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NCT00490139

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

Version 194 to 195 · Novartis Pharmaceuticals

Patch inspector

Version 194 to 195

131 operations 6 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
design_info_changeenrollment_count_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "signal": "timeline_minor_adjustment",
    "category": "timeline_minor_adjustment",
    "new_type": "ACTUAL",
    "old_type": null,
    "severity": "low",
    "direction": "later",
    "new_value": "2007-05-16",
    "old_value": "2007-05",
    "delta_days": 15,
    "date_struct": "startDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_actual_date_correction",
    "category": "timeline_actual_date_correction",
    "new_type": "ACTUAL",
    "old_type": "ACTUAL",
    "severity": "low",
    "direction": "later",
    "new_value": "2013-12-06",
    "old_value": "2013-12",
    "delta_days": 5,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_minor_adjustment",
    "category": "timeline_minor_adjustment",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "later",
    "new_value": "2022-11-21",
    "old_value": "2022-11",
    "delta_days": 20,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:02:34+00
Raw hash
55af6f104d62610018dbb67b4b552db9694ea2dd805a6efc2b15b14067e71214
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 2 ops
remove /protocolSection/designModule/designInfo/interventionModel
Triage: High
Design Change Operation 12
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
Before
PARALLEL
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 13
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
8381
After
8386
Timeline Start, primary completion, and completion date movement. Triage: Medium 4 ops
replace /protocolSection/statusModule/startDateStruct/date
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
2007-05
After
2007-05-16
add /protocolSection/statusModule/startDateStruct/type
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
After
ACTUAL
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2013-12
After
2013-12-06
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2022-11
After
2022-11-21
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 114 ops
remove /protocolSection/contactsLocationsModule/locations/4
Triage: Uncategorized
Uncategorized Operation 14
Before
{
  "zip": "85259",
  "city": "Scottsdale",
  "state": "Arizona",
  "country": "United States",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 33.50921,
    "lon": -111.89903
  }
}
replace /protocolSection/contactsLocationsModule/locations/69/city
Triage: Uncategorized
Uncategorized Operation 15
Before
Fort Fauderdale
After
Fort Lauderdale
add /protocolSection/contactsLocationsModule/locations/69/geoPoint
Triage: Uncategorized
Uncategorized Operation 16
After
{
  "lat": 26.12231,
  "lon": -80.14338
}
replace /protocolSection/contactsLocationsModule/locations/149/zip
Triage: Uncategorized
Uncategorized Operation 17
Before
61104
After
61114
add /protocolSection/contactsLocationsModule/locations/164
Triage: Uncategorized
Uncategorized Operation 18
After
{
  "zip": "46545",
  "city": "Mishawaka",
  "state": "Indiana",
  "country": "United States",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 41.66199,
    "lon": -86.15862
  }
}
replace /protocolSection/contactsLocationsModule/locations/202/city
Triage: Uncategorized
Uncategorized Operation 19
Before
Shawnee Mission
After
Shawnee
replace /protocolSection/contactsLocationsModule/locations/202/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 20
Before
39.02
After
39.04167
replace /protocolSection/contactsLocationsModule/locations/202/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 21
Before
-94.66583
After
-94.72024
replace /protocolSection/contactsLocationsModule/locations/268/city
Triage: Uncategorized
Uncategorized Operation 22
Before
Bemidhi
After
Bemidji
add /protocolSection/contactsLocationsModule/locations/268/geoPoint
Triage: Uncategorized
Uncategorized Operation 23
After
{
  "lat": 47.47356,
  "lon": -94.88028
}
remove /protocolSection/contactsLocationsModule/locations/283
Triage: Uncategorized
Uncategorized Operation 24
Before
{
  "zip": "55905",
  "city": "Rochester",
  "state": "Minnesota",
  "country": "United States",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 44.02163,
    "lon": -92.4699
  }
}
replace /protocolSection/contactsLocationsModule/locations/310/city
Triage: Uncategorized
Uncategorized Operation 25
Before
Saint Jospeh
After
Saint Joseph
add /protocolSection/contactsLocationsModule/locations/310/geoPoint
Triage: Uncategorized
Uncategorized Operation 26
After
{
  "lat": 39.76861,
