NCT02366143 · ADVERSE EVENTS

Adverse events

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-09-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)
Other-event reporting threshold: 5%

The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm C (Bev+CP) Bevacizumab+Paclitaxel+Carboplatin	142 / 394	381 / 394	311 / 394
Arm B (Atezo+Bev+CP) Atezolizumab+Bevacizumab+Paclitaxel+Carboplatin	190 / 393	375 / 393	285 / 393
Arm A (Atezo+CP) Atezolizumab+Paclitaxel+Carboplatin	170 / 400	385 / 400	293 / 400

Group identifiers: EG000: Arm C (Bev+CP) · EG001: Arm B (Atezo+Bev+CP) · EG002: Arm A (Atezo+CP)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
4
num At Risk
394
num Events
4
group Id
EG001
num Affected
5
num At Risk
393
num Events
5
group Id
EG002
num Affected
5
num At Risk
400
num Events
6
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
1
num At Risk
394
num Events
1
group Id
EG001
num Affected
0
num At Risk
393
num Events
0
group Id
EG002
num Affected
0
num At Risk
400
num Events
0
term
BONE MARROW FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
17
num At Risk
394
num Events
18
group Id
EG001
num Affected
27
num At Risk
393
num Events
30
group Id
EG002
num Affected
13
num At Risk
400
num Events
13
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
1
num At Risk
394
num Events
1
group Id
EG001
num Affected
0
num At Risk
393
num Events
0
group Id
EG002
num Affected
0
num At Risk
400
num Events
0
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
0
num At Risk
394
num Events
0
group Id
EG001
num Affected
1
num At Risk
393
num Events
1
group Id
EG002
num Affected
0
num At Risk
400
num Events
0
term
MYELOSUPPRESSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
2
num At Risk
394
num Events
2
group Id
EG001
num Affected
4
num At Risk
393
num Events
4
group Id
EG002
num Affected
1
num At Risk
400
num Events
1
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
0
num At Risk
394
num Events
0
group Id
EG001
num Affected
1
num At Risk
393
num Events
1
group Id
EG002
num Affected
0
num At Risk
400
num Events
0
term
NORMOCHROMIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
2
num At Risk
394
num Events
2
group Id
EG001
num Affected
1
num At Risk
393
num Events
1
group Id
EG002
num Affected
0
num At Risk
400
num Events
0
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
0
num At Risk
394
num Events
0
group Id
EG001
num Affected
0
num At Risk
393
num Events
0
group Id
EG002
num Affected
1
num At Risk
400
num Events
1
term
SPONTANEOUS HAEMATOMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
2
num At Risk
394
num Events
2
group Id
EG001
num Affected
6
num At Risk
393
num Events
6
group Id
EG002
num Affected
1
num At Risk
400
num Events
1
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
3
num At Risk
394
num Events
3
group Id
EG001
num Affected
2
num At Risk
393
num Events
2
group Id
EG002
num Affected
1
num At Risk
400
num Events
1
term
ACUTE MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
1
num At Risk
394
num Events
1
group Id
EG001
num Affected
2
num At Risk
393
num Events
2
group Id
EG002
num Affected
2
num At Risk
400
num Events
2
term
ATRIAL FIBRILLATION

