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NCT02003924 · OUTCOME

Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression 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 anxiety/depression 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:not anxious or depressed

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	595	Not reported	Not reported	Not reported	Not reported
Placebo	310	Not reported	Not reported	Not reported	Not reported

Baseline:slightly anxious or depressed

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	231	Not reported	Not reported	Not reported	Not reported
Placebo	100	Not reported	Not reported	Not reported	Not reported

Baseline:moderately anxious or depressed

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	24	Not reported	Not reported	Not reported	Not reported

Baseline:severely anxious or depressed

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	6	Not reported	Not reported	Not reported	Not reported
Placebo	5	Not reported	Not reported	Not reported	Not reported

Baseline:extremely anxious or depressed

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

Week 17:not anxious or depressed

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	517	Not reported	Not reported	Not reported	Not reported
Placebo	265	Not reported	Not reported	Not reported	Not reported

Week 17:slightly anxious or depressed

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	251	Not reported	Not reported	Not reported	Not reported
Placebo	119	Not reported	Not reported	Not reported	Not reported

Week 17:moderately anxious or depressed

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	62	Not reported	Not reported	Not reported	Not reported
Placebo	31	Not reported	Not reported	Not reported	Not reported

Week 17:severely anxious or depressed

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	7	Not reported	Not reported	Not reported	Not reported
Placebo	4	Not reported	Not reported	Not reported	Not reported

Week 17:extremely anxious or depressed

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

Week 33:not anxious or depressed

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	458	Not reported	Not reported	Not reported	Not reported
Placebo	223	Not reported	Not reported	Not reported	Not reported

Week 33:slightly anxious or depressed

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	208	Not reported	Not reported	Not reported	Not reported
Placebo	89	Not reported	Not reported	Not reported	Not reported

Week 33:moderately anxious or depressed

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	61	Not reported	Not reported	Not reported	Not reported
Placebo	23	Not reported	Not reported	Not reported	Not reported

Week 33:severely anxious or depressed

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	9	Not reported	Not reported	Not reported	Not reported
Placebo	5	Not reported	Not reported	Not reported	Not reported

Week 33:extremely anxious or depressed

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

Week 49:not anxious or depressed

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	410	Not reported	Not reported	Not reported	Not reported
Placebo	155	Not reported	Not reported	Not reported	Not reported

Week 49:slightly anxious or depressed

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	172	Not reported	Not reported	Not reported	Not reported
Placebo	72	Not reported	Not reported	Not reported	Not reported

Week 49:moderately anxious or depressed

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	41	Not reported	Not reported	Not reported	Not reported
Placebo	20	Not reported	Not reported	Not reported	Not reported

Week 49:severely anxious or depressed

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	8	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Week 49:extremely anxious or depressed

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:not anxious or depressed

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	336	Not reported	Not reported	Not reported	Not reported
Placebo	128	Not reported	Not reported	Not reported	Not reported

Week 65:slightly anxious or depressed

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	149	Not reported	Not reported	Not reported	Not reported
Placebo	56	Not reported	Not reported	Not reported	Not reported

Week 65:moderately anxious or depressed

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	43	Not reported	Not reported	Not reported	Not reported
Placebo	8	Not reported	Not reported	Not reported	Not reported

Week 65:severely anxious or depressed

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

Week 65:extremely anxious or depressed

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 anxious or depressed

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	288	Not reported	Not reported	Not reported	Not reported
Placebo	86	Not reported	Not reported	Not reported	Not reported

Week 81:slightly anxious or depressed

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	106	Not reported	Not reported	Not reported	Not reported
Placebo	48	Not reported	Not reported	Not reported	Not reported

Week 81:moderately anxious or depressed

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	34	Not reported	Not reported	Not reported	Not reported
Placebo	9	Not reported	Not reported	Not reported	Not reported

Week 81:severely anxious or depressed

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

Week 81:extremely anxious or depressed

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:not anxious or depressed

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	220	Not reported	Not reported	Not reported	Not reported
Placebo	61	Not reported	Not reported	Not reported	Not reported

