NCT03038100 · ADVERSE EVENTS

Adverse events

A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer · Source last updated 2023-02-17

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: 12 August 2022 (up to 65 months)
Other-event reporting threshold: 5%

All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.	304 / 642	637 / 642	272 / 651
Placebo With Paclitaxel, Carboplatin and Bevacizumab Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.	215 / 644	637 / 644	289 / 650

Group identifiers: EG000: Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab · EG001: Placebo With Paclitaxel, Carboplatin and Bevacizumab

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 25.0
stats
group Id
EG000
num Affected
0
num At Risk
642
num Events
0
group Id
EG001
num Affected
2
num At Risk
644
num Events
2
term
AGRANULOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
6
num At Risk
642
num Events
7
group Id
EG001
num Affected
10
num At Risk
644
num Events
10
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
54
num At Risk
642
num Events
59
group Id
EG001
num Affected
24
num At Risk
644
num Events
25
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
642
num Events
0
group Id
EG001
num Affected
1
num At Risk
644
num Events
1
term
GRANULOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
642
num Events
1
group Id
EG001
num Affected
0
num At Risk
644
num Events
0
term
IMMUNE THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
3
num At Risk
642
num Events
3
group Id
EG001
num Affected
2
num At Risk
644
num Events
2
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
5
num At Risk
642
num Events
5
group Id
EG001
num Affected
5
num At Risk
644
num Events
5
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
642
num Events
1
group Id
EG001
num Affected
2
num At Risk
644
num Events
2
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
8
num At Risk
642
num Events
11
group Id
EG001
num Affected
10
num At Risk
644
num Events
12
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
642
num Events
1
group Id
EG001
num Affected
0
num At Risk
644
num Events
0
term
THROMBOTIC MICROANGIOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
642
num Events
2
group Id
EG001
num Affected
0
num At Risk
644
num Events
0
term
ACUTE MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
642
num Events
1
group Id
EG001
num Affected
0
num At Risk
644
num Events
0
term
ANGINA UNSTABLE

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 25.0
stats
group Id
EG000
num Affected
284
num At Risk
642
num Events
468
group Id
EG001
num Affected
266
num At Risk
644
num Events
440
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
69
num At Risk
642
num Events
197
group Id
EG001
num Affected
76
num At Risk
644
num Events
243
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
195
num At Risk
642
num Events
477
group Id
EG001
num Affected
197
num At Risk
644
num Events
507
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
137
num At Risk
642
num Events
278
group Id
EG001
num Affected
134
num At Risk
644
num Events
275
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
51
num At Risk
642
num Events
56
group Id
EG001
num Affected
23
num At Risk
644
num Events
26
term
HYPERTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
118
num At Risk
642
num Events
131
group Id
EG001
num Affected
54
num At Risk
644
num Events
57
term
HYPOTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
31
num At Risk
642
num Events
34
group Id
EG001
num Affected
45
num At Risk
644
num Events
48
term
VISION BLURRED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
39
num At Risk
642
num Events
51
group Id
EG001
num Affected
49
num At Risk
644
num Events
60
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
182
num At Risk
642
num Events
253
group Id
EG001
num Affected
173
num At Risk
644
num Events
241
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
49
num At Risk
642
num Events
56
group Id
EG001
num Affected
66
num At Risk
644
num Events
98
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
226
num At Risk
642
num Events
297
group Id
EG001
num Affected
240
num At Risk
644
num Events
334
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
223
num At Risk
642
num Events
336
group Id
EG001
num Affected
199
num At Risk
644
num Events
328
term
DIARRHOEA

Complete source fields

description

event Groups

deaths Num Affected
272
deaths Num At Risk
651
description
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
id
EG000
other Num Affected
637
other Num At Risk
642
serious Num Affected
304
serious Num At Risk
642
title
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
deaths Num Affected
289
deaths Num At Risk
650
description
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
id
EG001
other Num Affected
637
other Num At Risk
644
serious Num Affected
215
serious Num At Risk
644
title
Placebo With Paclitaxel, Carboplatin and Bevacizumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
284
num At Risk
642
num Events
468
group Id
EG001
num Affected
266
num At Risk
644
num Events
440
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
69
num At Risk
642
num Events
197
group Id
EG001
num Affected
76
num At Risk
644
num Events
243
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
195
num At Risk
642
num Events
477
group Id
EG001
num Affected
197
num At Risk
644
num Events
507
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
137
num At Risk
642
num Events
278
group Id
EG001
num Affected
134
num At Risk
644
num Events
275
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
51
num At Risk
642
num Events
56
group Id
EG001
num Affected
23
num At Risk
644
num Events
26
term
HYPERTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
118
num At Risk
642
num Events
131
group Id
EG001
num Affected
54
num At Risk
644
num Events
57
term
HYPOTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
31
num At Risk
642
num Events
34
group Id
EG001
num Affected
45
num At Risk
644
num Events
48
term
VISION BLURRED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
39
num At Risk
642
num Events
51
group Id
EG001
num Affected
49
num At Risk
644
num Events
60
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
182
num At Risk
642
num Events
253
group Id
EG001
num Affected
173
num At Risk
644
num Events
241
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
49
num At Risk
642
num Events
56
group Id
EG001
num Affected
66
num At Risk
644
num Events
98
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
226
num At Risk
642
num Events
297
group Id
EG001
num Affected
240
num At Risk
644
num Events
334
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
223
num At Risk
642
num Events
336
group Id
EG001
num Affected
199
num At Risk
644
num Events
328
term
DIARRHOEA

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
642
num Events
0
group Id
EG001
num Affected
2
num At Risk
644
num Events
2
term
AGRANULOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
6
num At Risk
642
num Events
7
group Id
EG001
num Affected
10
num At Risk
644
num Events
10
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
54
num At Risk
642
num Events
59
group Id
EG001
num Affected
24
num At Risk
644
num Events
25
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
642
num Events
0
group Id
EG001
num Affected
1
num At Risk
644
num Events
1
term
GRANULOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
642
num Events
1
group Id
EG001
num Affected
0
num At Risk
644
num Events
0
term
IMMUNE THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
3
num At Risk
642
num Events
3
group Id
EG001
num Affected
2
num At Risk
644
num Events
2
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
5
num At Risk
642
num Events
5
group Id
EG001
num Affected
5
num At Risk
644
num Events
5
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
642
num Events
1
group Id
EG001
num Affected
2
num At Risk
644
num Events
2
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
8
num At Risk
642
num Events
11
group Id
EG001
num Affected
10
num At Risk
644
num Events
12
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
642
num Events
1
group Id
EG001
num Affected
0
num At Risk
644
num Events
0
term
THROMBOTIC MICROANGIOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
642
num Events
2
group Id
EG001
num Affected
0
num At Risk
644
num Events
0
term
ACUTE MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
642
num Events
1
group Id
EG001
num Affected
0
num At Risk
644
num Events
0
term
ANGINA UNSTABLE

time Frame

From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)

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

Preserved source evidence · Not medical advice