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
104
num At Risk
394
num Events
124
group Id
EG001
num Affected
116
num At Risk
393
num Events
134
group Id
EG002
num Affected
146
num At Risk
400
num Events
183
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
14
num At Risk
394
num Events
17
group Id
EG001
num Affected
14
num At Risk
393
num Events
20
group Id
EG002
num Affected
20
num At Risk
400
num Events
35
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
70
num At Risk
394
num Events
107
group Id
EG001
num Affected
72
num At Risk
393
num Events
111
group Id
EG002
num Affected
60
num At Risk
400
num Events
85
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
45
num At Risk
394
num Events
64
group Id
EG001
num Affected
53
num At Risk
393
num Events
74
group Id
EG002
num Affected
49
num At Risk
400
num Events
78
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
13
num At Risk
394
num Events
13
group Id
EG001
num Affected
50
num At Risk
393
num Events
56
group Id
EG002
num Affected
33
num At Risk
400
num Events
40
term
HYPOTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
20
num At Risk
394
num Events
24
group Id
EG001
num Affected
36
num At Risk
393
num Events
48
group Id
EG002
num Affected
29
num At Risk
400
num Events
36
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
92
num At Risk
394
num Events
115
group Id
EG001
num Affected
122
num At Risk
393
num Events
151
group Id
EG002
num Affected
103
num At Risk
400
num Events
128
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
98
num At Risk
394
num Events
133
group Id
EG001
num Affected
125
num At Risk
393
num Events
221
group Id
EG002
num Affected
82
num At Risk
400
num Events
137
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
6
num At Risk
394
num Events
6
group Id
EG001
num Affected
20
num At Risk
393
num Events
22
group Id
EG002
num Affected
13
num At Risk
400
num Events
16
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
9
num At Risk
394
num Events
11
group Id
EG001
num Affected
20
num At Risk
393
num Events
20
group Id
EG002
num Affected
11
num At Risk
400
num Events
13
term
GASTROOESOPHAGEAL REFLUX DISEASE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
124
num At Risk
394
num Events
177
group Id
EG001
num Affected
149
num At Risk
393
num Events
223
group Id
EG002
num Affected
130
num At Risk
400
num Events
210
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
24
num At Risk
394
num Events
30
group Id
EG001
num Affected
54
num At Risk
393
num Events
73
group Id
EG002
num Affected
23
num At Risk
400
num Events
27
term
STOMATITIS

Complete source fields

description

The safety population included all treated participants, defined as randomized participants who received any amount of any component of study treatment.

event Groups

deaths Num Affected
311
deaths Num At Risk
394
description
Bevacizumab+Paclitaxel+Carboplatin
id
EG000
other Num Affected
381
other Num At Risk
394
serious Num Affected
142
serious Num At Risk
394
title
Arm C (Bev+CP)
deaths Num Affected
285
deaths Num At Risk
393
description
Atezolizumab+Bevacizumab+Paclitaxel+Carboplatin
id
EG001
other Num Affected
375
other Num At Risk
393
serious Num Affected
190
serious Num At Risk
393
title
Arm B (Atezo+Bev+CP)
deaths Num Affected
293
deaths Num At Risk
400
description
Atezolizumab+Paclitaxel+Carboplatin
id
EG002
other Num Affected
385
other Num At Risk
400
serious Num Affected
170
serious Num At Risk
400
title
Arm A (Atezo+CP)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
104
num At Risk
394
num Events
124
group Id
EG001
num Affected
116
num At Risk
393
num Events
134
group Id
EG002
num Affected
146
num At Risk
400
num Events
183
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
14
num At Risk
394
num Events
17
group Id
EG001
num Affected
14
num At Risk
393
num Events
20
group Id
EG002
num Affected
20
num At Risk
400
num Events
35
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
70
num At Risk
394
num Events
107
group Id
EG001
num Affected
72
num At Risk
393
num Events
111
group Id
EG002
num Affected
60
num At Risk
400
num Events
85
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
45
num At Risk
394
num Events
64
group Id
EG001
num Affected
53
num At Risk
393
num Events
74
group Id
EG002
num Affected
49
num At Risk
400
num Events
78
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
13
num At Risk
394
num Events
13
group Id
EG001
num Affected
50
num At Risk
393
num Events
56
group Id
EG002
num Affected
33
num At Risk
400
num Events
40
term
HYPOTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
20
num At Risk
394
num Events
24
group Id
EG001
num Affected
36
num At Risk
393
num Events
48
group Id
EG002
num Affected
29
num At Risk
400
num Events
36
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
92
num At Risk
394
num Events
115
group Id
EG001
num Affected
122
num At Risk
393
num Events
151
group Id
EG002
num Affected
103
num At Risk
400
num Events
128
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
98
num At Risk
394
num Events
133
group Id
EG001
num Affected
125
num At Risk
393
num Events
221
group Id
EG002
num Affected
82
num At Risk
400
num Events
137
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
6
num At Risk
394
num Events
6
group Id
EG001
num Affected
20
num At Risk
393
num Events
22
group Id
EG002
num Affected
13
num At Risk
400
num Events
16
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
9
num At Risk
394
num Events
11
group Id
EG001
num Affected
20
num At Risk
393
num Events
20
group Id
EG002
num Affected
11
num At Risk
400
num Events
13
term
GASTROOESOPHAGEAL REFLUX DISEASE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
124
num At Risk
394
num Events
177
group Id
EG001
num Affected
149
num At Risk
393
num Events
223
group Id
EG002
num Affected
130
num At Risk
400
num Events
210
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
24
num At Risk
394
num Events
30
group Id
EG001
num Affected
54
num At Risk
393
num Events
73
group Id
EG002
num Affected
23
num At Risk
400
num Events
27
term
STOMATITIS