  "lon": -94.84663
}
add /protocolSection/contactsLocationsModule/locations/374
Triage: Uncategorized
Uncategorized Operation 27
After
{
  "zip": "10003",
  "city": "New York",
  "state": "New York",
  "country": "United States",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 40.71427,
    "lon": -74.00597
  }
}
replace /protocolSection/contactsLocationsModule/locations/425/city
Triage: Uncategorized
Uncategorized Operation 28
Before
Deleware
After
Delaware
add /protocolSection/contactsLocationsModule/locations/425/geoPoint
Triage: Uncategorized
Uncategorized Operation 29
After
{
  "lat": 40.29867,
  "lon": -83.06797
}
replace /protocolSection/contactsLocationsModule/locations/455/city
Triage: Uncategorized
Uncategorized Operation 30
Before
Wpafb
After
Wright-Patterson Air Force Base
add /protocolSection/contactsLocationsModule/locations/455/geoPoint
Triage: Uncategorized
Uncategorized Operation 31
After
{
  "lat": 39.81791,
  "lon": -84.04995
}
replace /protocolSection/contactsLocationsModule/locations/464/city
Triage: Uncategorized
Uncategorized Operation 32
Before
Glesham
After
Gresham
add /protocolSection/contactsLocationsModule/locations/464/geoPoint
Triage: Uncategorized
Uncategorized Operation 33
After
{
  "lat": 45.49818,
  "lon": -122.43148
}
replace /protocolSection/contactsLocationsModule/locations/510/zip
Triage: Uncategorized
Uncategorized Operation 34
Before
29425
After
29406
add /protocolSection/contactsLocationsModule/locations/523
Triage: Uncategorized
Uncategorized Operation 35
After
{
  "zip": "38138",
  "city": "Germantown",
  "state": "Tennessee",
  "country": "United States",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 35.08676,
    "lon": -89.81009
  }
}
remove /protocolSection/contactsLocationsModule/locations/528
Triage: Uncategorized
Uncategorized Operation 36
Before
{
  "zip": "38120",
  "city": "Memphis",
  "state": "Tennessee",
  "country": "United States",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 35.14953,
    "lon": -90.04898
  }
}
replace /protocolSection/contactsLocationsModule/locations/570/zip
Triage: Uncategorized
Uncategorized Operation 37
Before
23230
After
23226
add /protocolSection/contactsLocationsModule/locations/627
Triage: Uncategorized
Uncategorized Operation 38
After
{
  "zip": "C1125ABD",
  "city": "Ciudad Autonoma de Buenos Aires",
  "state": "Buenos Aires",
  "country": "Argentina",
  "facility": "Novartis Investigative Site"
}
remove /protocolSection/contactsLocationsModule/locations/629
Triage: Uncategorized
Uncategorized Operation 39
Before
{
  "zip": "C1125ABD",
  "city": "Ciudad Autónoma de Buenos Aires",
  "state": "Buenos Aires",
  "country": "Argentina",
  "facility": "Novartis Investigative Site"
}
remove /protocolSection/contactsLocationsModule/locations/629
Triage: Uncategorized
Uncategorized Operation 40
Before
{
  "zip": "M5500AYB",
  "city": "Mendoza",
  "state": "Mendoza Province",
  "country": "Argentina",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -32.88946,
    "lon": -68.84582
  }
}
remove /protocolSection/contactsLocationsModule/locations/630
Triage: Uncategorized
Uncategorized Operation 41
Before
{
  "zip": "3000",
  "city": "Santa Fe",
  "state": "Santa Fe Province",
  "country": "Argentina",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -31.64881,
    "lon": -60.70868
  }
}
add /protocolSection/contactsLocationsModule/locations/631
Triage: Uncategorized
Uncategorized Operation 42
After
{
  "zip": "M5500AYB",
  "city": "Mendoza",
  "country": "Argentina",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -32.88946,
    "lon": -68.84582
  }
}
add /protocolSection/contactsLocationsModule/locations/634
Triage: Uncategorized
Uncategorized Operation 43
After
{
  "zip": "3000",
  "city": "Santa Fe",
  "country": "Argentina",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -31.64881,
    "lon": -60.70868
  }
}
add /protocolSection/contactsLocationsModule/locations/680
Triage: Uncategorized
Uncategorized Operation 44
After
{
  "zip": "9400",
  "city": "Wolfsberg",
  "country": "Austria",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 46.84056,
    "lon": 14.84417
  }
}
remove /protocolSection/contactsLocationsModule/locations/713
Triage: Uncategorized
Uncategorized Operation 45
Before
{
  "zip": "20560-120",
  "city": "Rio de Janeiro",
  "state": "Rio de Janeiro",
  "country": "Brazil",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -22.90642,
    "lon": -43.18223
  }
}
add /protocolSection/contactsLocationsModule/locations/722
Triage: Uncategorized
Uncategorized Operation 46
After
{
  "zip": "20560-120",
  "city": "Rio de Janeiro",
  "country": "Brazil",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -22.90642,
