An Investigational Immuno-therapy Trial of Nivolumab, or... | NCT02477826 | Trialant
NCT02477826
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Oct 30, 2025Actual
Enrollment
2,747Actual
Phase
Phase 3
Conditions
Non-Small Cell Lung Cancer
Interventions
Nivolumab
Ipilimumab
Carboplatin
Cisplatin
Gemcitabine
Pemetrexed
Paclitaxel
Countries
United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Colombia
Czechia
Finland
France
Germany
Greece
Hungary
Ireland
Israel
Italy
Japan
Lebanon
Mexico
Netherlands
Peru
Poland
Romania
Russia
South Africa
South Korea
Spain
Switzerland
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02477826
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA209-227
Secondary IDs
ID
Type
Description
Link
2014-003630-23
EudraCT Number
Brief Title
An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Official Title
An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Acronym
CheckMate 227
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 5, 2015Actual
Primary Completion Date
Oct 25, 2024Actual
Completion Date
Oct 25, 2024Actual
First Submitted Date
Jun 18, 2015
First Submission Date that Met QC Criteria
Jun 18, 2015
First Posted Date
Jun 23, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 21, 2025
Results First Submitted that Met QC Criteria
Oct 21, 2025
Results First Posted Date
Oct 30, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 21, 2025
Last Update Posted Date
Oct 30, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Name
Class
Ono Pharmaceutical Co., Ltd.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.
Detailed Description
Not provided
Conditions Module
Conditions
Non-Small Cell Lung Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,747Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A: Nivolumab
Experimental
Nivolumab intravenously (IV) as specified
Drug: Nivolumab
Arm B: Nivolumab + Ipilimumab
Experimental
Nivolumab + Ipilimumab IV as specified
Drug: Nivolumab
Drug: Ipilimumab
Arm C: Nivolumab + Platinum doublet chemotherapy
Experimental
Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
Drug: Nivolumab
Drug: Carboplatin
Drug: Cisplatin
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Paclitaxel
Arm D: Platinum doublet chemotherapy
Experimental
Chemotherapy administered on specified days of IV chemotherapy
Drug: Carboplatin
Drug: Cisplatin
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Paclitaxel
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Nivolumab
Drug
Arm A: Nivolumab
Arm B: Nivolumab + Ipilimumab
Arm C: Nivolumab + Platinum doublet chemotherapy
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Progression-Free Survival Per BICR
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
Overall Survival
OS for all randomized participants is the time between randomization date and the date of death from any cause.
From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks)
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) Per BICR
Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
Exclusion Criteria:
Subjects with untreated Central nervous system (CNS) metastases are excluded
Subjects with an active, known or suspected autoimmune disease are excluded
Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection
Other protocol defined inclusion/exclusion criteria apply
Peters S, Paz-Ares LG, Reck M, Carbone DP, Brahmer JR, Borghaei H, Lu S, O'Byrne KJ, John T, Ciuleanu TE, Schenker M, Bernabe Caro R, Nishio M, Cobo M, Lee JS, Zurawski B, Pluzanski A, Aoyama T, Tschaika M, Devas V, Grootendorst DJ, Ramalingam SS. Long-Term Survival Outcomes With First-Line Nivolumab Plus Ipilimumab-Based Treatment in Patients With Metastatic NSCLC and Tumor Programmed Death-Ligand 1 Lower Than 1%: A Pooled Analysis. J Thorac Oncol. 2025 Jan;20(1):94-108. doi: 10.1016/j.jtho.2024.09.1439. Epub 2024 Oct 4.
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
FG001
Periods
Title
Milestones
Reasons Not Completed
Pre-Treatment
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Aug 15, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Saudi Arabia
Turkey (Türkiye)
United Arab Emirates
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Opdivo
Ipilimumab
Drug
Arm B: Nivolumab + Ipilimumab
Yervoy
Carboplatin
Drug
Arm C: Nivolumab + Platinum doublet chemotherapy
Arm D: Platinum doublet chemotherapy
Cisplatin
Drug
Arm C: Nivolumab + Platinum doublet chemotherapy
Arm D: Platinum doublet chemotherapy
Gemcitabine
Drug
Arm C: Nivolumab + Platinum doublet chemotherapy
Arm D: Platinum doublet chemotherapy
Pemetrexed
Drug
Arm C: Nivolumab + Platinum doublet chemotherapy
Arm D: Platinum doublet chemotherapy
Paclitaxel
Drug
Arm C: Nivolumab + Platinum doublet chemotherapy
Arm D: Platinum doublet chemotherapy
From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale
The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.
Week 12
San Francisco
California
94115
United States
Local Institution - 0021
New Haven
Connecticut
06520
United States
Local Institution - 0001
Atlanta
Georgia
30322
United States
Local Institution - 0013
Marietta
Georgia
30060
United States
Local Institution - 0004
Lexington
Kentucky
40503
United States
Local Institution - 0115
St Louis
Missouri
63110
United States
Local Institution - 0005
Buffalo
New York
14263
United States
Local Institution - 0019
New York
New York
10065
United States
Local Institution - 0014
Cleveland
Ohio
44106
United States
Local Institution - 0009
Columbus
Ohio
43210
United States
Local Institution - 0007
Allentown
Pennsylvania
18103
United States
Local Institution - 0075
Langhorne
Pennsylvania
19047
United States
Local Institution - 0299
Philadelphia
Pennsylvania
19107
United States
Local Institution - 0012
Philadelphia
Pennsylvania
19111-2412
United States
Local Institution - 0015
Sayre
Pennsylvania
18840
United States
Local Institution - 0008
Charleston
South Carolina
29425
United States
Local Institution - 0080
Greenville
South Carolina
29605
United States
Local Institution - 0010
Greenville
South Carolina
29607
United States
Local Institution - 0020
Nashville
Tennessee
37232
United States
Local Institution - 0306
Dallas
Texas
75390-8852
United States
Local Institution - 0003
Dallas
Texas
75390
United States
Local Institution - 0102
Houston
Texas
77030
United States
Local Institution - 0011
Salt Lake City
Utah
84108
United States
Local Institution - 0074
Kennewick
Washington
99336
United States
Local Institution - 0170
Berazategui
Buenos Aires
1880
Argentina
Local Institution - 0171
Capital Federal
Buenos Aires
1426
Argentina
Local Institution - 0172
Ciudad Autonoma de Buenos Aire
Buenos Aires
1181
Argentina
Local Institution - 0176
Ciudad de Buenos Aires
Buenos Aires
1025
Argentina
Local Institution - 0296
Mar del Plata
Buenos Aires
7600
Argentina
Local Institution - 0130
San Miguel de Tucumán
Tucumán Province
4000
Argentina
Local Institution - 0268
Córdoba
5000
Argentina
Local Institution - 0272
Córdoba
5016
Argentina
Local Institution - 0297
Córdoba
X50004FHP
Argentina
Local Institution - 0177
Viedma
8500
Argentina
Local Institution - 0182
Garran