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
4
num At Risk
394
num Events
4
group Id
EG001
num Affected
5
num At Risk
393
num Events
5
group Id
EG002
num Affected
5
num At Risk
400
num Events
6
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
1
num At Risk
394
num Events
1
group Id
EG001
num Affected
0
num At Risk
393
num Events
0
group Id
EG002
num Affected
0
num At Risk
400
num Events
0
term
BONE MARROW FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
17
num At Risk
394
num Events
18
group Id
EG001
num Affected
27
num At Risk
393
num Events
30
group Id
EG002
num Affected
13
num At Risk
400
num Events
13
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
1
num At Risk
394
num Events
1
group Id
EG001
num Affected
0
num At Risk
393
num Events
0
group Id
EG002
num Affected
0
num At Risk
400
num Events
0
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
0
num At Risk
394
num Events
0
group Id
EG001
num Affected
1
num At Risk
393
num Events
1
group Id
EG002
num Affected
0
num At Risk
400
num Events
0
term
MYELOSUPPRESSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
2
num At Risk
394
num Events
2
group Id
EG001
num Affected
4
num At Risk
393
num Events
4
group Id
EG002
num Affected
1
num At Risk
400
num Events
1
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
0
num At Risk
394
num Events
0
group Id
EG001
num Affected
1
num At Risk
393
num Events
1
group Id
EG002
num Affected
0
num At Risk
400
num Events
0
term
NORMOCHROMIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
2
num At Risk
394
num Events
2
group Id
EG001
num Affected
1
num At Risk
393
num Events
1
group Id
EG002
num Affected
0
num At Risk
400
num Events
0
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
0
num At Risk
394
num Events
0
group Id
EG001
num Affected
0
num At Risk
393
num Events
0
group Id
EG002
num Affected
1
num At Risk
400
num Events
1
term
SPONTANEOUS HAEMATOMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
2
num At Risk
394
num Events
2
group Id
EG001
num Affected
6
num At Risk
393
num Events
6
group Id
EG002
num Affected
1
num At Risk
400
num Events
1
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
3
num At Risk
394
num Events
3
group Id
EG001
num Affected
2
num At Risk
393
num Events
2
group Id
EG002
num Affected
1
num At Risk
400
num Events
1
term
ACUTE MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 23.1
stats
group Id
EG000
num Affected
1
num At Risk
394
num Events
1
group Id
EG001
num Affected
2
num At Risk
393
num Events
2
group Id
EG002
num Affected
2
num At Risk
400
num Events
2
term
ATRIAL FIBRILLATION

time Frame

From the first study drug to the data cutoff date 7 December 2020 (up to approximately 68 months)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice