NCT03498716 · ADVERSE EVENTS

Adverse events

A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer · Source last updated 2024-08-21

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: Up to 5 years
Other-event reporting threshold: 5%

All-cause Mortality: ITT population population included all randomized participants, whether or not the assigned study treatment was received.; Adverse Events: Safety Evaluable Population included all participants who received any amount of any study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Chemotherapy Participants were administered paclitaxel, 80 mg/m\^2, IV infusion QW for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated every Q2W for a maximum of 20 weeks supported with G-CSF or GM-CSF treatment.	173 / 1084	1068 / 1084	58 / 1098
Atezolizumab and Chemotherapy Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m\^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.	280 / 1093	1082 / 1093	72 / 1101

Group identifiers: EG000: Chemotherapy · EG001: Atezolizumab and Chemotherapy

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
3
num At Risk
1084
num Events
3
group Id
EG001
num Affected
6
num At Risk
1093
num Events
6
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
0
num At Risk
1084
num Events
0
group Id
EG001
num Affected
1
num At Risk
1093
num Events
1
term
Anaemia macrocytic
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
1084
num Events
0
group Id
EG001
num Affected
1
num At Risk
1093
num Events
1
term
Autoimmune haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
23
num At Risk
1084
num Events
25
group Id
EG001
num Affected
29
num At Risk
1093
num Events
35
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
1084
num Events
1
group Id
EG001
num Affected
0
num At Risk
1093
num Events
0
term
Granulocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
5
num At Risk
1084
num Events
6
group Id
EG001
num Affected
18
num At Risk
1093
num Events
28
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
1084
num Events
0
group Id
EG001
num Affected
1
num At Risk
1093
num Events
1
term
Lymphadenopathy mediastinal
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
1084
num Events
1
group Id
EG001
num Affected
2
num At Risk
1093
num Events
2
term
Lymphopenia
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
1084
num Events
0
group Id
EG001
num Affected
1
num At Risk
1093
num Events
1
term
Methaemoglobinaemia
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
1084
num Events
4
group Id
EG001
num Affected
4
num At Risk
1093
num Events
4
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
31
num At Risk
1084
num Events
41
group Id
EG001
num Affected
40
num At Risk
1093
num Events
76
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
1
num At Risk
1084
num Events
1
group Id
EG001
num Affected
0
num At Risk
1093
num Events
0
term
Pancytopenia

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
422
num At Risk
1084
num Events
546
group Id
EG001
num Affected
420
num At Risk
1093
num Events
586
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
139
num At Risk
1084
num Events
274
group Id
EG001
num Affected
137
num At Risk
1093
num Events
317
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
240
num At Risk
1084
num Events
437
group Id
EG001
num Affected
236
num At Risk
1093
num Events
474
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
3
num At Risk
1084
num Events
3
group Id
EG001
num Affected
62
num At Risk
1093
num Events
65
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
6
num At Risk
1084
num Events
6
group Id
EG001
num Affected
161
num At Risk
1093
num Events
173
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
61
num At Risk
1084
num Events
73
group Id
EG001
num Affected
72
num At Risk
1093
num Events
79
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
52
num At Risk
1084
num Events
53
group Id
EG001
num Affected
79
num At Risk
1093
num Events
92
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
210
num At Risk
1084
num Events
252
group Id
EG001
num Affected
231
num At Risk
1093
num Events
270
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
188
num At Risk
1084
num Events
260
group Id
EG001
num Affected
287
num At Risk
1093
num Events
430
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
58
num At Risk
1084
num Events
73
group Id
EG001
num Affected
65
num At Risk
1093
num Events
71
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
531
num At Risk
1084
num Events
865
group Id
EG001
num Affected
553
num At Risk
1093
num Events
958
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
120
num At Risk
1084
num Events
133
group Id
EG001
num Affected
143
num At Risk
1093
num Events
166
term
Stomatitis

Complete source fields

description

event Groups

deaths Num Affected
58
deaths Num At Risk
1098
description
Participants were administered paclitaxel, 80 mg/m\^2, IV infusion QW for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated every Q2W for a maximum of 20 weeks supported with G-CSF or GM-CSF treatment.
id
EG000
other Num Affected
1068
other Num At Risk
1084
serious Num Affected
173
serious Num At Risk
1084
title
Chemotherapy
deaths Num Affected
72
deaths Num At Risk
1101
description
Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m\^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.
id
EG001
other Num Affected
1082
other Num At Risk
1093
serious Num Affected
280
serious Num At Risk
1093
title
Atezolizumab and Chemotherapy

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
422
num At Risk
1084
num Events
546
group Id
EG001
num Affected
420
num At Risk
1093
num Events
586
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
139
num At Risk
1084
num Events
274
group Id
EG001
num Affected
137
num At Risk
1093
num Events
317
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
240
num At Risk
1084
num Events
437
group Id
EG001
num Affected
236
num At Risk
1093
num Events
474
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
3
num At Risk
1084
num Events
3
group Id
EG001
num Affected
62
num At Risk
1093
num Events
65
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
6
num At Risk
1084
num Events
6
group Id
EG001
num Affected
161
num At Risk
1093
num Events
173
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
61
num At Risk
1084
num Events
73
group Id
EG001
num Affected
72
num At Risk
1093
num Events
79
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
52
num At Risk
1084
num Events
53
group Id
EG001
num Affected
79
num At Risk
1093
num Events
92
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
210
num At Risk
1084
num Events
252
group Id
EG001
num Affected
231
num At Risk
1093
num Events
270
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
188
num At Risk
1084
num Events
260
group Id
EG001
num Affected
287
num At Risk
1093
num Events
430
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
58
num At Risk
1084
num Events
73
group Id
EG001
num Affected
65
num At Risk
1093
num Events
71
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
531
num At Risk
1084
num Events
865
group Id
EG001
num Affected
553
num At Risk
1093
num Events
958
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
120
num At Risk
1084
num Events
133
group Id
EG001
num Affected
143
num At Risk
1093
num Events
166
term
Stomatitis

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
3
num At Risk
1084
num Events
3
group Id
EG001
num Affected
6
num At Risk
1093
num Events
6
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
0
num At Risk
1084
num Events
0
group Id
EG001
num Affected
1
num At Risk
1093
num Events
1
term
Anaemia macrocytic
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
1084
num Events
0
group Id
EG001
num Affected
1
num At Risk
1093
num Events
1
term
Autoimmune haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
23
num At Risk
1084
num Events
25
group Id
EG001
num Affected
29
num At Risk
1093
num Events
35
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
1084
num Events
1
group Id
EG001
num Affected
0
num At Risk
1093
num Events
0
term
Granulocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
5
num At Risk
1084
num Events
6
group Id
EG001
num Affected
18
num At Risk
1093
num Events
28
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
1084
num Events
0
group Id
EG001
num Affected
1
num At Risk
1093
num Events
1
term
Lymphadenopathy mediastinal
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
1084
num Events
1
group Id
EG001
num Affected
2
num At Risk
1093
num Events
2
term
Lymphopenia
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
1084
num Events
0
group Id
EG001
num Affected
1
num At Risk
1093
num Events
1
term
Methaemoglobinaemia
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
1084
num Events
4
group Id
EG001
num Affected
4
num At Risk
1093
num Events
4
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
31
num At Risk
1084
num Events
41
group Id
EG001
num Affected
40
num At Risk
1093
num Events
76
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
1
num At Risk
1084
num Events
1
group Id
EG001
num Affected
0
num At Risk
1093
num Events
0
term
Pancytopenia

time Frame

Up to 5 years

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

Preserved source evidence · Not medical advice