NCT02319837 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) · Source last updated 2026-07-09

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 treatment-emergent safety reporting period was from the first dose of study treatment on Day 1 through a minimum of 30 days after the last dose of study treatment, or the start day of new antineoplastic drug therapy minus 1 day (up to 98 months). For all-cause mortality, deaths as of the PCD data cutoff include deaths occuring during and after the treatment-emergent safety reporting period.
Other-event reporting threshold: 5%

For all-cause mortality, ITT population was used for analysis, which included all participants randomly assigned to treatment. For serious adverse events and other adverse events, safety population was used for analysis, which included all randomized participants who received at least 1 dose of any study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Enzalutamide + Leuprolide Participants were randomized to receive enzalutamide capsules 160 milligrams (mg)/day, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory prostate-specific antigen (PSA) evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.	123 / 353	339 / 353	33 / 355
Placebo + Leuprolide Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.	112 / 354	341 / 354	55 / 358
Enzalutamide Monotherapy Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.	131 / 354	345 / 354	42 / 355

Group identifiers: EG000: Enzalutamide + Leuprolide · EG001: Placebo + Leuprolide · EG002: Enzalutamide Monotherapy

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
1
num At Risk
354
group Id
EG002
num Affected
1
num At Risk
354
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
354
group Id
EG002
num Affected
0
num At Risk
354
term
Blood loss anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
1
num At Risk
354
group Id
EG002
num Affected
0
num At Risk
354
term
Lymphadenopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
1
num At Risk
354
group Id
EG002
num Affected
0
num At Risk
354
term
Splenic embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
1
num At Risk
354
group Id
EG002
num Affected
0
num At Risk
354
term
Splenic infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
3
num At Risk
353
group Id
EG001
num Affected
1
num At Risk
354
group Id
EG002
num Affected
1
num At Risk
354
term
Acute coronary syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
353
group Id
EG001
num Affected
4
num At Risk
354
group Id
EG002
num Affected
3
num At Risk
354
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
3
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
354
group Id
EG002
num Affected
4
num At Risk
354
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
354
group Id
EG002
num Affected
0
num At Risk
354
term
Angina unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
354
group Id
EG002
num Affected
1
num At Risk
354
term
Aortic valve disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
354
group Id
EG002
num Affected
0
num At Risk
354
term
Aortic valve stenosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
4
num At Risk
353
group Id
EG001
num Affected
3
num At Risk
354
group Id
EG002
num Affected
1
num At Risk
354
term
Atrial fibrillation

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 25.1
stats
group Id
EG000
num Affected
24
num At Risk
353
group Id
EG001
num Affected
11
num At Risk
354
group Id
EG002
num Affected
17
num At Risk
354
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
17
num At Risk
353
group Id
EG001
num Affected
20
num At Risk
354
group Id
EG002
num Affected
22
num At Risk
354
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
39
num At Risk
353
group Id
EG001
num Affected
21
num At Risk
354
group Id
EG002
num Affected
39
num At Risk
354
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
151
num At Risk
353
group Id
EG001
num Affected
116
num At Risk
354
group Id
EG002
num Affected
165
num At Risk
354
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
27
num At Risk
353
group Id
EG001
num Affected
36
num At Risk
354
group Id
EG002
num Affected
31
num At Risk
354
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
46
num At Risk
353
group Id
EG001
num Affected
31
num At Risk
354
group Id
EG002
num Affected
33
num At Risk
354
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
49
num At Risk
353
group Id
EG001
num Affected
30
num At Risk
354
group Id
EG002
num Affected
46
num At Risk
354
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
7
num At Risk
353
group Id
EG001
num Affected
9
num At Risk
354
group Id
EG002
num Affected
20
num At Risk
354
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
42
num At Risk
353
group Id
EG001
num Affected
29
num At Risk
354
group Id
EG002
num Affected
53
num At Risk
354
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
19
num At Risk
353
group Id
EG001
num Affected
12
num At Risk
354
group Id
EG002
num Affected
10
num At Risk
354
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
25
num At Risk
353
group Id
EG001
num Affected
34
num At Risk
354
group Id
EG002
num Affected
42
num At Risk
354
term
COVID-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
25
num At Risk
353
group Id
EG001
num Affected
22
num At Risk
354
group Id
EG002
num Affected
31
num At Risk
354
term
Nasopharyngitis

