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NCT02003924 · OUTCOME

Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score

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: NUMBER
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

EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the self-care questionnaire are reported.

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 for 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:no problems washing or dressing

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	805	Not reported	Not reported	Not reported	Not reported
Placebo	415	Not reported	Not reported	Not reported	Not reported

Baseline:slight problems washing or dressing

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	51	Not reported	Not reported	Not reported	Not reported
Placebo	23	Not reported	Not reported	Not reported	Not reported

Baseline:moderate problems washing or dressing

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	22	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Baseline:severe problems washing or dressing

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	2	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Baseline:unable to wash or dress

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	4	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 17:no problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	840
Placebo	419

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	752	Not reported	Not reported	Not reported	Not reported
Placebo	388	Not reported	Not reported	Not reported	Not reported

Week 17:slight problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	840
Placebo	419

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	60	Not reported	Not reported	Not reported	Not reported
Placebo	26	Not reported	Not reported	Not reported	Not reported

Week 17:moderate problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	840
Placebo	419

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	21	Not reported	Not reported	Not reported	Not reported
Placebo	5	Not reported	Not reported	Not reported	Not reported

Week 17:severe problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	840
Placebo	419

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	0	Not reported	Not reported	Not reported	Not reported

Week 17:unable to wash or dress

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	840
Placebo	419

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:no problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	738
Placebo	342

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	642	Not reported	Not reported	Not reported	Not reported
Placebo	310	Not reported	Not reported	Not reported	Not reported

Week 33:slight problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	738
Placebo	342

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	64	Not reported	Not reported	Not reported	Not reported
Placebo	20	Not reported	Not reported	Not reported	Not reported

Week 33:moderate problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	738
Placebo	342

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	21	Not reported	Not reported	Not reported	Not reported
Placebo	10	Not reported	Not reported	Not reported	Not reported

Week 33:severe problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	738
Placebo	342

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	4	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 33:unable to wash or dress

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	738
Placebo	342

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	7	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 49:no problems washing or dressing

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	546	Not reported	Not reported	Not reported	Not reported
Placebo	230	Not reported	Not reported	Not reported	Not reported

Week 49:slight problems washing or dressing

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	59	Not reported	Not reported	Not reported	Not reported
Placebo	9	Not reported	Not reported	Not reported	Not reported

Week 49:moderate problems washing or dressing

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	23	Not reported	Not reported	Not reported	Not reported
Placebo	7	Not reported	Not reported	Not reported	Not reported

Week 49:severe problems washing or dressing

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	3	Not reported	Not reported	Not reported	Not reported
Placebo	3	Not reported	Not reported	Not reported	Not reported

Week 49:unable to wash or dress

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	4	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 65:no problems washing or dressing

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	453	Not reported	Not reported	Not reported	Not reported
Placebo	179	Not reported	Not reported	Not reported	Not reported

Week 65:slight problems washing or dressing

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	57	Not reported	Not reported	Not reported	Not reported
Placebo	11	Not reported	Not reported	Not reported	Not reported

Week 65:moderate problems washing or dressing

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	14	Not reported	Not reported	Not reported	Not reported
Placebo	3	Not reported	Not reported	Not reported	Not reported

Week 65:severe problems washing or dressing

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	9	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 65:unable to wash or dress

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 81:no problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	435
Placebo	148

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	356	Not reported	Not reported	Not reported	Not reported
Placebo	132	Not reported	Not reported	Not reported	Not reported

Week 81:slight problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	435
Placebo	148

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	57	Not reported	Not reported	Not reported	Not reported
Placebo	11	Not reported	Not reported	Not reported	Not reported

Week 81:moderate problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	435
Placebo	148

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	17	Not reported	Not reported	Not reported	Not reported
Placebo	3	Not reported	Not reported	Not reported	Not reported

Week 81:severe problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	435
Placebo	148

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	1	Not reported	Not reported	Not reported	Not reported

Week 81:unable to wash or dress

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	435
Placebo	148

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	1	Not reported	Not reported	Not reported	Not reported

