NCT04975308 · ADVERSE EVENTS

Adverse events

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer · Source last updated 2026-07-22

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: Baseline up to 28 months
Other-event reporting threshold: 5%

Adverse events were reported for the "Safety Analysis Population."

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A: Imlunestrant Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.	46 / 327	250 / 327	62 / 327
Arm B: Investigator's Choice of Endocrine Therapy - Exemestane This group includes Arm B participants for whom the Investigator's Choice of Endocrine Therapy was Exemestane. Participants received exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle until disease progression or a criterion for discontinuation was met.	6 / 32	26 / 32	8 / 32
Arm B: Investigator's Choice of Endocrine Therapy - Fulvestrant This group includes Arm B participants for whom the Investigator's Choice of Endocrine Therapy was Fulvestrant. Participants received Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.	49 / 292	229 / 292	82 / 292
Arm C: Imlunestrant + Abemaciclib Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.	42 / 208	203 / 208	36 / 208

Group identifiers: EG000: Arm A: Imlunestrant · EG001: Arm B: Investigator's Choice of Endocrine Therapy - Exemestane · EG002: Arm B: Investigator's Choice of Endocrine Therapy - Fulvestrant · EG003: Arm C: Imlunestrant + Abemaciclib

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 27.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
2
num At Risk
292
num Events
2
group Id
EG003
num Affected
2
num At Risk
208
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
292
num Events
0
group Id
EG003
num Affected
1
num At Risk
208
num Events
1
term
Cytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
292
num Events
2
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
2
num At Risk
292
num Events
2
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
292
num Events
1
group Id
EG003
num Affected
1
num At Risk
208
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
292
num Events
1
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
292
num Events
0
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
327
num Events
2
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
292
num Events
0
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
2
num At Risk
292
num Events
2
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
292
num Events
1
group Id
EG003
num Affected
1
num At Risk
208
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
292
num Events
0
group Id
EG003
num Affected
1
num At Risk
208
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
292
num Events
0
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Right ventricular failure

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 27.0
stats
group Id
EG000
num Affected
38
num At Risk
327
num Events
52
group Id
EG001
num Affected
8
num At Risk
32
num Events
11
group Id
EG002
num Affected
45
num At Risk
292
num Events
62
group Id
EG003
num Affected
91
num At Risk
208
num Events
128
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
7
num At Risk
327
num Events
11
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
7
num At Risk
292
num Events
13
group Id
EG003
num Affected
22
num At Risk
208
num Events
32
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
10
num At Risk
327
num Events
13
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
5
num At Risk
292
num Events
5
group Id
EG003
num Affected
55
num At Risk
208
num Events
111
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
6
num At Risk
327
num Events
8
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
8
num At Risk
292
num Events
8
group Id
EG003
num Affected
20
num At Risk
208
num Events
23
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
20
num At Risk
327
num Events
21
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
10
num At Risk
292
num Events
12
group Id
EG003
num Affected
26
num At Risk
208
num Events
32
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
12
num At Risk
327
num Events
14
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
5
num At Risk
292
num Events
5
group Id
EG003
num Affected
17
num At Risk
208
num Events
21
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
35
num At Risk
327
num Events
38
group Id
EG001
num Affected
3
num At Risk
32
num Events
3
group Id
EG002
num Affected
19
num At Risk
292
num Events
22
group Id
EG003
num Affected
15
num At Risk
208
num Events
16
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
71
num At Risk
327
num Events
101
group Id
EG001
num Affected
3
num At Risk
32
num Events
3
group Id
EG002
num Affected
37
num At Risk
292
num Events
41
group Id
EG003
num Affected
180
num At Risk
208
num Events
372
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
59
num At Risk
327
num Events
74
group Id
EG001
num Affected
4
num At Risk
32
num Events
4
group Id
EG002
num Affected
39
num At Risk
292
num Events
45
group Id
EG003
num Affected
104
num At Risk
208
num Events
144
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
31
num At Risk
327
num Events
44
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
15
num At Risk
292
num Events
17
group Id
EG003
num Affected
66
num At Risk
208
num Events
112
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
33
num At Risk
327
num Events
39
group Id
EG001
num Affected
5
num At Risk
32
num Events
5
group Id
EG002
num Affected
21
num At Risk
292
num Events
23
group Id
EG003
num Affected
35
num At Risk
208
num Events
46
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
45
num At Risk
327
num Events
48
group Id
EG001
num Affected
2
num At Risk
32
num Events
2
group Id
EG002
num Affected
19
num At Risk
292
num Events
19
group Id
EG003
num Affected
46
num At Risk
208
num Events
59
term
Fatigue

Complete source fields

description

Adverse events were reported for the "Safety Analysis Population."

