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NCT02003924 · OUTCOME

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer · Source last updated 2026-01-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

What was measured

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 42 are reported. Question 42 was following: "Have you had blood in your stools?"

Analysis population: The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.

Groups in this outcome

Enzalutamide 160 mg

Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.

Placebo

Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	933
Placebo	468

Reported measurements

Baseline: not at all

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	884
Placebo	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	836	Not reported	Not reported	Not reported	Not reported
Placebo	422	Not reported	Not reported	Not reported	Not reported

Baseline: a little

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	884
Placebo	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	48	Not reported	Not reported	Not reported	Not reported
Placebo	17	Not reported	Not reported	Not reported	Not reported

Baseline: quite a bit

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	884
Placebo	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Baseline: very much

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	884
Placebo	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Baseline: not answered

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	884
Placebo	439

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 17: not at all

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	839
Placebo	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	801	Not reported	Not reported	Not reported	Not reported
Placebo	399	Not reported	Not reported	Not reported	Not reported

Week 17: a little

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	839
Placebo	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	36	Not reported	Not reported	Not reported	Not reported
Placebo	18	Not reported	Not reported	Not reported	Not reported

Week 17: quite a bit

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	839
Placebo	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	2	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Week 17: very much

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	839
Placebo	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 17: not answered

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	839
Placebo	419

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 33: not at all

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	737
Placebo	341

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	707	Not reported	Not reported	Not reported	Not reported
Placebo	330	Not reported	Not reported	Not reported	Not reported

Week 33: a little

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	737
Placebo	341

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	29	Not reported	Not reported	Not reported	Not reported
Placebo	11	Not reported	Not reported	Not reported	Not reported

Week 33: quite a bit

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	737
Placebo	341

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	1	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 33: very much

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	737
Placebo	341

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 33: not answered

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	737
Placebo	341

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 49: not at all

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	635
Placebo	250

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	608	Not reported	Not reported	Not reported	Not reported
Placebo	245	Not reported	Not reported	Not reported	Not reported

Week 49: a little

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	635
Placebo	250

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	27	Not reported	Not reported	Not reported	Not reported
Placebo	5	Not reported	Not reported	Not reported	Not reported

Week 49: quite a bit

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	635
Placebo	250

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 49: very much

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	635
Placebo	250

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 49: not answered

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	635
Placebo	250

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 65: not at all

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	536
Placebo	193

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	514	Not reported	Not reported	Not reported	Not reported
Placebo	180	Not reported	Not reported	Not reported	Not reported

Week 65: a little

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	536
Placebo	193

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	19	Not reported	Not reported	Not reported	Not reported
Placebo	13	Not reported	Not reported	Not reported	Not reported

Week 65: quite a bit

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	536
Placebo	193

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	3	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 65: very much

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	536
Placebo	193

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 65: not answered

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	536
Placebo	193

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 81: not at all

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	434
Placebo	148

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	420	Not reported	Not reported	Not reported	Not reported
Placebo	143	Not reported	Not reported	Not reported	Not reported

Week 81: a little

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	434
Placebo	148

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	14	Not reported	Not reported	Not reported	Not reported
Placebo	4	Not reported	Not reported	Not reported	Not reported

Week 81: quite a bit

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	434
Placebo	148

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 81: very much

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	434
Placebo	148

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 81: not answered

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	434
Placebo	148

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 97: not at all

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	365
Placebo	95

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	357	Not reported	Not reported	Not reported	Not reported
Placebo	93	Not reported	Not reported	Not reported	Not reported

Week 97: a little

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	365
Placebo	95

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	8	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Week 97: quite a bit

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	365
Placebo	95

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 97: very much

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	365
Placebo	95

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 97: not answered

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	365
Placebo	95

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 113: not at all

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	275
Placebo	73

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	262	Not reported	Not reported	Not reported	Not reported
Placebo	72	Not reported	Not reported	Not reported	Not reported

Week 113: a little

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	275
Placebo	73

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	13	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 113: quite a bit

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	275
Placebo	73

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 113: very much

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	275
Placebo	73

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 113: not answered

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	275
Placebo	73

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 129: not at all

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	192
Placebo	41

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	186	Not reported	Not reported	Not reported	Not reported
Placebo	41	Not reported	Not reported	Not reported	Not reported

Week 129: a little

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	192
Placebo	41

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	5	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 129: quite a bit

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	192
Placebo	41

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	1	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 129: very much

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	192
Placebo	41

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 129: not answered

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	192
Placebo	41

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 145: not at all

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	116
Placebo	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	114	Not reported	Not reported	Not reported	Not reported
Placebo	21	Not reported	Not reported	Not reported	Not reported

Week 145: a little

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	116
Placebo	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	2	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 145: quite a bit

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	116
Placebo	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 145: very much

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	116
Placebo	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 145: not answered

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	116
Placebo	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 161: not at all

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	40
Placebo	8

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	38	Not reported	Not reported	Not reported	Not reported
Placebo	8	Not reported	Not reported	Not reported	Not reported

Week 161: a little

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	40
Placebo	8

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	2	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 161: quite a bit

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	40
Placebo	8

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 161: very much

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	40
Placebo	8

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 161: not answered

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	40
Placebo	8

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 177: not at all

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	6
Placebo	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	6	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 177: a little

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	6
Placebo	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 177: quite a bit

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	6
Placebo	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 177: very much

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	6
Placebo	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 177: not answered

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	6
Placebo	1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	0	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
836
group Id
OG001
value
422
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline: not at all
categories
measurements
group Id
OG000
value
48
group Id
OG001
value
17
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline: a little
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline: quite a bit
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline: very much
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline: not answered
categories
measurements
group Id
OG000
value
801
group Id
OG001
value
399
denoms
counts
group Id
OG000
value
839
group Id
OG001
value
419
units
Participants
title
Week 17: not at all
categories
measurements
group Id
OG000
value
36
group Id
OG001
value
18
denoms
counts
group Id
OG000
value
839
group Id
OG001
value
419
units
Participants
title
Week 17: a little
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
839
group Id
OG001
value
419
units
Participants
title
Week 17: quite a bit
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
839
group Id
OG001
value
419
units
Participants
title
Week 17: very much
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
839
group Id
OG001
value
419
units
Participants
title
Week 17: not answered
categories
measurements
group Id
OG000
value
707
group Id
OG001
value
330
denoms
counts
group Id
OG000
value
737
group Id
OG001
value
341
units
Participants
title
Week 33: not at all
categories
measurements
group Id
OG000
value
29
group Id
OG001
value
11
denoms
counts
group Id
OG000
value
737
group Id
OG001
value
341
units
Participants
title
Week 33: a little

denoms

counts
group Id
OG000
value
933
group Id
OG001
value
468
units
Participants

description

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 42 are reported. Question 42 was following: "Have you had blood in your stools?"

groups

description
Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
id
OG000
title
Enzalutamide 160 mg
description
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
id
OG001
title
Placebo

param Type

COUNT_OF_PARTICIPANTS

population Description

The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.

reporting Status

POSTED

time Frame

Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

title

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice