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NCT00490139

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

Version 3 to 4 · Novartis Pharmaceuticals

Patch inspector

Version 3 to 4

59 operations 7 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
primary_outcome_any_changesecondary_outcome_any_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/completionDateStruct",
    "reason": "date_unparsed_or_missing",
    "signal": "timeline_shift",
    "category": "timeline_shift",
    "new_type": "ESTIMATED",
    "old_type": null,
    "severity": "medium",
    "direction": "unknown",
    "new_value": "2012-06",
    "old_value": null,
    "date_struct": "completionDateStruct"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:00:54+00
Raw hash
585994b9caa4d46b7ccd8ecb6c8ad91bec30d5ccf70f788cfc57e090a9d2ff0d
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 1 ops
add /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 9
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
Overall survival
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 1 ops
add /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 10
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Overall survival
Timeline Start, primary completion, and completion date movement. Triage: Medium 1 ops
add /protocolSection/statusModule/completionDateStruct
Triage: Medium
Timeline Shift Operation 6
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
After
{
  "date": "2012-06",
  "type": "ESTIMATED"
}
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 49 ops
remove /protocolSection/contactsLocationsModule/locations/2
Triage: Uncategorized
Uncategorized Operation 11
Before
{
  "zip": "75651",
  "city": "Paris Cedex 13",
  "status": "ACTIVE_NOT_RECRUITING",
  "country": "Argentina",
  "facility": "GSK Clinical Trials Call Centre"
}
add /protocolSection/contactsLocationsModule/locations/7
Triage: Uncategorized
Uncategorized Operation 12
After
{
  "zip": "110-744",
  "city": "Youngun-dong - Seoul",
  "status": "NOT_YET_RECRUITING",
  "country": "Argentina",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre"
}
remove /protocolSection/contactsLocationsModule/locations/59
Triage: Uncategorized
Uncategorized Operation 13
Before
{
  "zip": "4000",
  "city": "Liège",
  "status": "NOT_YET_RECRUITING",
  "country": "Belgium",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 50.63373,
    "lon": 5.56749
  }
}
add /protocolSection/contactsLocationsModule/locations/142
Triage: Uncategorized
Uncategorized Operation 14
After
{
  "zip": "75651",
  "city": "Paris",
  "status": "ACTIVE_NOT_RECRUITING",
  "country": "France",
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 48.85341,
    "lon": 2.3488
  }
}
replace /protocolSection/contactsLocationsModule/locations/435/city
Triage: Uncategorized
Uncategorized Operation 15
Before
Fermo (AP)
After
Fermo
replace /protocolSection/contactsLocationsModule/locations/493/status
Triage: Uncategorized
Uncategorized Operation 16
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/495/city
Triage: Uncategorized
Uncategorized Operation 17
Before
Mexico City
After
Chihuahua City
replace /protocolSection/contactsLocationsModule/locations/495/zip
Triage: Uncategorized
Uncategorized Operation 18
Before
03100
After
31000
remove /protocolSection/contactsLocationsModule/locations/495/contacts/0/phone
Triage: Uncategorized
Uncategorized Operation 19
Before
1 877 379 3718
replace /protocolSection/contactsLocationsModule/locations/495/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 20
Before
19.42847
After
28.63528
replace /protocolSection/contactsLocationsModule/locations/495/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 21
Before
-99.12766
After
-106.08889
add /protocolSection/contactsLocationsModule/locations/496
Triage: Uncategorized
Uncategorized Operation 22
After
{
  "zip": "11000",
  "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
  }
}
add /protocolSection/contactsLocationsModule/locations/497
Triage: Uncategorized
Uncategorized Operation 23
After
{
  "zip": "1120",
  "city": "Mexico City",
  "status": "NOT_YET_RECRUITING",
  "country": "Mexico",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 19.42847,
    "lon": -99.12766
  }
}
add /protocolSection/contactsLocationsModule/locations/498
Triage: Uncategorized
Uncategorized Operation 24
After
{
  "zip": "6720",
  "city": "Mexico City",
  "status": "NOT_YET_RECRUITING",
  "country": "Mexico",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 19.42847,
    "lon": -99.12766
  }
}
add /protocolSection/contactsLocationsModule/locations/499
Triage: Uncategorized
Uncategorized Operation 25
After
{
  "zip": "CP 14000",
  "city": "Mexico City",
  "status": "NOT_YET_RECRUITING",
  "country": "Mexico",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 19.42847,
    "lon": -99.12766
  }
}
add /protocolSection/contactsLocationsModule/locations/500
Triage: Uncategorized
Uncategorized Operation 26
After
{
  "zip": "97500",
  "city": "Mérida",
  "status": "RECRUITING",
  "country": "Mexico",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 20.967,
    "lon": -89.62318
  }
}
replace /protocolSection/contactsLocationsModule/locations/535/zip
Triage: Uncategorized
Uncategorized Operation 27
Before
44000
After
1590
