A Phase 3 interventional study of Enzalutamide and Placebo in Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer and Cancer of the Prostate, sponsored by Pfizer. Completed at 397 sites in 32 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 1,401 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Exclusion Criteria:
Sugar pill manufactured to mimic enzalutamide 40 mg capsule
Drug: Placebo
160 mg by mouth once daily
Drug: Enzalutamide
160 mg by mouth once daily
Also known as: MDV3100, Xtandi
Sugar pill to mimic enzalutamide
Metastasis Free Survival (MFS)
MFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review \[BICR\]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,\[RECIST 1.1\])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates.
Time frame: From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Time to Prostate-Specific Antigen (PSA) Progression
Time to PSA progression was defined as the time from randomization to the date of first PSA value demonstrating progression, which was subsequently confirmed. For participants with PSA decline at Week 17, PSA progression was defined according to Prostate Cancer Working Group 2 (PCWG2) guidelines as the date that a 25% or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 17) was documented, which was confirmed by a second consecutive value obtained at least 3 weeks or later. Participants without confirmed PSA progression at the time of analysis were right censored at the date of last PSA assessment before the analysis data cut-off date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
Time frame: From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Time to First Use of New Antineoplastic Therapy
Time to first use of new antineoplastic therapy was defined as the time from randomization to first use of new antineoplastic for prostate cancer. Participants not starting treatment with a new antineoplastic therapy at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
Time frame: From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Overall Survival
Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.
Time frame: From randomization until death (up to a maximum of 68.8 months)
Time to Pain Progression
Pain was assessed using the score from the Brief Pain Inventory-Short Form (BPI-SF) question 3: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." Time to this event was defined as the time from randomization to onset of pain progression, where pain progression was defined as a 2-point or more increase from baseline in the question 3 score. Participants without observed pain progression at the time of analysis were right censored at the date of last pain assessment for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
Time frame: From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Time to First Use of Cytotoxic Chemotherapy
Time to first use of cytotoxic chemotherapy was defined as the time from randomization to the first use of cytotoxic chemotherapy for prostate cancer. Participants not starting treatment with a cytotoxic chemotherapy for prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
Time frame: From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Chemotherapy-Free Disease Specific Survival
Chemotherapy-free disease-specific survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer as assessed by the investigator. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died due to prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
Time frame: From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Chemotherapy-Free Survival
Chemotherapy-free survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died at the time of analysis were censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
Time frame: From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Percentage of Participants With Prostate Specific Antigen (PSA) Response
PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.
Time frame: From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score
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.
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score
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.
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score
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 usual activities questionnaire are reported.
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score
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.
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score
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.
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS)
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-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 31 are reported. Question 31 was following: "Have you had to urinate frequently during the day?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 32 are reported. Question 32 was following: "Have you had to urinate frequently at night?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 33 are reported. Question 33 was following: "When you felt the urge to pass urine, did you have to hurry to get to the toilet?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 34 are reported. Question 34 was following: "Was it difficult for you to get enough sleep, because you needed to get up frequently at night to urinate?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 35 are reported. Question 35 was following: "Have you had difficulty going out of the house because you needed to be close to a toilet?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 36 are reported. Question 36 was following: "Have you had any unintentional release (leakage) of urine?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 37 are reported. Question 37 was following: "Did you have pain when you urinated?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 38 are reported. Question 38 was following: "Has wearing an incontinence aid been a problem for you?". This question was answered by only those participants who wore incontinence aid.
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 39
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 39 are reported. Question 39 was following: "Have your daily activities been limited by your urinary problems?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 40
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 40 are reported. Question 40 was following: "Have your daily activities been limited by your bowel problems?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 41
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 41 are reported. Question 41 was following: "Have you had any unintentional release (leakage) of stools?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 42 are reported. Question 42 was following: "Have you had blood in your stools?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 43
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 43 are reported. Question 43 was following: "Did you have a bloated feeling in your abdomen?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 44
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 44 are reported. Question 44 was following: "Did you have hot flushes?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 45
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 45 are reported. Question 45 was following: "Have you had sore or enlarged nipples or breasts?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 46
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 46 are reported. Question 46 was following: "Have you had swelling in your legs or ankles?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 47
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 47 are reported. Question 47 was following: "Has weight loss been a problem for you?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 48
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 48 are reported. Question 48 was following: "Has weight gain been a problem for you?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 49
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 49 are reported. Question 49 was following: "Have you felt less masculine as a result of your illness or treatment?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 50
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 50 are reported. Question 50 was following: "To what extent were you interested in sex?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 51
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 51 are reported. Question 51 was following: "To what extent were you sexually active (with or without intercourse)?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 52
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 52 are reported. Question 52 was following: "To what extent was sex enjoyable for you?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 53
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 53 are reported. Question 53 was following: "Did you have difficulty getting or maintaining an erection?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 54
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 54 are reported. Question 54 was following: "Did you have ejaculation problems (e.g, dry ejaculation)?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 55
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 55 are reported. Question 55 was following: "Have you felt uncomfortable about being sexually intimate?"
Time frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first). AEs included both non-serious adverse events (AEs) and SAEs.
Time frame: From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Number of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0
An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first).Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.
Time frame: From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious adverse events (AEs) and SAEs.
Time frame: From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology
Hematology parameters: Haemoglobin (grams per liter \[g/L\]); leukocytes (log 10 raised to power 9 per liter \[10\*9/L\]); lymphocytes (log 10 raised to power 6 per liter \[10\*6/L\]); neutrophils (log 10 raised to power 6 per liter \[10\*6/L\]); platelets (log 10 raised to power 9 per litre \[10\*9/L\]).
Time frame: From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Chemistry
Chemistry parameters: Alanine aminotransferase (units per liter \[U/L\]); albumin (g/L); alkaline phosphatase (U/L); bilirubin (micromoles per liter \[umol/L\]); calcium (millimoles per liter \[mmol/L\]); creatine kinase (U/L); creatinine (umol/L); glucose, magnesium, phosphate, potassium, sodium (mmol/L).
Time frame: From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Number of Participants With Clinically Significant Vital Signs
Vital signs included Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and heart rate.
Time frame: From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
The study was conducted at 254 sites in 32 countries.
| Milestone | Enzalutamide 160 mg | Placebo | Placebo Participants Crossover to Enzalutamide 160 mg |
|---|---|---|---|
| Started | 933 | 468 | 0 |
| Treated | 930 | 465 | 0 |
| Completed | 478 | 87 | 0 |
| Not completed | 455 | 381 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 | 0 |
| Withdrew: Protocol violation | 1 | 2 | 0 |
| Withdrew: Withdrawal consent to continue treatment | 71 | 47 | 0 |
| Withdrew: Disease progression | 229 | 247 | 0 |
| Withdrew: Adverse event | 120 | 31 | 0 |
| Withdrew: Randomized but not treated | 3 | 3 | 0 |
| Withdrew: Other | 29 | 50 | 0 |
| Milestone | Enzalutamide 160 mg | Placebo | Placebo Participants Crossover to Enzalutamide 160 mg |
|---|---|---|---|
| Started | 478 | 0 | 87 |
| Treated | 478 | 0 | 87 |
| Completed | 378 | 0 | 70 |
| Not completed | 100 | 0 | 17 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Withdrawal consent to continue treatment | 9 | 0 | 1 |
| Withdrew: Disease progression | 59 | 0 | 5 |
| Withdrew: Adverse event | 25 | 0 | 10 |
| Withdrew: Other | 7 | 0 | 0 |
| Milestone | Enzalutamide 160 mg | Placebo | Placebo Participants Crossover to Enzalutamide 160 mg |
|---|---|---|---|
| Started | 933 | 381 | 87 |
| Completed | 566 | 144 | 80 |
| Not completed | 367 | 237 | 7 |
| Withdrew: Death | 288 | 174 | 4 |
| Withdrew: Lost to follow-up | 8 | 6 | 1 |
| Withdrew: Withdrew consent to be followed | 66 | 55 | 1 |
| Withdrew: Other | 5 | 2 | 1 |
MFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review \[BICR\]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,\[RECIST 1.1\])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates.
