NCT02807636 · ADVERSE EVENTS

Adverse events

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma · Source last updated 2025-02-24

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: 9 April 2024 (up to approximately 93 months)
Other-event reporting threshold: 5%

Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo+Gemcitabine+Carboplatin/Cisplatin Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).	197 / 389	379 / 389	303 / 389
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).	244 / 454	441 / 454	332 / 454
Atezolizumab Monotherapy Eligible participants received open-label atezolizumab as monotherapy.	163 / 354	300 / 354	272 / 354

Group identifiers: EG000: Placebo+Gemcitabine+Carboplatin/Cisplatin · EG001: Atezolizumab+Gemcitabine+Carboplatin/Cisplatin · EG002: Atezolizumab Monotherapy

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 26.1
stats
group Id
EG000
num Affected
19
num At Risk
389
num Events
26
group Id
EG001
num Affected
30
num At Risk
454
num Events
34
group Id
EG002
num Affected
4
num At Risk
354
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
9
num At Risk
389
num Events
9
group Id
EG001
num Affected
14
num At Risk
454
num Events
15
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
389
num Events
1
group Id
EG001
num Affected
0
num At Risk
454
num Events
0
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Haematotoxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
389
num Events
0
group Id
EG001
num Affected
2
num At Risk
454
num Events
3
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
389
num Events
0
group Id
EG001
num Affected
0
num At Risk
454
num Events
0
group Id
EG002
num Affected
2
num At Risk
354
num Events
2
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
3
num At Risk
389
num Events
7
group Id
EG001
num Affected
3
num At Risk
454
num Events
6
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
4
num At Risk
389
num Events
5
group Id
EG001
num Affected
8
num At Risk
454
num Events
10
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
4
num At Risk
389
num Events
4
group Id
EG001
num Affected
6
num At Risk
454
num Events
6
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
22
num At Risk
389
num Events
28
group Id
EG001
num Affected
21
num At Risk
454
num Events
30
group Id
EG002
num Affected
1
num At Risk
354
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
389
num Events
0
group Id
EG001
num Affected
1
num At Risk
454
num Events
1
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
389
num Events
1
group Id
EG001
num Affected
3
num At Risk
454
num Events
3
group Id
EG002
num Affected
2
num At Risk
354
num Events
3
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
389
num Events
1
group Id
EG001
num Affected
1
num At Risk
454
num Events
1
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Acute myocardial infarction

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 26.1
stats
group Id
EG000
num Affected
257
num At Risk
389
num Events
481
group Id
EG001
num Affected
308
num At Risk
454
num Events
495
group Id
EG002
num Affected
68
num At Risk
354
num Events
83
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
64
num At Risk
389
num Events
192
group Id
EG001
num Affected
64
num At Risk
454
num Events
132
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
148
num At Risk
389
num Events
421
group Id
EG001
num Affected
215
num At Risk
454
num Events
510
group Id
EG002
num Affected
2
num At Risk
354
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
117
num At Risk
389
num Events
297
group Id
EG001
num Affected
183
num At Risk
454
num Events
378
group Id
EG002
num Affected
12
num At Risk
354
num Events
13
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
6
num At Risk
389
num Events
6
group Id
EG001
num Affected
35
num At Risk
454
num Events
40
group Id
EG002
num Affected
18
num At Risk
354
num Events
20
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
12
num At Risk
389
num Events
12
group Id
EG001
num Affected
44
num At Risk
454
num Events
47
group Id
EG002
num Affected
30
num At Risk
354
num Events
31
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
37
num At Risk
389
num Events
54
group Id
EG001
num Affected
43
num At Risk
454
num Events
53
group Id
EG002
num Affected
22
num At Risk
354
num Events
27
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
111
num At Risk
389
num Events
149
group Id
EG001
num Affected
140
num At Risk
454
num Events
187
group Id
EG002
num Affected
67
num At Risk
354
num Events
74
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
73
num At Risk
389
num Events
96
group Id
EG001
num Affected
96
num At Risk
454
num Events
146
group Id
EG002
num Affected
42
num At Risk
354
num Events
59
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
22
num At Risk
389
num Events
28
group Id
EG001
num Affected
20
num At Risk
454
num Events
21
group Id
EG002
num Affected
5
num At Risk
354
num Events
10
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
181
num At Risk
389
num Events
317
group Id
EG001
num Affected
202
num At Risk
454
num Events
329
group Id
EG002
num Affected
43
num At Risk
354
num Events
53
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
106
num At Risk
389
num Events
175
group Id
EG001
num Affected
122
num At Risk
454
num Events
178
group Id
EG002
num Affected
33
num At Risk
354
num Events
43
term
Vomiting