Australian Capital Territory
2605
Australia
Local Institution - 0301
Blacktown
New South Wales
2148
Australia
Local Institution - 0300
Gosford
New South Wales
2250
Australia
Local Institution - 0045
Brisbane
Queensland
4102
Australia
Local Institution - 0046
Elizabeth Vale
South Australia
5112
Australia
Local Institution - 0043
Clayton
Victoria
3168
Australia
Local Institution - 0042
Fitzroy
Victoria
3065
Australia
Local Institution - 0180
Perth
Western Australia
6150
Australia
Local Institution - 0040
Murdoch
6150
Australia
Local Institution - 0183
North Tamworth
2340
Australia
Local Institution - 0241
Graz
8036
Austria
Local Institution - 0240
Vienna
1090
Austria
Local Institution - 0239
Wels
4600
Austria
Local Institution - 0034
Charleroi
Hainaut
6060
Belgium
Local Institution - 0121
Roeselare
West-Vlaanderen
8800
Belgium
Local Institution - 0030
Edegem
2650
Belgium
Local Institution - 0031
Ghent
9000
Belgium
Local Institution - 0117
Hasselt
3500
Belgium
Local Institution - 0033
Sint-Niklaas
9100
Belgium
Local Institution - 0125
Salvador
Estado de Bahia
40170-110
Brazil
Local Institution - 0124
Ijuí
Rio Grande do Sul
98700-000
Brazil
Local Institution - 0123
Porto Alegre
Rio Grande do Sul
90610-000
Brazil
Local Institution - 0127
Barretos
São Paulo
14784-400
Brazil
Local Institution - 0129
Rio de Janeiro
20231-050
Brazil
Local Institution - 0144
São Paulo
01321-001
Brazil
Local Institution - 0126
São Paulo
01509-010
Brazil
Local Institution - 0128
São Paulo
05403-010
Brazil
Local Institution - 0103
Edmonton
Alberta
T6G 1Z2
Canada
Local Institution - 0290
St. John's
Newfoundland and Labrador
A1B 3V6
Canada
Local Institution - 0104
London
Ontario
N6A 5W9
Canada
Local Institution - 0122
Montreal
Quebec
H3T 1E2
Canada
Local Institution - 0106
Québec
Quebec
G1J 1Z4
Canada
Local Institution - 0302
Québec
Quebec
G1V 4G5
Canada
Local Institution - 0107
Rimouski
Quebec
G5L 5T1
Canada
Local Institution - 0291
Sherbrooke
Quebec
J1H 5N4
Canada
Local Institution - 0292
Trois-Rivières
Quebec
G8Z 3R9
Canada
Local Institution - 0173
Santiago
Santiago Metropolitan
7500921
Chile
Local Institution - 0131
Santiago
Santiago Metropolitan
8420383
Chile
Local Institution - 0174
Viña del Mar
Valparaiso
254 0364
Chile
Local Institution - 0380
Hefei
Anhui
230001
China
Local Institution - 0313
Beijing
Beijing Municipality
100001
China
Local Institution - 0315
Beijing
Beijing Municipality
100021
China
Local Institution - 0316
Beijing
Beijing Municipality
100021
China
Local Institution - 0314
Beijing
Beijing Municipality
100032
China
Local Institution - 0365
Chongqing
Chongqing Municipality
400037
China
Local Institution - 0364
Chongqing
Chongqing Municipality
400038
China
Local Institution - 0378
Chongqing
Chongqing Municipality
400042
China
Local Institution - 0322
Guangzhou
Guangdong
510060
China
Local Institution - 0372
Guangzhou
Guangdong
510095
China
Local Institution - 0319
Guanzhou
Guangdong
510080
China
Local Institution - 0323
Haikou
Hainan
570311
China
Local Institution - 0325
Haerbin
Heilongjiang
150081
China
Local Institution - 0324
Zhengzhou
Henan
0
China
Local Institution - 0379
Zhengzhou
Henan
450052
China
Local Institution - 0375
Wuhan
Hubei
430024
China
Local Institution - 0362
Changsha
Hunan
410013
China
Local Institution - 0347
Nanchang
Jiangxi
0
China
Local Institution - 0329
Changchun
Jilin
130012
China
Local Institution - 0361
Changchun
Jilin
130021
China
Local Institution - 0359
Shenyang
Liaoning
110000
China
Local Institution - 0371
Xi'an
Shaanxi
710061
China
Local Institution - 0333
Xi'an
Shan3xi
710038
China
Local Institution - 0360
Qingdao
Shandong
266061
China
Local Institution - 0336
Shanghai
Shanghai Municipality
200030
China
Local Institution - 0334
Shanghai
Shanghai Municipality
200032
China
Local Institution - 0376
Chengdu
Sichuan
610041
China
Local Institution - 0373
Tianjin
Tianjin Municipality
300060
China
Local Institution - 0340
Ürümqi
Xinjiang
830011
China
Local Institution - 0343
Hangzhou
Zhejiang
310003
China
Local Institution - 0370
Hangzhou
Zhejiang
310009
China
Local Institution - 0342
Hangzhou
Zhejiang
310022
China
Local Institution - 0328
Changsha
0
China
Local Institution - 0341
Hangzhou
310016
China
Local Institution - 0345
Kunming
0
China
Local Institution - 0337
Shanghai
200030
China
Local Institution - 0374
Shantou
0
China
Local Institution - 0273
Pereira
Risaralda Department
0
Colombia
Local Institution - 0237
Bogotá
0
Colombia
Local Institution - 0238
Bogotá
0
Colombia
Local Institution - 0282
Medellín
050034
Colombia
Local Institution - 0112
Hradec Králové
500 05
Czechia
Local Institution - 0113
Olomouc
779 00
Czechia
Local Institution - 0111
Prague
140 59
Czechia
Local Institution - 0232
Příbram
261 01
Czechia
Local Institution - 0270
Oulu
90029
Finland
Local Institution - 0271
Turku
20520
Finland
Local Institution - 0222
Bron
Rhône
69677
France
Local Institution - 0216
Angers
49055
France
Local Institution - 0229
Besançon
0
France
Local Institution - 0283
Caen
14076
France
Local Institution - 0218
Créteil
94010
France
Local Institution - 0228
Limoges
87042
France
Local Institution - 0215
Marseille
13915
France
Local Institution - 0230
Paris
75018
France
Local Institution - 0227
Pessac
33604
France
Local Institution - 0223
Rennes
350330
France
Local Institution - 0225
Rouen
76000
France
Local Institution - 0217
Saint-Herblain
44805
France
Local Institution - 0221
Saint-Priest-en-Jarez
42271
France
Local Institution - 0224
Strasbourg
67000
France
Local Institution - 0226
Toulon
83056
France
Local Institution - 0231
Magdeburg
Saxony-Anhalt
39120
Germany
Local Institution - 0213
Bad Berka
99437
Germany
Local Institution - 0208
Berlin
13125
Germany
Local Institution - 0205
Essen
45147
Germany
Local Institution - 0210
Frankfurt
60590
Germany
Local Institution - 0211
Gera
07548
Germany
Local Institution - 0203
Großhansdorf
22927
Germany
Local Institution - 0209
Halle
06120
Germany
Local Institution - 0202
Heidelberg
69126
Germany
Local Institution - 0214
Hemer
58675
Germany
Local Institution - 0206
Immenstadt im Allgäu
87509
Germany
Local Institution - 0204
München
81925
Germany
Local Institution - 0201
Stuttgart
70376
Germany
Local Institution - 0212
Wiesbaden
65199
Germany
Local Institution - 0094
Athens
Attikí
115 27
Greece
Local Institution - 0095
Heraklion
711 10
Greece
Local Institution - 0190
Neo Faliro
18547
Greece
Local Institution - 0101
Thessaloniki
54007
Greece
Local Institution - 0025
Budapest
1083
Hungary
Local Institution - 0024
Budapest
1121
Hungary
Local Institution - 0026
Mátraháza
3233
Hungary
Local Institution - 0054
Dublin
Dublin
Ireland
Local Institution - 0053
Beaumont
Dublin 9
Ireland
Local Institution - 0055
Galway
0
Ireland
Local Institution - 0100
Limerick
0
Ireland
Local Institution - 0187
Jerusalem
91120
Israel
Local Institution - 0186
Kfar Saba
44281
Israel
Local Institution - 0185
Petah Tikva
49100
Israel
Local Institution - 0184
Tel Litwinsky
52621
Israel
Local Institution - 0188
Ẕerifin
70300
Israel
Local Institution - 0083
Milan
Lombardy
20141
Italy
Azienda Ospedaliera Moscati
Avellino
83024
Italy
Local Institution - 0179