| months | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Metastasis Free Survival (MFS) | 36.6 (33.1 to NA) | 14.7 (14.2 to 15.0) |
Time to PSA progression was defined as the time from randomization to the date of first PSA value demonstrating progression, which was subsequently confirmed. For participants with PSA decline at Week 17, PSA progression was defined according to Prostate Cancer Working Group 2 (PCWG2) guidelines as the date that a 25% or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 17) was documented, which was confirmed by a second consecutive value obtained at least 3 weeks or later. Participants without confirmed PSA progression at the time of analysis were right censored at the date of last PSA assessment before the analysis data cut-off date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
| months | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Time to Prostate-Specific Antigen (PSA) Progression | 37.2 (33.1 to NA) | 3.9 (3.8 to 4.0) |
Time to first use of new antineoplastic therapy was defined as the time from randomization to first use of new antineoplastic for prostate cancer. Participants not starting treatment with a new antineoplastic therapy at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
| months | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Time to First Use of New Antineoplastic Therapy | 39.6 (37.7 to NA) | 17.7 (16.2 to 19.7) |
Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.
| months | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Overall Survival | 67.0 (64.0 to NA) | 56.3 (54.4 to 63.0) |
Pain was assessed using the score from the Brief Pain Inventory-Short Form (BPI-SF) question 3: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." Time to this event was defined as the time from randomization to onset of pain progression, where pain progression was defined as a 2-point or more increase from baseline in the question 3 score. Participants without observed pain progression at the time of analysis were right censored at the date of last pain assessment for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
| months | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Time to Pain Progression | 18.5 (17.0 to 22.1) | 18.4 (14.8 to 22.1) |
Time to first use of cytotoxic chemotherapy was defined as the time from randomization to the first use of cytotoxic chemotherapy for prostate cancer. Participants not starting treatment with a cytotoxic chemotherapy for prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
| months | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Time to First Use of Cytotoxic Chemotherapy | NA (38.1 to NA) | 39.7 (38.9 to 41.3) |
Chemotherapy-free disease-specific survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer as assessed by the investigator. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died due to prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
| months | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Chemotherapy-Free Disease Specific Survival | 39.6 (37.7 to NA) | 38.9 (30.9 to 41.3) |
Chemotherapy-free survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died at the time of analysis were censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
| months | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Chemotherapy-Free Survival | 38.1 (37.7 to NA) | 34.0 (30.3 to 39.7) |
PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.
| percentage of participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Decrease from Baseline >= 50% | 76.3 (73.5 to 79.0) | 2.4 (1.2 to 4.2) |
| Decrease from Baseline >= 90% | 55.9 (52.7 to 59.2) | 0.4 (0.1 to 1.5) |
| Decrease to Undetectable Level | 9.6 (7.8 to 11.7) | 0 (0 to 0.8) |
The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.
| units on a scale | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline | 119.5 ± 17.75 | 120.8 ± 16.73 |
| Change at Week 17 | -4.0 ± 14.03 | -3.0 ± 13.87 |
| Change at Week 33 | -4.6 ± 14.82 | -3.5 ± 13.74 |
| Change at Week 49 | -3.9 ± 14.70 | -5.0 ± 15.71 |
| Change at Week 65 | -4.0 ± 15.84 | -5.7 ± 15.04 |
| Change at Week 81 | -4.1 ± 15.01 | -7.5 ± 16.42 |
| Change at Week 97 | -4.9 ± 15.31 | -5.9 ± 15.80 |
| Change at Week 113 | -5.5 ± 16.07 | -5.8 ± 13.16 |
| Change at Week 129 | -6.3 ± 17.33 | -8.1 ± 13.99 |
| Change at Week 145 | -5.5 ± 18.75 | -9.8 ± 15.47 |
| Change at Week 161 | -8.9 ± 19.88 | -7.0 ± 10.95 |
| Change at Week 177 | -4.8 ± 13.19 | -5.0 |
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.
| participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline-No problem in walking | 578 | 298 |
| Baseline-slight problem in walking | 183 | 100 |
| Baseline-moderate problem in walking | 100 | 33 |
| Baseline-severe problem in walking | 21 | 7 |
| Baseline-unable to walk | 2 | 1 |
| Week 17-no problem in walking | 526 | 274 |
| Week 17-slight problem in walking | 190 | 88 |
| Week 17-moderate problem in walking | 87 | 50 |
| Week 17-severe problem in walking | 32 | 6 |
| Week 17-unable to walk | 5 | 1 |
| Week 33-no problem in walking | 431 | 223 |
| Week 33-slight problem in walking | 162 | 85 |
| Week 33-moderate problem in walking | 103 | 24 |
| Week 33-severe problem in walking | 36 | 10 |
| Week 33-unable to walk | 6 | 0 |
| Week 49-no problem in walking | 362 | 156 |
| Week 49-slight problem in walking | 158 | 57 |
| Week 49-moderate problem in walking | 86 | 27 |
| Week 49-severe problem in walking | 25 | 8 |
| Week 49-unable to walk | 4 | 2 |
| Week 65-no problem in walking | 319 | 121 |
| Week 65-slight problem in walking | 109 | 44 |
| Week 65-moderate problem in walking | 75 | 22 |
| Week 65-severe problem in walking | 29 | 6 |
| Week 65-unable to walk | 4 | 0 |
| Week 81-no problem in walking | 236 | 88 |
| Week 81-slight problem in walking | 111 | 39 |
| Week 81-moderate problem in walking | 61 | 15 |
| Week 81-severe problem in walking | 26 | 4 |
| Week 81-unable to walk | 1 | 2 |
| Week 97-no problem in walking | 189 | 59 |
| Week 97-slight problem in walking | 94 | 24 |
| Week 97-moderate problem in walking | 54 | 8 |
| Week 97-severe problem in walking | 22 | 4 |
| Week 97-unable to walk | 6 | 0 |
| Week 113-no problem in walking | 140 | 45 |
| Week 113-slight problem in walking | 76 | 14 |
| Week 113-moderate problem in walking | 41 | 11 |
| Week 113-severe problem in walking | 14 | 2 |
| Week 113-unable to walk | 4 | 1 |
| Week 129-no problem in walking | 94 | 26 |
| Week 129-slight problem in walking | 48 | 9 |
| Week 129-moderate problem in walking | 36 | 5 |
| Week 129-severe problem in walking | 15 | 1 |
| Week 129-unable to walk | 0 | 0 |
| Week 145-no problem in walking | 56 | 13 |
| Week 145-slight problem in walking | 35 | 5 |
| Week 145-moderate problem in walking | 18 | 2 |
| Week 145-severe problem in walking | 7 | 1 |
| Week 145-unable to walk | 0 | 0 |
| Week 161-no problem in walking | 22 | 2 |
| Week 161-slight problem in walking | 7 | 5 |
| Week 161-moderate problem in walking | 6 | 1 |
| Week 161-severe problem in walking | 5 | 0 |
| Week 161-unable to walk | 0 | 0 |
| Week 177-no problem in walking | 3 | 0 |
| Week 177-slight problem in walking | 2 | 1 |
| Week 177-moderate problem in walking | 1 | 0 |
| Week 177-severe problem in walking | 0 | 0 |
| Week 177-unable to walk | 0 | 0 |
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.
| participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline:no problems washing or dressing | 805 | 415 |
| Baseline:slight problems washing or dressing | 51 | 23 |
| Baseline:moderate problems washing or dressing | 22 | 1 |
| Baseline:severe problems washing or dressing | 2 | 0 |
| Baseline:unable to wash or dress | 4 | 0 |
| Week 17:no problems washing or dressing | 752 | 388 |
| Week 17:slight problems washing or dressing | 60 | 26 |
| Week 17:moderate problems washing or dressing | 21 | 5 |
| Week 17:severe problems washing or dressing | 6 | 0 |
| Week 17:unable to wash or dress | 1 | 0 |
| Week 33:no problems washing or dressing | 642 | 310 |
| Week 33:slight problems washing or dressing | 64 | 20 |
| Week 33:moderate problems washing or dressing | 21 | 10 |
| Week 33:severe problems washing or dressing | 4 | 1 |
| Week 33:unable to wash or dress | 7 | 1 |
| Week 49:no problems washing or dressing | 546 | 230 |
| Week 49:slight problems washing or dressing | 59 | 9 |
| Week 49:moderate problems washing or dressing | 23 | 7 |
| Week 49:severe problems washing or dressing | 3 | 3 |
| Week 49:unable to wash or dress | 4 | 1 |
| Week 65:no problems washing or dressing | 453 | 179 |
| Week 65:slight problems washing or dressing | 57 | 11 |
| Week 65:moderate problems washing or dressing | 14 | 3 |
| Week 65:severe problems washing or dressing | 9 | 0 |
| Week 65:unable to wash or dress | 3 | 0 |
| Week 81:no problems washing or dressing | 356 | 132 |
| Week 81:slight problems washing or dressing | 57 | 11 |
| Week 81:moderate problems washing or dressing | 17 | 3 |
| Week 81:severe problems washing or dressing | 3 | 1 |
| Week 81:unable to wash or dress | 2 | 1 |
| Week 97:no problems washing or dressing | 292 | 85 |
| Week 97:slight problems washing or dressing | 51 | 8 |
| Week 97:moderate problems washing or dressing | 16 | 2 |
| Week 97:severe problems washing or dressing | 1 | 0 |
| Week 97:unable to wash or dress | 5 | 0 |
| Week 113:no problems washing or dressing | 214 | 60 |
| Week 113:slight problems washing or dressing | 46 | 7 |
| Week 113:moderate problems washing or dressing | 11 | 5 |
| Week 113:severe problems washing or dressing | 0 | 0 |
| Week 113:unable to wash or dress | 4 | 1 |
| Week 129:no problems washing or dressing | 147 | 35 |
| Week 129:slight problems washing or dressing | 28 | 5 |
| Week 129:moderate problems washing or dressing | 16 | 1 |
| Week 129:severe problems washing or dressing | 2 | 0 |
| Week 129:unable to wash or dress | 0 | 0 |
| Week 145:no problems washing or dressing | 92 | 15 |
| Week 145:slight problems washing or dressing | 16 | 5 |
| Week 145:moderate problems washing or dressing | 6 | 0 |
| Week 145:severe problems washing or dressing | 2 | 0 |
| Week 145:unable to wash or dress | 0 | 1 |
| Week 161:no problems washing or dressing | 33 | 7 |
| Week 161:slight problems washing or dressing | 3 | 0 |
| Week 161:moderate problems washing or dressing | 2 | 1 |
| Week 161:severe problems washing or dressing | 1 | 0 |
| Week 161:unable to wash or dress | 1 | 0 |
| Week 177:no problems washing or dressing | 3 | 1 |
| Week 177:slight problems washing or dressing | 3 | 0 |
| Week 177:moderate problems washing or dressing | 0 | 0 |
| Week 177:severe problems washing or dressing | 0 | 0 |
| Week 171:unable to wash or dress | 0 | 0 |
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 usual activities questionnaire are reported.
| participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline:no problems doing usual activities | 646 | 356 |
| Baseline:slight problems doing usual activities | 167 | 64 |
| Baseline:moderate problems | 56 | 14 |
| Baseline:severe problems | 10 | 5 |
| Baseline:unable to do usual activities | 5 | 0 |
| Week 17:no problems doing usual activities | 571 | 305 |
| Week 17:slight problems doing usual activities | 181 | 89 |
| Week 17:moderate problems | 60 | 24 |
| Week 17:severe problems | 21 | 0 |
| Week 17:unable to do usual activities | 7 | 1 |
| Week 33:no problems doing usual activities | 474 | 249 |
| Week 33:slight problems doing usual activities | 170 | 68 |
| Week 33:moderate problems | 68 | 18 |
| Week 33:severe problems | 21 | 7 |
| Week 33:unable to do usual activities | 5 | 0 |
| Week 49:no problems doing usual activities | 418 | 185 |
| Week 49:slight problems doing usual activities | 137 | 43 |
| Week 49:moderate problems | 55 | 14 |
| Week 49:severe problems | 20 | 6 |
| Week 49:unable to do usual activities | 5 | 2 |
| Week 65:no problems doing usual activities | 338 | 136 |
| Week 65:slight problems doing usual activities | 123 | 42 |
| Week 65:moderate problems | 60 | 11 |
| Week 65:severe problems | 5 | 4 |
| Week 65:unable to do usual activities | 10 | 0 |
| Week 81:no problems doing usual activities | 267 | 106 |
| Week 81:slight problems doing usual activities | 105 | 29 |
| Week 81:moderate problems | 49 | 7 |
| Week 81:severe problems | 10 | 3 |
| Week 81:unable to do usual activities | 4 | 3 |
| Week 97:no problems doing usual activities | 224 | 69 |
| Week 97:slight problems doing usual activities | 90 | 16 |
| Week 97:moderate problems | 39 | 8 |
| Week 97:severe problems | 9 | 0 |
| Week 97:unable to do usual activities | 3 | 2 |
| Week 113:no problems doing usual activities | 165 | 47 |
| Week 113:slight problems doing usual activities | 69 | 16 |
| Week 113:moderate problems | 33 | 6 |
| Week 113:severe problems | 5 | 3 |
| Week 113:unable to do usual activities | 3 | 1 |
| Week 129: Week :no problems doing usual activities | 108 | 30 |
| Week 129 :slight problems doing usual activities | 56 | 8 |
| Week 129:moderate problems | 26 | 3 |
| Week 129:severe problems | 3 | 0 |
| Week 129:unable to do usual activities | 0 | 0 |
| Week 145:no problems doing usual activities | 67 | 14 |
| Week 145:slight problems doing usual activities | 35 | 4 |
| Week 145:moderate problems | 11 | 2 |
| Week 145:severe problems | 3 | 1 |
| Week 145:unable to do usual activities | 0 | 0 |
| Week 161:no problems doing usual activities | 23 | 5 |
| Week 161:slight problems doing usual activities | 9 | 2 |
| Week 161:moderate problems | 5 | 1 |
| Week 161:severe problems | 2 | 0 |
| Week 161:unable to do usual activities | 1 | 0 |
| Week 177:no problems doing usual activities | 3 | 0 |
| Week 177:slight problems doing usual activities | 2 | 1 |
| Week 177:moderate problems | 1 | 0 |
| Week 177:severe problems | 0 | 0 |
| Week 177:unable to do usual activities | 0 | 0 |
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.