Complete source fields

description

event Groups

deaths Num Affected
303
deaths Num At Risk
389
description
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
id
EG000
other Num Affected
379
other Num At Risk
389
serious Num Affected
197
serious Num At Risk
389
title
Placebo+Gemcitabine+Carboplatin/Cisplatin
deaths Num Affected
332
deaths Num At Risk
454
description
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
id
EG001
other Num Affected
441
other Num At Risk
454
serious Num Affected
244
serious Num At Risk
454
title
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
deaths Num Affected
272
deaths Num At Risk
354
description
Eligible participants received open-label atezolizumab as monotherapy.
id
EG002
other Num Affected
300
other Num At Risk
354
serious Num Affected
163
serious Num At Risk
354
title
Atezolizumab Monotherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
257
num At Risk
389
num Events
481
group Id
EG001
num Affected
308
num At Risk
454
num Events
495
group Id
EG002
num Affected
68
num At Risk
354
num Events
83
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
64
num At Risk
389
num Events
192
group Id
EG001
num Affected
64
num At Risk
454
num Events
132
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
148
num At Risk
389
num Events
421
group Id
EG001
num Affected
215
num At Risk
454
num Events
510
group Id
EG002
num Affected
2
num At Risk
354
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
117
num At Risk
389
num Events
297
group Id
EG001
num Affected
183
num At Risk
454
num Events
378
group Id
EG002
num Affected
12
num At Risk
354
num Events
13
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
6
num At Risk
389
num Events
6
group Id
EG001
num Affected
35
num At Risk
454
num Events
40
group Id
EG002
num Affected
18
num At Risk
354
num Events
20
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
12
num At Risk
389
num Events
12
group Id
EG001
num Affected
44
num At Risk
454
num Events
47
group Id
EG002
num Affected
30
num At Risk
354
num Events
31
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
37
num At Risk
389
num Events
54
group Id
EG001
num Affected
43
num At Risk
454
num Events
53
group Id
EG002
num Affected
22
num At Risk
354
num Events
27
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
111
num At Risk
389
num Events
149
group Id
EG001
num Affected
140
num At Risk
454
num Events
187
group Id
EG002
num Affected
67
num At Risk
354
num Events
74
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
73
num At Risk
389
num Events
96
group Id
EG001
num Affected
96
num At Risk
454
num Events
146
group Id
EG002
num Affected
42
num At Risk
354
num Events
59
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
22
num At Risk
389
num Events
28
group Id
EG001
num Affected
20
num At Risk
454
num Events
21
group Id
EG002
num Affected
5
num At Risk
354
num Events
10
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
181
num At Risk
389
num Events
317
group Id
EG001
num Affected
202
num At Risk
454
num Events
329
group Id
EG002
num Affected
43
num At Risk
354
num Events
53
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
106
num At Risk
389
num Events
175
group Id
EG001
num Affected
122
num At Risk
454
num Events
178
group Id
EG002
num Affected
33
num At Risk
354
num Events
43
term
Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
19
num At Risk
389
num Events
26
group Id
EG001
num Affected
30
num At Risk
454
num Events
34
group Id
EG002
num Affected
4
num At Risk
354
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
9
num At Risk
389
num Events
9
group Id
EG001
num Affected
14
num At Risk
454
num Events
15
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
389
num Events
1
group Id
EG001
num Affected
0
num At Risk
454
num Events
0
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Haematotoxicity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
389
num Events
0
group Id
EG001
num Affected
2
num At Risk
454
num Events
3
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
389
num Events
0
group Id
EG001
num Affected
0
num At Risk
454
num Events
0
group Id
EG002
num Affected
2
num At Risk
354
num Events
2
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
3
num At Risk
389
num Events
7
group Id
EG001
num Affected
3
num At Risk
454
num Events
6
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
4
num At Risk
389
num Events
5
group Id
EG001
num Affected
8
num At Risk
454
num Events
10
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
4
num At Risk
389
num Events
4
group Id
EG001
num Affected
6
num At Risk
454
num Events
6
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
22
num At Risk
389
num Events
28
group Id
EG001
num Affected
21
num At Risk
454
num Events
30
group Id
EG002
num Affected
1
num At Risk
354
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
389
num Events
0
group Id
EG001
num Affected
1
num At Risk
454
num Events
1
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
389
num Events
1
group Id
EG001
num Affected
3
num At Risk
454
num Events
3
group Id
EG002
num Affected
2
num At Risk
354
num Events
3
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
389
num Events
1
group Id
EG001
num Affected
1
num At Risk
454
num Events
1
group Id
EG002
num Affected
0
num At Risk
354
num Events
0
term
Acute myocardial infarction

time Frame

From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)

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

Preserved source evidence · Not medical advice