NCT02425891 · ADVERSE EVENTS

Adverse events

A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) · Source last updated 2022-07-19

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: 31 August 2021 (up to approximately 74 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. In placebo+nab-paclitaxel arm, 6 participants received atezolizumab in error \& 9 participants crossed over from placebo+nab-paclitaxel arm to atezolizumab+nab-paclitaxel arm.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo (q2w) + Nab-Paclitaxel Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	80 / 430	414 / 430	333 / 451
Atezolizumab (q2w) + Nab-Paclitaxel Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.	110 / 460	450 / 460	314 / 451

Group identifiers: EG000: Placebo (q2w) + Nab-Paclitaxel · EG001: Atezolizumab (q2w) + Nab-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 version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
1
num At Risk
460
num Events
1
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
5
num At Risk
460
num Events
5
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
0
num At Risk
460
num Events
0
term
HAEMOLYSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
0
num At Risk
460
num Events
0
term
LEUKOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
430
num Events
0
group Id
EG001
num Affected
1
num At Risk
460
num Events
1
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
430
num Events
0
group Id
EG001
num Affected
1
num At Risk
460
num Events
1
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
0
num At Risk
460
num Events
0
term
ACUTE MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
430
num Events
0
group Id
EG001
num Affected
1
num At Risk
460
num Events
1
term
ANGINA UNSTABLE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
1
num At Risk
460
num Events
1
term
ARRHYTHMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
430
num Events
2
group Id
EG001
num Affected
1
num At Risk
460
num Events
1
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
430
num Events
2
group Id
EG001
num Affected
0
num At Risk
460
num Events
0
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
0
num At Risk
460
num Events
0
term
CARDIAC FAILURE CONGESTIVE

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 24.0
stats
group Id
EG000
num Affected
115
num At Risk
430
num Events
186
group Id
EG001
num Affected
129
num At Risk
460
num Events
221
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
23
num At Risk
430
num Events
50
group Id
EG001
num Affected
30
num At Risk
460
num Events
68
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
66
num At Risk
430
num Events
176
group Id
EG001
num Affected
101
num At Risk
460
num Events
238
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
15
num At Risk
430
num Events
15
group Id
EG001
num Affected
67
num At Risk
460
num Events
80
term
HYPOTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
15
num At Risk
430
num Events
15
group Id
EG001
num Affected
31
num At Risk
460
num Events
33
term
DRY EYE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
33
num At Risk
430
num Events
33
group Id
EG001
num Affected
28
num At Risk
460
num Events
28
term
LACRIMATION INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
53
num At Risk
430
num Events
63
group Id
EG001
num Affected
53
num At Risk
460
num Events
59
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
25
num At Risk
430
num Events
26
group Id
EG001
num Affected
29
num At Risk
460
num Events
35
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
108
num At Risk
430
num Events
132
group Id
EG001
num Affected
115
num At Risk
460
num Events
140
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
146
num At Risk
430
num Events
212
group Id
EG001
num Affected
151
num At Risk
460
num Events
307
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
16
num At Risk
430
num Events
17
group Id
EG001
num Affected
39
num At Risk
460
num Events
39
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
31
num At Risk
430
num Events
38
group Id
EG001
num Affected
30
num At Risk
460
num Events
34
term
DYSPEPSIA

Complete source fields

description

event Groups

deaths Num Affected
333
deaths Num At Risk
451
description
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
id
EG000
other Num Affected
414
other Num At Risk
430
serious Num Affected
80
serious Num At Risk
430
title
Placebo (q2w) + Nab-Paclitaxel
deaths Num Affected
314
deaths Num At Risk
451
description
Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
id
EG001
other Num Affected
450
other Num At Risk
460
serious Num Affected
110
serious Num At Risk
460
title
Atezolizumab (q2w) + Nab-Paclitaxel

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
115
num At Risk
430
num Events
186
group Id
EG001
num Affected
129
num At Risk
460
num Events
221
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
23
num At Risk
430
num Events
50
group Id
EG001
num Affected
30
num At Risk
460
num Events
68
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
66
num At Risk
430
num Events
176
group Id
EG001
num Affected
101
num At Risk
460
num Events
238
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
15
num At Risk
430
num Events
15
group Id
EG001
num Affected
67
num At Risk
460
num Events
80
term
HYPOTHYROIDISM
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
15
num At Risk
430
num Events
15
group Id
EG001
num Affected
31
num At Risk
460
num Events
33
term
DRY EYE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
33
num At Risk
430
num Events
33
group Id
EG001
num Affected
28
num At Risk
460
num Events
28
term
LACRIMATION INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
53
num At Risk
430
num Events
63
group Id
EG001
num Affected
53
num At Risk
460
num Events
59
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
25
num At Risk
430
num Events
26
group Id
EG001
num Affected
29
num At Risk
460
num Events
35
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
108
num At Risk
430
num Events
132
group Id
EG001
num Affected
115
num At Risk
460
num Events
140
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
146
num At Risk
430
num Events
212
group Id
EG001
num Affected
151
num At Risk
460
num Events
307
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
16
num At Risk
430
num Events
17
group Id
EG001
num Affected
39
num At Risk
460
num Events
39
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
31
num At Risk
430
num Events
38
group Id
EG001
num Affected
30
num At Risk
460
num Events
34
term
DYSPEPSIA

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
1
num At Risk
460
num Events
1
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
5
num At Risk
460
num Events
5
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
0
num At Risk
460
num Events
0
term
HAEMOLYSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
0
num At Risk
460
num Events
0
term
LEUKOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
430
num Events
0
group Id
EG001
num Affected
1
num At Risk
460
num Events
1
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
430
num Events
0
group Id
EG001
num Affected
1
num At Risk
460
num Events
1
term
PANCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
0
num At Risk
460
num Events
0
term
ACUTE MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
0
num At Risk
430
num Events
0
group Id
EG001
num Affected
1
num At Risk
460
num Events
1
term
ANGINA UNSTABLE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
1
num At Risk
460
num Events
1
term
ARRHYTHMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
430
num Events
2
group Id
EG001
num Affected
1
num At Risk
460
num Events
1
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
2
num At Risk
430
num Events
2
group Id
EG001
num Affected
0
num At Risk
460
num Events
0
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 24.0
stats
group Id
EG000
num Affected
1
num At Risk
430
num Events
1
group Id
EG001
num Affected
0
num At Risk
460
num Events
0
term
CARDIAC FAILURE CONGESTIVE

time Frame

From the first study drug to the data cutoff date: 31 August 2021 (up to approximately 74 months)

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

Preserved source evidence · Not medical advice