Week 97:no problems washing or dressing

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	292	Not reported	Not reported	Not reported	Not reported
Placebo	85	Not reported	Not reported	Not reported	Not reported

Week 97:slight problems washing or dressing

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	51	Not reported	Not reported	Not reported	Not reported
Placebo	8	Not reported	Not reported	Not reported	Not reported

Week 97:moderate problems washing or dressing

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	16	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Week 97:severe problems washing or dressing

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	1	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 97:unable to wash or dress

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	5	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 113:no problems washing or dressing

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	214	Not reported	Not reported	Not reported	Not reported
Placebo	60	Not reported	Not reported	Not reported	Not reported

Week 113:slight problems washing or dressing

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	46	Not reported	Not reported	Not reported	Not reported
Placebo	7	Not reported	Not reported	Not reported	Not reported

Week 113:moderate problems washing or dressing

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	11	Not reported	Not reported	Not reported	Not reported
Placebo	5	Not reported	Not reported	Not reported	Not reported

Week 113:severe problems washing or dressing

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:unable to wash or dress

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	4	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 129:no problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	193
Placebo	41

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	147	Not reported	Not reported	Not reported	Not reported
Placebo	35	Not reported	Not reported	Not reported	Not reported

Week 129:slight problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	193
Placebo	41

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	28	Not reported	Not reported	Not reported	Not reported
Placebo	5	Not reported	Not reported	Not reported	Not reported

Week 129:moderate problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	193
Placebo	41

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide 160 mg	16	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 129:severe problems washing or dressing

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	193
Placebo	41

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 129:unable to wash or dress

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	193
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:no problems washing or dressing

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	92	Not reported	Not reported	Not reported	Not reported
Placebo	15	Not reported	Not reported	Not reported	Not reported

Week 145:slight problems washing or dressing

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	16	Not reported	Not reported	Not reported	Not reported
Placebo	5	Not reported	Not reported	Not reported	Not reported

Week 145:moderate problems washing or dressing

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	6	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 145:severe problems washing or dressing

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:unable to wash or dress

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	1	Not reported	Not reported	Not reported	Not reported

Week 161:no problems washing or dressing

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	33	Not reported	Not reported	Not reported	Not reported
Placebo	7	Not reported	Not reported	Not reported	Not reported

Week 161:slight problems washing or dressing

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	3	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 161:moderate problems washing or dressing

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	1	Not reported	Not reported	Not reported	Not reported

Week 161:severe problems washing or dressing

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	1	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 161:unable to wash or dress

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	1	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 177:no problems washing or dressing

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	3	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 177:slight problems washing or dressing

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	3	Not reported	Not reported	Not reported	Not reported
Placebo	0	Not reported	Not reported	Not reported	Not reported

Week 177:moderate problems washing or dressing

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:severe problems washing or dressing

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 171:unable to wash or dress

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
805
group Id
OG001
value
415
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:no problems washing or dressing
categories
measurements
group Id
OG000
value
51
group Id
OG001
value
23
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:slight problems washing or dressing
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:moderate problems washing or dressing
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:severe problems washing or dressing
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:unable to wash or dress
categories
measurements
group Id
OG000
value
752
group Id
OG001
value
388
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:no problems washing or dressing
categories
measurements
group Id
OG000
value
60
group Id
OG001
value
26
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:slight problems washing or dressing
categories
measurements
group Id
OG000
value
21
group Id
OG001
value
5
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:moderate problems washing or dressing
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:severe problems washing or dressing
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:unable to wash or dress
categories
measurements
group Id
OG000
value
642
group Id
OG001
value
310
denoms
counts
group Id
OG000
value
738
group Id
OG001
value
342
units
Participants
title
Week 33:no problems washing or dressing
categories
measurements
group Id
OG000
value
64
group Id
OG001
value
20
denoms
counts
group Id
OG000
value
738
group Id
OG001
value
342
units
Participants
title
Week 33:slight problems washing or dressing

denoms

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

description

EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the self-care questionnaire are reported.

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

NUMBER

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 for 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 Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score

type

SECONDARY

unit Of Measure

participants

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Preserved source evidence · Not medical advice