NCT03041311 · ADVERSE EVENTS

Adverse events

Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC · Source last updated 2025-09-25

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: Treatment-emergent adverse events collected beginning with informed consent through 30 days after last dose of study drug. Treatment emergent serious adverse events collected through 90 days after last dose of study drug, assessed up to a maximum of 1192 days (maximum duration of exposure plus 30 days).
Other-event reporting threshold: 5%

Adverse events were assessed using the safety analysis set, which included all randomized patients who received at least 1 dose of any study drug (etoposide, carboplatin, atezolizumab, or trilaciclib). Analyses using the safety analysis set were conducted based on the actual treatment received.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Trilaciclib+Etoposide/Carboplatin/Atezolizumab Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.	17 / 52	49 / 52	42 / 54
Placebo+Etoposide/Carboplatin/Atezolizumab Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.	25 / 53	52 / 53	44 / 53

Group identifiers: EG000: Trilaciclib+Etoposide/Carboplatin/Atezolizumab · EG001: Placebo+Etoposide/Carboplatin/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
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
3
num At Risk
52
num Events
5
group Id
EG001
num Affected
8
num At Risk
53
num Events
8
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
0
num At Risk
52
num Events
0
group Id
EG001
num Affected
2
num At Risk
53
num Events
2
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
1
num At Risk
52
num Events
1
group Id
EG001
num Affected
1
num At Risk
53
num Events
1
term
Urinary Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
0
num At Risk
52
num Events
0
group Id
EG001
num Affected
1
num At Risk
53
num Events
1
term
Bronchiolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
0
num At Risk
52
num Events
0
group Id
EG001
num Affected
1
num At Risk
53
num Events
1
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
0
num At Risk
52
num Events
0
group Id
EG001
num Affected
1
num At Risk
53
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
0
num At Risk
52
num Events
0
group Id
EG001
num Affected
1
num At Risk
53
num Events
2
term
Empyema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
0
num At Risk
52
num Events
0
group Id
EG001
num Affected
1
num At Risk
53
num Events
2
term
Meningoencephalitis herpetic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
2
num At Risk
52
num Events
2
group Id
EG001
num Affected
2
num At Risk
53
num Events
2
term
Chronic obstructive pulmonary disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
1
num At Risk
52
num Events
1
group Id
EG001
num Affected
2
num At Risk
53
num Events
2
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
1
num At Risk
52
num Events
1
group Id
EG001
num Affected
1
num At Risk
53
num Events
1
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
1
num At Risk
52
num Events
1
group Id
EG001
num Affected
0
num At Risk
53
num Events
0
term
Haemoptysis

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 23.1.
stats
group Id
EG000
num Affected
19
num At Risk
52
num Events
60
group Id
EG001
num Affected
32
num At Risk
53
num Events
122
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
19
num At Risk
52
num Events
35
group Id
EG001
num Affected
28
num At Risk
53
num Events
85
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
7
num At Risk
52
num Events
14
group Id
EG001
num Affected
21
num At Risk
53
num Events
44
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
4
num At Risk
52
num Events
5
group Id
EG001
num Affected
14
num At Risk
53
num Events
38
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
16
num At Risk
52
num Events
24
group Id
EG001
num Affected
20
num At Risk
53
num Events
32
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
8
num At Risk
52
num Events
17
group Id
EG001
num Affected
9
num At Risk
53
num Events
21
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
5
num At Risk
52
num Events
5
group Id
EG001
num Affected
7
num At Risk
53
num Events
7
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
8
num At Risk
52
num Events
8
group Id
EG001
num Affected
4
num At Risk
53
num Events
5
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
4
num At Risk
52
num Events
4
group Id
EG001
num Affected
4
num At Risk
53
num Events
4
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
2
num At Risk
52
num Events
2
group Id
EG001
num Affected
4
num At Risk
53
num Events
5
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
1
num At Risk
52
num Events
1
group Id
EG001
num Affected
3
num At Risk
53
num Events
3
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
20
num At Risk
52
num Events
36
group Id
EG001
num Affected
18
num At Risk
53
num Events
30
term
Nausea