Week 97:slightly anxious or depressed

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	114	Not reported	Not reported	Not reported	Not reported
Placebo	27	Not reported	Not reported	Not reported	Not reported

Week 97:moderately anxious or depressed

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	26	Not reported	Not reported	Not reported	Not reported
Placebo	6	Not reported	Not reported	Not reported	Not reported

Week 97:severely anxious or depressed

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

Week 97:extremely anxious or depressed

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	1	Not reported	Not reported	Not reported	Not reported

Week 113:not anxious or depressed

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	167	Not reported	Not reported	Not reported	Not reported
Placebo	43	Not reported	Not reported	Not reported	Not reported

Week 113:slightly anxious or depressed

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	87	Not reported	Not reported	Not reported	Not reported
Placebo	27	Not reported	Not reported	Not reported	Not reported

Week 113:moderately anxious or depressed

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

Week 113:severely anxious or depressed

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

Week 113:extremely anxious or depressed

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 anxious or depressed

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	121	Not reported	Not reported	Not reported	Not reported
Placebo	28	Not reported	Not reported	Not reported	Not reported

Week 129:slightly anxious or depressed

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	51	Not reported	Not reported	Not reported	Not reported
Placebo	10	Not reported	Not reported	Not reported	Not reported

Week 129:moderately anxious or depressed

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

Week 129:severely anxious or depressed

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	1	Not reported	Not reported	Not reported	Not reported

Week 129:extremely anxious or depressed

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

Week 145:not anxious or depressed

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	73	Not reported	Not reported	Not reported	Not reported
Placebo	12	Not reported	Not reported	Not reported	Not reported

Week 145:slightly anxious or depressed

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	30	Not reported	Not reported	Not reported	Not reported
Placebo	8	Not reported	Not reported	Not reported	Not reported

Week 145:moderately anxious or depressed

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

Week 145:severely anxious or depressed

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:extremely anxious or depressed

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 161:not anxious or depressed

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

Week 161:slightly anxious or depressed

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	16	Not reported	Not reported	Not reported	Not reported
Placebo	4	Not reported	Not reported	Not reported	Not reported

Week 161:moderately anxious or depressed

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	1	Not reported	Not reported	Not reported	Not reported

Week 161:severely anxious or depressed

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:extremely anxious or depressed

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:not anxious or depressed

Analysis denominator · Participants

Group	Source count
Enzalutamide 160 mg	933
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:slightly anxious or depressed

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:moderately anxious or depressed

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:severely anxious or depressed

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:extremely anxious or depressed

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
595
group Id
OG001
value
310
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:not anxious or depressed
categories
measurements
group Id
OG000
value
231
group Id
OG001
value
100
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:slightly anxious or depressed
categories
measurements
group Id
OG000
value
51
group Id
OG001
value
24
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:moderately anxious or depressed
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
5
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:severely anxious or depressed
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
884
group Id
OG001
value
439
units
Participants
title
Baseline:extremely anxious or depressed
categories
measurements
group Id
OG000
value
517
group Id
OG001
value
265
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:not anxious or depressed
categories
measurements
group Id
OG000
value
251
group Id
OG001
value
119
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:slightly anxious or depressed
categories
measurements
group Id
OG000
value
62
group Id
OG001
value
31
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:moderately anxious or depressed
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:severely anxious or depressed
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
840
group Id
OG001
value
419
units
Participants
title
Week 17:extremely anxious or depressed
categories
measurements
group Id
OG000
value
458
group Id
OG001
value
223
denoms
counts
group Id
OG000
value
738
group Id
OG001
value
342
units
Participants
title
Week 33:not anxious or depressed
categories
measurements
group Id
OG000
value
208
group Id
OG001
value
89
denoms
counts
group Id
OG000
value
738
group Id
OG001
value
342
units
Participants
title
Week 33:slightly anxious or depressed

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 anxiety/depression 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) Anxiety/ Depression Domain Score

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice