NCT00451958 · ADVERSE EVENTS

Adverse events

A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy · Source last updated 2013-03-21

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 start of CS21A and up to 4.5 years.
Other-event reporting threshold: 5%

The population comprised all participants who were enrolled into CS21A and who received at least one dose of degarelix during the study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Degarelix 80 mg / Degarelix 80 mg The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.	43 / 207	181 / 207	Not reported / Not reported
Degarelix 160 mg / Degarelix 160 mg The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.	60 / 202	177 / 202	Not reported / Not reported
Leuprolide 7.5 mg / Degarelix 80 mg During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.	23 / 69	63 / 69	Not reported / Not reported
Leuprolide 7.5 mg / Degarelix 160 mg During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.	22 / 66	58 / 66	Not reported / Not reported

Group identifiers: EG000: Degarelix 80 mg / Degarelix 80 mg · EG001: Degarelix 160 mg / Degarelix 160 mg · EG002: Leuprolide 7.5 mg / Degarelix 80 mg · EG003: Leuprolide 7.5 mg / Degarelix 160 mg

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 14.0
stats
group Id
EG000
num Affected
1
num At Risk
207
group Id
EG001
num Affected
5
num At Risk
202
group Id
EG002
num Affected
1
num At Risk
69
group Id
EG003
num Affected
1
num At Risk
66
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
207
group Id
EG001
num Affected
1
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
1
num At Risk
66
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
207
group Id
EG001
num Affected
0
num At Risk
202
group Id
EG002
num Affected
1
num At Risk
69
group Id
EG003
num Affected
0
num At Risk
66
term
Retroperitoneal lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
3
num At Risk
207
group Id
EG001
num Affected
1
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
2
num At Risk
66
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
207
group Id
EG001
num Affected
1
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
1
num At Risk
66
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
207
group Id
EG001
num Affected
2
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
1
num At Risk
66
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
207
group Id
EG001
num Affected
1
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
0
num At Risk
66
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
207
group Id
EG001
num Affected
1
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
1
num At Risk
66
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
207
group Id
EG001
num Affected
0
num At Risk
202
group Id
EG002
num Affected
1
num At Risk
69
group Id
EG003
num Affected
1
num At Risk
66
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
207
group Id
EG001
num Affected
0
num At Risk
202
group Id
EG002
num Affected
2
num At Risk
69
group Id
EG003
num Affected
0
num At Risk
66
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
207
group Id
EG001
num Affected
2
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
0
num At Risk
66
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
207
group Id
EG001
num Affected
1
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
0
num At Risk
66
term
Angina pectoris

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 14.0
stats
group Id
EG000
num Affected
17
num At Risk
207
group Id
EG001
num Affected
18
num At Risk
202
group Id
EG002
num Affected
10
num At Risk
69
group Id
EG003
num Affected
6
num At Risk
66
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
207
group Id
EG001
num Affected
6
num At Risk
202
group Id
EG002
num Affected
4
num At Risk
69
group Id
EG003
num Affected
4
num At Risk
66
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
207
group Id
EG001
num Affected
4
num At Risk
202
group Id
EG002
num Affected
1
num At Risk
69
group Id
EG003
num Affected
6
num At Risk
66
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
17
num At Risk
207
group Id
EG001
num Affected
13
num At Risk
202
group Id
EG002
num Affected
12
num At Risk
69
group Id
EG003
num Affected
10
num At Risk
66
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
18
num At Risk
207
group Id
EG001
num Affected
12
num At Risk
202
group Id
EG002
num Affected
9
num At Risk
69
group Id
EG003
num Affected
2
num At Risk
66
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
10
num At Risk
207
group Id
EG001
num Affected
15
num At Risk
202
group Id
EG002
num Affected
3
num At Risk
69
group Id
EG003
num Affected
6
num At Risk
66
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
4
num At Risk
207
group Id
EG001
num Affected
7
num At Risk
202
group Id
EG002
num Affected
6
num At Risk
69
group Id
EG003
num Affected
3
num At Risk
66
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
65
num At Risk
207
group Id
EG001
num Affected
67
num At Risk
202
group Id
EG002
num Affected
20
num At Risk
69
group Id
EG003
num Affected
16
num At Risk
66
term
Injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
40
num At Risk
207
group Id
EG001
num Affected
51
num At Risk
202
group Id
EG002
num Affected
10
num At Risk
69
group Id
EG003
num Affected
16
num At Risk
66
term
Injection site erythema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
20
num At Risk
207
group Id
EG001
num Affected
22
num At Risk
202
group Id
EG002
num Affected
8
num At Risk
69
group Id
EG003
num Affected
9
num At Risk
66
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
17
num At Risk
207
group Id
EG001
num Affected
16
num At Risk
202
group Id
EG002
num Affected
6
num At Risk
69
group Id
EG003
num Affected
4
num At Risk
66
term
Injection site swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
12
num At Risk
207
group Id
EG001
num Affected
15
num At Risk
202
group Id
EG002
num Affected
9
num At Risk
69
group Id
EG003
num Affected
6
num At Risk
66
term
Fatigue