Complete source fields

description

event Groups

deaths Num Affected
42
deaths Num At Risk
54
description
Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.
id
EG000
other Num Affected
49
other Num At Risk
52
serious Num Affected
17
serious Num At Risk
52
title
Trilaciclib+Etoposide/Carboplatin/Atezolizumab
deaths Num Affected
44
deaths Num At Risk
53
description
Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.
id
EG001
other Num Affected
52
other Num At Risk
53
serious Num Affected
25
serious Num At Risk
53
title
Placebo+Etoposide/Carboplatin/Atezolizumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
19
num At Risk
52
num Events
60
group Id
EG001
num Affected
32
num At Risk
53
num Events
122
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
19
num At Risk
52
num Events
35
group Id
EG001
num Affected
28
num At Risk
53
num Events
85
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
7
num At Risk
52
num Events
14
group Id
EG001
num Affected
21
num At Risk
53
num Events
44
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
4
num At Risk
52
num Events
5
group Id
EG001
num Affected
14
num At Risk
53
num Events
38
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
16
num At Risk
52
num Events
24
group Id
EG001
num Affected
20
num At Risk
53
num Events
32
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
8
num At Risk
52
num Events
17
group Id
EG001
num Affected
9
num At Risk
53
num Events
21
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
5
num At Risk
52
num Events
5
group Id
EG001
num Affected
7
num At Risk
53
num Events
7
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
8
num At Risk
52
num Events
8
group Id
EG001
num Affected
4
num At Risk
53
num Events
5
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
4
num At Risk
52
num Events
4
group Id
EG001
num Affected
4
num At Risk
53
num Events
4
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
2
num At Risk
52
num Events
2
group Id
EG001
num Affected
4
num At Risk
53
num Events
5
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
1
num At Risk
52
num Events
1
group Id
EG001
num Affected
3
num At Risk
53
num Events
3
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
20
num At Risk
52
num Events
36
group Id
EG001
num Affected
18
num At Risk
53
num Events
30
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
3
num At Risk
52
num Events
5
group Id
EG001
num Affected
8
num At Risk
53
num Events
8
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
0
num At Risk
52
num Events
0
group Id
EG001
num Affected
2
num At Risk
53
num Events
2
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
1
num At Risk
52
num Events
1
group Id
EG001
num Affected
1
num At Risk
53
num Events
1
term
Urinary Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
0
num At Risk
52
num Events
0
group Id
EG001
num Affected
1
num At Risk
53
num Events
1
term
Bronchiolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
0
num At Risk
52
num Events
0
group Id
EG001
num Affected
1
num At Risk
53
num Events
1
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
0
num At Risk
52
num Events
0
group Id
EG001
num Affected
1
num At Risk
53
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
0
num At Risk
52
num Events
0
group Id
EG001
num Affected
1
num At Risk
53
num Events
2
term
Empyema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
0
num At Risk
52
num Events
0
group Id
EG001
num Affected
1
num At Risk
53
num Events
2
term
Meningoencephalitis herpetic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
2
num At Risk
52
num Events
2
group Id
EG001
num Affected
2
num At Risk
53
num Events
2
term
Chronic obstructive pulmonary disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
1
num At Risk
52
num Events
1
group Id
EG001
num Affected
2
num At Risk
53
num Events
2
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
1
num At Risk
52
num Events
1
group Id
EG001
num Affected
1
num At Risk
53
num Events
1
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 23.1.
stats
group Id
EG000
num Affected
1
num At Risk
52
num Events
1
group Id
EG001
num Affected
0
num At Risk
53
num Events
0
term
Haemoptysis

time Frame

Treatment-emergent adverse events collected beginning with informed consent through 30 days after last dose of study drug. Treatment emergent serious adverse events collected through 90 days after last dose of study drug, assessed up to a maximum of 1192 days (maximum duration of exposure plus 30 days).

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