Bergamo
24127
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna
40138
Italy
Local Institution - 0084
Livorno
57124
Italy
Policlinico G. Martino
Messina
98125
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
20133
Italy
Istituto Nazionale Tumori Fondazione Pascale
Naples
80131
Italy
Local Institution - 0087
Perugia
06132
Italy
Ospedale Santa Maria delle Croci
Ravenna
48121
Italy
Ifo-Istituto Regina Elena
Roma
00144
Italy
Local Institution - 0089
Roma
00161
Italy
Local Institution - 0085
Terni
05100
Italy
Local Institution - 0153
Nagoya
Aichi-ken
4600001
Japan
Local Institution - 0152
Nagoya
Aichi-ken
4648681
Japan
Local Institution - 0260
Chiba
Chiba
260-8677
Japan
Local Institution - 0148
Kashiwa-shi
Chiba
2778577
Japan
Local Institution - 0159
Matsuyama
Ehime
791-0280
Japan
Local Institution - 0160
Fukuoka
Fukuoka
8120054
Japan
Local Institution - 0259
Kurume-shi
Fukuoka
8300011
Japan
Local Institution - 0255
Ota-shi
Gunma
3730828
Japan
Local Institution - 0258
Hiroshima
Hiroshima
7308518
Japan
Local Institution - 0163
Sapporo
Hokkaido
0030804
Japan
Local Institution - 0253
Sapporo
Hokkaido
0608648
Japan
Local Institution - 0252
Akashi-shi
Hyōgo
6738558
Japan
Local Institution - 0156
Kobe
Hyōgo
6500047
Japan
Local Institution - 0146
Kanazawa
Ishikawa-ken
9208641
Japan
Local Institution - 0161
Yokohama
Kanagawa
2210855
Japan
Local Institution - 0150
Yokohama
Kanagawa
2360051
Japan
Local Institution - 0275
Natori-shi
Miyagi
9811293
Japan
Local Institution - 0254
Sendai
Miyagi
9800873
Japan
Local Institution - 0145
Sendai
Miyagi
9808574
Japan
Local Institution - 0164
Niigata
Niigata
9518566
Japan
Local Institution - 0158
Kurashiki-shi
Okayama-ken
7100052
Japan
Local Institution - 0155
Hirakata-shi
Osaka
5731191
Japan
Local Institution - 0154
Osaka
Osaka
5340021
Japan
Local Institution - 0251
Osakasayama-shi
Osaka
5890014
Japan
Local Institution - 0257
Takatsuki-shi
Osaka
5698686
Japan
Local Institution - 0353
Hidaka-shi
Saitama
3501298
Japan
Local Institution - 0256
Kitaadachi-gun
Saitama
3620806
Japan
Local Institution - 0151
Sunto-gun
Shizuoka
4118777
Japan
Local Institution - 0147
Chuo-ku
Tokyo
1040045
Japan
Local Institution - 0149
Koto-ku
Tokyo
1358550
Japan
Local Institution - 0278
Shinjuku-ku
Tokyo
1600023
Japan
Local Institution - 0157
Wakayama
Wakayama
641-8510
Japan
Local Institution - 0354
Ube-shi
Yamaguchi
7550241
Japan
Local Institution - 0165
Okayama
700-8558
Japan
Local Institution - 0162
Tokyo
113-8603
Japan
Local Institution - 0287
Beirut
00961
Lebanon
Local Institution - 0286
Beirut
166830
Lebanon
Local Institution - 0197
Guadalajara
Jalisco
44270
Mexico
Local Institution - 0191
Zapopan
Jalisco
44280
Mexico
Local Institution - 0196
Df
Mexico City
06720
Mexico
Local Institution - 0193
Mexico City
Mexico City
14080
Mexico
Local Institution - 0267
Morelia
Michoacán
58000
Mexico
Local Institution - 0277
Monterrey
Nuevo León
64060
Mexico
Local Institution - 0198
Cuautitlán
State of Mexico
54769
Mexico
Local Institution - 0303
Mérida
Yucatán
97070
Mexico
Local Institution - 0192
Chihuahua City
31217
Mexico
Local Institution - 0195
San Luis Potosí City
78200
Mexico
Local Institution - 0236
San Luis Potosí City
78213
Mexico
Local Institution - 0194
Toluca
50180
Mexico
Local Institution - 0036
Amsterdam
1066 CX
Netherlands
Local Institution - 0189
Amsterdam
1081 HV
Netherlands
Local Institution - 0169
Breda
4818 CK
Netherlands
Local Institution - 0037
Rotterdam
3014 GD
Netherlands
Local Institution - 0039
Veldhoven
5504 DB
Netherlands
Local Institution - 0262
Lima
0
Peru
Local Institution - 0263
Lima
0
Peru
Local Institution - 0350
Lima
27
Peru
Local Institution - 0261
Lima
34
Peru
Local Institution - 0351
Lima
Lima 41
Peru
Local Institution - 0060
Bydgoszcz
85-796
Poland
Local Institution - 0058
Gdansk
80-19
Poland
Local Institution - 0063
Gdynia
81-519
Poland
Local Institution - 0072
Gliwice
44-101
Poland
Local Institution - 0057
Lodz
93-513
Poland
Local Institution - 0059
Warsaw
02-781
Poland
Local Institution - 0070
Wroclaw
52-229
Poland
Local Institution - 0167
Craiova
200542
Romania
Local Institution - 0250
Floreşti
407280
Romania
Local Institution - 0166
Romania
400015
Romania
Local Institution - 0284
Sector 2
022328
Romania
Local Institution - 0137
Chelyabinsk
454048
Russia
Local Institution - 0142
Kazan'
420029
Russia
Local Institution - 0022
Moscow
115478
Russia
Local Institution - 0028
Saint Petersburg
194291
Russia
Local Institution - 0049
Saint Petersburg
197758
Russia
Local Institution - 0027
Saint Petersburg
198255
Russia
Local Institution - 0143
Ufa
450054
Russia
Local Institution - 0264
Pretoria
Gauteng
0002
South Africa
Local Institution - 0234
Sandton
Gauteng
2196
South Africa
Local Institution - 0233
Saxonwold, Johannesburg
Gauteng
2196
South Africa
Local Institution - 0305
Vereeniging
1936
South Africa
Local Institution - 0136
Seongnam-si
Kyǒnggi-do
436-707
South Korea
Local Institution - 0249
Cheongju-si
28644
South Korea
Local Institution - 0133
Gangnam-gu
06351
South Korea
Local Institution - 0132
Seoul
05505
South Korea
Local Institution - 0135
Seoul
06591
South Korea
Local Institution - 0064
Majadahonda
Madrid
28222
Spain
Local Institution - 0066
Barcelona
08035
Spain
Local Institution - 0067
Barcelona
08916
Spain
Local Institution - 0065
Madrid
28041
Spain
Local Institution - 0069
Seville
41013
Spain
Local Institution - 0068
Valencia
46014
Spain
Local Institution - 0243
Basel
4031
Switzerland
Local Institution - 0246
Chur
7000
Switzerland
Local Institution - 0244
Lausanne
1011
Switzerland
Local Institution - 0245
Winterthur
8401
Switzerland
Local Institution - 0139
Taichung
407
Taiwan
Local Institution - 0138
Taipei
100
Taiwan
Local Institution - 0140
Taipei
112
Taiwan
Local Institution - 0310
Taipei
235
Taiwan
Local Institution - 0141
Taoyuan City
333
Taiwan
Local Institution - 0266
Middlesbrough
Cleveland
TS4 3BW
United Kingdom
Local Institution - 0098
London
Greater London
SW3 6JJ
United Kingdom
Local Institution - 0099
Southampton
Hampshire
SO16 0YD
United Kingdom
Local Institution - 0118
Leicester
Leicestershire
LE1 5WW
United Kingdom
Local Institution - 0265
Birmingham
B4 6DHH
United Kingdom
Local Institution - 0051
Cambridgeshire
CB2 2QQ
United Kingdom
Local Institution - 0109
Edinburgh
EH4 2XU
United Kingdom
Local Institution - 0097
London
N18 1QX
United Kingdom
Local Institution - 0050
London
SE1 9RT
United Kingdom
Local Institution - 0119
Surrey
SM2 5PT
United Kingdom
Derived
Mason M, Lapuente-Santana O, Halkola AS, Wang W, Mall R, Xiao X, Kaufman J, Fu J, Pfeil J, Banerjee J, Chung V, Chang H, Chasalow SD, Lin HY, Chai R, Yu T, Finotello F, Mirtti T, Mayranpaa MI, Bao J, Verschuren EW, Ahmed EI, Ceccarelli M, Miller LD, Monaco G, Hendrickx WRL, Sherif S, Yang L, Tang M, Gu SS, Zhang W, Zhang Y, Zeng Z, Das Sahu A, Liu Y, Yang W, Bedognetti D, Tang J, Eduati F, Laajala TD, Geese WJ, Guinney J, Szustakowski JD, Vincent BG, Carbone DP. A community challenge to predict clinical outcomes after immune checkpoint blockade in non-small cell lung cancer. J Transl Med. 2024 Feb 21;22(1):190. doi: 10.1186/s12967-023-04705-3.