    "lon": -43.18223
  }
}
add /protocolSection/contactsLocationsModule/locations/735
Triage: Uncategorized
Uncategorized Operation 47
After
{
  "zip": "M4C 3E7",
  "city": "Toronto",
  "state": "Ontario",
  "country": "Canada",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 43.70643,
    "lon": -79.39864
  }
}
add /protocolSection/contactsLocationsModule/locations/738
Triage: Uncategorized
Uncategorized Operation 48
After
{
  "zip": "H2W 1S6",
  "city": "Montreal",
  "state": "Quebec",
  "country": "Canada",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 45.50884,
    "lon": -73.58781
  }
}
add /protocolSection/contactsLocationsModule/locations/741
Triage: Uncategorized
Uncategorized Operation 49
After
{
  "zip": "S7N 4H4",
  "city": "Saskatoon",
  "state": "Saskatchewan",
  "country": "Canada",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.13238,
    "lon": -106.66892
  }
}
replace /protocolSection/contactsLocationsModule/locations/775/city
Triage: Uncategorized
Uncategorized Operation 50
Before
Århus C
After
Arhus C
replace /protocolSection/contactsLocationsModule/locations/778/city
Triage: Uncategorized
Uncategorized Operation 51
Before
Hillerød
After
Hilleroed
remove /protocolSection/contactsLocationsModule/locations/778/geoPoint
Triage: Uncategorized
Uncategorized Operation 52
Before
{
  "lat": 55.92791,
  "lon": 12.30081
}
replace /protocolSection/contactsLocationsModule/locations/823/zip
Triage: Uncategorized
Uncategorized Operation 53
Before
30907
After
30029
remove /protocolSection/contactsLocationsModule/locations/824
Triage: Uncategorized
Uncategorized Operation 54
Before
{
  "zip": "75014",
  "city": "Paris",
  "country": "France",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 48.85341,
    "lon": 2.3488
  }
}
add /protocolSection/contactsLocationsModule/locations/826
Triage: Uncategorized
Uncategorized Operation 55
After
{
  "zip": "75674",
  "city": "Paris",
  "country": "France",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 48.85341,
    "lon": 2.3488
  }
}
add /protocolSection/contactsLocationsModule/locations/827
Triage: Uncategorized
Uncategorized Operation 56
After
{
  "zip": "22190",
  "city": "Perin Sur Mer",
  "country": "France",
  "facility": "Novartis Investigative Site"
}
remove /protocolSection/contactsLocationsModule/locations/833
Triage: Uncategorized
Uncategorized Operation 57
Before
{
  "zip": "22015 cedex",
  "city": "Saint-Brieuc",
  "country": "France",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 48.51513,
    "lon": -2.76838
  }
}
remove /protocolSection/contactsLocationsModule/locations/917
Triage: Uncategorized
Uncategorized Operation 58
Before
{
  "zip": "14770",
  "city": "Brandenburg an der Havel",
  "state": "Brandenburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.41667,
    "lon": 12.55
  }
}
remove /protocolSection/contactsLocationsModule/locations/921
Triage: Uncategorized
Uncategorized Operation 59
Before
{
  "zip": "20246",
  "city": "Hamburg",
  "state": "Free and Hanseatic City of Hamburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
remove /protocolSection/contactsLocationsModule/locations/921
Triage: Uncategorized
Uncategorized Operation 60
Before
{
  "zip": "20259",
  "city": "Hamburg",
  "state": "Free and Hanseatic City of Hamburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
remove /protocolSection/contactsLocationsModule/locations/921
Triage: Uncategorized
Uncategorized Operation 61
Before
{
  "zip": "20357",
  "city": "Hamburg",
  "state": "Free and Hanseatic City of Hamburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
remove /protocolSection/contactsLocationsModule/locations/921
Triage: Uncategorized
Uncategorized Operation 62
Before
{
  "zip": "22081",
  "city": "Hamburg",
  "state": "Free and Hanseatic City of Hamburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
remove /protocolSection/contactsLocationsModule/locations/921
Triage: Uncategorized
Uncategorized Operation 63
Before
{
  "zip": "22359",
  "city": "Hamburg",
  "state": "Free and Hanseatic City of Hamburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
remove /protocolSection/contactsLocationsModule/locations/921
Triage: Uncategorized
Uncategorized Operation 64
Before
{
  "zip": "22457",
  "city": "Hamburg",
  "state": "Free and Hanseatic City of Hamburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
remove /protocolSection/contactsLocationsModule/locations/921
Triage: Uncategorized
Uncategorized Operation 65
Before
{
  "zip": "28209",
  "city": "Bremen",
  "state": "Free Hanseatic City of Bremen",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.07582,
    "lon": 8.80717
  }
}
remove /protocolSection/contactsLocationsModule/locations/921
