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NCT02003924 · OUTCOME

Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility 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 visual analogue scale (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 mobility 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 problem in walking

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	578	Not reported	Not reported	Not reported	Not reported
Placebo	298	Not reported	Not reported	Not reported	Not reported

Baseline-slight problem in walking

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	183	Not reported	Not reported	Not reported	Not reported
Placebo	100	Not reported	Not reported	Not reported	Not reported

Baseline-moderate problem in walking

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	100	Not reported	Not reported	Not reported	Not reported
Placebo	33	Not reported	Not reported	Not reported	Not reported

Baseline-severe problem in walking

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	21	Not reported	Not reported	Not reported	Not reported
Placebo	7	Not reported	Not reported	Not reported	Not reported

Baseline-unable to walk

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	1	Not reported	Not reported	Not reported	Not reported

Week 17-no problem in walking

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	526	Not reported	Not reported	Not reported	Not reported
Placebo	274	Not reported	Not reported	Not reported	Not reported

Week 17-slight problem in walking

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	190	Not reported	Not reported	Not reported	Not reported
Placebo	88	Not reported	Not reported	Not reported	Not reported

Week 17-moderate problem in walking

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	87	Not reported	Not reported	Not reported	Not reported
Placebo	50	Not reported	Not reported	Not reported	Not reported

Week 17-severe problem in walking

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	32	Not reported	Not reported	Not reported	Not reported
Placebo	6	Not reported	Not reported	Not reported	Not reported

Week 17-unable to walk

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	5	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 33-no problem in walking

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	431	Not reported	Not reported	Not reported	Not reported
Placebo	223	Not reported	Not reported	Not reported	Not reported

Week 33-slight problem in walking

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	162	Not reported	Not reported	Not reported	Not reported
Placebo	85	Not reported	Not reported	Not reported	Not reported

Week 33-moderate problem in walking

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	103	Not reported	Not reported	Not reported	Not reported
Placebo	24	Not reported	Not reported	Not reported	Not reported

Week 33-severe problem in walking

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	36	Not reported	Not reported	Not reported	Not reported
Placebo	10	Not reported	Not reported	Not reported	Not reported

Week 33-unable to walk

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

Week 49-no problem in walking

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	362	Not reported	Not reported	Not reported	Not reported
Placebo	156	Not reported	Not reported	Not reported	Not reported

Week 49-slight problem in walking

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	158	Not reported	Not reported	Not reported	Not reported
Placebo	57	Not reported	Not reported	Not reported	Not reported

Week 49-moderate problem in walking

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	86	Not reported	Not reported	Not reported	Not reported
Placebo	27	Not reported	Not reported	Not reported	Not reported

Week 49-severe problem in walking

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	25	Not reported	Not reported	Not reported	Not reported
Placebo	8	Not reported	Not reported	Not reported	Not reported

Week 49-unable to walk

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	2	Not reported	Not reported	Not reported	Not reported

Week 65-no problem in walking

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	319	Not reported	Not reported	Not reported	Not reported
Placebo	121	Not reported	Not reported	Not reported	Not reported

Week 65-slight problem in walking

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	109	Not reported	Not reported	Not reported	Not reported
Placebo	44	Not reported	Not reported	Not reported	Not reported

Week 65-moderate problem in walking

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	75	Not reported	Not reported	Not reported	Not reported
Placebo	22	Not reported	Not reported	Not reported	Not reported

Week 65-severe problem in walking

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	29	Not reported	Not reported	Not reported	Not reported
Placebo	6	Not reported	Not reported	Not reported	Not reported

Week 65-unable to walk

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

Week 81-no problem in walking

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	236	Not reported	Not reported	Not reported	Not reported
Placebo	88	Not reported	Not reported	Not reported	Not reported

Week 81-slight problem in walking

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	111	Not reported	Not reported	Not reported	Not reported
Placebo	39	Not reported	Not reported	Not reported	Not reported

Week 81-moderate problem in walking

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	61	Not reported	Not reported	Not reported	Not reported
Placebo	15	Not reported	Not reported	Not reported	Not reported

Week 81-severe problem in walking

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	26	Not reported	Not reported	Not reported	Not reported
Placebo	4	Not reported	Not reported	Not reported	Not reported