Brahmer JR, Lee JS, Ciuleanu TE, Bernabe Caro R, Nishio M, Urban L, Audigier-Valette C, Lupinacci L, Sangha R, Pluzanski A, Burgers J, Mahave M, Ahmed S, Schoenfeld AJ, Paz-Ares LG, Reck M, Borghaei H, O'Byrne KJ, Gupta RG, Bushong J, Li L, Blum SI, Eccles LJ, Ramalingam SS. Five-Year Survival Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Metastatic Non-Small-Cell Lung Cancer in CheckMate 227. J Clin Oncol. 2023 Feb 20;41(6):1200-1212. doi: 10.1200/JCO.22.01503. Epub 2022 Oct 12.
Reck M, Ciuleanu TE, Lee JS, Schenker M, Audigier-Valette C, Zurawski B, Linardou H, Otterson GA, Salman P, Nishio M, de la Mora Jimenez E, Lesniewski-Kmak K, Albert I, Ahmed S, Syrigos K, Penrod JR, Yuan Y, Blum SI, Nathan FE, Sun X, Moreno-Koehler A, Taylor F, O'Byrne KJ. First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in Advanced NSCLC With 1% or Greater Tumor PD-L1 Expression: Patient-Reported Outcomes From CheckMate 227 Part 1. J Thorac Oncol. 2021 Apr;16(4):665-676. doi: 10.1016/j.jtho.2020.12.019. Epub 2021 Jan 21.
Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim SW, Carcereny Costa E, Park K, Alexandru A, Lupinacci L, de la Mora Jimenez E, Sakai H, Albert I, Vergnenegre A, Peters S, Syrigos K, Barlesi F, Reck M, Borghaei H, Brahmer JR, O'Byrne KJ, Geese WJ, Bhagavatheeswaran P, Rabindran SK, Kasinathan RS, Nathan FE, Ramalingam SS. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019 Nov 21;381(21):2020-2031. doi: 10.1056/NEJMoa1910231. Epub 2019 Sep 28.
Reck M, Schenker M, Lee KH, Provencio M, Nishio M, Lesniewski-Kmak K, Sangha R, Ahmed S, Raimbourg J, Feeney K, Corre R, Franke FA, Richardet E, Penrod JR, Yuan Y, Nathan FE, Bhagavatheeswaran P, DeRosa M, Taylor F, Lawrance R, Brahmer J. Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial. Eur J Cancer. 2019 Jul;116:137-147. doi: 10.1016/j.ejca.2019.05.008. Epub 2019 Jun 11.
Hellmann MD, Ciuleanu TE, Pluzanski A, Lee JS, Otterson GA, Audigier-Valette C, Minenza E, Linardou H, Burgers S, Salman P, Borghaei H, Ramalingam SS, Brahmer J, Reck M, O'Byrne KJ, Geese WJ, Green G, Chang H, Szustakowski J, Bhagavatheeswaran P, Healey D, Fu Y, Nathan F, Paz-Ares L. Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden. N Engl J Med. 2018 May 31;378(22):2093-2104. doi: 10.1056/NEJMoa1801946. Epub 2018 Apr 16.
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
FG002
Part 1-Arm C: Chemotherapy
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
FG003
Part 1-Arm D: Nivo + Ipi
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
FG004
Part 1-Arm G: Nivo + Chemo
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
FG005
Part 1-Arm F: Chemotherapy
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
FG006
Part 2 - Arm H: Nivolumab + Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
FG007
Part 2 - Arm I: Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
FG008
Part 3 -Arm J: Nivolumab + Ipilimumab
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
FG009
Part 3 - Arm K: Chemotherapy
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
FG000396 subjects
FG001396 subjects
FG002397 subjects
FG003187 subjects
FG004177 subjects
FG005186 subjects
FG006377 subjects
FG007378 subjects
FG008126 subjects
FG009127 subjects
COMPLETED
FG000391 subjects
FG001391 subjects
FG002387 subjects
FG003185 subjects
FG004172 subjects
FG005183 subjects
FG006375 subjects
FG007371 subjects
FG008126 subjects
FG009123 subjects
NOT COMPLETED
FG0005 subjects
FG0015 subjects
FG00210 subjects
FG0032 subjects
FG0045 subjects
FG0053 subjects
FG0062 subjects
FG0077 subjects
FG0080 subjects
FG0094 subjects
Type
Comment
Reasons
Adverse events unrelated to study drug
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0075 subjects
FG0080 subjects
FG0090 subjects
Other reasons
FG0004 subjects
FG0011 subjects
FG0024 subjects
FG0031 subjects
FG004
Subject no longer meets study criteria
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Subject withdrew consent
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Subject request to discontinue study treatment
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Treatment Period
Type
Comment
Milestone Data
STARTED
FG000391 subjects
FG001391 subjects
FG002387 subjects
FG003185 subjects
FG004172 subjects
FG005183 subjects
FG006375 subjects
FG007371 subjects
FG008126 subjects
FG009123 subjects
COMPLETED
FG00045 subjects
FG00137 subjects
FG00294 subjects
FG00314 subjects
FG004
NOT COMPLETED
FG000346 subjects
FG001354 subjects
FG002293 subjects
FG003171 subjects
FG004
Type
Comment
Reasons
Not reported
FG0008 subjects
FG0016 subjects
FG0024 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1-Arm B: Nivo + Ipi
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
BG001
Part 1-Arm A: Nivolumab
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
BG002
Part 1-Arm C: Chemotherapy
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
BG003
Part 1-Arm D: Nivo + Ipi
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
BG004
Part 1-Arm G: Nivo + Chemo
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
BG005
Part 1-Arm F: Chemotherapy
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
BG006
Part 2 - Arm H: Nivolumab + Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
BG007
Part 2 - Arm I: Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
BG008
Part 3 -Arm J: Nivolumab + Ipilimumab
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
BG009
Part 3 - Arm K: Chemotherapy
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000396
BG001396
BG002397
BG003187
BG004177
BG005186
BG006377
BG007378
BG008126
BG009127
BG0102747
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
< 65
BG000199
BG001210
BG002207
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000141
BG001124
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG000299
BG001317
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Progression-Free Survival Per BICR
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
All randomized participants
Posted
Median
95% Confidence Interval
months
From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
ID
Title
Description
OG000
Part 1-Arm B: Nivo + Ipi
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
OG001
Part 1-Arm A: Nivolumab
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
OG002
Part 1-Arm C: Chemotherapy
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG003
Part 1-Arm D: Nivo + Ipi
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
OG004
Part 1-Arm G: Nivo + Chemo
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG005
Part 1-Arm F: Chemotherapy
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG006
Part 2 - Arm H: Nivolumab + Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG007
Part 2 - Arm I: Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG008
Part 3 -Arm J: Nivolumab + Ipilimumab
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
OG009
Part 3 - Arm K: Chemotherapy
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
Units
Counts
Participants
OG000396
OG001396
OG002397
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.06(4.07 to 6.31)
OG0014.17(3.22 to 5.32)
OG0025.55(4.63 to 5.82)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard Ratio (HR)
0.79
2-Sided
95
0.67
0.93
Superiority
OG001
OG002
Primary
Overall Survival
OS for all randomized participants is the time between randomization date and the date of death from any cause.
All randomized participants
Posted
Median
95% Confidence Interval
months
From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks)
ID
Title
Description
OG000
Part 1-Arm B: Nivo + Ipi
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
OG001
Part 1-Arm A: Nivolumab
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
OG002
Part 1-Arm C: Chemotherapy
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
Secondary
Objective Response Rate (ORR) Per BICR
Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All randomized participants
Posted
Number
95% Confidence Interval
percentage of participants
From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
ID
Title
Description
OG000
Part 1-Arm B: Nivo + Ipi
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
OG001
Part 1-Arm A: Nivolumab
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
Secondary
Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale
The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.