Triage: Uncategorized
Uncategorized Operation 66
Before
{
  "zip": "28239",
  "city": "Bremen",
  "state": "Free Hanseatic City of Bremen",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.07582,
    "lon": 8.80717
  }
}
remove /protocolSection/contactsLocationsModule/locations/936
Triage: Uncategorized
Uncategorized Operation 67
Before
{
  "zip": "65197",
  "city": "Wiesbaden",
  "state": "Hesse",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 50.08601,
    "lon": 8.24435
  }
}
remove /protocolSection/contactsLocationsModule/locations/1031
Triage: Uncategorized
Uncategorized Operation 68
Before
{
  "zip": "24558",
  "city": "Henstedt-Ulzburg",
  "state": "Schleswig-Holstein",
  "country": "Germany",
  "facility": "Novartis Investigative Site"
}
remove /protocolSection/contactsLocationsModule/locations/1037
Triage: Uncategorized
Uncategorized Operation 69
Before
{
  "zip": "10117",
  "city": "Berlin",
  "state": "State of Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
remove /protocolSection/contactsLocationsModule/locations/1037
Triage: Uncategorized
Uncategorized Operation 70
Before
{
  "zip": "10317",
  "city": "Berlin",
  "state": "State of Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
remove /protocolSection/contactsLocationsModule/locations/1037
Triage: Uncategorized
Uncategorized Operation 71
Before
{
  "zip": "10365",
  "city": "Berlin",
  "state": "State of Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
remove /protocolSection/contactsLocationsModule/locations/1037
Triage: Uncategorized
Uncategorized Operation 72
Before
{
  "zip": "10367",
  "city": "Berlin",
  "state": "State of Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
remove /protocolSection/contactsLocationsModule/locations/1037
Triage: Uncategorized
Uncategorized Operation 73
Before
{
  "zip": "10713",
  "city": "Berlin",
  "state": "State of Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
remove /protocolSection/contactsLocationsModule/locations/1037
Triage: Uncategorized
Uncategorized Operation 74
Before
{
  "zip": "10967",
  "city": "Berlin",
  "state": "State of Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
remove /protocolSection/contactsLocationsModule/locations/1037
Triage: Uncategorized
Uncategorized Operation 75
Before
{
  "zip": "12559",
  "city": "Berlin",
  "state": "State of Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
remove /protocolSection/contactsLocationsModule/locations/1037
Triage: Uncategorized
Uncategorized Operation 76
Before
{
  "zip": "13125",
  "city": "Berlin",
  "state": "State of Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
remove /protocolSection/contactsLocationsModule/locations/1037
Triage: Uncategorized
Uncategorized Operation 77
Before
{
  "zip": "13589",
  "city": "Berlin",
  "state": "State of Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
remove /protocolSection/contactsLocationsModule/locations/1037
Triage: Uncategorized
Uncategorized Operation 78
Before
{
  "zip": "14169",
  "city": "Berlin",
  "state": "State of Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
remove /protocolSection/contactsLocationsModule/locations/1037
Triage: Uncategorized
Uncategorized Operation 79
Before
{
  "zip": "14197",
  "city": "Berlin",
  "state": "State of Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/1042
Triage: Uncategorized
Uncategorized Operation 80
After
{
  "zip": "10117",
  "city": "Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/1043
Triage: Uncategorized
Uncategorized Operation 81
After
{
  "zip": "10317",
  "city": "Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/1044
Triage: Uncategorized
Uncategorized Operation 82
After
{
  "zip": "10365",
  "city": "Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/1045
Triage: Uncategorized
Uncategorized Operation 83
After
{
  "zip": "10367",
  "city": "Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/1046
Triage: Uncategorized
Uncategorized Operation 84
After
{
  "zip": "10713",
  "city": "Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/1047
Triage: Uncategorized
Uncategorized Operation 85
After
{
  "zip": "10967",
  "city": "Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/1048
Triage: Uncategorized
Uncategorized Operation 86
After
{
  "zip": "12559",
  "city": "Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/1049
Triage: Uncategorized
Uncategorized Operation 87
After
{
  "zip": "13125",
  "city": "Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/1050
Triage: Uncategorized
Uncategorized Operation 88
After
{
  "zip": "13589",
  "city": "Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/1051
Triage: Uncategorized
Uncategorized Operation 89
After
{
  "zip": "14169",