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline:no pain or discomfort | 546 | 292 |
| Baseline:slight pain or discomfort | 240 | 117 |
| Baseline:moderate pain or discomfort | 86 | 25 |
| Baseline:severe pain or discomfort | 10 | 4 |
| Baseline:extreme pain or discomfort | 2 | 1 |
| Week 17:no pain or discomfort | 464 | 248 |
| Week 17:slight pain or discomfort | 269 | 128 |
| Week 17: moderate pain or discomfort | 92 | 41 |
| Week 17:severe pain or discomfort | 13 | 2 |
| Week 17:extreme pain or discomfort | 2 | 0 |
| Week 33:no pain or discomfort | 405 | 204 |
| Week 33:slight pain or discomfort | 237 | 110 |
| Week 33:moderate pain or discomfort | 79 | 21 |
| Week 33:severe pain or discomfort | 16 | 7 |
| Week 33:extreme pain or discomfort | 1 | 0 |
| Week 49:no pain or discomfort | 340 | 134 |
| Week 49:slight pain or discomfort | 209 | 82 |
| Week 49:moderate pain or discomfort | 75 | 32 |
| Week 49:severe pain or discomfort | 10 | 1 |
| Week 49:extreme pain or discomfort | 1 | 1 |
| Week 65:no pain or discomfort | 298 | 102 |
| Week 65:slight pain or discomfort | 162 | 72 |
| Week 65:moderate pain or discomfort | 61 | 15 |
| Week 65:severe pain or discomfort | 11 | 3 |
| Week 65:extreme pain or discomfort | 4 | 1 |
| Week 81:no pain or discomfort | 231 | 86 |
| Week 81:slight pain or discomfort | 133 | 45 |
| Week 81:moderate pain or discomfort | 61 | 13 |
| Week 81 :severe pain or discomfort | 10 | 2 |
| Week 81:extreme pain or discomfort | 0 | 2 |
| Week 97:no pain or discomfort | 202 | 58 |
| Week 97:slight pain or discomfort | 115 | 28 |
| Week 97:moderate pain or discomfort | 43 | 7 |
| Week 97:severe pain or discomfort | 5 | 2 |
| Week 97:extreme pain or discomfort | 0 | 0 |
| Week 113:no pain or discomfort | 152 | 47 |
| Week 113:slight pain or discomfort | 80 | 19 |
| Week 113:moderate pain or discomfort | 37 | 5 |
| Week 113:severe pain or discomfort | 6 | 2 |
| Week 113:extreme pain or discomfort | 0 | 0 |
| Week 129:no pain or discomfort | 108 | 27 |
| Week 129:slight pain or discomfort | 55 | 11 |
| Week 129:moderate pain or discomfort | 28 | 3 |
| Week 129:severe pain or discomfort | 2 | 0 |
| Week 129:extreme pain or discomfort | 0 | 0 |
| Week 145:no pain or discomfort | 62 | 12 |
| Week 145:slight pain or discomfort | 38 | 8 |
| Week 145:moderate pain or discomfort | 15 | 1 |
| Week 145:severe pain or discomfort | 1 | 0 |
| Week 145:extreme pain or discomfort | 0 | 0 |
| Week 161:no pain or discomfort | 24 | 2 |
| Week 161:slight pain or discomfort | 8 | 5 |
| Week 161:moderate pain or discomfort | 5 | 1 |
| Week 161:severe pain or discomfort | 3 | 0 |
| Week 161:extreme pain or discomfort | 0 | 0 |
| Week 177:no pain or discomfort | 3 | 0 |
| Week 177:slight pain or discomfort | 1 | 1 |
| Week 177:moderate pain or discomfort | 2 | 0 |
| Week 177:severe pain or discomfort | 0 | 0 |
| Week 177:extreme pain or discomfort | 0 | 0 |
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.
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline:not anxious or depressed | 595 | 310 |
| Baseline:slightly anxious or depressed | 231 | 100 |
| Baseline:moderately anxious or depressed | 51 | 24 |
| Baseline:severely anxious or depressed | 6 | 5 |
| Baseline:extremely anxious or depressed | 1 | 0 |
| Week 17:not anxious or depressed | 517 | 265 |
| Week 17:slightly anxious or depressed | 251 | 119 |
| Week 17:moderately anxious or depressed | 62 | 31 |
| Week 17:severely anxious or depressed | 7 | 4 |
| Week 17:extremely anxious or depressed | 3 | 0 |
| Week 33:not anxious or depressed | 458 | 223 |
| Week 33:slightly anxious or depressed | 208 | 89 |
| Week 33:moderately anxious or depressed | 61 | 23 |
| Week 33:severely anxious or depressed | 9 | 5 |
| Week 33:extremely anxious or depressed | 2 | 2 |
| Week 49:not anxious or depressed | 410 | 155 |
| Week 49:slightly anxious or depressed | 172 | 72 |
| Week 49:moderately anxious or depressed | 41 | 20 |
| Week 49:severely anxious or depressed | 8 | 2 |
| Week 49:extremely anxious or depressed | 4 | 1 |
| Week 65:not anxious or depressed | 336 | 128 |
| Week 65:slightly anxious or depressed | 149 | 56 |
| Week 65:moderately anxious or depressed | 43 | 8 |
| Week 65:severely anxious or depressed | 8 | 1 |
| Week 65:extremely anxious or depressed | 0 | 0 |
| Week 81:not anxious or depressed | 288 | 86 |
| Week 81:slightly anxious or depressed | 106 | 48 |
| Week 81:moderately anxious or depressed | 34 | 9 |
| Week 81:severely anxious or depressed | 7 | 3 |
| Week 81:extremely anxious or depressed | 0 | 2 |
| Week 97:not anxious or depressed | 220 | 61 |
| Week 97:slightly anxious or depressed | 114 | 27 |
| Week 97:moderately anxious or depressed | 26 | 6 |
| Week 97:severely anxious or depressed | 4 | 0 |
| Week 97:extremely anxious or depressed | 1 | 1 |
| Week 113:not anxious or depressed | 167 | 43 |
| Week 113:slightly anxious or depressed | 87 | 27 |
| Week 113:moderately anxious or depressed | 18 | 3 |
| Week 113:severely anxious or depressed | 3 | 0 |
| Week 113:extremely anxious or depressed | 0 | 0 |
| Week 129:not anxious or depressed | 121 | 28 |
| Week 129:slightly anxious or depressed | 51 | 10 |
| Week 129:moderately anxious or depressed | 18 | 2 |
| Week 129:severely anxious or depressed | 2 | 1 |
| Week 129:extremely anxious or depressed | 1 | 0 |
| Week 145:not anxious or depressed | 73 | 12 |
| Week 145:slightly anxious or depressed | 30 | 8 |
| Week 145:moderately anxious or depressed | 10 | 1 |
| Week 145:severely anxious or depressed | 2 | 0 |
| Week 145:extremely anxious or depressed | 1 | 0 |
| Week 161:not anxious or depressed | 23 | 3 |
| Week 161:slightly anxious or depressed | 16 | 4 |
| Week 161:moderately anxious or depressed | 0 | 1 |
| Week 161:severely anxious or depressed | 0 | 0 |
| Week 161:extremely anxious or depressed | 1 | 0 |
| Week 177:not anxious or depressed | 2 | 1 |
| Week 177:slightly anxious or depressed | 2 | 0 |
| Week 177:moderately anxious or depressed | 2 | 0 |
| Week 177:severely anxious or depressed | 0 | 0 |
| Week 177:extremely anxious or depressed | 0 | 0 |
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-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.