All randomized participants
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Part 1-Arm B: Nivo + Ipi
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
OG001
Part 1-Arm A: Nivolumab
Time Frame
Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Description
Randomized participants
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1-Arm B: Nivo + Ipi
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
316
391
275
391
366
391
EG001
Part 1-Arm A: Nivolumab
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
333
391
239
391
356
391
EG002
Part 1-Arm C: Chemotherapy
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
339
387
213
387
361
387
EG003
Part 1-Arm D: Nivo + Ipi
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
159
185
128
185
172
185
EG004
Part 1-Arm G: Nivo + Chemo
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
157
172
112
172
167
172
EG005
Part 1-Arm F: Chemotherapy
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
174
183
91
183
165
183
EG006
Part 2 - Arm H: Nivolumab + Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
314
375
240
375
357
375
EG007
Part 2 - Arm I: Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
335
371
180
371
345
371
EG008
Part 3 -Arm J: Nivolumab + Ipilimumab
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
95
126
78
126
124
126
EG009
Part 3 - Arm K: Chemotherapy
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
94
123
60
123
121
123
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0004 affected391 at risk
EG0014 affected391 at risk
EG0029 affected387 at risk
EG0034 affected185 at risk
EG00410 affected172 at risk
EG0058 affected183 at risk
EG00614 affected375 at risk
EG00710 affected371 at risk
EG0081 affected126 at risk
EG0092 affected123 at risk
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Bone marrow failure
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Febrile bone marrow aplasia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0013 affected391 at risk
EG0029 affected387 at risk
EG003
Haematotoxicity
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Heparin-induced thrombocytopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Myelosuppression
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0022 affected387 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0013 affected391 at risk
EG0022 affected387 at risk
EG003
Splenic haematoma
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Splenic haemorrhage
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Splenic thrombosis
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0025 affected387 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Acute coronary syndrome
Cardiac disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Acute left ventricular failure
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Acute myocardial infarction
Cardiac disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Angina pectoris
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Angina unstable
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Arrhythmia
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Atrial fibrillation
Cardiac disorders
27.0
Systematic Assessment
EG0004 affected391 at risk
EG0014 affected391 at risk
EG0020 affected387 at risk
EG003
Atrial flutter
Cardiac disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Atrioventricular block complete
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Bradycardia
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Cardiac arrest
Cardiac disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0014 affected391 at risk
EG0020 affected387 at risk
EG003
Cardiac failure
Cardiac disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0012 affected391 at risk
EG0021 affected387 at risk
EG003
Cardiac failure acute
Cardiac disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Cardiac failure congestive
Cardiac disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Cardiac fibrillation
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Cardiac tamponade
Cardiac disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0013 affected391 at risk
EG0020 affected387 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Cardiogenic shock
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Coronary artery disease
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypertensive cardiomyopathy
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Immune-mediated myocarditis
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Myocardial infarction
Cardiac disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Myocardial ischaemia
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Myocarditis
Cardiac disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Palpitations
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Pericardial effusion
Cardiac disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0015 affected391 at risk
EG0022 affected387 at risk
EG003
Pericardial effusion malignant
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0014 affected391 at risk
EG0020 affected387 at risk
EG003
Pericarditis
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Pleuropericarditis
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Right ventricular failure
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Supraventricular tachyarrhythmia
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Tachycardia
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Torsade de pointes
Cardiac disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Tracheo-oesophageal fistula
Congenital, familial and genetic disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Vertigo
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Adrenal insufficiency
Endocrine disorders
27.0
Systematic Assessment
EG00010 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Autoimmune hypothyroidism
Endocrine disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Hyperparathyroidism secondary
Endocrine disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hyperthyroidism
Endocrine disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypophysitis
Endocrine disorders
27.0
Systematic Assessment
EG0005 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypopituitarism
Endocrine disorders
27.0
Systematic Assessment
EG0005 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Hypothyroidism
Endocrine disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Immune-mediated hypophysitis
Endocrine disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Primary adrenal insufficiency
Endocrine disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Secondary adrenocortical insufficiency
Endocrine disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Cataract
Eye disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Diplopia
Eye disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Abdominal distension
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0012 affected391 at risk
EG0022 affected387 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Ascites
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Colitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0009 affected391 at risk
EG0014 affected391 at risk
EG0020 affected387 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Colitis microscopic
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Constipation
Gastrointestinal disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0012 affected391 at risk
EG0022 affected387 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0006 affected391 at risk
EG0013 affected391 at risk
EG0024 affected387 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Dysphagia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Enterocolitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Erosive oesophagitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Gastritis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0022 affected387 at risk
EG003
Gingival hypertrophy
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Haematemesis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Ileus
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0012 affected391 at risk
EG0020 affected387 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Immune-mediated gastritis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Immune-mediated pancreatitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Large intestinal ulcer
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Malignant ascites
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Melaena
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Nausea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0012 affected391 at risk
EG0027 affected387 at risk
EG003
Odynophagia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Oesophageal fistula
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Oesophagitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Pancreatitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Rectal ulcer
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Stomatitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0012 affected391 at risk
EG0020 affected387 at risk
EG003
Subileus
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Vomiting
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0017 affected391 at risk
EG0027 affected387 at risk
EG003
Adverse drug reaction
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Asthenia
General disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0014 affected391 at risk
EG0025 affected387 at risk
EG003
Chest discomfort
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Chest pain
General disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Chills
General disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Complication associated with device
General disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Death
General disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0012 affected391 at risk
EG0021 affected387 at risk
EG003
Drug withdrawal syndrome
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Face oedema
General disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Fatigue
General disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0013 affected391 at risk
EG0021 affected387 at risk
EG003
General physical health deterioration
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0014 affected391 at risk
EG0023 affected387 at risk
EG003
Generalised oedema
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0012 affected391 at risk
EG0020 affected387 at risk
EG003
Hyperthermia
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Hypothermia
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Inflammation
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Influenza like illness
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Malaise
General disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Mucosal inflammation
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0013 affected391 at risk
EG0021 affected387 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Non-cardiac chest pain
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Pain
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Performance status decreased
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pyrexia
General disorders
27.0
Systematic Assessment
EG0005 affected391 at risk
EG0015 affected391 at risk
EG0025 affected387 at risk
EG003
Sudden death
General disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0015 affected391 at risk
EG0020 affected387 at risk
EG003
Swelling
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Systemic inflammatory response syndrome
General disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Acute hepatic failure
Hepatobiliary disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Bile duct stone
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Cholangitis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Cholecystitis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0012 affected391 at risk
EG0021 affected387 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Cholestasis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hepatic failure
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hepatitis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0014 affected391 at risk
EG0020 affected387 at risk
EG003
Hepatorenal failure
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Hydrocholecystis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Immune-mediated hepatic disorder
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Liver disorder
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Liver injury