  "city": "Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/1052
Triage: Uncategorized
Uncategorized Operation 90
After
{
  "zip": "14197",
  "city": "Berlin",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/1053
Triage: Uncategorized
Uncategorized Operation 91
After
{
  "zip": "14770",
  "city": "Brandenburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 50.69716,
    "lon": 6.14466
  }
}
add /protocolSection/contactsLocationsModule/locations/1054
Triage: Uncategorized
Uncategorized Operation 92
After
{
  "zip": "28209",
  "city": "Bremen",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.07582,
    "lon": 8.80717
  }
}
add /protocolSection/contactsLocationsModule/locations/1055
Triage: Uncategorized
Uncategorized Operation 93
After
{
  "zip": "28239",
  "city": "Bremen",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.07582,
    "lon": 8.80717
  }
}
add /protocolSection/contactsLocationsModule/locations/1057
Triage: Uncategorized
Uncategorized Operation 94
After
{
  "zip": "20246",
  "city": "Hamburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
add /protocolSection/contactsLocationsModule/locations/1058
Triage: Uncategorized
Uncategorized Operation 95
After
{
  "zip": "20259",
  "city": "Hamburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
add /protocolSection/contactsLocationsModule/locations/1059
Triage: Uncategorized
Uncategorized Operation 96
After
{
  "zip": "20357",
  "city": "Hamburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
add /protocolSection/contactsLocationsModule/locations/1060
Triage: Uncategorized
Uncategorized Operation 97
After
{
  "zip": "22081",
  "city": "Hamburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
add /protocolSection/contactsLocationsModule/locations/1061
Triage: Uncategorized
Uncategorized Operation 98
After
{
  "zip": "22359",
  "city": "Hamburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
add /protocolSection/contactsLocationsModule/locations/1062
Triage: Uncategorized
Uncategorized Operation 99
After
{
  "zip": "22457",
  "city": "Hamburg",
  "country": "Germany",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
replace /protocolSection/contactsLocationsModule/locations/1069/city
Triage: Uncategorized
Uncategorized Operation 100
Before
Heraklion, Crete
After
Heraklion,Crete
add /protocolSection/contactsLocationsModule/locations/1103/zip
Triage: Uncategorized
Uncategorized Operation 101
After
52621
remove /protocolSection/contactsLocationsModule/locations/1178
Triage: Uncategorized
Uncategorized Operation 102
Before
{
  "zip": "31000",
  "city": "Chihuahua City",
  "state": "Chihuahua",
  "country": "Mexico",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 28.63528,
    "lon": -106.08889
  }
}
add /protocolSection/contactsLocationsModule/locations/1180
Triage: Uncategorized
Uncategorized Operation 103
After
{
  "zip": "31000",
  "city": "Chihuahua City",
  "country": "Mexico",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 28.63528,
    "lon": -106.08889
  }
}
add /protocolSection/contactsLocationsModule/locations/1182
Triage: Uncategorized
Uncategorized Operation 104
After
{
  "zip": "11000",
  "city": "Mexico City",
  "country": "Mexico",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 19.42847,
    "lon": -99.12766
  }
}
remove /protocolSection/contactsLocationsModule/locations/1184
Triage: Uncategorized
Uncategorized Operation 105
Before
{
  "zip": "11000",
  "city": "México D.F.",
  "country": "Mexico",
  "facility": "Novartis Investigative Site"
}
remove /protocolSection/contactsLocationsModule/locations/1212
Triage: Uncategorized
Uncategorized Operation 106
Before
{
  "zip": "1590",
  "city": "Islamabad",
  "country": "Pakistan",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 33.72148,
    "lon": 73.04329
  }
}
replace /protocolSection/contactsLocationsModule/locations/1216/city
Triage: Uncategorized
Uncategorized Operation 107
Before
Lima
After
Rawalpindi
remove /protocolSection/contactsLocationsModule/locations/1216/state
Triage: Uncategorized
Uncategorized Operation 108
Before
Lima Province
replace /protocolSection/contactsLocationsModule/locations/1216/zip
Triage: Uncategorized
Uncategorized Operation 109
Before
Lima 11
After
1590
replace /protocolSection/contactsLocationsModule/locations/1216/country
Triage: Uncategorized
Uncategorized Operation 110
Before
Peru
After
Pakistan
replace /protocolSection/contactsLocationsModule/locations/1216/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 111
Before
-12.04318
After
33.59733
replace /protocolSection/contactsLocationsModule/locations/1216/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 112
Before
-77.02824
After
73.0479
remove /protocolSection/contactsLocationsModule/locations/1217
Triage: Uncategorized
Uncategorized Operation 113
Before
{
  "zip": "Lima 13",
  "city": "Lima",
  "state": "Lima Province",
  "country": "Peru",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -12.04318,
    "lon": -77.02824
  }
}
remove /protocolSection/contactsLocationsModule/locations/1217
Triage: Uncategorized
Uncategorized Operation 114
Before
{
  "zip": "Lima 34",
  "city": "Lima",
  "state": "Lima Province",
  "country": "Peru",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -12.04318,
    "lon": -77.02824
  }
}
add /protocolSection/contactsLocationsModule/locations/1218
Triage: Uncategorized
Uncategorized Operation 115
After
{
  "zip": "Lima 11",
  "city": "Lima",
  "country": "Peru",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -12.04318,
    "lon": -77.02824
  }
}
add /protocolSection/contactsLocationsModule/locations/1219
Triage: Uncategorized
Uncategorized Operation 116
After
{
  "zip": "Lima 13",
  "city": "Lima",
  "country": "Peru",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -12.04318,
    "lon": -77.02824
  }
}
add /protocolSection/contactsLocationsModule/locations/1220
Triage: Uncategorized
Uncategorized Operation 117
After
{
  "zip": "Lima 34",
  "city": "Lima",
  "country": "Peru",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": -12.04318,
    "lon": -77.02824
  }
}
replace /protocolSection/contactsLocationsModule/locations/1235/zip
Triage: Uncategorized
Uncategorized Operation 118
Before
35-055
After
35-021
replace /protocolSection/contactsLocationsModule/locations/1258/zip
Triage: Uncategorized
Uncategorized Operation 119
Before
443066
After
443031
replace /protocolSection/contactsLocationsModule/locations/1283/city
Triage: Uncategorized
Uncategorized Operation 120
Before
Suwon
After
Suwon-si, Gyeonggi-do
replace /protocolSection/contactsLocationsModule/locations/1283/zip
Triage: Uncategorized
Uncategorized Operation 121
Before
440-380
After
443-380
remove /protocolSection/contactsLocationsModule/locations/1283/geoPoint
Triage: Uncategorized
Uncategorized Operation 122
Before
{
  "lat": 37.29111,
  "lon": 127.00889
}
add /protocolSection/contactsLocationsModule/locations/1292
Triage: Uncategorized
Uncategorized Operation 123
After
{
  "zip": "20014",
  "city": "Donostia / San Sebastian",
  "country": "Spain",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 43.31283,
    "lon": -1.97499
  }
}
replace /protocolSection/contactsLocationsModule/locations/1308/city
Triage: Uncategorized
Uncategorized Operation 124
Before
Móstoles
After
Mostoles (Madrid)
replace /protocolSection/contactsLocationsModule/locations/1308/zip
Triage: Uncategorized
Uncategorized Operation 125
Before
28935
After
28460
remove /protocolSection/contactsLocationsModule/locations/1315
Triage: Uncategorized
Uncategorized Operation 126
Before
{
  "zip": "20014",
  "city": "San Sebastián",
  "country": "Spain",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 43.56667,
    "lon": -5.9
  }
}
remove /protocolSection/contactsLocationsModule/locations/1394
Triage: Uncategorized
Uncategorized Operation 127
Before
{
  "zip": "SW3 6JJ",
  "city": "London",
  "country": "United Kingdom",
  "facility": "Novartis Investigative Site",
  "geoPoint": {
    "lat": 51.50853,
    "lon": -0.12574
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 5 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2016-04
After
2017-05
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 6
Before
2016-04-03
After
2017-05-23
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 7
Before
2016-05-05
After
2017-06-16
replace /protocolSection/statusModule/lastUpdatePostDateStruct/type
Triage: Uncategorized
Uncategorized Operation 8
Before
ESTIMATED
After
ACTUAL
add /protocolSection/ipdSharingStatementModule
Triage: Uncategorized
Uncategorized Operation 128
After
{
  "ipdSharing": "UNDECIDED",
  "description": "<p>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies.\nThese requests are reviewed and approved by an independent review panel on the basis of scientific merit.\nAll data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.</p><p>This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</p>"
}
Results outcome measures Posted result outcome measures and result-level endpoint data. Triage: Uncategorized 3 ops
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/0/testedNonInferiority
Triage: Uncategorized
Uncategorized Operation 129
Before
false
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/1/testedNonInferiority
Triage: Uncategorized
Uncategorized Operation 130
Before
false
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/analyses/2/testedNonInferiority
Triage: Uncategorized
