Skip to content

TriangleGet started

← Full study record

NCT02003924 · OUTCOME

Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort 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: 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

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 pain/discomfort 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 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:no pain or discomfort

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	546	Not reported	Not reported	Not reported	Not reported
Placebo	292	Not reported	Not reported	Not reported	Not reported

Baseline:slight pain or discomfort

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	240	Not reported	Not reported	Not reported	Not reported
Placebo	117	Not reported	Not reported	Not reported	Not reported

Baseline:moderate pain or discomfort

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	86	Not reported	Not reported	Not reported	Not reported
Placebo	25	Not reported	Not reported	Not reported	Not reported

Baseline:severe pain or discomfort

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	10	Not reported	Not reported	Not reported	Not reported
Placebo	4	Not reported	Not reported	Not reported	Not reported

Baseline:extreme pain or discomfort

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 pain or discomfort

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	464	Not reported	Not reported	Not reported	Not reported
Placebo	248	Not reported	Not reported	Not reported	Not reported

Week 17:slight pain or discomfort

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	269	Not reported	Not reported	Not reported	Not reported
Placebo	128	Not reported	Not reported	Not reported	Not reported

Week 17: moderate pain or discomfort

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	92	Not reported	Not reported	Not reported	Not reported
Placebo	41	Not reported	Not reported	Not reported	Not reported

Week 17:severe pain or discomfort

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	13	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Week 17:extreme pain or discomfort

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

Week 33:no pain or discomfort

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	405	Not reported	Not reported	Not reported	Not reported
Placebo	204	Not reported	Not reported	Not reported	Not reported

Week 33:slight pain or discomfort

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	237	Not reported	Not reported	Not reported	Not reported
Placebo	110	Not reported	Not reported	Not reported	Not reported

Week 33:moderate pain or discomfort

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	79	Not reported	Not reported	Not reported	Not reported
Placebo	21	Not reported	Not reported	Not reported	Not reported

Week 33:severe pain or discomfort

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	16	Not reported	Not reported	Not reported	Not reported
Placebo	7	Not reported	Not reported	Not reported	Not reported

Week 33:extreme pain or discomfort

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

Week 49:no pain or discomfort

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	340	Not reported	Not reported	Not reported	Not reported
Placebo	134	Not reported	Not reported	Not reported	Not reported

Week 49:slight pain or discomfort

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	209	Not reported	Not reported	Not reported	Not reported
Placebo	82	Not reported	Not reported	Not reported	Not reported

Week 49:moderate pain or discomfort

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	75	Not reported	Not reported	Not reported	Not reported
Placebo	32	Not reported	Not reported	Not reported	Not reported

Week 49:severe pain or discomfort

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	10	Not reported	Not reported	Not reported	Not reported
Placebo	1	Not reported	Not reported	Not reported	Not reported

Week 49:extreme pain or discomfort

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

Week 65:no pain or discomfort

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	298	Not reported	Not reported	Not reported	Not reported
Placebo	102	Not reported	Not reported	Not reported	Not reported

Week 65:slight pain or discomfort

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	162	Not reported	Not reported	Not reported	Not reported
Placebo	72	Not reported	Not reported	Not reported	Not reported

Week 65:moderate pain or discomfort

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

Week 65:severe pain or discomfort

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

Week 65:extreme pain or discomfort

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	1	Not reported	Not reported	Not reported	Not reported

Week 81:no pain or discomfort

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	231	Not reported	Not reported	Not reported	Not reported
Placebo	86	Not reported	Not reported	Not reported	Not reported

Week 81:slight pain or discomfort

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	133	Not reported	Not reported	Not reported	Not reported
Placebo	45	Not reported	Not reported	Not reported	Not reported

Week 81:moderate pain or discomfort

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	13	Not reported	Not reported	Not reported	Not reported

Week 81 :severe pain or discomfort

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	10	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Week 81:extreme pain or discomfort

