NCT02294461 · ADVERSE EVENTS

Adverse events

An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants · Source last updated 2025-10-24

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: All cause mortality: From the date of randomization up to 123 months and 24 days AE: From first dose on Day 1 until 28 days after the last dose of study drug, or one day before the date of initiation of cytotoxic chemotherapy or an investigational agent for treatment of prostate cancer, whichever comes first, up to 123 months and 24 days
Other-event reporting threshold: 5%

Data reported for deaths are the number of participants who died regardless of time (could be beyond treatment emergent adverse event time frame).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Enzalutamide Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months).	87 / 202	169 / 202	85 / 202
Placebo Participants received enzalutamide matching placebo orally once a day during DB period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months).	57 / 193	125 / 193	57 / 193
Placebo Patients Crossover to Enzalutamide 160 mg Eligible participants who received enzalutamide matching placebo during DB period and who provided consent to take part in OLP, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months).	24 / 51	31 / 51	21 / 51

Group identifiers: EG000: Enzalutamide · EG001: Placebo · EG002: Placebo Patients Crossover to Enzalutamide 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 v23.0
stats
group Id
EG000
num Affected
4
num At Risk
202
num Events
6
group Id
EG001
num Affected
4
num At Risk
193
num Events
4
group Id
EG002
num Affected
1
num At Risk
51
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
1
num At Risk
193
num Events
1
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
202
num Events
0
group Id
EG001
num Affected
1
num At Risk
193
num Events
2
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
202
num Events
0
group Id
EG001
num Affected
1
num At Risk
193
num Events
1
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Arteriosclerosis coronary artery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
5
num At Risk
202
num Events
5
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
1
num At Risk
51
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Cardiac failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
2
num At Risk
202
num Events
2
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Cardiopulmonary 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 v23.0
stats
group Id
EG000
num Affected
30
num At Risk
202
num Events
45
group Id
EG001
num Affected
16
num At Risk
193
num Events
25
group Id
EG002
num Affected
10
num At Risk
51
num Events
13
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
27
num At Risk
202
num Events
31
group Id
EG001
num Affected
15
num At Risk
193
num Events
15
group Id
EG002
num Affected
3
num At Risk
51
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
8
num At Risk
202
num Events
12
group Id
EG001
num Affected
4
num At Risk
193
num Events
5
group Id
EG002
num Affected
4
num At Risk
51
num Events
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
23
num At Risk
202
num Events
32
group Id
EG001
num Affected
11
num At Risk
193
num Events
12
group Id
EG002
num Affected
2
num At Risk
51
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
11
num At Risk
202
num Events
11
group Id
EG001
num Affected
7
num At Risk
193
num Events
8
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
11
num At Risk
202
num Events
13
group Id
EG001
num Affected
7
num At Risk
193
num Events
7
group Id
EG002
num Affected
2
num At Risk
51
num Events
2
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
29
num At Risk
202
num Events
36
group Id
EG001
num Affected
15
num At Risk
193
num Events
20
group Id
EG002
num Affected
3
num At Risk
51
num Events
4
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
14
num At Risk
202
num Events
20
group Id
EG001
num Affected
6
num At Risk
193
num Events
8
group Id
EG002
num Affected
4
num At Risk
51
num Events
7
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
12
num At Risk
202
num Events
13
group Id
EG001
num Affected
11
num At Risk
193
num Events
14
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
22
num At Risk
202
num Events
28
group Id
EG001
num Affected
7
num At Risk
193
num Events
7
group Id
EG002
num Affected
3
num At Risk
51
num Events
3
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
5
num At Risk
202
num Events
12
group Id
EG001
num Affected
1
num At Risk
193
num Events
1
group Id
EG002
num Affected
3
num At Risk
51
num Events
3
term
Periodontitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
13
num At Risk
202
num Events
19
group Id
EG001
num Affected
5
num At Risk
193
num Events
5
group Id
EG002
num Affected
6
num At Risk
51
num Events
6
term
Upper respiratory tract infection

Complete source fields

description

Data reported for deaths are the number of participants who died regardless of time (could be beyond treatment emergent adverse event time frame).

