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NCT00490139

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

Version 196 to 197 · Novartis Pharmaceuticals

Patch inspector

Version 196 to 197

19 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
arms_or_interventions_changeenrollment_count_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_earlier_shift",
    "category": "timeline_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "earlier",
    "new_value": "2021-07-01",
    "old_value": "2022-11-21",
    "delta_days": 508,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:02:35+00
Raw hash
94119fdd6e78ea5cefc03447121964b194629c583ae6dae0ac9be75b759c8080
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 3 ops
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 5
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
8386
After
8385
add /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
Triage: High
Arm Intervention Change Operation 6
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Lapatinib
add /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1
Triage: High
Arm Intervention Change Operation 7
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Arm 3: Trastuzumab followed by Lapatinib
Timeline Start, primary completion, and completion date movement. Triage: Medium 1 ops
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2022-11-21
After
2021-07-01
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 12 ops
replace /protocolSection/contactsLocationsModule/locations/202/city
Triage: Uncategorized
Uncategorized Operation 8
Before
Shawnee
After
Shawnee Mission
replace /protocolSection/contactsLocationsModule/locations/202/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 9
Before
39.04167
After
39.02
replace /protocolSection/contactsLocationsModule/locations/202/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 10
Before
-94.72024
After
-94.66583
remove /protocolSection/contactsLocationsModule/locations/1193
Triage: Uncategorized
Uncategorized Operation 11
Before
{
  "zip": "7909 AA",
  "city": "Hoogeveen",
  "country": "Netherlands",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.7225,
    "lon": 6.47639
  }
}
remove /protocolSection/contactsLocationsModule/locations/1205
Triage: Uncategorized
Uncategorized Operation 12
Before
{
  "zip": "6002",
  "city": "Newtown, Wellington",
  "country": "New Zealand",
  "facility": "Novartis Investigative Site"
}
add /protocolSection/contactsLocationsModule/locations/1206
Triage: Uncategorized
Uncategorized Operation 13
After
{
  "zip": "6021",
  "city": "Wellington",
  "country": "New Zealand",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -41.28664,
    "lon": 174.77557
  }
}
add /protocolSection/contactsLocationsModule/locations/1226
Triage: Uncategorized
Uncategorized Operation 14
After
{
  "zip": "80-210",
  "city": "Gdansk",
  "country": "Poland",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 54.35227,
    "lon": 18.64912
  }
}
remove /protocolSection/contactsLocationsModule/locations/1228
Triage: Uncategorized
Uncategorized Operation 15
Before
{
  "zip": "80-219",
  "city": "Gdansk",
  "country": "Poland",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 54.35227,
    "lon": 18.64912
  }
}
add /protocolSection/contactsLocationsModule/locations/1269
Triage: Uncategorized
Uncategorized Operation 16
After
{
  "zip": "2199",
  "city": "Johannesburg",
  "country": "South Africa",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -26.20227,
    "lon": 28.04363
  }
}
remove /protocolSection/contactsLocationsModule/locations/1275
Triage: Uncategorized
Uncategorized Operation 17
Before
{
  "zip": "2199",
  "city": "Sandton",
  "country": "South Africa",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -26.104,
    "lon": 28.054
  }
}
remove /protocolSection/contactsLocationsModule/locations/1375
Triage: Uncategorized
Uncategorized Operation 18
Before
{
  "zip": "CF14 2TL",
  "city": "Cardiff",
  "country": "United Kingdom",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 51.48,
    "lon": -3.18
  }
}
add /protocolSection/contactsLocationsModule/locations/1409
Triage: Uncategorized
Uncategorized Operation 19
After
{
  "zip": "CF14 2TL",
  "city": "Whitchurch, Cardiff",
  "country": "United Kingdom",
  "facility": "Novartis Investigative Site"
}
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
2017-10
After
2018-10
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2017-10-09
After
2018-10-04
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 4
Before
2017-11-08
After
2018-11-01
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2018-10"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2021-07-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2018-10-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2018-11-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 8385
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0",
    "value": "Drug: Lapatinib"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1",
    "value": "Arm 3: Trastuzumab followed by Lapatinib"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/202/city",
    "value": "Shawnee Mission"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/202/geoPoint/lat",
    "value": 39.02
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/202/geoPoint/lon",
    "value": -94.66583
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1193"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1205"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1206",
    "value": {
      "zip": "6021",
      "city": "Wellington",
      "country": "New Zealand",
      "facility": "Novartis Investigative Site",
      "geoPoint": {
        "lat": -41.28664,
        "lon": 174.77557
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1226",
    "value": {
      "zip": "80-210",
      "city": "Gdansk",
      "country": "Poland",
      "facility": "Novartis Investigative Site",
      "geoPoint": {
        "lat": 54.35227,
        "lon": 18.64912
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1228"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1269",
    "value": {
      "zip": "2199",
      "city": "Johannesburg",
      "country": "South Africa",
      "facility": "Novartis Investigative Site",
      "geoPoint": {
        "lat": -26.20227,
        "lon": 28.04363
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1275"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1375"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1409",
    "value": {
      "zip": "CF14 2TL",
      "city": "Whitchurch, Cardiff",
      "country": "United Kingdom",
      "facility": "Novartis Investigative Site"
    }
  }
]