Complete source fields

description

The population comprised all participants who were enrolled into CS21A and who received at least one dose of degarelix during the study.

event Groups

description
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
id
EG000
other Num Affected
181
other Num At Risk
207
serious Num Affected
43
serious Num At Risk
207
title
Degarelix 80 mg / Degarelix 80 mg
description
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
id
EG001
other Num Affected
177
other Num At Risk
202
serious Num Affected
60
serious Num At Risk
202
title
Degarelix 160 mg / Degarelix 160 mg
description
During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
id
EG002
other Num Affected
63
other Num At Risk
69
serious Num Affected
23
serious Num At Risk
69
title
Leuprolide 7.5 mg / Degarelix 80 mg
description
During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
id
EG003
other Num Affected
58
other Num At Risk
66
serious Num Affected
22
serious Num At Risk
66
title
Leuprolide 7.5 mg / Degarelix 160 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
17
num At Risk
207
group Id
EG001
num Affected
18
num At Risk
202
group Id
EG002
num Affected
10
num At Risk
69
group Id
EG003
num Affected
6
num At Risk
66
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
207
group Id
EG001
num Affected
6
num At Risk
202
group Id
EG002
num Affected
4
num At Risk
69
group Id
EG003
num Affected
4
num At Risk
66
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
207
group Id
EG001
num Affected
4
num At Risk
202
group Id
EG002
num Affected
1
num At Risk
69
group Id
EG003
num Affected
6
num At Risk
66
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
17
num At Risk
207
group Id
EG001
num Affected
13
num At Risk
202
group Id
EG002
num Affected
12
num At Risk
69
group Id
EG003
num Affected
10
num At Risk
66
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
18
num At Risk
207
group Id
EG001
num Affected
12
num At Risk
202
group Id
EG002
num Affected
9
num At Risk
69
group Id
EG003
num Affected
2
num At Risk
66
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
10
num At Risk
207
group Id
EG001
num Affected
15
num At Risk
202
group Id
EG002
num Affected
3
num At Risk
69
group Id
EG003
num Affected
6
num At Risk
66
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
4
num At Risk
207
group Id
EG001
num Affected
7
num At Risk
202
group Id
EG002
num Affected
6
num At Risk
69
group Id
EG003
num Affected
3
num At Risk
66
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
65
num At Risk
207
group Id
EG001
num Affected
67
num At Risk
202
group Id
EG002
num Affected
20
num At Risk
69
group Id
EG003
num Affected
16
num At Risk
66
term
Injection site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
40
num At Risk
207
group Id
EG001
num Affected
51
num At Risk
202
group Id
EG002
num Affected
10
num At Risk
69
group Id
EG003
num Affected
16
num At Risk
66
term
Injection site erythema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
20
num At Risk
207
group Id
EG001
num Affected
22
num At Risk
202
group Id
EG002
num Affected
8
num At Risk
69
group Id
EG003
num Affected
9
num At Risk
66
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
17
num At Risk
207
group Id
EG001
num Affected
16
num At Risk
202
group Id
EG002
num Affected
6
num At Risk
69
group Id
EG003
num Affected
4
num At Risk
66
term
Injection site swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
12
num At Risk
207
group Id
EG001
num Affected
15
num At Risk
202
group Id
EG002
num Affected
9
num At Risk
69
group Id
EG003
num Affected
6
num At Risk
66
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
207
group Id
EG001
num Affected
5
num At Risk
202
group Id
EG002
num Affected
1
num At Risk
69
group Id
EG003
num Affected
1
num At Risk
66
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
207
group Id
EG001
num Affected
1
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
1
num At Risk
66
term
Anaemia of malignant disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
207
group Id
EG001
num Affected
0
num At Risk
202
group Id
EG002
num Affected
1
num At Risk
69
group Id
EG003
num Affected
0
num At Risk
66
term
Retroperitoneal lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
3
num At Risk
207
group Id
EG001
num Affected
1
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
2
num At Risk
66
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
207
group Id
EG001
num Affected
1
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
1
num At Risk
66
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
207
group Id
EG001
num Affected
2
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
1
num At Risk
66
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
207
group Id
EG001
num Affected
1
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
0
num At Risk
66
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
207
group Id
EG001
num Affected
1
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
1
num At Risk
66
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
207
group Id
EG001
num Affected
0
num At Risk
202
group Id
EG002
num Affected
1
num At Risk
69
group Id
EG003
num Affected
1
num At Risk
66
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
207
group Id
EG001
num Affected
0
num At Risk
202
group Id
EG002
num Affected
2
num At Risk
69
group Id
EG003
num Affected
0
num At Risk
66
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
207
group Id
EG001
num Affected
2
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
0
num At Risk
66
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
0
num At Risk
207
group Id
EG001
num Affected
1
num At Risk
202
group Id
EG002
num Affected
0
num At Risk
69
group Id
EG003
num Affected
0
num At Risk
66
term
Angina pectoris

time Frame

From start of CS21A and up to 4.5 years.

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

Preserved source evidence · Not medical advice