NCT03085095 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer · Source last updated 2022-01-18

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: Day 1 (after dosing) through up to 52 weeks
Other-event reporting threshold: 5%

All randomized participants who received at least 1 dose of study drug in the primary analysis part of the study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Relugolix Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.	76 / 622	493 / 622	7 / 622
Leuprolide Acetate Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, and Taiwan), every 3 months by subcutaneous injection.	47 / 308	239 / 308	9 / 308

Group identifiers: EG000: Relugolix · EG001: Leuprolide Acetate

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
22.0
stats
group Id
EG000
num Affected
0
num At Risk
622
group Id
EG001
num Affected
3
num At Risk
308
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
0
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
5
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
2
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
0
num At Risk
308
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
0
num At Risk
308
term
Aortic valve stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
0
num At Risk
308
term
Atrioventricular block complete
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
0
num At Risk
308
term
Atrioventricular block second degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
0
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Angina unstable

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
Gastrointestinal disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
76
num At Risk
622
group Id
EG001
num Affected
30
num At Risk
308
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
76
num At Risk
622
group Id
EG001
num Affected
21
num At Risk
308
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
36
num At Risk
622
group Id
EG001
num Affected
13
num At Risk
308
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
32
num At Risk
622
group Id
EG001
num Affected
21
num At Risk
308
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
134
num At Risk
622
group Id
EG001
num Affected
57
num At Risk
308
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
22.0
stats
group Id
EG000
num Affected
59
num At Risk
622
group Id
EG001
num Affected
29
num At Risk
308
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
22.0
stats
group Id
EG000
num Affected
49
num At Risk
622
group Id
EG001
num Affected
20
num At Risk
308
term
Weight increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
75
num At Risk
622
group Id
EG001
num Affected
28
num At Risk
308
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
50
num At Risk
622
group Id
EG001
num Affected
28
num At Risk
308
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
32
num At Risk
622
group Id
EG001
num Affected
19
num At Risk
308
term
Pain in extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
35
num At Risk
622
group Id
EG001
num Affected
17
num At Risk
308
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
35
num At Risk
622
group Id
EG001
num Affected
13
num At Risk
308
term
Headache

Complete source fields

description

All randomized participants who received at least 1 dose of study drug in the primary analysis part of the study.

event Groups

deaths Num Affected
7
deaths Num At Risk
622
description
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
id
EG000
other Num Affected
493
other Num At Risk
622
serious Num Affected
76
serious Num At Risk
622
title
Relugolix
deaths Num Affected
9
deaths Num At Risk
308
description
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, and Taiwan), every 3 months by subcutaneous injection.
id
EG001
other Num Affected
239
other Num At Risk
308
serious Num Affected
47
serious Num At Risk
308
title
Leuprolide Acetate

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
76
num At Risk
622
group Id
EG001
num Affected
30
num At Risk
308
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
76
num At Risk
622
group Id
EG001
num Affected
21
num At Risk
308
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
36
num At Risk
622
group Id
EG001
num Affected
13
num At Risk
308
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
32
num At Risk
622
group Id
EG001
num Affected
21
num At Risk
308
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
134
num At Risk
622
group Id
EG001
num Affected
57
num At Risk
308
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
22.0
stats
group Id
EG000
num Affected
59
num At Risk
622
group Id
EG001
num Affected
29
num At Risk
308
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
22.0
stats
group Id
EG000
num Affected
49
num At Risk
622
group Id
EG001
num Affected
20
num At Risk
308
term
Weight increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
75
num At Risk
622
group Id
EG001
num Affected
28
num At Risk
308
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
50
num At Risk
622
group Id
EG001
num Affected
28
num At Risk
308
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
32
num At Risk
622
group Id
EG001
num Affected
19
num At Risk
308
term
Pain in extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
35
num At Risk
622
group Id
EG001
num Affected
17
num At Risk
308
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
35
num At Risk
622
group Id
EG001
num Affected
13
num At Risk
308
term
Headache

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
0
num At Risk
622
group Id
EG001
num Affected
3
num At Risk
308
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
0
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
5
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
2
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
0
num At Risk
308
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
0
num At Risk
308
term
Aortic valve stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
0
num At Risk
308
term
Atrioventricular block complete
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
0
num At Risk
308
term
Atrioventricular block second degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
1
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
22.0
stats
group Id
EG000
num Affected
0
num At Risk
622
group Id
EG001
num Affected
1
num At Risk
308
term
Angina unstable

time Frame

Day 1 (after dosing) through up to 52 weeks

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Preserved source evidence · Not medical advice