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Anaphylactic reaction
Immune system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Anaphylactic shock
Immune system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Contrast media allergy
Immune system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Contrast media reaction
Immune system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Drug hypersensitivity
Immune system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Hypersensitivity
Immune system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Infusion related hypersensitivity reaction
Immune system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Abscess
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Abscess limb
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Anal abscess
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Appendicitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Aspergillus infection
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Bacteraemia
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Bacterial diarrhoea
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Bacterial infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Bronchitis
Infections and infestations
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Catheter site infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Cellulitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Clostridium difficile infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Dermo-hypodermitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Diabetic foot infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Diverticulitis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Diverticulitis intestinal perforated
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Empyema
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Encephalitis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Enteritis infectious
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Enterocolitis infectious
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Erysipelas
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Febrile infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Gastroenteritis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Gastroenteritis viral
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Gastrointestinal infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Groin infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Herpes zoster
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Infection
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Infectious pleural effusion
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Influenza
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Injection site infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Klebsiella urinary tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Large intestine infection
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Lower respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Lung abscess
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Meningitis viral
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Metapneumovirus infection
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Myelitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Nasopharyngitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Neutropenic infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Neutropenic sepsis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Oesophageal candidiasis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Osteomyelitis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Peritonitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pleural infection
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pneumonia
Infections and infestations
27.0
Systematic Assessment
EG00040 affected391 at risk
EG00129 affected391 at risk
EG00231 affected387 at risk
EG003
Pneumonia adenoviral
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pneumonia aspiration
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0012 affected391 at risk
EG0020 affected387 at risk
EG003
Pneumonia bacterial
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Pneumonia influenzal
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pneumonia klebsiella
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pneumonia necrotising
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pneumonia viral
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pseudomembranous colitis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pulmonary sepsis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0013 affected391 at risk
EG0020 affected387 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pyelonephritis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Rectal abscess
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0004 affected391 at risk
EG0015 affected391 at risk
EG0023 affected387 at risk
EG003
Respiratory tract infection viral
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Salmonellosis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Sepsis
Infections and infestations
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0013 affected391 at risk
EG0023 affected387 at risk
EG003
Septic shock
Infections and infestations
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0014 affected391 at risk
EG0021 affected387 at risk
EG003
Skin infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Soft tissue infection
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Staphylococcal infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Systemic candida
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Thrombophlebitis septic
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Tooth infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Upper respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0025 affected387 at risk
EG003
Urinary tract infection
Infections and infestations
27.0
Systematic Assessment
EG0004 affected391 at risk
EG0012 affected391 at risk
EG0024 affected387 at risk
EG003
Urosepsis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Vascular device infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Viral infection
Infections and infestations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Viral pericarditis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Wound infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Contusion
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Fall
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Femoral nerve injury
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0013 affected391 at risk
EG0021 affected387 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Fracture displacement
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Head injury
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Injury
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Overdose
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0022 affected387 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Radiation oesophagitis
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Radiation pneumonitis
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Alanine aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0013 affected391 at risk
EG0020 affected387 at risk
EG003
Amylase increased
Investigations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Blood alkaline phosphatase increased
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Blood calcium decreased
Investigations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Blood creatine phosphokinase increased
Investigations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Blood creatinine increased
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Blood glucose increased
Investigations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Blood potassium decreased
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Electrocardiogram QT prolonged
Investigations
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Eosinophil count increased
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
General physical condition abnormal
Investigations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hepatic enzyme increased
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Lipase increased
Investigations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Liver function test abnormal
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Liver function test increased
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Lymphocyte count decreased
Investigations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Neutrophil count decreased
Investigations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pancreatic enzymes increased
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Platelet count decreased
Investigations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0023 affected387 at risk
EG003
Transaminases increased
Investigations
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Troponin increased
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Weight decreased
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
White blood cell count decreased
Investigations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Acidosis
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Adult failure to thrive
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0012 affected391 at risk
EG0020 affected387 at risk
EG003
Dehydration
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0014 affected391 at risk
EG0021 affected387 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Diabetic metabolic decompensation
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0014 affected391 at risk
EG0021 affected387 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0013 affected391 at risk
EG0022 affected387 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Ketoacidosis
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Autoimmune arthritis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0012 affected391 at risk
EG0021 affected387 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypertrophic osteoarthropathy
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Polymyalgia rheumatica
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Acute leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Benign breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0005 affected391 at risk
EG0013 affected391 at risk
EG0023 affected387 at risk
EG003
Cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Extranodal marginal zone B-cell lymphoma (MALT type)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Female reproductive neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Gastric neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Haematological malignancy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hepatic cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hepatobiliary cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Intestinal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Intestinal metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Lymphangiosis carcinomatosa
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG00098 affected391 at risk
EG001102 affected391 at risk
EG00287 affected387 at risk
EG003
Metastases to adrenals
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Metastases to pleura
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Oncologic complication
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Paraneoplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Tumour compression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0012 affected391 at risk
EG0021 affected387 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Tumour invasion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Tumour necrosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0012 affected391 at risk
EG0021 affected387 at risk
EG003
Tumour pseudoprogression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Atonic seizures
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Brain oedema
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Cerebellar infarction
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Cerebral infarction
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0024 affected387 at risk
EG003
Cerebral ischaemia
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Cerebral microangiopathy
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Cerebrovascular accident
Nervous system disorders
27.0
Systematic Assessment
EG0004 affected391 at risk
EG0015 affected391 at risk
