",
      "state": "New Jersey",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Richard Cantor",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 41.03343,
        "lon": -74.63849
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/226",
    "value": {
      "zip": "10011",
      "city": "New York",
      "state": "New York",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Paula Klein",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 40.71427,
        "lon": -74.00597
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/236",
    "value": {
      "zip": "28139",
      "city": "Rutherfordton",
      "state": "North Carolina",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "James Bearden",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 35.36929,
        "lon": -81.95677
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/303",
    "value": {
      "zip": "19111",
      "city": "Philadelphia",
      "state": "Pennsylvania",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Lori Goldstein",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 39.95238,
        "lon": -75.16362
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/306",
    "value": {
      "zip": "18508",
      "city": "Scranton",
      "state": "Pennsylvania",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Richard Cantor",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Center",
      "geoPoint": {
        "lat": 41.40916,
        "lon": -75.6649
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/313",
    "value": {
      "zip": "29621",
      "city": "Anderson",
      "state": "South Carolina",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "James Bearden",
          "role": "CONTACT",
          "phone": "877-379-3718"
        }
      ],
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