NCT01946204 · ADVERSE EVENTS

Adverse events

A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer · Source last updated 2026-08-31

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: Up to approximately 43 months
Other-event reporting threshold: 5%

Safety population included all participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.	92 / 398	329 / 398	1 / 398
Apalutamide Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.	199 / 803	716 / 803	10 / 803

Group identifiers: EG000: Placebo · EG001: Apalutamide

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 Version 19.1
stats
group Id
EG000
num Affected
2
num At Risk
398
group Id
EG001
num Affected
2
num At Risk
803
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
398
group Id
EG001
num Affected
0
num At Risk
803
term
Haemolytic Uraemic Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
398
group Id
EG001
num Affected
2
num At Risk
803
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Acute Coronary Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Acute Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Angina Unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Aortic Valve Incompetence
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
2
num At Risk
398
group Id
EG001
num Affected
7
num At Risk
803
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Atrial Flutter

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 Version 19.1
stats
group Id
EG000
num Affected
15
num At Risk
398
group Id
EG001
num Affected
51
num At Risk
803
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
5
num At Risk
398
group Id
EG001
num Affected
48
num At Risk
803
term
Hypothyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
22
num At Risk
398
group Id
EG001
num Affected
37
num At Risk
803
term
Abdominal Discomfort
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
33
num At Risk
398
group Id
EG001
num Affected
64
num At Risk
803
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
32
num At Risk
398
group Id
EG001
num Affected
44
num At Risk
803
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
52
num At Risk
398
group Id
EG001
num Affected
87
num At Risk
803
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
60
num At Risk
398
group Id
EG001
num Affected
159
num At Risk
803
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
22
num At Risk
398
group Id
EG001
num Affected
58
num At Risk
803
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
63
num At Risk
398
group Id
EG001
num Affected
145
num At Risk
803
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
24
num At Risk
398
group Id
EG001
num Affected
43
num At Risk
803
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
33
num At Risk
398
group Id
EG001
num Affected
89
num At Risk
803
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
84
num At Risk
398
group Id
EG001
num Affected
244
num At Risk
803
term
Fatigue

Complete source fields

description

Safety population included all participants who received at least one dose of study drug.

event Groups

deaths Num Affected
1
deaths Num At Risk
398
description
Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
id
EG000
other Num Affected
329
other Num At Risk
398
serious Num Affected
92
serious Num At Risk
398
title
Placebo
deaths Num Affected
10
deaths Num At Risk
803
description
Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
id
EG001
other Num Affected
716
other Num At Risk
803
serious Num Affected
199
serious Num At Risk
803
title
Apalutamide

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
15
num At Risk
398
group Id
EG001
num Affected
51
num At Risk
803
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
5
num At Risk
398
group Id
EG001
num Affected
48
num At Risk
803
term
Hypothyroidism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
22
num At Risk
398
group Id
EG001
num Affected
37
num At Risk
803
term
Abdominal Discomfort
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
33
num At Risk
398
group Id
EG001
num Affected
64
num At Risk
803
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
32
num At Risk
398
group Id
EG001
num Affected
44
num At Risk
803
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
52
num At Risk
398
group Id
EG001
num Affected
87
num At Risk
803
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
60
num At Risk
398
group Id
EG001
num Affected
159
num At Risk
803
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
22
num At Risk
398
group Id
EG001
num Affected
58
num At Risk
803
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
63
num At Risk
398
group Id
EG001
num Affected
145
num At Risk
803
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
24
num At Risk
398
group Id
EG001
num Affected
43
num At Risk
803
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
33
num At Risk
398
group Id
EG001
num Affected
89
num At Risk
803
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
84
num At Risk
398
group Id
EG001
num Affected
244
num At Risk
803
term
Fatigue

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
2
num At Risk
398
group Id
EG001
num Affected
2
num At Risk
803
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
398
group Id
EG001
num Affected
0
num At Risk
803
term
Haemolytic Uraemic Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
398
group Id
EG001
num Affected
2
num At Risk
803
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Acute Coronary Syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Acute Myocardial Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Angina Pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Angina Unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Aortic Valve Incompetence
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
2
num At Risk
398
group Id
EG001
num Affected
7
num At Risk
803
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
398
group Id
EG001
num Affected
1
num At Risk
803
term
Atrial Flutter

time Frame

Up to approximately 43 months

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

Preserved source evidence · Not medical advice