| units on a scale | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline | 76.2 ± 16.92 | 77.5 ± 15.97 |
| Week 17 | 74.7 ± 17.19 | 74.9 ± 16.79 |
| Week 33 | 74.6 ± 16.69 | 74.0 ± 17.51 |
| Week 49 | 74.7 ± 18.02 | 73.7 ± 18.28 |
| Week 65 | 74.5 ± 17.79 | 73.0 ± 17.11 |
| Week 81 | 75.5 ± 17.06 | 73.3 ± 16.82 |
| Week 97 | 74.4 ± 17.39 | 75.2 ± 17.88 |
| Week 113 | 73.6 ± 18.05 | 74.7 ± 15.06 |
| Week 129 | 72.8 ± 18.25 | 77.1 ± 12.83 |
| Week 145 | 75.3 ± 17.02 | 74.2 ± 18.13 |
| Week 161 | 74.6 ± 21.28 | 73.8 ± 17.60 |
| Week 177 | 74.5 ± 19.31 | 69.0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 31 are reported. Question 31 was following: "Have you had to urinate frequently during the day?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 285 | 162 |
| Baseline: a little | 348 | 160 |
| Baseline: quite a bit | 207 | 92 |
| Baseline: very much | 44 | 25 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 275 | 134 |
| Week 17: a little | 324 | 168 |
| Week 17: quite a bit | 194 | 90 |
| Week 17: very much | 46 | 27 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 236 | 105 |
| Week 33: a little | 285 | 145 |
| Week 33: quite a bit | 176 | 70 |
| Week 33: very much | 40 | 21 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 200 | 82 |
| Week 49: a little | 260 | 92 |
| Week 49: quite a bit | 148 | 67 |
| Week 49: very much | 27 | 9 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 172 | 54 |
| Week 65: a little | 209 | 79 |
| Week 65: quite a bit | 125 | 48 |
| Week 65: very much | 30 | 12 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 141 | 46 |
| Week 81: a little | 181 | 60 |
| Week 81: quite a bit | 92 | 31 |
| Week 81: very much | 20 | 11 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 118 | 33 |
| Week 97: a little | 146 | 40 |
| Week 97: quite a bit | 80 | 19 |
| Week 97: very much | 21 | 3 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 101 | 17 |
| Week 113: a little | 112 | 40 |
| Week 113: quite a bit | 46 | 14 |
| Week 113: very much | 16 | 2 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 70 | 11 |
| Week 129: a little | 79 | 16 |
| Week 129: quite a bit | 39 | 10 |
| Week 129: very much | 4 | 4 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 42 | 2 |
| Week 145: a little | 51 | 14 |
| Week 145: quite a bit | 20 | 4 |
| Week 145: very much | 3 | 1 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 9 | 2 |
| Week 161: a little | 20 | 4 |
| Week 161: quite a bit | 7 | 1 |
| Week 161: very much | 4 | 1 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 0 | 0 |
| Week 177: a little | 4 | 1 |
| Week 177: quite a bit | 2 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 32 are reported. Question 32 was following: "Have you had to urinate frequently at night?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 193 | 108 |
| Baseline: a little | 423 | 195 |
| Baseline: quite a bit | 200 | 103 |
| Baseline: very much | 68 | 33 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 194 | 88 |
| Week 17: a little | 407 | 199 |
| Week 17: quite a bit | 184 | 98 |
| Week 17: very much | 54 | 34 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 173 | 83 |
| Week 33: a little | 351 | 161 |
| Week 33: quite a bit | 169 | 69 |
| Week 33: very much | 44 | 28 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 148 | 59 |
| Week 49: a little | 313 | 116 |
| Week 49: quite a bit | 141 | 59 |
| Week 49: very much | 33 | 16 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 118 | 41 |
| Week 65: a little | 266 | 89 |
| Week 65: quite a bit | 111 | 48 |
| Week 65: very much | 41 | 15 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 91 | 38 |
| Week 81: a little | 231 | 60 |
| Week 81: quite a bit | 89 | 38 |
| Week 81: very much | 23 | 12 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 88 | 19 |
| Week 97: a little | 169 | 53 |
| Week 97: quite a bit | 82 | 19 |
| Week 97: very much | 26 | 4 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 67 | 16 |
| Week 113: a little | 137 | 32 |
| Week 113: quite a bit | 54 | 23 |
| Week 113: very much | 17 | 2 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 50 | 9 |
| Week 129: a little | 97 | 18 |
| Week 129: quite a bit | 37 | 10 |
| Week 129: very much | 8 | 4 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 31 | 2 |
| Week 145: a little | 59 | 14 |
| Week 145: quite a bit | 24 | 5 |
| Week 145: very much | 2 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 9 | 0 |
| Week 161: a little | 23 | 7 |
| Week 161: quite a bit | 5 | 0 |
| Week 161: very much | 3 | 1 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 2 | 0 |
| Week 177: a little | 2 | 1 |
| Week 177: quite a bit | 2 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 33 are reported. Question 33 was following: "When you felt the urge to pass urine, did you have to hurry to get to the toilet?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 406 | 197 |
| Baseline: a little | 266 | 147 |
| Baseline: quite a bit | 150 | 70 |
| Baseline: very much | 62 | 25 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 350 | 191 |
| Week 17: a little | 297 | 150 |
| Week 17: quite a bit | 127 | 55 |
| Week 17: very much | 65 | 23 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 279 | 147 |
| Week 33: a little | 278 | 126 |
| Week 33: quite a bit | 126 | 48 |
| Week 33: very much | 54 | 20 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 272 | 100 |
| Week 49: a little | 222 | 95 |
| Week 49: quite a bit | 96 | 38 |
| Week 49: very much | 45 | 17 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 213 | 76 |
| Week 65: a little | 213 | 72 |
| Week 65: quite a bit | 71 | 31 |
| Week 65: very much | 39 | 14 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 181 | 63 |
| Week 81: a little | 157 | 52 |
| Week 81: quite a bit | 69 | 27 |
| Week 81: very much | 27 | 6 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 146 | 40 |
| Week 97: a little | 131 | 40 |
| Week 97: quite a bit | 59 | 12 |
| Week 97: very much | 29 | 3 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 114 | 29 |
| Week 113: a little | 106 | 34 |
| Week 113: quite a bit | 40 | 9 |
| Week 113: very much | 15 | 1 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 86 | 10 |
| Week 129: a little | 72 | 21 |
| Week 129: quite a bit | 26 | 6 |
| Week 129: very much | 8 | 4 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 51 | 5 |
| Week 145: a little | 39 | 12 |
| Week 145: quite a bit | 21 | 4 |
| Week 145: very much | 5 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 17 | 0 |
| Week 161: a little | 19 | 5 |
| Week 161: quite a bit | 3 | 3 |
| Week 161: very much | 1 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 2 | 0 |
| Week 177: a little | 1 | 1 |
| Week 177: quite a bit | 3 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 34 are reported. Question 34 was following: "Was it difficult for you to get enough sleep, because you needed to get up frequently at night to urinate?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 479 | 235 |
| Baseline: a little | 273 | 146 |
| Baseline: quite a bit | 93 | 40 |
| Baseline: very much | 39 | 18 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 437 | 214 |
| Week 17: a little | 295 | 144 |
| Week 17: quite a bit | 75 | 45 |
| Week 17: very much | 32 | 16 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 392 | 180 |
| Week 33: a little | 246 | 112 |
| Week 33: quite a bit | 75 | 33 |
| Week 33: very much | 24 | 16 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 340 | 119 |
| Week 49: a little | 211 | 94 |
| Week 49: quite a bit | 65 | 28 |
