NCT02409342 · ADVERSE EVENTS

Adverse events

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110] · Source last updated 2023-03-15

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 until the data cut-off on 8 March 2022 (up to approximately 79.5 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
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).	77 / 263	230 / 263	211 / 287
Atezolizumab Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).	97 / 286	238 / 286	201 / 285

Group identifiers: EG000: Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) · EG001: Atezolizumab

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 24.1
stats
group Id
EG000
num Affected
10
num At Risk
263
num Events
15
group Id
EG001
num Affected
1
num At Risk
286
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
5
num At Risk
263
num Events
5
group Id
EG001
num Affected
0
num At Risk
286
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
263
num Events
1
group Id
EG001
num Affected
0
num At Risk
286
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
5
num At Risk
263
num Events
5
group Id
EG001
num Affected
0
num At Risk
286
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
3
num At Risk
263
num Events
3
group Id
EG001
num Affected
0
num At Risk
286
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
9
num At Risk
263
num Events
10
group Id
EG001
num Affected
1
num At Risk
286
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
263
num Events
1
group Id
EG001
num Affected
0
num At Risk
286
num Events
0
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
263
num Events
0
group Id
EG001
num Affected
1
num At Risk
286
num Events
1
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
263
num Events
0
group Id
EG001
num Affected
2
num At Risk
286
num Events
2
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
263
num Events
1
group Id
EG001
num Affected
1
num At Risk
286
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
263
num Events
0
group Id
EG001
num Affected
1
num At Risk
286
num Events
1
term
Autoimmune myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
2
num At Risk
263
num Events
2
group Id
EG001
num Affected
1
num At Risk
286
num Events
1
term
Cardiac arrest

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 24.1
stats
group Id
EG000
num Affected
120
num At Risk
263
num Events
153
group Id
EG001
num Affected
50
num At Risk
286
num Events
73
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
21
num At Risk
263
num Events
31
group Id
EG001
num Affected
4
num At Risk
286
num Events
6
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
71
num At Risk
263
num Events
128
group Id
EG001
num Affected
5
num At Risk
286
num Events
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
40
num At Risk
263
num Events
62
group Id
EG001
num Affected
8
num At Risk
286
num Events
8
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
3
num At Risk
263
num Events
3
group Id
EG001
num Affected
27
num At Risk
286
num Events
28
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
58
num At Risk
263
num Events
75
group Id
EG001
num Affected
42
num At Risk
286
num Events
48
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
30
num At Risk
263
num Events
39
group Id
EG001
num Affected
39
num At Risk
286
num Events
55
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
88
num At Risk
263
num Events
148
group Id
EG001
num Affected
42
num At Risk
286
num Events
49
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
14
num At Risk
263
num Events
16
group Id
EG001
num Affected
12
num At Risk
286
num Events
14
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
34
num At Risk
263
num Events
45
group Id
EG001
num Affected
21
num At Risk
286
num Events
27
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
47
num At Risk
263
num Events
66
group Id
EG001
num Affected
41
num At Risk
286
num Events
58
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
10
num At Risk
263
num Events
10
group Id
EG001
num Affected
21
num At Risk
286
num Events
28
term
Chest pain

Complete source fields

description

event Groups

deaths Num Affected
211
deaths Num At Risk
287
description
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
id
EG000
other Num Affected
230
other Num At Risk
263
serious Num Affected
77
serious Num At Risk
263
title
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
deaths Num Affected
201
deaths Num At Risk
285
description
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
id
EG001
other Num Affected
238
other Num At Risk
286
serious Num Affected
97
serious Num At Risk
286
title
Atezolizumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
120
num At Risk
263
num Events
153
group Id
EG001
num Affected
50
num At Risk
286
num Events
73
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
21
num At Risk
263
num Events
31
group Id
EG001
num Affected
4
num At Risk
286
num Events
6
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
71
num At Risk
263
num Events
128
group Id
EG001
num Affected
5
num At Risk
286
num Events
7
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
40
num At Risk
263
num Events
62
group Id
EG001
num Affected
8
num At Risk
286
num Events
8
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
3
num At Risk
263
num Events
3
group Id
EG001
num Affected
27
num At Risk
286
num Events
28
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
58
num At Risk
263
num Events
75
group Id
EG001
num Affected
42
num At Risk
286
num Events
48
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
30
num At Risk
263
num Events
39
group Id
EG001
num Affected
39
num At Risk
286
num Events
55
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
88
num At Risk
263
num Events
148
group Id
EG001
num Affected
42
num At Risk
286
num Events
49
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
14
num At Risk
263
num Events
16
group Id
EG001
num Affected
12
num At Risk
286
num Events
14
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
34
num At Risk
263
num Events
45
group Id
EG001
num Affected
21
num At Risk
286
num Events
27
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
47
num At Risk
263
num Events
66
group Id
EG001
num Affected
41
num At Risk
286
num Events
58
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
10
num At Risk
263
num Events
10
group Id
EG001
num Affected
21
num At Risk
286
num Events
28
term
Chest pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
10
num At Risk
263
num Events
15
group Id
EG001
num Affected
1
num At Risk
286
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
5
num At Risk
263
num Events
5
group Id
EG001
num Affected
0
num At Risk
286
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
263
num Events
1
group Id
EG001
num Affected
0
num At Risk
286
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
5
num At Risk
263
num Events
5
group Id
EG001
num Affected
0
num At Risk
286
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
3
num At Risk
263
num Events
3
group Id
EG001
num Affected
0
num At Risk
286
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
9
num At Risk
263
num Events
10
group Id
EG001
num Affected
1
num At Risk
286
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
263
num Events
1
group Id
EG001
num Affected
0
num At Risk
286
num Events
0
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
263
num Events
0
group Id
EG001
num Affected
1
num At Risk
286
num Events
1
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
263
num Events
0
group Id
EG001
num Affected
2
num At Risk
286
num Events
2
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
1
num At Risk
263
num Events
1
group Id
EG001
num Affected
1
num At Risk
286
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
0
num At Risk
263
num Events
0
group Id
EG001
num Affected
1
num At Risk
286
num Events
1
term
Autoimmune myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 24.1
stats
group Id
EG000
num Affected
2
num At Risk
263
num Events
2
group Id
EG001
num Affected
1
num At Risk
286
num Events
1
term
Cardiac arrest

time Frame

From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)

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Preserved source evidence · Not medical advice