Week 81-unable to walk

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	1	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Week 97-no problem in walking

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	189	Not reported	Not reported	Not reported	Not reported
Placebo	59	Not reported	Not reported	Not reported	Not reported

Week 97-slight problem in walking

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	94	Not reported	Not reported	Not reported	Not reported
Placebo	24	Not reported	Not reported	Not reported	Not reported

Week 97-moderate problem in walking

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	54	Not reported	Not reported	Not reported	Not reported
Placebo	8	Not reported	Not reported	Not reported	Not reported

Week 97-severe problem in walking

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	22	Not reported	Not reported	Not reported	Not reported
Placebo	4	Not reported	Not reported	Not reported	Not reported

Week 97-unable to walk

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

Week 113-no problem in walking

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	140	Not reported	Not reported	Not reported	Not reported
Placebo	45	Not reported	Not reported	Not reported	Not reported

Week 113-slight problem in walking

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	76	Not reported	Not reported	Not reported	Not reported
Placebo	14	Not reported	Not reported	Not reported	Not reported

Week 113-moderate problem in walking

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	41	Not reported	Not reported	Not reported	Not reported
Placebo	11	Not reported	Not reported	Not reported	Not reported

Week 113-severe problem in walking

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	14	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Week 113-unable to walk

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 problem in walking

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	94	Not reported	Not reported	Not reported	Not reported
Placebo	26	Not reported	Not reported	Not reported	Not reported

Week 129-slight problem in walking

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	48	Not reported	Not reported	Not reported	Not reported
Placebo	9	Not reported	Not reported	Not reported	Not reported

Week 129-moderate problem in walking

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	36	Not reported	Not reported	Not reported	Not reported
Placebo	5	Not reported	Not reported	Not reported	Not reported

Week 129-severe problem in walking

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	15	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 129-unable to walk

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 problem in walking

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	56	Not reported	Not reported	Not reported	Not reported
Placebo	13	Not reported	Not reported	Not reported	Not reported

Week 145-slight problem in walking

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	35	Not reported	Not reported	Not reported	Not reported
Placebo	5	Not reported	Not reported	Not reported	Not reported

Week 145-moderate problem in walking

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	18	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Week 145-severe problem in walking

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	7	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 145-unable to walk

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-no problem in walking

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	22	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Week 161-slight problem in walking

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	7	Not reported	Not reported	Not reported	Not reported
Placebo	5	Not reported	Not reported	Not reported	Not reported

Week 161-moderate problem in walking

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	6	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 161-severe problem in walking

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

Week 161-unable to walk

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-no problem in walking

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-slight problem in walking

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	2	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 177-moderate problem in walking

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

Week 177-severe problem in walking

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-unable to walk

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
578
group Id
OG001
value
298
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline-No problem in walking
categories
measurements
group Id
OG000
value
183
group Id
OG001
value
100
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline-slight problem in walking
categories
measurements
group Id
OG000
value
100
group Id
OG001
value
33
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline-moderate problem in walking
categories
measurements
group Id
OG000
value
21
group Id
OG001
value
7
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline-severe problem in walking
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline-unable to walk
categories
measurements
group Id
OG000
value
526
group Id
OG001
value
274
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17-no problem in walking
categories
measurements
group Id
OG000
value
190
group Id
OG001
value
88
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17-slight problem in walking
categories
measurements
group Id
OG000
value
87
group Id
OG001
value
50
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17-moderate problem in walking
categories
measurements
group Id
OG000
value
32
group Id
OG001
value
6
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17-severe problem in walking
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17-unable to walk
categories
measurements
group Id
OG000
value
431
group Id
OG001
value
223
denoms
counts
group Id
OG000
value
738
group Id
OG001
value
342
units
Participants
title
Week 33-no problem in walking
categories
measurements
group Id
OG000
value
162
group Id
OG001
value
85
denoms
counts
group Id
OG000
value
738
group Id
OG001
value
342
units
Participants
title
Week 33-slight problem in walking

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 visual analogue scale (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 mobility 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) Mobility Domain Score

type

SECONDARY

unit Of Measure

participants

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Preserved source evidence · Not medical advice