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

Week 97:no pain or discomfort

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	202	Not reported	Not reported	Not reported	Not reported
Placebo	58	Not reported	Not reported	Not reported	Not reported

Week 97:slight pain or discomfort

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	115	Not reported	Not reported	Not reported	Not reported
Placebo	28	Not reported	Not reported	Not reported	Not reported

Week 97:moderate pain or discomfort

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	43	Not reported	Not reported	Not reported	Not reported
Placebo	7	Not reported	Not reported	Not reported	Not reported

Week 97:severe pain or discomfort

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	2	Not reported	Not reported	Not reported	Not reported

Week 97:extreme pain or discomfort

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:no pain or discomfort

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	152	Not reported	Not reported	Not reported	Not reported
Placebo	47	Not reported	Not reported	Not reported	Not reported

Week 113:slight pain or discomfort

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	80	Not reported	Not reported	Not reported	Not reported
Placebo	19	Not reported	Not reported	Not reported	Not reported

Week 113:moderate pain or discomfort

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	37	Not reported	Not reported	Not reported	Not reported
Placebo	5	Not reported	Not reported	Not reported	Not reported

Week 113:severe pain or discomfort

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	6	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Week 113:extreme pain or discomfort

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:no pain or discomfort

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	108	Not reported	Not reported	Not reported	Not reported
Placebo	27	Not reported	Not reported	Not reported	Not reported

Week 129:slight pain or discomfort

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	55	Not reported	Not reported	Not reported	Not reported
Placebo	11	Not reported	Not reported	Not reported	Not reported

Week 129:moderate pain or discomfort

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	3	Not reported	Not reported	Not reported	Not reported

Week 129:severe pain or discomfort

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:extreme pain or discomfort

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 pain or discomfort

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	62	Not reported	Not reported	Not reported	Not reported
Placebo	12	Not reported	Not reported	Not reported	Not reported

Week 145:slight pain or discomfort

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	38	Not reported	Not reported	Not reported	Not reported
Placebo	8	Not reported	Not reported	Not reported	Not reported

Week 145:moderate pain or discomfort

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

Week 145:severe pain or discomfort

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

Week 145:extreme pain or discomfort

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 pain or discomfort

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	24	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Week 161:slight pain or discomfort

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	8	Not reported	Not reported	Not reported	Not reported
Placebo	5	Not reported	Not reported	Not reported	Not reported

Week 161:moderate pain or discomfort

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	1	Not reported	Not reported	Not reported	Not reported

Week 161:severe pain or discomfort

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:extreme pain or discomfort

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 pain or discomfort

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 pain or discomfort

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	1	Not reported	Not reported	Not reported	Not reported

Week 177:moderate pain or discomfort

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	0	Not reported	Not reported	Not reported	Not reported

Week 177:severe pain or discomfort

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:extreme pain or discomfort

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
546
group Id
OG001
value
292
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:no pain or discomfort
categories
measurements
group Id
OG000
value
240
group Id
OG001
value
117
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:slight pain or discomfort
categories
measurements
group Id
OG000
value
86
group Id
OG001
value
25
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:moderate pain or discomfort
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:severe pain or discomfort
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:extreme pain or discomfort
categories
measurements
group Id
OG000
value
464
group Id
OG001
value
248
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:no pain or discomfort
categories
measurements
group Id
OG000
value
269
group Id
OG001
value
128
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:slight pain or discomfort
categories
measurements
group Id
OG000
value
92
group Id
OG001
value
41
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17: moderate pain or discomfort
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:severe pain or discomfort
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:extreme pain or discomfort
categories
measurements
group Id
OG000
value
405
group Id
OG001
value
204
denoms
counts
group Id
OG000
value
738
group Id
OG001
value
342
units
Participants
title
Week 33:no pain or discomfort
categories
measurements
group Id
OG000
value
237
group Id
OG001
value
110
denoms
counts
group Id
OG000
value
738
group Id
OG001
value
342
units
Participants
title
Week 33:slight pain or discomfort

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 pain/discomfort 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

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 Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice