NCT02763579 · ADVERSE EVENTS

Adverse events

A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC) · Source last updated 2023-07-28

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 administration to the data cutoff date: 7 July 2022 (up to 49 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 component of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo + Carboplatin + Etoposide - Global Participants in the Global population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.	69 / 196	187 / 196	11 / 196
Atezolizumab + Carboplatin + Etoposide - Global Participants in the Global population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.	81 / 198	191 / 198	5 / 198
Placebo + Carboplatin + Etoposide - China Participants in the China population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.	14 / 52	52 / 52	1 / 52
Atezolizumab + Carboplatin + Etoposide - China Participants in the China population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.	22 / 57	56 / 57	3 / 57

Group identifiers: EG000: Placebo + Carboplatin + Etoposide - Global · EG001: Atezolizumab + Carboplatin + Etoposide - Global · EG002: Placebo + Carboplatin + Etoposide - China · EG003: Atezolizumab + Carboplatin + Etoposide - China

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 25.0
stats
group Id
EG000
num Affected
2
num At Risk
196
num Events
2
group Id
EG001
num Affected
3
num At Risk
198
num Events
4
group Id
EG002
num Affected
1
num At Risk
52
num Events
1
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
196
num Events
1
group Id
EG001
num Affected
0
num At Risk
198
num Events
0
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
9
num At Risk
196
num Events
9
group Id
EG001
num Affected
5
num At Risk
198
num Events
5
group Id
EG002
num Affected
2
num At Risk
52
num Events
2
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
196
num Events
0
group Id
EG001
num Affected
0
num At Risk
198
num Events
0
group Id
EG002
num Affected
1
num At Risk
52
num Events
1
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Granulocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
196
num Events
1
group Id
EG001
num Affected
0
num At Risk
198
num Events
0
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
196
num Events
1
group Id
EG001
num Affected
2
num At Risk
198
num Events
2
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
196
num Events
0
group Id
EG001
num Affected
0
num At Risk
198
num Events
0
group Id
EG002
num Affected
1
num At Risk
52
num Events
1
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
8
num At Risk
196
num Events
8
group Id
EG001
num Affected
7
num At Risk
198
num Events
7
group Id
EG002
num Affected
1
num At Risk
52
num Events
1
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
4
num At Risk
196
num Events
4
group Id
EG001
num Affected
0
num At Risk
198
num Events
0
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
4
num At Risk
196
num Events
4
group Id
EG001
num Affected
5
num At Risk
198
num Events
5
group Id
EG002
num Affected
2
num At Risk
52
num Events
2
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
3
num At Risk
196
num Events
4
group Id
EG001
num Affected
1
num At Risk
198
num Events
1
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
196
num Events
0
group Id
EG001
num Affected
1
num At Risk
198
num Events
1
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Atrioventricular block complete

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 25.0
stats
group Id
EG000
num Affected
69
num At Risk
196
num Events
84
group Id
EG001
num Affected
86
num At Risk
198
num Events
101
group Id
EG002
num Affected
40
num At Risk
52
num Events
50
group Id
EG003
num Affected
46
num At Risk
57
num Events
76
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
19
num At Risk
196
num Events
32
group Id
EG001
num Affected
24
num At Risk
198
num Events
44
group Id
EG002
num Affected
14
num At Risk
52
num Events
22
group Id
EG003
num Affected
9
num At Risk
57
num Events
24
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
66
num At Risk
196
num Events
105
group Id
EG001
num Affected
71
num At Risk
198
num Events
122
group Id
EG002
num Affected
17
num At Risk
52
num Events
41
group Id
EG003
num Affected
11
num At Risk
57
num Events
32
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
29
num At Risk
196
num Events
44
group Id
EG001
num Affected
31
num At Risk
198
num Events
46
group Id
EG002
num Affected
16
num At Risk
52
num Events
31
group Id
EG003
num Affected
17
num At Risk
57
num Events
27
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
196
num Events
2
group Id
EG001
num Affected
2
num At Risk
198
num Events
2
group Id
EG002
num Affected
4
num At Risk
52
num Events
4
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
5
num At Risk
196
num Events
5
group Id
EG001
num Affected
11
num At Risk
198
num Events
11
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
2
num At Risk
57
num Events
2
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
196
num Events
1
group Id
EG001
num Affected
20
num At Risk
198
num Events
20
group Id
EG002
num Affected
2
num At Risk
52
num Events
2
group Id
EG003
num Affected
8
num At Risk
57
num Events
9
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
196
num Events
2
group Id
EG001
num Affected
5
num At Risk
198
num Events
5
group Id
EG002
num Affected
1
num At Risk
52
num Events
1
group Id
EG003
num Affected
3
num At Risk
57
num Events
3
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
11
num At Risk
196
num Events
11
group Id
EG001
num Affected
10
num At Risk
198
num Events
10
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
58
num At Risk
196
num Events
70
group Id
EG001
num Affected
52
num At Risk
198
num Events
65
group Id
EG002
num Affected
8
num At Risk
52
num Events
12
group Id
EG003
num Affected
10
num At Risk
57
num Events
19
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
30
num At Risk
196
num Events
46
group Id
EG001
num Affected
34
num At Risk
198
num Events
46
group Id
EG002
num Affected
2
num At Risk
52
num Events
2
group Id
EG003
num Affected
4
num At Risk
57
num Events
5
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
65
num At Risk
196
num Events
95
group Id
EG001
num Affected
77
num At Risk
198
num Events
112
group Id
EG002
num Affected
10
num At Risk
52
num Events
15
group Id
EG003
num Affected
21
num At Risk
57
num Events
47
term
Nausea

Complete source fields

description

event Groups

deaths Num Affected
11
deaths Num At Risk
196
description
Participants in the Global population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
id
EG000
other Num Affected
187
other Num At Risk
196
serious Num Affected
69
serious Num At Risk
196
title
Placebo + Carboplatin + Etoposide - Global
deaths Num Affected
5
deaths Num At Risk
198
description
Participants in the Global population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
id
EG001
other Num Affected
191
other Num At Risk
198
serious Num Affected
81
serious Num At Risk
198
title
Atezolizumab + Carboplatin + Etoposide - Global
deaths Num Affected
1
deaths Num At Risk
52
description
Participants in the China population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
id
EG002
other Num Affected
52
other Num At Risk
52
serious Num Affected
14
serious Num At Risk
52
title
Placebo + Carboplatin + Etoposide - China
deaths Num Affected
3
deaths Num At Risk
57
description
Participants in the China population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
id
EG003
other Num Affected
56
other Num At Risk
57
serious Num Affected
22
serious Num At Risk
57
title
Atezolizumab + Carboplatin + Etoposide - China