event Groups

deaths Num Affected
85
deaths Num At Risk
202
description
Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months).
id
EG000
other Num Affected
169
other Num At Risk
202
serious Num Affected
87
serious Num At Risk
202
title
Enzalutamide
deaths Num Affected
57
deaths Num At Risk
193
description
Participants received enzalutamide matching placebo orally once a day during DB period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months).
id
EG001
other Num Affected
125
other Num At Risk
193
serious Num Affected
57
serious Num At Risk
193
title
Placebo
deaths Num Affected
21
deaths Num At Risk
51
description
Eligible participants who received enzalutamide matching placebo during DB period and who provided consent to take part in OLP, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months).
id
EG002
other Num Affected
31
other Num At Risk
51
serious Num Affected
24
serious Num At Risk
51
title
Placebo Patients Crossover to Enzalutamide 160 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
30
num At Risk
202
num Events
45
group Id
EG001
num Affected
16
num At Risk
193
num Events
25
group Id
EG002
num Affected
10
num At Risk
51
num Events
13
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
27
num At Risk
202
num Events
31
group Id
EG001
num Affected
15
num At Risk
193
num Events
15
group Id
EG002
num Affected
3
num At Risk
51
num Events
3
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
8
num At Risk
202
num Events
12
group Id
EG001
num Affected
4
num At Risk
193
num Events
5
group Id
EG002
num Affected
4
num At Risk
51
num Events
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
23
num At Risk
202
num Events
32
group Id
EG001
num Affected
11
num At Risk
193
num Events
12
group Id
EG002
num Affected
2
num At Risk
51
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
11
num At Risk
202
num Events
11
group Id
EG001
num Affected
7
num At Risk
193
num Events
8
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
11
num At Risk
202
num Events
13
group Id
EG001
num Affected
7
num At Risk
193
num Events
7
group Id
EG002
num Affected
2
num At Risk
51
num Events
2
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
29
num At Risk
202
num Events
36
group Id
EG001
num Affected
15
num At Risk
193
num Events
20
group Id
EG002
num Affected
3
num At Risk
51
num Events
4
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
14
num At Risk
202
num Events
20
group Id
EG001
num Affected
6
num At Risk
193
num Events
8
group Id
EG002
num Affected
4
num At Risk
51
num Events
7
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
12
num At Risk
202
num Events
13
group Id
EG001
num Affected
11
num At Risk
193
num Events
14
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
22
num At Risk
202
num Events
28
group Id
EG001
num Affected
7
num At Risk
193
num Events
7
group Id
EG002
num Affected
3
num At Risk
51
num Events
3
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
5
num At Risk
202
num Events
12
group Id
EG001
num Affected
1
num At Risk
193
num Events
1
group Id
EG002
num Affected
3
num At Risk
51
num Events
3
term
Periodontitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
13
num At Risk
202
num Events
19
group Id
EG001
num Affected
5
num At Risk
193
num Events
5
group Id
EG002
num Affected
6
num At Risk
51
num Events
6
term
Upper respiratory tract infection

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
4
num At Risk
202
num Events
6
group Id
EG001
num Affected
4
num At Risk
193
num Events
4
group Id
EG002
num Affected
1
num At Risk
51
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
1
num At Risk
193
num Events
1
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
202
num Events
0
group Id
EG001
num Affected
1
num At Risk
193
num Events
2
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
0
num At Risk
202
num Events
0
group Id
EG001
num Affected
1
num At Risk
193
num Events
1
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Arteriosclerosis coronary artery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
5
num At Risk
202
num Events
5
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
1
num At Risk
51
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
1
num At Risk
202
num Events
1
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Cardiac failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v23.0
stats
group Id
EG000
num Affected
2
num At Risk
202
num Events
2
group Id
EG001
num Affected
0
num At Risk
193
num Events
0
group Id
EG002
num Affected
0
num At Risk
51
num Events
0
term
Cardiopulmonary failure

time Frame

All cause mortality: From the date of randomization up to 123 months and 24 days AE: From first dose on Day 1 until 28 days after the last dose of study drug, or one day before the date of initiation of cytotoxic chemotherapy or an investigational agent for treatment of prostate cancer, whichever comes first, up to 123 months and 24 days

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Preserved source evidence · Not medical advice