| Week 49: very much | 19 | 9 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 286 | 92 |
| Week 65: a little | 183 | 67 |
| Week 65: quite a bit | 47 | 29 |
| Week 65: very much | 20 | 5 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 221 | 70 |
| Week 81: a little | 165 | 55 |
| Week 81: quite a bit | 37 | 18 |
| Week 81: very much | 11 | 5 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 185 | 47 |
| Week 97: a little | 122 | 33 |
| Week 97: quite a bit | 43 | 14 |
| Week 97: very much | 15 | 1 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 135 | 31 |
| Week 113: a little | 102 | 33 |
| Week 113: quite a bit | 29 | 7 |
| Week 113: very much | 9 | 2 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 103 | 13 |
| Week 129: a little | 67 | 23 |
| Week 129: quite a bit | 19 | 4 |
| Week 129: very much | 3 | 1 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 59 | 9 |
| Week 145: a little | 44 | 10 |
| Week 145: quite a bit | 11 | 1 |
| Week 145: very much | 2 | 1 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 21 | 2 |
| Week 161: a little | 16 | 5 |
| Week 161: quite a bit | 3 | 0 |
| Week 161: very much | 0 | 1 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 3 | 0 |
| Week 177: a little | 1 | 1 |
| Week 177: quite a bit | 2 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 35 are reported. Question 35 was following: "Have you had difficulty going out of the house because you needed to be close to a toilet?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 646 | 330 |
| Baseline: a little | 177 | 84 |
| Baseline: quite a bit | 45 | 18 |
| Baseline: very much | 16 | 7 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 604 | 295 |
| Week 17: a little | 174 | 100 |
| Week 17: quite a bit | 46 | 15 |
| Week 17: very much | 15 | 9 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 501 | 242 |
| Week 33: a little | 171 | 74 |
| Week 33: quite a bit | 50 | 20 |
| Week 33: very much | 15 | 5 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 436 | 174 |
| Week 49: a little | 153 | 53 |
| Week 49: quite a bit | 38 | 20 |
| Week 49: very much | 8 | 3 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 369 | 132 |
| Week 65: a little | 125 | 50 |
| Week 65: quite a bit | 28 | 9 |
| Week 65: very much | 14 | 2 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 308 | 105 |
| Week 81: a little | 94 | 35 |
| Week 81: quite a bit | 23 | 8 |
| Week 81: very much | 9 | 0 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 241 | 67 |
| Week 97: a little | 91 | 21 |
| Week 97: quite a bit | 26 | 6 |
| Week 97: very much | 7 | 1 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 180 | 47 |
| Week 113: a little | 70 | 21 |
| Week 113: quite a bit | 18 | 5 |
| Week 113: very much | 7 | 0 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 131 | 26 |
| Week 129: a little | 48 | 13 |
| Week 129: quite a bit | 8 | 1 |
| Week 129: very much | 5 | 1 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 74 | 13 |
| Week 145: a little | 36 | 6 |
| Week 145: quite a bit | 6 | 0 |
| Week 145: very much | 0 | 2 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 24 | 4 |
| Week 161: a little | 13 | 4 |
| Week 161: quite a bit | 3 | 0 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 3 | 0 |
| Week 177: a little | 3 | 1 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 36 are reported. Question 36 was following: "Have you had any unintentional release (leakage) of urine?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 550 | 283 |
| Baseline: a little | 273 | 124 |
| Baseline: quite a bit | 36 | 20 |
| Baseline: very much | 25 | 12 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 511 | 255 |
| Week 17: a little | 264 | 126 |
| Week 17: quite a bit | 39 | 27 |
| Week 17: very much | 25 | 11 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 428 | 208 |
| Week 33: a little | 246 | 104 |
| Week 33: quite a bit | 34 | 19 |
| Week 33: very much | 29 | 10 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 369 | 146 |
| Week 49: a little | 209 | 78 |
| Week 49: quite a bit | 41 | 22 |
| Week 49: very much | 16 | 4 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 307 | 115 |
| Week 65: a little | 170 | 66 |
| Week 65: quite a bit | 47 | 8 |
| Week 65: very much | 12 | 4 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 248 | 93 |
| Week 81: a little | 158 | 41 |
| Week 81: quite a bit | 23 | 11 |
| Week 81: very much | 5 | 3 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 195 | 55 |
| Week 97: a little | 134 | 33 |
| Week 97: quite a bit | 25 | 7 |
| Week 97: very much | 11 | 0 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 160 | 42 |
| Week 113: a little | 91 | 28 |
| Week 113: quite a bit | 17 | 3 |
| Week 113: very much | 7 | 0 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 109 | 22 |
| Week 129: a little | 68 | 13 |
| Week 129: quite a bit | 13 | 5 |
| Week 129: very much | 2 | 1 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 58 | 9 |
| Week 145: a little | 45 | 11 |
| Week 145: quite a bit | 10 | 0 |
| Week 145: very much | 3 | 1 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 18 | 3 |
| Week 161: a little | 21 | 4 |
| Week 161: quite a bit | 0 | 1 |
| Week 161: very much | 1 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 1 | 0 |
| Week 177: a little | 3 | 1 |
| Week 177: quite a bit | 1 | 0 |
| Week 177: very much | 1 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 37 are reported. Question 37 was following: "Did you have pain when you urinated?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 775 | 380 |
| Baseline: a little | 92 | 47 |
| Baseline: quite a bit | 10 | 8 |
| Baseline: very much | 7 | 4 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 762 | 351 |
| Week 17: a little | 65 | 58 |
| Week 17: quite a bit | 12 | 8 |
| Week 17: very much | 0 | 2 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 662 | 291 |
| Week 33: a little | 63 | 39 |
| Week 33: quite a bit | 11 | 8 |
| Week 33: very much | 1 | 3 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 577 | 209 |
| Week 49: a little | 49 | 34 |
| Week 49: quite a bit | 6 | 3 |
| Week 49: very much | 3 | 4 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 492 | 161 |
| Week 65: a little | 32 | 29 |
| Week 65: quite a bit | 9 | 2 |
| Week 65: very much | 3 | 1 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 389 | 119 |
| Week 81: a little | 40 | 27 |
| Week 81: quite a bit | 4 | 2 |
| Week 81: very much | 1 | 0 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 332 | 84 |
| Week 97: a little | 28 | 11 |
| Week 97: quite a bit | 4 | 0 |
| Week 97: very much | 1 | 0 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 247 | 57 |
| Week 113: a little | 26 | 13 |
| Week 113: quite a bit | 1 | 3 |
| Week 113: very much | 1 | 0 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 173 | 34 |
| Week 129: a little | 16 | 7 |
| Week 129: quite a bit | 1 | 0 |
| Week 129: very much | 2 | 0 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 102 | 15 |
| Week 145: a little | 14 | 6 |
| Week 145: quite a bit | 0 | 0 |
| Week 145: very much | 0 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 36 | 6 |
| Week 161: a little | 3 | 1 |
| Week 161: quite a bit | 1 | 1 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 6 | 0 |
| Week 177: a little | 0 | 1 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 38 are reported. Question 38 was following: "Has wearing an incontinence aid been a problem for you?". This question was answered by only those participants who wore incontinence aid.