EG0023 affected387 at risk
EG003
Cerebrovascular disorder
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Dizziness
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0012 affected391 at risk
EG0021 affected387 at risk
EG003
Dysarthria
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Embolic cerebral infarction
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Encephalitis autoimmune
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Encephalopathy
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Epilepsy
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Facial paralysis
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Haemorrhagic cerebral infarction
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Haemorrhagic transformation stroke
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Headache
Nervous system disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Hemiparesis
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypoaesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Ischaemic stroke
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0023 affected387 at risk
EG003
Lethargy
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Myasthenia gravis
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Myasthenic syndrome
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Nerve compression
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Neuralgia
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Neuropathy peripheral
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Paralysis recurrent laryngeal nerve
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Paraplegia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Partial seizures
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Polyneuropathy
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Presyncope
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Quadriparesis
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Seizure
Nervous system disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Sensory loss
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Somnolence
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Spinal cord compression
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0022 affected387 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Syncope
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Transient ischaemic attack
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Vasogenic cerebral oedema
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Vertebrobasilar artery dissection
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Vocal cord paralysis
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Device dislocation
Product Issues
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Device physical property issue
Product Issues
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Anxiety
Psychiatric disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Bipolar disorder
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Completed suicide
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Confusional state
Psychiatric disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Delirium
Psychiatric disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Depression
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Disorientation
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Mental status changes
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0012 affected391 at risk
EG0021 affected387 at risk
EG003
Suicide attempt
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Acute kidney injury
Renal and urinary disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0014 affected391 at risk
EG0024 affected387 at risk
EG003
Autoimmune nephritis
Renal and urinary disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Azotaemia
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Nephrogenic diabetes insipidus
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Nephropathy toxic
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Renal failure
Renal and urinary disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0011 affected391 at risk
EG0022 affected387 at risk
EG003
Renal vascular thrombosis
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Urinary retention
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Vaginal prolapse
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0023 affected387 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Bronchial haemorrhage
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0013 affected391 at risk
EG0021 affected387 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0008 affected391 at risk
EG0019 affected391 at risk
EG0028 affected387 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0012 affected391 at risk
EG0027 affected387 at risk
EG003
Hypercapnia
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0012 affected391 at risk
EG0020 affected387 at risk
EG003
Immune-mediated lung disease
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0004 affected391 at risk
EG0012 affected391 at risk
EG0021 affected387 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Lung opacity
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Malignant pleural effusion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0009 affected391 at risk
EG0014 affected391 at risk
EG0021 affected387 at risk
EG003
Mediastinal disorder
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Oesophagobronchial fistula
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0005 affected391 at risk
EG0014 affected391 at risk
EG0021 affected387 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG00020 affected391 at risk
EG00111 affected391 at risk
EG0024 affected387 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0011 affected391 at risk
EG0022 affected387 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG00013 affected391 at risk
EG0017 affected391 at risk
EG0025 affected387 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0012 affected391 at risk
EG0021 affected387 at risk
EG003
Pulmonary hilum mass
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Pulmonary venous thrombosis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Respiratory alkalosis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0014 affected391 at risk
EG0025 affected387 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Autoimmune dermatitis
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Exfoliative rash
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Neutrophilic dermatosis
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0012 affected391 at risk
EG0020 affected387 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Aortic thrombosis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Arterial thrombosis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Arteritis
Vascular disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Circulatory collapse
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Deep vein thrombosis
Vascular disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0012 affected391 at risk
EG0022 affected387 at risk
EG003
Embolism
Vascular disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0013 affected391 at risk
EG0022 affected387 at risk
EG003
Extremity necrosis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Haematoma
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0012 affected391 at risk
EG0020 affected387 at risk
EG003
Hypertension
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0021 affected387 at risk
EG003
Hypertensive crisis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Hypotension
Vascular disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypovolaemic shock
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Infarction
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Orthostatic hypotension
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Peripheral artery stenosis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Peripheral embolism
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Peripheral ischaemia
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Shock
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Subclavian vein thrombosis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Superficial vein thrombosis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Superior vena cava occlusion
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Superior vena cava syndrome
Vascular disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0012 affected391 at risk
EG0021 affected387 at risk
EG003
Thrombosis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Vasculitis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Vena cava thrombosis
Vascular disorders
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Venous thrombosis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Venous thrombosis limb
Vascular disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG00047 affected391 at risk
EG00151 affected391 at risk
EG002159 affected387 at risk
EG00325 affected185 at risk
EG00480 affected172 at risk
EG00576 affected183 at risk
EG006174 affected375 at risk
EG007151 affected371 at risk
EG00863 affected126 at risk
EG00993 affected123 at risk
Leukocytosis
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0006 affected391 at risk
EG0014 affected391 at risk
EG0021 affected387 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0013 affected391 at risk
EG00221 affected387 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0004 affected391 at risk
EG0017 affected391 at risk
EG00270 affected387 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0006 affected391 at risk
EG0017 affected391 at risk
EG00239 affected387 at risk
EG003
Hyperthyroidism
Endocrine disorders
27.0
Systematic Assessment
EG00033 affected391 at risk
EG00118 affected391 at risk
EG0027 affected387 at risk
EG003
Hypothyroidism
Endocrine disorders
27.0
Systematic Assessment
EG00061 affected391 at risk
EG00130 affected391 at risk
EG0024 affected387 at risk
EG003
Lacrimation increased
Eye disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0011 affected391 at risk
EG00218 affected387 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.0
Systematic Assessment
EG00030 affected391 at risk
EG00130 affected391 at risk
EG00221 affected387 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
27.0
Systematic Assessment
EG00018 affected391 at risk
EG00116 affected391 at risk
EG00222 affected387 at risk
EG003
Constipation
Gastrointestinal disorders
27.0
Systematic Assessment
EG00078 affected391 at risk
EG00170 affected391 at risk
EG002104 affected387 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.0
Systematic Assessment
EG000102 affected391 at risk
EG00188 affected391 at risk
EG00266 affected387 at risk
EG003
Dry mouth
Gastrointestinal disorders
27.0
Systematic Assessment
EG00017 affected391 at risk
EG00111 affected391 at risk
EG0023 affected387 at risk
EG003
Dyspepsia
Gastrointestinal disorders
27.0
Systematic Assessment
EG00015 affected391 at risk
EG00110 affected391 at risk
EG00210 affected387 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
27.0
Systematic Assessment
EG0004 affected391 at risk
EG0010 affected391 at risk
EG0023 affected387 at risk
EG003
Nausea
Gastrointestinal disorders
27.0
Systematic Assessment
EG00093 affected391 at risk
EG00181 affected391 at risk
EG002174 affected387 at risk
EG003
Stomatitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG00025 affected391 at risk
EG00112 affected391 at risk
EG00228 affected387 at risk
EG003
Vomiting
Gastrointestinal disorders
27.0
Systematic Assessment
EG00052 affected391 at risk
EG00141 affected391 at risk
EG00273 affected387 at risk
EG003
Asthenia
General disorders
27.0
Systematic Assessment
EG00093 affected391 at risk
EG00178 affected391 at risk
EG00266 affected387 at risk
EG003
Chest discomfort
General disorders
27.0
Systematic Assessment
EG0004 affected391 at risk
EG0013 affected391 at risk
EG0023 affected387 at risk
EG003
Chest pain
General disorders
27.0
Systematic Assessment
EG00019 affected391 at risk
EG00118 affected391 at risk
EG00213 affected387 at risk
EG003
Fatigue
General disorders
27.0
Systematic Assessment
EG000107 affected391 at risk
EG00188 affected391 at risk
EG002101 affected387 at risk
EG003
Malaise
General disorders
27.0
Systematic Assessment
EG00011 affected391 at risk
EG00113 affected391 at risk
EG00217 affected387 at risk
EG003
Mucosal inflammation
General disorders
27.0
Systematic Assessment
EG00013 affected391 at risk
EG00112 affected391 at risk
EG00212 affected387 at risk
EG003
Non-cardiac chest pain
General disorders
27.0
Systematic Assessment