replace /protocolSection/contactsLocationsModule/locations/537/city
Triage: Uncategorized
Uncategorized Operation 28
Before
Lahore
After
Karachi
replace /protocolSection/contactsLocationsModule/locations/537/zip
Triage: Uncategorized
Uncategorized Operation 29
Before
54600
After
74800
remove /protocolSection/contactsLocationsModule/locations/537/contacts/0/phone
Triage: Uncategorized
Uncategorized Operation 30
Before
1 877 379 3718
replace /protocolSection/contactsLocationsModule/locations/537/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 31
Before
31.558
After
24.8608
replace /protocolSection/contactsLocationsModule/locations/537/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 32
Before
74.35071
After
67.0104
add /protocolSection/contactsLocationsModule/locations/538
Triage: Uncategorized
Uncategorized Operation 33
After
{
  "zip": "53400",
  "city": "Lahore",
  "status": "RECRUITING",
  "country": "Pakistan",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 31.558,
    "lon": 74.35071
  }
}
add /protocolSection/contactsLocationsModule/locations/539
Triage: Uncategorized
Uncategorized Operation 34
After
{
  "zip": "54000",
  "city": "Lahore",
  "status": "NOT_YET_RECRUITING",
  "country": "Pakistan",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 31.558,
    "lon": 74.35071
  }
}
replace /protocolSection/contactsLocationsModule/locations/544/status
Triage: Uncategorized
Uncategorized Operation 35
Before
NOT_YET_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/545
Triage: Uncategorized
Uncategorized Operation 36
After
{
  "zip": "1000",
  "city": "Manila",
  "status": "NOT_YET_RECRUITING",
  "country": "Philippines",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 14.6042,
    "lon": 120.9822
  }
}
add /protocolSection/contactsLocationsModule/locations/548
Triage: Uncategorized
Uncategorized Operation 37
After
{
  "city": "Quezon City",
  "status": "RECRUITING",
  "country": "Philippines",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 14.6488,
    "lon": 121.0509
  }
}
add /protocolSection/contactsLocationsModule/locations/549
Triage: Uncategorized
Uncategorized Operation 38
After
{
  "city": "San Juan City",
  "status": "RECRUITING",
  "country": "Philippines",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 14.6,
    "lon": 121.0333
  }
}
replace /protocolSection/contactsLocationsModule/locations/590/status
Triage: Uncategorized
Uncategorized Operation 39
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/590/zip
Triage: Uncategorized
Uncategorized Operation 40
Before
11907
After
119074
replace /protocolSection/contactsLocationsModule/locations/602/status
Triage: Uncategorized
Uncategorized Operation 41
Before
NOT_YET_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/605
Triage: Uncategorized
Uncategorized Operation 42
After
{
  "zip": "120 752",
  "city": "Seoul",
  "status": "RECRUITING",
  "country": "South Korea",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 37.566,
    "lon": 126.9784
  }
}
replace /protocolSection/contactsLocationsModule/locations/607/city
Triage: Uncategorized
Uncategorized Operation 43
Before
Youngun-dong - Seoul
After
Suwong, Kyonggi-do
replace /protocolSection/contactsLocationsModule/locations/607/zip
Triage: Uncategorized
Uncategorized Operation 44
Before
110-744
After
443 721
remove /protocolSection/contactsLocationsModule/locations/607/contacts/0/phone
Triage: Uncategorized
Uncategorized Operation 45
Before
1 877 379 3718
replace /protocolSection/contactsLocationsModule/locations/622/status
Triage: Uncategorized
Uncategorized Operation 46
Before
NOT_YET_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/669
Triage: Uncategorized
Uncategorized Operation 47
After
{
  "zip": "SA2 8QA",
  "city": "Swansea",
  "status": "NOT_YET_RECRUITING",
  "country": "Switzerland",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT",
      "phone": "1 877 379 3718"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre"
}
add /protocolSection/contactsLocationsModule/locations/674
Triage: Uncategorized
Uncategorized Operation 48
After
{
  "city": "Kaohsiung City",
  "status": "NOT_YET_RECRUITING",
  "country": "Taiwan",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 22.61626,
    "lon": 120.31333
  }
}
replace /protocolSection/contactsLocationsModule/locations/676/status
Triage: Uncategorized
Uncategorized Operation 49
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/677/status
Triage: Uncategorized
Uncategorized Operation 50
Before
NOT_YET_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/678
Triage: Uncategorized
Uncategorized Operation 51
After
{
  "zip": "100",
  "city": "Taipei",
  "status": "NOT_YET_RECRUITING",
  "country": "Taiwan",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 25.05306,
    "lon": 121.52639
  }
}
add /protocolSection/contactsLocationsModule/locations/679
Triage: Uncategorized
Uncategorized Operation 52
After
{
  "zip": "104",
  "city": "Taipei",
  "status": "NOT_YET_RECRUITING",
  "country": "Taiwan",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 25.05306,
    "lon": 121.52639
  }
}
add /protocolSection/contactsLocationsModule/locations/680
Triage: Uncategorized
Uncategorized Operation 53
After
{
  "zip": "105",
  "city": "Taipei",
  "status": "NOT_YET_RECRUITING",