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 83 | 37 |
| Baseline: a little | 40 | 19 |
| Baseline: quite a bit | 15 | 3 |
| Baseline: very much | 6 | 8 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 77 | 34 |
| Week 17: a little | 48 | 21 |
| Week 17: quite a bit | 15 | 7 |
| Week 17: very much | 6 | 6 |
| Week 17: not answered | 693 | 351 |
| Week 33: not at all | 76 | 30 |
| Week 33: a little | 47 | 28 |
| Week 33: quite a bit | 16 | 4 |
| Week 33: very much | 5 | 4 |
| Week 33: not answered | 593 | 275 |
| Week 49: not at all | 73 | 18 |
| Week 49: a little | 43 | 16 |
| Week 49: quite a bit | 12 | 9 |
| Week 49: very much | 4 | 2 |
| Week 49: not answered | 503 | 205 |
| Week 65: not at all | 63 | 12 |
| Week 65: a little | 40 | 17 |
| Week 65: quite a bit | 9 | 5 |
| Week 65: very much | 3 | 1 |
| Week 65: not answered | 421 | 158 |
| Week 81: not at all | 52 | 15 |
| Week 81: a little | 33 | 9 |
| Week 81: quite a bit | 10 | 1 |
| Week 81: very much | 3 | 3 |
| Week 81: not answered | 336 | 120 |
| Week 97: not at all | 50 | 8 |
| Week 97: a little | 28 | 8 |
| Week 97: quite a bit | 7 | 2 |
| Week 97: very much | 3 | 0 |
| Week 97: not answered | 277 | 77 |
| Week 113: not at all | 31 | 12 |
| Week 113: a little | 18 | 7 |
| Week 113: quite a bit | 8 | 2 |
| Week 113: very much | 2 | 0 |
| Week 113: not answered | 216 | 52 |
| Week 129: not at all | 27 | 5 |
| Week 129: a little | 18 | 5 |
| Week 129: quite a bit | 2 | 1 |
| Week 129: very much | 0 | 0 |
| Week 129: not answered | 145 | 30 |
| Week 145: not at all | 16 | 2 |
| Week 145: a little | 10 | 4 |
| Week 145: quite a bit | 5 | 0 |
| Week 145: very much | 0 | 0 |
| Week 145: not answered | 85 | 15 |
| Week 161: not at all | 10 | 1 |
| Week 161: a little | 3 | 2 |
| Week 161: quite a bit | 1 | 1 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 26 | 4 |
| Week 177: not at all | 3 | 0 |
| Week 177: a little | 1 | 0 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 2 | 1 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 39 are reported. Question 39 was following: "Have your daily activities been limited by your urinary problems?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 666 | 338 |
| Baseline: a little | 173 | 80 |
| Baseline: quite a bit | 35 | 11 |
| Baseline: very much | 10 | 10 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 632 | 305 |
| Week 17: a little | 160 | 99 |
| Week 17: quite a bit | 36 | 6 |
| Week 17: very much | 11 | 9 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 523 | 242 |
| Week 33: a little | 172 | 79 |
| Week 33: quite a bit | 31 | 14 |
| Week 33: very much | 11 | 6 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 444 | 173 |
| Week 49: a little | 152 | 58 |
| Week 49: quite a bit | 31 | 18 |
| Week 49: very much | 8 | 1 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 382 | 128 |
| Week 65: a little | 124 | 51 |
| Week 65: quite a bit | 20 | 12 |
| Week 65: very much | 10 | 2 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 310 | 103 |
| Week 81: a little | 98 | 35 |
| Week 81: quite a bit | 21 | 8 |
| Week 81: very much | 5 | 2 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 242 | 72 |
| Week 97: a little | 100 | 18 |
| Week 97: quite a bit | 18 | 4 |
| Week 97: very much | 5 | 1 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 188 | 54 |
| Week 113: a little | 71 | 14 |
| Week 113: quite a bit | 13 | 3 |
| Week 113: very much | 3 | 2 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 127 | 25 |
| Week 129: a little | 55 | 14 |
| Week 129: quite a bit | 7 | 1 |
| Week 129: very much | 3 | 1 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 77 | 11 |
| Week 145: a little | 34 | 9 |
| Week 145: quite a bit | 4 | 1 |
| Week 145: very much | 1 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 27 | 2 |
| Week 161: a little | 10 | 6 |
| Week 161: quite a bit | 3 | 0 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 3 | 0 |
| Week 177: a little | 3 | 1 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 40 are reported. Question 40 was following: "Have your daily activities been limited by your bowel problems?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 758 | 393 |
| Baseline: a little | 112 | 40 |
| Baseline: quite a bit | 9 | 4 |
| Baseline: very much | 5 | 2 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 707 | 352 |
| Week 17: a little | 107 | 57 |
| Week 17: quite a bit | 19 | 6 |
| Week 17: very much | 6 | 4 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 621 | 292 |
| Week 33: a little | 98 | 40 |
| Week 33: quite a bit | 14 | 8 |
| Week 33: very much | 4 | 1 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 525 | 211 |
| Week 49: a little | 88 | 29 |
| Week 49: quite a bit | 20 | 7 |
| Week 49: very much | 2 | 3 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 441 | 165 |
| Week 65: a little | 78 | 24 |
| Week 65: quite a bit | 11 | 3 |
| Week 65: very much | 6 | 1 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 360 | 121 |
| Week 81: a little | 56 | 23 |
| Week 81: quite a bit | 17 | 3 |
| Week 81: very much | 1 | 1 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 289 | 84 |
| Week 97: a little | 58 | 11 |
| Week 97: quite a bit | 17 | 0 |
| Week 97: very much | 1 | 0 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 219 | 62 |
| Week 113: a little | 46 | 11 |
| Week 113: quite a bit | 8 | 0 |
| Week 113: very much | 2 | 0 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 153 | 36 |
| Week 129: a little | 33 | 5 |
| Week 129: quite a bit | 5 | 0 |
| Week 129: very much | 1 | 0 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 93 | 17 |
| Week 145: a little | 19 | 4 |
| Week 145: quite a bit | 4 | 0 |
| Week 145: very much | 0 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 29 | 8 |
| Week 161: a little | 9 | 0 |
| Week 161: quite a bit | 2 | 0 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 4 | 1 |
| Week 177: a little | 2 | 0 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 41 are reported. Question 41 was following: "Have you had any unintentional release (leakage) of stools?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 794 | 404 |
| Baseline: a little | 78 | 32 |
| Baseline: quite a bit | 11 | 2 |
| Baseline: very much | 1 | 1 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 751 | 372 |
| Week 17: a little | 79 | 43 |
| Week 17: quite a bit | 8 | 3 |
| Week 17: very much | 1 | 1 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 638 | 307 |
| Week 33: a little | 92 | 32 |
| Week 33: quite a bit | 4 | 1 |
| Week 33: very much | 3 | 1 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 554 | 221 |
| Week 49: a little | 73 | 25 |
| Week 49: quite a bit | 5 | 4 |
| Week 49: very much | 3 | 0 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 467 | 175 |
| Week 65: a little | 57 | 16 |
| Week 65: quite a bit | 9 | 1 |
| Week 65: very much | 3 | 1 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 380 | 136 |
| Week 81: a little | 51 | 12 |
| Week 81: quite a bit | 2 | 0 |
| Week 81: very much | 1 | 0 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 315 | 86 |
| Week 97: a little | 47 | 9 |
| Week 97: quite a bit | 3 | 0 |
| Week 97: very much | 0 | 0 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 233 | 66 |
| Week 113: a little | 40 | 7 |
| Week 113: quite a bit | 2 | 0 |
| Week 113: very much | 0 | 0 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 167 | 39 |
| Week 129: a little | 25 | 2 |
| Week 129: quite a bit | 0 | 0 |
| Week 129: very much | 0 | 0 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 93 | 20 |
| Week 145: a little | 22 | 1 |
| Week 145: quite a bit | 0 | 0 |
| Week 145: very much | 1 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 30 | 8 |
| Week 161: a little | 9 | 0 |
| Week 161: quite a bit | 0 | 0 |
| Week 161: very much | 1 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 4 | 1 |
| Week 177: a little | 2 | 0 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 42 are reported. Question 42 was following: "Have you had blood in your stools?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 836 | 422 |
| Baseline: a little | 48 | 17 |
| Baseline: quite a bit | 0 | 0 |
| Baseline: very much | 0 | 0 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 801 | 399 |
| Week 17: a little | 36 | 18 |
| Week 17: quite a bit | 2 | 2 |
| Week 17: very much | 0 | 0 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 707 | 330 |
| Week 33: a little | 29 | 11 |
| Week 33: quite a bit | 1 | 0 |
| Week 33: very much | 0 | 0 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 608 | 245 |
| Week 49: a little | 27 | 5 |
| Week 49: quite a bit | 0 | 0 |
| Week 49: very much | 0 | 0 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 514 | 180 |
| Week 65: a little | 19 | 13 |
| Week 65: quite a bit | 3 | 0 |
| Week 65: very much | 0 | 0 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 420 | 143 |
| Week 81: a little | 14 | 4 |
| Week 81: quite a bit | 0 | 1 |