event Groups

deaths Num Affected
62
deaths Num At Risk
327
description
Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
id
EG000
other Num Affected
250
other Num At Risk
327
serious Num Affected
46
serious Num At Risk
327
title
Arm A: Imlunestrant
deaths Num Affected
8
deaths Num At Risk
32
description
This group includes Arm B participants for whom the Investigator's Choice of Endocrine Therapy was Exemestane. Participants received exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle until disease progression or a criterion for discontinuation was met.
id
EG001
other Num Affected
26
other Num At Risk
32
serious Num Affected
6
serious Num At Risk
32
title
Arm B: Investigator's Choice of Endocrine Therapy - Exemestane
deaths Num Affected
82
deaths Num At Risk
292
description
This group includes Arm B participants for whom the Investigator's Choice of Endocrine Therapy was Fulvestrant. Participants received Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.
id
EG002
other Num Affected
229
other Num At Risk
292
serious Num Affected
49
serious Num At Risk
292
title
Arm B: Investigator's Choice of Endocrine Therapy - Fulvestrant
deaths Num Affected
36
deaths Num At Risk
208
description
Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.
id
EG003
other Num Affected
203
other Num At Risk
208
serious Num Affected
42
serious Num At Risk
208
title
Arm C: Imlunestrant + Abemaciclib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
38
num At Risk
327
num Events
52
group Id
EG001
num Affected
8
num At Risk
32
num Events
11
group Id
EG002
num Affected
45
num At Risk
292
num Events
62
group Id
EG003
num Affected
91
num At Risk
208
num Events
128
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
7
num At Risk
327
num Events
11
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
7
num At Risk
292
num Events
13
group Id
EG003
num Affected
22
num At Risk
208
num Events
32
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
10
num At Risk
327
num Events
13
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
5
num At Risk
292
num Events
5
group Id
EG003
num Affected
55
num At Risk
208
num Events
111
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
6
num At Risk
327
num Events
8
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
8
num At Risk
292
num Events
8
group Id
EG003
num Affected
20
num At Risk
208
num Events
23
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
20
num At Risk
327
num Events
21
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
10
num At Risk
292
num Events
12
group Id
EG003
num Affected
26
num At Risk
208
num Events
32
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
12
num At Risk
327
num Events
14
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
5
num At Risk
292
num Events
5
group Id
EG003
num Affected
17
num At Risk
208
num Events
21
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
35
num At Risk
327
num Events
38
group Id
EG001
num Affected
3
num At Risk
32
num Events
3
group Id
EG002
num Affected
19
num At Risk
292
num Events
22
group Id
EG003
num Affected
15
num At Risk
208
num Events
16
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
71
num At Risk
327
num Events
101
group Id
EG001
num Affected
3
num At Risk
32
num Events
3
group Id
EG002
num Affected
37
num At Risk
292
num Events
41
group Id
EG003
num Affected
180
num At Risk
208
num Events
372
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
59
num At Risk
327
num Events
74
group Id
EG001
num Affected
4
num At Risk
32
num Events
4
group Id
EG002
num Affected
39
num At Risk
292
num Events
45
group Id
EG003
num Affected
104
num At Risk
208
num Events
144
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
31
num At Risk
327
num Events
44
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
15
num At Risk
292
num Events
17
group Id
EG003
num Affected
66
num At Risk
208
num Events
112
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
33
num At Risk
327
num Events
39
group Id
EG001
num Affected
5
num At Risk
32
num Events
5
group Id
EG002
num Affected
21
num At Risk
292
num Events
23
group Id
EG003
num Affected
35
num At Risk
208
num Events
46
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
45
num At Risk
327
num Events
48
group Id
EG001
num Affected
2
num At Risk
32
num Events
2
group Id
EG002
num Affected
19
num At Risk
292
num Events
19
group Id
EG003
num Affected
46
num At Risk
208
num Events
59
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
2
num At Risk
292
num Events
2
group Id
EG003
num Affected
2
num At Risk
208
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
292
num Events
0
group Id
EG003
num Affected
1
num At Risk
208
num Events
1
term
Cytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
292
num Events
2
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
2
num At Risk
292
num Events
2
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
292
num Events
1
group Id
EG003
num Affected
1
num At Risk
208
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
292
num Events
1
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
292
num Events
0
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
2
num At Risk
327
num Events
2
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
292
num Events
0
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
1
num At Risk
32
num Events
1
group Id
EG002
num Affected
2
num At Risk
292
num Events
2
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
1
num At Risk
292
num Events
1
group Id
EG003
num Affected
1
num At Risk
208
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
292
num Events
0
group Id
EG003
num Affected
1
num At Risk
208
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
32
num Events
0
group Id
EG002
num Affected
0
num At Risk
292
num Events
0
group Id
EG003
num Affected
0
num At Risk
208
num Events
0
term
Right ventricular failure

time Frame

Baseline up to 28 months

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

Preserved source evidence · Not medical advice