  "country": "Taiwan",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 25.05306,
    "lon": 121.52639
  }
}
add /protocolSection/contactsLocationsModule/locations/682
Triage: Uncategorized
Uncategorized Operation 54
After
{
  "zip": "10330",
  "city": "Bangkok",
  "status": "NOT_YET_RECRUITING",
  "country": "Thailand",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 13.75398,
    "lon": 100.50144
  }
}
add /protocolSection/contactsLocationsModule/locations/684
Triage: Uncategorized
Uncategorized Operation 55
After
{
  "zip": "10400",
  "city": "Bangkok",
  "status": "NOT_YET_RECRUITING",
  "country": "Thailand",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 13.75398,
    "lon": 100.50144
  }
}
add /protocolSection/contactsLocationsModule/locations/685
Triage: Uncategorized
Uncategorized Operation 56
After
{
  "zip": "10400",
  "city": "Bangkok",
  "status": "RECRUITING",
  "country": "Thailand",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre",
  "geoPoint": {
    "lat": 13.75398,
    "lon": 100.50144
  }
}
add /protocolSection/contactsLocationsModule/locations/689
Triage: Uncategorized
Uncategorized Operation 57
After
{
  "zip": "65000",
  "city": "Phitsanoolok",
  "status": "NOT_YET_RECRUITING",
  "country": "Thailand",
  "contacts": [
    {
      "name": "GSK Clinical Trials Call Centre",
      "role": "CONTACT"
    }
  ],
  "facility": "GSK Clinical Trials Call Centre"
}
replace /protocolSection/contactsLocationsModule/locations/745/city
Triage: Uncategorized
Uncategorized Operation 58
Before
Romford
After
Romfprd
remove /protocolSection/contactsLocationsModule/locations/745/geoPoint
Triage: Uncategorized
Uncategorized Operation 59
Before
{
  "lat": 51.57515,
  "lon": 0.18582
}
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: Uncategorized 1 ops
add /protocolSection/designModule/enrollmentInfo/type
Triage: Uncategorized
Uncategorized Operation 8
After
ESTIMATED
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2007-07
After
2007-11
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2007-07-30
After
2007-11-02
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2007-07-31
After
2007-11-05
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 3 ops
replace /protocolSection/identificationModule/briefTitle
Triage: Uncategorized
Uncategorized Operation 1
Before
Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study
After
ALTTO(Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation)Study; BIG 2-06 / N063D
remove /protocolSection/identificationModule/acronym
Triage: Uncategorized
Uncategorized Operation 2
Before
ALTTO
remove /protocolSection/sponsorCollaboratorsModule/collaborators/0
Triage: Uncategorized
Uncategorized Operation 7
Before
{
  "name": "Breast International Group",
  "class": "OTHER"
}
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/briefTitle",
    "value": "ALTTO(Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation)Study; BIG 2-06 / N063D"
  },
  {
    "op": "remove",
    "path": "/protocolSection/identificationModule/acronym"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2007-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2007-11-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2007-11-05"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/completionDateStruct",
    "value": {
      "date": "2012-06",
      "type": "ESTIMATED"
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/sponsorCollaboratorsModule/collaborators/0"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ESTIMATED"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "Overall survival"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "Overall survival"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/2"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/7",
    "value": {
      "zip": "110-744",
      "city": "Youngun-dong - Seoul",
      "status": "NOT_YET_RECRUITING",
      "country": "Argentina",
      "contacts": [
        {
          "name": "GSK Clinical Trials Call Centre",
          "role": "CONTACT",
          "phone": "1 877 379 3718"
        }
      ],
      "facility": "GSK Clinical Trials Call Centre"
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/59"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/142",
    "value": {
      "zip": "75651",
      "city": "Paris",
      "status": "ACTIVE_NOT_RECRUITING",
      "country": "France",
      "facility": "GSK Clinical Trials Call Centre",
      "geoPoint": {
        "lat": 48.85341,
        "lon": 2.3488
      }
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/435/city",
    "value": "Fermo"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/493/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/495/city",
    "value": "Chihuahua City"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/495/zip",
    "value": "31000"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/495/contacts/0/phone"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/495/geoPoint/lat",
    "value": 28.63528
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/495/geoPoint/lon",
    "value": -106.08889
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/496",
    "value": {
      "zip": "11000",
      "city": "Mexico City",
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