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
69
num At Risk
196
num Events
84
group Id
EG001
num Affected
86
num At Risk
198
num Events
101
group Id
EG002
num Affected
40
num At Risk
52
num Events
50
group Id
EG003
num Affected
46
num At Risk
57
num Events
76
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
19
num At Risk
196
num Events
32
group Id
EG001
num Affected
24
num At Risk
198
num Events
44
group Id
EG002
num Affected
14
num At Risk
52
num Events
22
group Id
EG003
num Affected
9
num At Risk
57
num Events
24
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
66
num At Risk
196
num Events
105
group Id
EG001
num Affected
71
num At Risk
198
num Events
122
group Id
EG002
num Affected
17
num At Risk
52
num Events
41
group Id
EG003
num Affected
11
num At Risk
57
num Events
32
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
29
num At Risk
196
num Events
44
group Id
EG001
num Affected
31
num At Risk
198
num Events
46
group Id
EG002
num Affected
16
num At Risk
52
num Events
31
group Id
EG003
num Affected
17
num At Risk
57
num Events
27
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
196
num Events
2
group Id
EG001
num Affected
2
num At Risk
198
num Events
2
group Id
EG002
num Affected
4
num At Risk
52
num Events
4
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
5
num At Risk
196
num Events
5
group Id
EG001
num Affected
11
num At Risk
198
num Events
11
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
2
num At Risk
57
num Events
2
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
196
num Events
1
group Id
EG001
num Affected
20
num At Risk
198
num Events
20
group Id
EG002
num Affected
2
num At Risk
52
num Events
2
group Id
EG003
num Affected
8
num At Risk
57
num Events
9
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
196
num Events
2
group Id
EG001
num Affected
5
num At Risk
198
num Events
5
group Id
EG002
num Affected
1
num At Risk
52
num Events
1
group Id
EG003
num Affected
3
num At Risk
57
num Events
3
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
11
num At Risk
196
num Events
11
group Id
EG001
num Affected
10
num At Risk
198
num Events
10
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
58
num At Risk
196
num Events
70
group Id
EG001
num Affected
52
num At Risk
198
num Events
65
group Id
EG002
num Affected
8
num At Risk
52
num Events
12
group Id
EG003
num Affected
10
num At Risk
57
num Events
19
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
30
num At Risk
196
num Events
46
group Id
EG001
num Affected
34
num At Risk
198
num Events
46
group Id
EG002
num Affected
2
num At Risk
52
num Events
2
group Id
EG003
num Affected
4
num At Risk
57
num Events
5
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
65
num At Risk
196
num Events
95
group Id
EG001
num Affected
77
num At Risk
198
num Events
112
group Id
EG002
num Affected
10
num At Risk
52
num Events
15
group Id
EG003
num Affected
21
num At Risk
57
num Events
47
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
2
num At Risk
196
num Events
2
group Id
EG001
num Affected
3
num At Risk
198
num Events
4
group Id
EG002
num Affected
1
num At Risk
52
num Events
1
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
196
num Events
1
group Id
EG001
num Affected
0
num At Risk
198
num Events
0
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
9
num At Risk
196
num Events
9
group Id
EG001
num Affected
5
num At Risk
198
num Events
5
group Id
EG002
num Affected
2
num At Risk
52
num Events
2
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
196
num Events
0
group Id
EG001
num Affected
0
num At Risk
198
num Events
0
group Id
EG002
num Affected
1
num At Risk
52
num Events
1
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Granulocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
196
num Events
1
group Id
EG001
num Affected
0
num At Risk
198
num Events
0
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
1
num At Risk
196
num Events
1
group Id
EG001
num Affected
2
num At Risk
198
num Events
2
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
196
num Events
0
group Id
EG001
num Affected
0
num At Risk
198
num Events
0
group Id
EG002
num Affected
1
num At Risk
52
num Events
1
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
8
num At Risk
196
num Events
8
group Id
EG001
num Affected
7
num At Risk
198
num Events
7
group Id
EG002
num Affected
1
num At Risk
52
num Events
1
group Id
EG003
num Affected
1
num At Risk
57
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
4
num At Risk
196
num Events
4
group Id
EG001
num Affected
0
num At Risk
198
num Events
0
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
4
num At Risk
196
num Events
4
group Id
EG001
num Affected
5
num At Risk
198
num Events
5
group Id
EG002
num Affected
2
num At Risk
52
num Events
2
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
3
num At Risk
196
num Events
4
group Id
EG001
num Affected
1
num At Risk
198
num Events
1
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 25.0
stats
group Id
EG000
num Affected
0
num At Risk
196
num Events
0
group Id
EG001
num Affected
1
num At Risk
198
num Events
1
group Id
EG002
num Affected
0
num At Risk
52
num Events
0
group Id
EG003
num Affected
0
num At Risk
57
num Events
0
term
Atrioventricular block complete

time Frame

From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).

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

Preserved source evidence · Not medical advice