NCT02514447 · ADVERSE EVENTS

Adverse events

Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy · 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: The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of trilaciclib (G1T28) + topotecan (assessed up to a maximum of 1689 days). All-Cause Mortality was assessed from the date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2196 days).
Other-event reporting threshold: 5%

The safety analysis set (AEs and SAEs) includes all enrolled patients who received at least 1 dose of study drug (topotecan or trilaciclib/placebo). Analyses using the safety analysis set will be conducted on the basis of the actual treatment received. The intent-to-treat (ITT) analysis set (All-Cause Mortality) includes all enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Placebos Topotecan	7 / 28	27 / 28	24 / 29
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²). Trilaciclib Topotecan	15 / 30	29 / 30	28 / 30
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Trilaciclib Topotecan	12 / 32	32 / 32	29 / 32
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²).	2 / 2	2 / 2	0 / 2
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²).	1 / 3	3 / 3	3 / 3
Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).	2 / 4	4 / 4	4 / 4
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).	0 / 8	8 / 8	8 / 8
Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).	1 / 7	7 / 7	6 / 7
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²).	1 / 8	8 / 8	5 / 8

Group identifiers: EG000: Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b · EG001: Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a · EG002: Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b · EG003: Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 · EG004: Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 · EG005: Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 · EG006: Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 · EG007: Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 · EG008: Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
1
num At Risk
30
num Events
2
group Id
EG002
num Affected
1
num At Risk
32
num Events
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
1
num At Risk
8
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
1
num At Risk
8
term
Bacteraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
1
num At Risk
8
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
1
num At Risk
8
term
Pneumonia pneumococcal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Septic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
2
num At Risk
30
num Events
2
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
1
num At Risk
8
term
Chronic obstructive pulmonary disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
2
num At Risk
30
num Events
2
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Pulmonary emobolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
2
num At Risk
30
num Events
2
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Fall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Muscular weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Metabolic encephalopathy

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
23
num At Risk
28
num Events
101
group Id
EG001
num Affected
18
num At Risk
30
num Events
58
group Id
EG002
num Affected
24
num At Risk
32
num Events
96
group Id
EG003
num Affected
2
num At Risk
2
num Events
19
group Id
EG004
num Affected
3
num At Risk
3
num Events
32
group Id
EG005
num Affected
2
num At Risk
4
num Events
7
group Id
EG006
num Affected
5
num At Risk
8
num Events
7
group Id
EG007
num Affected
5
num At Risk
7
num Events
14
group Id
EG008
num Affected
5
num At Risk
8
num Events
26
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
19
num At Risk
28
num Events
96
group Id
EG001
num Affected
17
num At Risk
30
num Events
65
group Id
EG002
num Affected
20
num At Risk
32
num Events
133
group Id
EG003
num Affected
2
num At Risk
2
num Events
47
group Id
EG004
num Affected
3
num At Risk
3
num Events
37
group Id
EG005
num Affected
3
num At Risk
4
num Events
18
group Id
EG006
num Affected
1
num At Risk
8
num Events
4
group Id
EG007
num Affected
4
num At Risk
7
num Events
17
group Id
EG008
num Affected
3
num At Risk
8
num Events
26
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
24
num At Risk
28
num Events
94
group Id
EG001
num Affected
14
num At Risk
30
num Events
55
group Id
EG002
num Affected
17
num At Risk
32
num Events
57
group Id
EG003
num Affected
2
num At Risk
2
num Events
35
group Id
EG004
num Affected
3
num At Risk
3
num Events
36
group Id
EG005
num Affected
2
num At Risk
4
num Events
5
group Id
EG006
num Affected
3
num At Risk
8
num Events
39
group Id
EG007
num Affected
4
num At Risk
7
num Events
11
group Id
EG008
num Affected
6
num At Risk
8
num Events
24
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
9
num At Risk
28
num Events
36
group Id
EG001
num Affected
7
num At Risk
30
num Events
14
group Id
EG002
num Affected
4
num At Risk
32
num Events
7
group Id
EG003
num Affected
2
num At Risk
2
num Events
38
group Id
EG004
num Affected
3
num At Risk
3
num Events
54
group Id
EG005
num Affected
1
num At Risk
4
num Events
12
group Id
EG006
num Affected
2
num At Risk
8
num Events
35
group Id
EG007
num Affected
2
num At Risk
7
num Events
16
group Id
EG008
num Affected
3
num At Risk
8
num Events
49
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
10
num At Risk
28
num Events
16
group Id
EG001
num Affected
16
num At Risk
30
num Events
22
group Id
EG002
num Affected
13
num At Risk
32
num Events
15
group Id
EG003
num Affected
2
num At Risk
2
num Events
3
group Id
EG004
num Affected
3
num At Risk
3
num Events
4
group Id
EG005
num Affected
2
num At Risk
4
num Events
2
group Id
EG006
num Affected
4
num At Risk
8
num Events
5
group Id
EG007
num Affected
1
num At Risk
7
num Events
3
group Id
EG008
num Affected
4
num At Risk
8
num Events
8
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
5
num At Risk
28
num Events
6
group Id
EG001
num Affected
2
num At Risk
30
num Events
2
group Id
EG002
num Affected
8
num At Risk
32
num Events
8
group Id
EG003
num Affected
1
num At Risk
2
num Events
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
4
num Events
2
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
4
num At Risk
28
num Events
4
group Id
EG001
num Affected
5
num At Risk
30
num Events
8
group Id
EG002
num Affected
2
num At Risk
32
num Events
3
group Id
EG003
num Affected
2
num At Risk
2
num Events
2
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
4
num Events
2
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
2
num At Risk
7
num Events
6
group Id
EG008
num Affected
2
num At Risk
8
num Events
3
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
7
num At Risk
30
num Events
9
group Id
EG002
num Affected
1
num At Risk
32
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
2
num At Risk
8
num Events
3
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
5
num At Risk
30
num Events
5
group Id
EG002
num Affected
3
num At Risk
32
num Events
3
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
3
num At Risk
30
num Events
3
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
8
num Events
2
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
3
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
14
num At Risk
28
num Events
21
group Id
EG001
num Affected
16
num At Risk
30
num Events
20
group Id
EG002
num Affected
9
num At Risk
32
num Events
18
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
3
num At Risk
3
num Events
3
group Id
EG005
num Affected
2
num At Risk
4
num Events
3
group Id
EG006
num Affected
3
num At Risk
8
num Events
3
group Id
EG007
num Affected
4
num At Risk
7
num Events
7
group Id
EG008
num Affected
3
num At Risk
8
num Events
4
term
Nausea

Complete source fields

description

event Groups

deaths Num Affected
24
deaths Num At Risk
29
description
Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Placebos Topotecan
id
EG000
other Num Affected
27
other Num At Risk
28
serious Num Affected
7
serious Num At Risk
28
title
Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b
deaths Num Affected
28
deaths Num At Risk
30
description
Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²). Trilaciclib Topotecan
id
EG001
other Num Affected
29
other Num At Risk
30
serious Num Affected
15
serious Num At Risk
30
title
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a
deaths Num Affected
29
deaths Num At Risk
32
description
Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Trilaciclib Topotecan
id
EG002
other Num Affected
32
other Num At Risk
32
serious Num Affected
12
serious Num At Risk
32
title
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b
deaths Num Affected
0
deaths Num At Risk
2
description
Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²).
id
EG003
other Num Affected
2
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1
deaths Num Affected
3
deaths Num At Risk
3
description
Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²).
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1
deaths Num Affected
4
deaths Num At Risk
4
description
Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
id
EG005
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1
deaths Num Affected
8
deaths Num At Risk
8
description
Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
id
EG006
other Num Affected
8
other Num At Risk
8
serious Num Affected
0
serious Num At Risk
8
title
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1
deaths Num Affected
6
deaths Num At Risk
7
description
Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
id
EG007
other Num Affected
7
other Num At Risk
7
serious Num Affected
1
serious Num At Risk
7
title
Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1
deaths Num Affected
5
deaths Num At Risk
8
description
Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²).
id
EG008
other Num Affected
8
other Num At Risk
8
serious Num Affected
1
serious Num At Risk
8
title
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
23
num At Risk
28
num Events
101
group Id
EG001
num Affected
18
num At Risk
30
num Events
58
group Id
EG002
num Affected
24
num At Risk
32
num Events
96
group Id
EG003
num Affected
2
num At Risk
2
num Events
19
group Id
EG004
num Affected
3
num At Risk
3
num Events
32
group Id
EG005
num Affected
2
num At Risk
4
num Events
7
group Id
EG006
num Affected
5
num At Risk
8
num Events
7
group Id
EG007
num Affected
5
num At Risk
7
num Events
14
group Id
EG008
num Affected
5
num At Risk
8
num Events
26
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
19
num At Risk
28
num Events
96
group Id
EG001
num Affected
17
num At Risk
30
num Events
65
group Id
EG002
num Affected
20
num At Risk
32
num Events
133
group Id
EG003
num Affected
2
num At Risk
2
num Events
47
group Id
EG004
num Affected
3
num At Risk
3
num Events
37
group Id
EG005
num Affected
3
num At Risk
4
num Events
18
group Id
EG006
num Affected
1
num At Risk
8
num Events
4
group Id
EG007
num Affected
4
num At Risk
7
num Events
17
group Id
EG008
num Affected
3
num At Risk
8
num Events
26
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
24
num At Risk
28
num Events
94
group Id
EG001
num Affected
14
num At Risk
30
num Events
55
group Id
EG002
num Affected
17
num At Risk
32
num Events
57
group Id
EG003
num Affected
2
num At Risk
2
num Events
35
group Id
EG004
num Affected
3
num At Risk
3
num Events
36
group Id
EG005
num Affected
2
num At Risk
4
num Events
5
group Id
EG006
num Affected
3
num At Risk
8
num Events
39
group Id
EG007
num Affected
4
num At Risk
7
num Events
11
group Id
EG008
num Affected
6
num At Risk
8
num Events
24
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
9
num At Risk
28
num Events
36
group Id
EG001
num Affected
7
num At Risk
30
num Events
14
group Id
EG002
num Affected
4
num At Risk
32
num Events
7
group Id
EG003
num Affected
2
num At Risk
2
num Events
38
group Id
EG004
num Affected
3
num At Risk
3
num Events
54
group Id
EG005
num Affected
1
num At Risk
4
num Events
12
group Id
EG006
num Affected
2
num At Risk
8
num Events
35
group Id
EG007
num Affected
2