EG00016 affected391 at risk
EG00120 affected391 at risk
EG00221 affected387 at risk
EG003
Oedema peripheral
General disorders
27.0
Systematic Assessment
EG00049 affected391 at risk
EG00126 affected391 at risk
EG00237 affected387 at risk
EG003
Pain
General disorders
27.0
Systematic Assessment
EG0006 affected391 at risk
EG0016 affected391 at risk
EG0026 affected387 at risk
EG003
Pyrexia
General disorders
27.0
Systematic Assessment
EG00074 affected391 at risk
EG00157 affected391 at risk
EG00238 affected387 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0010 affected391 at risk
EG0021 affected387 at risk
EG003
Bronchitis
Infections and infestations
27.0
Systematic Assessment
EG00017 affected391 at risk
EG00111 affected391 at risk
EG0029 affected387 at risk
EG003
Nasopharyngitis
Infections and infestations
27.0
Systematic Assessment
EG00027 affected391 at risk
EG00123 affected391 at risk
EG00222 affected387 at risk
EG003
Pneumonia
Infections and infestations
27.0
Systematic Assessment
EG00021 affected391 at risk
EG00120 affected391 at risk
EG00217 affected387 at risk
EG003
Upper respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG00014 affected391 at risk
EG00117 affected391 at risk
EG00212 affected387 at risk
EG003
Fall
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG00012 affected391 at risk
EG0016 affected391 at risk
EG0022 affected387 at risk
EG003
Alanine aminotransferase increased
Investigations
27.0
Systematic Assessment
EG00043 affected391 at risk
EG00140 affected391 at risk
EG00227 affected387 at risk
EG003
Amylase increased
Investigations
27.0
Systematic Assessment
EG00030 affected391 at risk
EG00122 affected391 at risk
EG00212 affected387 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.0
Systematic Assessment
EG00047 affected391 at risk
EG00137 affected391 at risk
EG00221 affected387 at risk
EG003
Bilirubin conjugated increased
Investigations
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Blood alkaline phosphatase increased
Investigations
27.0
Systematic Assessment
EG00021 affected391 at risk
EG00113 affected391 at risk
EG00212 affected387 at risk
EG003
Blood bilirubin increased
Investigations
27.0
Systematic Assessment
EG0005 affected391 at risk
EG0015 affected391 at risk
EG0023 affected387 at risk
EG003
Blood creatinine increased
Investigations
27.0
Systematic Assessment
EG00023 affected391 at risk
EG00115 affected391 at risk
EG00221 affected387 at risk
EG003
Blood glucose increased
Investigations
27.0
Systematic Assessment
EG0002 affected391 at risk
EG0012 affected391 at risk
EG0023 affected387 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0015 affected391 at risk
EG0024 affected387 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
27.0
Systematic Assessment
EG0005 affected391 at risk
EG0013 affected391 at risk
EG0020 affected387 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
27.0
Systematic Assessment
EG00010 affected391 at risk
EG0016 affected391 at risk
EG0023 affected387 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
27.0
Systematic Assessment
EG0006 affected391 at risk
EG0017 affected391 at risk
EG0029 affected387 at risk
EG003
Lipase increased
Investigations
27.0
Systematic Assessment
EG00031 affected391 at risk
EG00127 affected391 at risk
EG00214 affected387 at risk
EG003
Lymphocyte count decreased
Investigations
27.0
Systematic Assessment
EG0007 affected391 at risk
EG0014 affected391 at risk
EG0029 affected387 at risk
EG003
Neutrophil count decreased
Investigations
27.0
Systematic Assessment
EG0009 affected391 at risk
EG00111 affected391 at risk
EG00250 affected387 at risk
EG003
Neutrophil count increased
Investigations
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Platelet count decreased
Investigations
27.0
Systematic Assessment
EG0006 affected391 at risk
EG00110 affected391 at risk
EG00231 affected387 at risk
EG003
Weight decreased
Investigations
27.0
Systematic Assessment
EG00037 affected391 at risk
EG00120 affected391 at risk
EG00222 affected387 at risk
EG003
Weight increased
Investigations
27.0
Systematic Assessment
EG0008 affected391 at risk
EG0018 affected391 at risk
EG0023 affected387 at risk
EG003
White blood cell count decreased
Investigations
27.0
Systematic Assessment
EG0008 affected391 at risk
EG0015 affected391 at risk
EG00219 affected387 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG000130 affected391 at risk
EG00197 affected391 at risk
EG002109 affected387 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG00024 affected391 at risk
EG00116 affected391 at risk
EG00214 affected387 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG00010 affected391 at risk
EG00112 affected391 at risk
EG0029 affected387 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0022 affected387 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0011 affected391 at risk
EG0020 affected387 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0013 affected391 at risk
EG0021 affected387 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG00025 affected391 at risk
EG00116 affected391 at risk
EG00214 affected387 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG00012 affected391 at risk
EG0019 affected391 at risk
EG0029 affected387 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG00027 affected391 at risk
EG00116 affected391 at risk
EG00212 affected387 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG00012 affected391 at risk
EG0017 affected391 at risk
EG00221 affected387 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG00039 affected391 at risk
EG00117 affected391 at risk
EG00220 affected387 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG00014 affected391 at risk
EG00110 affected391 at risk
EG00211 affected387 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected391 at risk
EG0010 affected391 at risk
EG0020 affected387 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG00072 affected391 at risk
EG00162 affected391 at risk
EG00219 affected387 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG00042 affected391 at risk
EG00136 affected391 at risk
EG00231 affected387 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG00023 affected391 at risk
EG00122 affected391 at risk
EG0029 affected387 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG00017 affected391 at risk
EG00124 affected391 at risk
EG00210 affected387 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0009 affected391 at risk
EG00118 affected391 at risk
EG00211 affected387 at risk
EG003
Dizziness
Nervous system disorders
27.0
Systematic Assessment
EG00030 affected391 at risk
EG00121 affected391 at risk
EG00227 affected387 at risk
EG003
Dysgeusia
Nervous system disorders
27.0
Systematic Assessment
EG00014 affected391 at risk
EG00110 affected391 at risk
EG00225 affected387 at risk
EG003
Headache
Nervous system disorders
27.0
Systematic Assessment
EG00054 affected391 at risk
EG00140 affected391 at risk
EG00231 affected387 at risk
EG003
Neuropathy peripheral
Nervous system disorders
27.0
Systematic Assessment
EG0001 affected391 at risk
EG0015 affected391 at risk
EG00211 affected387 at risk
EG003
Paraesthesia
Nervous system disorders
27.0
Systematic Assessment
EG00014 affected391 at risk
EG0012 affected391 at risk
EG0029 affected387 at risk
EG003
Anxiety
Psychiatric disorders
27.0
Systematic Assessment
EG00022 affected391 at risk
EG00112 affected391 at risk
EG00219 affected387 at risk
EG003
Insomnia
Psychiatric disorders
27.0
Systematic Assessment
EG00043 affected391 at risk
EG00132 affected391 at risk
EG00230 affected387 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG00075 affected391 at risk
EG00182 affected391 at risk
EG00245 affected387 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG00098 affected391 at risk
EG00193 affected391 at risk
EG00261 affected387 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0003 affected391 at risk
EG0019 affected391 at risk
EG00213 affected387 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG00034 affected391 at risk
EG00126 affected391 at risk
EG00222 affected387 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0007 affected391 at risk
EG00110 affected391 at risk
EG00220 affected387 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG00022 affected391 at risk
EG00123 affected391 at risk
EG0023 affected387 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG00028 affected391 at risk
EG00130 affected391 at risk
EG00215 affected387 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0008 affected391 at risk
EG0019 affected391 at risk
EG00234 affected387 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG00037 affected391 at risk
EG00114 affected391 at risk
EG00212 affected387 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG00092 affected391 at risk
EG00144 affected391 at risk
EG00217 affected387 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG00093 affected391 at risk
EG00155 affected391 at risk
EG00231 affected387 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG00028 affected391 at risk
EG00113 affected391 at risk
EG0027 affected387 at risk
EG003
Hypertension
Vascular disorders
27.0
Systematic Assessment
EG00021 affected391 at risk
EG00115 affected391 at risk
EG00213 affected387 at risk
EG003
Hypotension
Vascular disorders
27.0
Systematic Assessment
EG00016 affected391 at risk
EG00113 affected391 at risk
EG0029 affected387 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
OG004
Part 1-Arm G: Nivo + Chemo
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG005
Part 1-Arm F: Chemotherapy
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG006
Part 2 - Arm H: Nivolumab + Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG007
Part 2 - Arm I: Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG008
Part 3 -Arm J: Nivolumab + Ipilimumab
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
OG009
Part 3 - Arm K: Chemotherapy
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
Units
Counts
Participants
OG000396
OG001396
OG002397
OG003187
OG004177
OG005186
OG006377
OG007378
OG008126
OG009127
Title
Denominators
Categories
Title
Measurements
OG00017.12(14.95 to 20.17)
OG00115.70(13.27 to 18.14)
OG00214.88(12.71 to 16.72)
OG00317.45(13.21 to 22.05)
OG00415.21(12.29 to 19.78)
OG00512.19(9.17 to 14.32)
OG00618.27(15.84 to 21.65)
OG00714.72(12.42 to 16.79)
OG00820.99(16.95 to 25.17)
OG00915.11(13.17 to 18.89)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard Ratio (HR)
0.78
2-Sided
95
0.67
0.91
Superiority
OG001
OG002
Hazard Ratio (HR)
0.91
2-Sided
95
0.78
1.05
Superiority
OG000
OG001
Hazard Ratio (HR)
0.86
2-Sided
95
0.74
1.01
Superiority
OG003
OG005
Hazard Ratio (HR)
0.64
2-Sided
95
0.51
0.79
Superiority
OG004
OG005
Hazard Ratio (HR)
0.77
2-Sided
95
0.63
0.96
Superiority
OG006
OG007
Hazard Ratio (HR)
0.75
2-Sided
95
0.64
0.87
Superiority
OG008
OG009
Hazard Ratio (HR)
0.85
2-Sided
95
0.64
1.14
Superiority
OG002
Part 1-Arm C: Chemotherapy
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG003
Part 1-Arm D: Nivo + Ipi
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
OG004
Part 1-Arm G: Nivo + Chemo
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG005
Part 1-Arm F: Chemotherapy
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG006
Part 2 - Arm H: Nivolumab + Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG007
Part 2 - Arm I: Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG008
Part 3 -Arm J: Nivolumab + Ipilimumab
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
OG009
Part 3 - Arm K: Chemotherapy
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
Units
Counts
Participants
OG000396
OG001396
OG002397
OG003187
OG004177
OG005186
OG006377
OG007378
OG008126
OG009127
Title
Denominators
Categories
Title
Measurements
OG00036.4(31.6 to 41.3)
OG00127.5(23.2 to 32.2)
OG00229.7(25.3 to 34.5)
OG00326.2(20.1 to 33.1)
OG00437.9(30.7 to 45.4)
OG00523.1(17.3 to 29.8)
OG00652.3(47.1 to 57.4)
OG00729.9(25.3 to 34.8)
OG00838.1(29.6 to 47.2)
OG00930.7(22.8 to 39.5)
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
OG002
Part 1-Arm C: Chemotherapy
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG003
Part 1-Arm D: Nivo + Ipi
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
OG004
Part 1-Arm G: Nivo + Chemo
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG005
Part 1-Arm F: Chemotherapy
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG006
Part 2 - Arm H: Nivolumab + Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG007
Part 2 - Arm I: Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
OG008
Part 3 -Arm J: Nivolumab + Ipilimumab
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
OG009
Part 3 - Arm K: Chemotherapy
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.