Complete source fields

description

event Groups

deaths Num Affected
33
deaths Num At Risk
355
description
Participants were randomized to receive enzalutamide capsules 160 milligrams (mg)/day, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory prostate-specific antigen (PSA) evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
id
EG000
other Num Affected
339
other Num At Risk
353
serious Num Affected
123
serious Num At Risk
353
title
Enzalutamide + Leuprolide
deaths Num Affected
55
deaths Num At Risk
358
description
Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
id
EG001
other Num Affected
341
other Num At Risk
354
serious Num Affected
112
serious Num At Risk
354
title
Placebo + Leuprolide
deaths Num Affected
42
deaths Num At Risk
355
description
Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
id
EG002
other Num Affected
345
other Num At Risk
354
serious Num Affected
131
serious Num At Risk
354
title
Enzalutamide Monotherapy

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
24
num At Risk
353
group Id
EG001
num Affected
11
num At Risk
354
group Id
EG002
num Affected
17
num At Risk
354
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
17
num At Risk
353
group Id
EG001
num Affected
20
num At Risk
354
group Id
EG002
num Affected
22
num At Risk
354
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
39
num At Risk
353
group Id
EG001
num Affected
21
num At Risk
354
group Id
EG002
num Affected
39
num At Risk
354
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
151
num At Risk
353
group Id
EG001
num Affected
116
num At Risk
354
group Id
EG002
num Affected
165
num At Risk
354
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
27
num At Risk
353
group Id
EG001
num Affected
36
num At Risk
354
group Id
EG002
num Affected
31
num At Risk
354
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
46
num At Risk
353
group Id
EG001
num Affected
31
num At Risk
354
group Id
EG002
num Affected
33
num At Risk
354
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
49
num At Risk
353
group Id
EG001
num Affected
30
num At Risk
354
group Id
EG002
num Affected
46
num At Risk
354
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
7
num At Risk
353
group Id
EG001
num Affected
9
num At Risk
354
group Id
EG002
num Affected
20
num At Risk
354
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
42
num At Risk
353
group Id
EG001
num Affected
29
num At Risk
354
group Id
EG002
num Affected
53
num At Risk
354
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
19
num At Risk
353
group Id
EG001
num Affected
12
num At Risk
354
group Id
EG002
num Affected
10
num At Risk
354
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
25
num At Risk
353
group Id
EG001
num Affected
34
num At Risk
354
group Id
EG002
num Affected
42
num At Risk
354
term
COVID-19
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
25
num At Risk
353
group Id
EG001
num Affected
22
num At Risk
354
group Id
EG002
num Affected
31
num At Risk
354
term
Nasopharyngitis

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
1
num At Risk
354
group Id
EG002
num Affected
1
num At Risk
354
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
354
group Id
EG002
num Affected
0
num At Risk
354
term
Blood loss anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
1
num At Risk
354
group Id
EG002
num Affected
0
num At Risk
354
term
Lymphadenopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
1
num At Risk
354
group Id
EG002
num Affected
0
num At Risk
354
term
Splenic embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
1
num At Risk
354
group Id
EG002
num Affected
0
num At Risk
354
term
Splenic infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
3
num At Risk
353
group Id
EG001
num Affected
1
num At Risk
354
group Id
EG002
num Affected
1
num At Risk
354
term
Acute coronary syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
353
group Id
EG001
num Affected
4
num At Risk
354
group Id
EG002
num Affected
3
num At Risk
354
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
3
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
354
group Id
EG002
num Affected
4
num At Risk
354
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
354
group Id
EG002
num Affected
0
num At Risk
354
term
Angina unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
354
group Id
EG002
num Affected
1
num At Risk
354
term
Aortic valve disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
354
group Id
EG002
num Affected
0
num At Risk
354
term
Aortic valve stenosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
4
num At Risk
353
group Id
EG001
num Affected
3
num At Risk
354
group Id
EG002
num Affected
1
num At Risk
354
term
Atrial fibrillation

time Frame

The treatment-emergent safety reporting period was from the first dose of study treatment on Day 1 through a minimum of 30 days after the last dose of study treatment, or the start day of new antineoplastic drug therapy minus 1 day (up to 98 months). For all-cause mortality, deaths as of the PCD data cutoff include deaths occuring during and after the treatment-emergent safety reporting period.

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