NCT03125902 · ADVERSE EVENTS

Adverse events

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) · Source last updated 2024-03-26

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 baseline up to 64 months
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Atezolizumab + Paclitaxel Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.	112 / 431	421 / 431	229 / 431
Placebo + Paclitaxel Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.	40 / 220	209 / 220	119 / 220

Group identifiers: EG000: Atezolizumab + Paclitaxel · EG001: Placebo + Paclitaxel

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 25.1
stats
group Id
EG000
num Affected
2
num At Risk
431
num Events
2
group Id
EG001
num Affected
2
num At Risk
220
num Events
2
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
431
num Events
1
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
BICYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
3
num At Risk
431
num Events
3
group Id
EG001
num Affected
1
num At Risk
220
num Events
1
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
431
num Events
0
group Id
EG001
num Affected
1
num At Risk
220
num Events
1
term
LYMPHADENITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
431
num Events
2
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
431
num Events
1
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
431
num Events
1
group Id
EG001
num Affected
1
num At Risk
217
num Events
1
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
431
num Events
0
group Id
EG001
num Affected
1
num At Risk
217
num Events
1
term
PERICARDITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
431
num Events
1
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
VERTIGO
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
431
num Events
0
group Id
EG001
num Affected
1
num At Risk
220
num Events
1
term
HYPOPHYSITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
431
num Events
1
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
HYPOTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
431
num Events
1
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
KERATITIS

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 25.1
stats
group Id
EG000
num Affected
128
num At Risk
431
num Events
277
group Id
EG001
num Affected
66
num At Risk
220
num Events
134
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
56
num At Risk
431
num Events
181
group Id
EG001
num Affected
20
num At Risk
220
num Events
44
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
98
num At Risk
431
num Events
253
group Id
EG001
num Affected
48
num At Risk
220
num Events
103
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
25
num At Risk
431
num Events
28
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
HYPERTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
49
num At Risk
431
num Events
65
group Id
EG001
num Affected
6
num At Risk
220
num Events
6
term
HYPOTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
37
num At Risk
431
num Events
45
group Id
EG001
num Affected
19
num At Risk
220
num Events
21
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
42
num At Risk
431
num Events
47
group Id
EG001
num Affected
15
num At Risk
220
num Events
22
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
82
num At Risk
431
num Events
103
group Id
EG001
num Affected
33
num At Risk
220
num Events
56
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
130
num At Risk
431
num Events
209
group Id
EG001
num Affected
50
num At Risk
220
num Events
88
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
24
num At Risk
431
num Events
32
group Id
EG001
num Affected
8
num At Risk
220
num Events
9
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
17
num At Risk
431
num Events
18
group Id
EG001
num Affected
11
num At Risk
220
num Events
12
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
117
num At Risk
431
num Events
167
group Id
EG001
num Affected
54
num At Risk
220
num Events
108
term
NAUSEA

Complete source fields

event Groups

deaths Num Affected
229
deaths Num At Risk
431
description
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
id
EG000
other Num Affected
421
other Num At Risk
431
serious Num Affected
112
serious Num At Risk
431
title
Atezolizumab + Paclitaxel
deaths Num Affected
119
deaths Num At Risk
220
description
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
id
EG001
other Num Affected
209
other Num At Risk
220
serious Num Affected
40
serious Num At Risk
220
title
Placebo + Paclitaxel

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
128
num At Risk
431
num Events
277
group Id
EG001
num Affected
66
num At Risk
220
num Events
134
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
56
num At Risk
431
num Events
181
group Id
EG001
num Affected
20
num At Risk
220
num Events
44
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
98
num At Risk
431
num Events
253
group Id
EG001
num Affected
48
num At Risk
220
num Events
103
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
25
num At Risk
431
num Events
28
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
HYPERTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
49
num At Risk
431
num Events
65
group Id
EG001
num Affected
6
num At Risk
220
num Events
6
term
HYPOTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
37
num At Risk
431
num Events
45
group Id
EG001
num Affected
19
num At Risk
220
num Events
21
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
42
num At Risk
431
num Events
47
group Id
EG001
num Affected
15
num At Risk
220
num Events
22
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
82
num At Risk
431
num Events
103
group Id
EG001
num Affected
33
num At Risk
220
num Events
56
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
130
num At Risk
431
num Events
209
group Id
EG001
num Affected
50
num At Risk
220
num Events
88
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
24
num At Risk
431
num Events
32
group Id
EG001
num Affected
8
num At Risk
220
num Events
9
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
17
num At Risk
431
num Events
18
group Id
EG001
num Affected
11
num At Risk
220
num Events
12
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
117
num At Risk
431
num Events
167
group Id
EG001
num Affected
54
num At Risk
220
num Events
108
term
NAUSEA

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
431
num Events
2
group Id
EG001
num Affected
2
num At Risk
220
num Events
2
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
431
num Events
1
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
BICYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
3
num At Risk
431
num Events
3
group Id
EG001
num Affected
1
num At Risk
220
num Events
1
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
431
num Events
0
group Id
EG001
num Affected
1
num At Risk
220
num Events
1
term
LYMPHADENITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
431
num Events
2
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
431
num Events
1
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
431
num Events
1
group Id
EG001
num Affected
1
num At Risk
217
num Events
1
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
431
num Events
0
group Id
EG001
num Affected
1
num At Risk
217
num Events
1
term
PERICARDITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
431
num Events
1
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
VERTIGO
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
431
num Events
0
group Id
EG001
num Affected
1
num At Risk
220
num Events
1
term
HYPOPHYSITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
431
num Events
1
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
HYPOTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
431
num Events
1
group Id
EG001
num Affected
0
num At Risk
220
num Events
0
term
KERATITIS

time Frame

From baseline up to 64 months

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

Preserved source evidence · Not medical advice