num At Risk
7
num Events
16
group Id
EG008
num Affected
3
num At Risk
8
num Events
49
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
10
num At Risk
28
num Events
16
group Id
EG001
num Affected
16
num At Risk
30
num Events
22
group Id
EG002
num Affected
13
num At Risk
32
num Events
15
group Id
EG003
num Affected
2
num At Risk
2
num Events
3
group Id
EG004
num Affected
3
num At Risk
3
num Events
4
group Id
EG005
num Affected
2
num At Risk
4
num Events
2
group Id
EG006
num Affected
4
num At Risk
8
num Events
5
group Id
EG007
num Affected
1
num At Risk
7
num Events
3
group Id
EG008
num Affected
4
num At Risk
8
num Events
8
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
5
num At Risk
28
num Events
6
group Id
EG001
num Affected
2
num At Risk
30
num Events
2
group Id
EG002
num Affected
8
num At Risk
32
num Events
8
group Id
EG003
num Affected
1
num At Risk
2
num Events
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
4
num Events
2
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
4
num At Risk
28
num Events
4
group Id
EG001
num Affected
5
num At Risk
30
num Events
8
group Id
EG002
num Affected
2
num At Risk
32
num Events
3
group Id
EG003
num Affected
2
num At Risk
2
num Events
2
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
4
num Events
2
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
2
num At Risk
7
num Events
6
group Id
EG008
num Affected
2
num At Risk
8
num Events
3
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
7
num At Risk
30
num Events
9
group Id
EG002
num Affected
1
num At Risk
32
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
2
num At Risk
8
num Events
3
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
5
num At Risk
30
num Events
5
group Id
EG002
num Affected
3
num At Risk
32
num Events
3
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
3
num At Risk
30
num Events
3
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
8
num Events
2
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
3
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
14
num At Risk
28
num Events
21
group Id
EG001
num Affected
16
num At Risk
30
num Events
20
group Id
EG002
num Affected
9
num At Risk
32
num Events
18
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
3
num At Risk
3
num Events
3
group Id
EG005
num Affected
2
num At Risk
4
num Events
3
group Id
EG006
num Affected
3
num At Risk
8
num Events
3
group Id
EG007
num Affected
4
num At Risk
7
num Events
7
group Id
EG008
num Affected
3
num At Risk
8
num Events
4
term
Nausea

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
1
num At Risk
30
num Events
2
group Id
EG002
num Affected
1
num At Risk
32
num Events
1
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
1
num At Risk
8
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
1
num At Risk
8
term
Bacteraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
1
num At Risk
8
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
1
num At Risk
8
term
Pneumonia pneumococcal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Septic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
2
num At Risk
30
num Events
2
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
1
num At Risk
8
term
Chronic obstructive pulmonary disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
2
num At Risk
30
num Events
2
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Pulmonary emobolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
2
num At Risk
30
num Events
2
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Fall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
0
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
1
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Muscular weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
30
group Id
EG002
num Affected
0
num At Risk
32
group Id
EG003
num Affected
1
num At Risk
2
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
8
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
8
term
Metabolic encephalopathy

time Frame

The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of trilaciclib (G1T28) + topotecan (assessed up to a maximum of 1689 days). All-Cause Mortality was assessed from the date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2196 days).

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Preserved source evidence · Not medical advice