Uncategorized Operation 131
Before
false
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 3 ops
replace /protocolSection/sponsorCollaboratorsModule/leadSponsor/name
Triage: Uncategorized
Uncategorized Operation 9
Before
Novartis
After
Novartis Pharmaceuticals
add /protocolSection/oversightModule/isFdaRegulatedDrug
Triage: Uncategorized
Uncategorized Operation 10
After
true
add /protocolSection/oversightModule/isFdaRegulatedDevice
Triage: Uncategorized
Uncategorized Operation 11
After
false
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2017-05"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2007-05-16"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/startDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2013-12-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2022-11-21"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2017-05-23"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2017-06-16"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/sponsorCollaboratorsModule/leadSponsor/name",
    "value": "Novartis Pharmaceuticals"
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule/isFdaRegulatedDrug",
    "value": true
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule/isFdaRegulatedDevice",
    "value": false
  },
  {
    "op": "remove",
    "path": "/protocolSection/designModule/designInfo/interventionModel"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 8386
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/4"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/69/city",
    "value": "Fort Lauderdale"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/69/geoPoint",
    "value": {
      "lat": 26.12231,
      "lon": -80.14338
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/149/zip",
    "value": "61114"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/164",
    "value": {
      "zip": "46545",
      "city": "Mishawaka",
      "state": "Indiana",
      "country": "United States",
      "facility": "Novartis Investigative Site",
      "geoPoint": {
        "lat": 41.66199,
        "lon": -86.15862
      }
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/202/city",
    "value": "Shawnee"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/202/geoPoint/lat",
    "value": 39.04167
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/202/geoPoint/lon",
    "value": -94.72024
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/268/city",
    "value": "Bemidji"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/268/geoPoint",
    "value": {
      "lat": 47.47356,
      "lon": -94.88028
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/283"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/310/city",
    "value": "Saint Joseph"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/310/geoPoint",
    "value": {
      "lat": 39.76861,
      "lon": -94.84663
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/374",
    "value": {
      "zip": "10003",
      "city": "New York",
      "state": "New York",
      "country": "United States",
      "facility": "Novartis Investigative Site",
      "geoPoint": {
        "lat": 40.71427,
        "lon": -74.00597
      }
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/425/city",
    "value": "Delaware"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/425/geoPoint",
    "value": {
      "lat": 40.29867,
      "lon": -83.06797
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/455/city",
    "value": "Wright-Patterson Air Force Base"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/455/geoPoint",
    "value": {
      "lat": 39.81791,
      "lon": -84.04995
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/464/city",
    "value": "Gresham"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/464/geoPoint",
    "value": {
      "lat": 45.49818,
      "lon": -122.43148
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/510/zip",
    "value": "29406"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/523",
    "value": {
      "zip": "38138",
      "city": "Germantown",
      "state": "Tennessee",
      "country": "United States",
      "facility": "Novartis Investigative Site",
      "geoPoint": {
        "lat": 35.08676,
        "lon": -89.81009
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/528"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/570/zip",
    "value": "23226"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/627",
    "value": {
      "zip": "C1125ABD",
      "city": "Ciudad Autonoma de Buenos Aires",
      "state": "Buenos Aires",
      "country": "Argentina",
      "facility": "Novartis Investigative Site"
    }
  },
  {
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