| Week 81: very much | 0 | 0 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 357 | 93 |
| Week 97: a little | 8 | 2 |
| Week 97: quite a bit | 0 | 0 |
| Week 97: very much | 0 | 0 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 262 | 72 |
| Week 113: a little | 13 | 1 |
| Week 113: quite a bit | 0 | 0 |
| Week 113: very much | 0 | 0 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 186 | 41 |
| Week 129: a little | 5 | 0 |
| Week 129: quite a bit | 1 | 0 |
| Week 129: very much | 0 | 0 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 114 | 21 |
| Week 145: a little | 2 | 0 |
| Week 145: quite a bit | 0 | 0 |
| Week 145: very much | 0 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 38 | 8 |
| Week 161: a little | 2 | 0 |
| Week 161: quite a bit | 0 | 0 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 6 | 1 |
| Week 177: a little | 0 | 0 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 43 are reported. Question 43 was following: "Did you have a bloated feeling in your abdomen?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 667 | 320 |
| Baseline: a little | 190 | 103 |
| Baseline: quite a bit | 22 | 16 |
| Baseline: very much | 5 | 0 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 601 | 283 |
| Week 17: a little | 199 | 121 |
| Week 17: quite a bit | 31 | 13 |
| Week 17: very much | 8 | 2 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 526 | 235 |
| Week 33: a little | 183 | 95 |
| Week 33: quite a bit | 22 | 8 |
| Week 33: very much | 6 | 3 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 449 | 174 |
| Week 49: a little | 163 | 63 |
| Week 49: quite a bit | 20 | 11 |
| Week 49: very much | 3 | 2 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 381 | 135 |
| Week 65: a little | 132 | 51 |
| Week 65: quite a bit | 19 | 7 |
| Week 65: very much | 4 | 0 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 304 | 103 |
| Week 81: a little | 110 | 44 |
| Week 81: quite a bit | 18 | 1 |
| Week 81: very much | 2 | 0 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 258 | 72 |
| Week 97: a little | 87 | 23 |
| Week 97: quite a bit | 19 | 0 |
| Week 97: very much | 1 | 0 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 199 | 55 |
| Week 113: a little | 66 | 18 |
| Week 113: quite a bit | 9 | 0 |
| Week 113: very much | 1 | 0 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 139 | 25 |
| Week 129: a little | 43 | 16 |
| Week 129: quite a bit | 8 | 0 |
| Week 129: very much | 2 | 0 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 87 | 13 |
| Week 145: a little | 24 | 8 |
| Week 145: quite a bit | 4 | 0 |
| Week 145: very much | 1 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 33 | 6 |
| Week 161: a little | 7 | 2 |
| Week 161: quite a bit | 0 | 0 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 4 | 0 |
| Week 177: a little | 2 | 1 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 44 are reported. Question 44 was following: "Did you have hot flushes?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 374 | 177 |
| Baseline: a little | 314 | 166 |
| Baseline: quite a bit | 151 | 68 |
| Baseline: very much | 45 | 28 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 265 | 182 |
| Week 17: a little | 311 | 153 |
| Week 17: quite a bit | 189 | 62 |
| Week 17: very much | 74 | 22 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 253 | 144 |
| Week 33: a little | 268 | 116 |
| Week 33: quite a bit | 155 | 60 |
| Week 33: very much | 61 | 21 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 227 | 112 |
| Week 49: a little | 235 | 94 |
| Week 49: quite a bit | 130 | 30 |
| Week 49: very much | 43 | 14 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 203 | 79 |
| Week 65: a little | 194 | 77 |
| Week 65: quite a bit | 104 | 30 |
| Week 65: very much | 35 | 7 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 175 | 69 |
| Week 81: a little | 157 | 58 |
| Week 81: quite a bit | 75 | 16 |
| Week 81: very much | 27 | 5 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 155 | 48 |
| Week 97: a little | 126 | 34 |
| Week 97: quite a bit | 57 | 12 |
| Week 97: very much | 27 | 1 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 114 | 33 |
| Week 113: a little | 102 | 24 |
| Week 113: quite a bit | 44 | 14 |
| Week 113: very much | 15 | 2 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 84 | 22 |
| Week 129: a little | 74 | 16 |
| Week 129: quite a bit | 23 | 3 |
| Week 129: very much | 11 | 0 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 45 | 10 |
| Week 145: a little | 46 | 10 |
| Week 145: quite a bit | 18 | 0 |
| Week 145: very much | 7 | 1 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 18 | 3 |
| Week 161: a little | 14 | 3 |
| Week 161: quite a bit | 5 | 2 |
| Week 161: very much | 3 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 3 | 0 |
| Week 177: a little | 0 | 0 |
| Week 177: quite a bit | 1 | 1 |
| Week 177: very much | 2 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 45 are reported. Question 45 was following: "Have you had sore or enlarged nipples or breasts?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 688 | 333 |
| Baseline: a little | 146 | 80 |
| Baseline: quite a bit | 38 | 24 |
| Baseline: very much | 12 | 2 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 626 | 315 |
| Week 17: a little | 160 | 80 |
| Week 17: quite a bit | 39 | 18 |
| Week 17: very much | 14 | 6 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 526 | 260 |
| Week 33: a little | 164 | 62 |
| Week 33: quite a bit | 34 | 15 |
| Week 33: very much | 13 | 4 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 444 | 188 |
| Week 49: a little | 138 | 52 |
| Week 49: quite a bit | 41 | 5 |
| Week 49: very much | 12 | 5 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 371 | 149 |
| Week 65: a little | 119 | 37 |
| Week 65: quite a bit | 31 | 7 |
| Week 65: very much | 15 | 0 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 306 | 115 |
| Week 81: a little | 84 | 26 |
| Week 81: quite a bit | 34 | 6 |
| Week 81: very much | 10 | 1 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 239 | 80 |
| Week 97: a little | 92 | 13 |
| Week 97: quite a bit | 30 | 1 |
| Week 97: very much | 4 | 1 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 190 | 55 |
| Week 113: a little | 62 | 12 |
| Week 113: quite a bit | 19 | 5 |
| Week 113: very much | 4 | 1 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 128 | 30 |
| Week 129: a little | 51 | 8 |
| Week 129: quite a bit | 9 | 3 |
| Week 129: very much | 4 | 0 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 78 | 17 |
| Week 145: a little | 29 | 3 |
| Week 145: quite a bit | 7 | 1 |
| Week 145: very much | 2 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 26 | 4 |
| Week 161: a little | 11 | 3 |
| Week 161: quite a bit | 1 | 0 |
| Week 161: very much | 2 | 1 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 2 | 0 |
| Week 177: a little | 2 | 1 |
| Week 177: quite a bit | 2 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 46 are reported. Question 46 was following: "Have you had swelling in your legs or ankles?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 663 | 323 |
| Baseline: a little | 189 | 89 |
| Baseline: quite a bit | 22 | 22 |
| Baseline: very much | 10 | 5 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 625 | 284 |
| Week 17: a little | 179 | 112 |
| Week 17: quite a bit | 30 | 21 |
| Week 17: very much | 5 | 2 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 530 | 243 |
| Week 33: a little | 159 | 76 |
| Week 33: quite a bit | 41 | 20 |
| Week 33: very much | 7 | 2 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 453 | 176 |
| Week 49: a little | 155 | 58 |
| Week 49: quite a bit | 23 | 15 |
| Week 49: very much | 4 | 1 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 378 | 135 |
| Week 65: a little | 127 | 48 |
| Week 65: quite a bit | 27 | 10 |
| Week 65: very much | 4 | 0 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 301 | 104 |
| Week 81: a little | 102 | 36 |
| Week 81: quite a bit | 27 | 7 |
| Week 81: very much | 4 | 1 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 259 | 69 |
| Week 97: a little | 79 | 20 |
| Week 97: quite a bit | 19 | 5 |
| Week 97: very much | 8 | 1 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 191 | 40 |
| Week 113: a little | 65 | 27 |
| Week 113: quite a bit | 16 | 6 |
| Week 113: very much | 3 | 0 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 134 | 27 |
| Week 129: a little | 48 | 14 |
| Week 129: quite a bit | 8 | 0 |
| Week 129: very much | 2 | 0 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 76 | 15 |
| Week 145: a little | 34 | 5 |
| Week 145: quite a bit | 5 | 1 |
| Week 145: very much | 1 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 31 | 6 |
| Week 161: a little | 8 | 2 |
| Week 161: quite a bit | 1 | 0 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 3 | 0 |
| Week 177: a little | 3 | 0 |
| Week 177: quite a bit | 0 | 1 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 47 are reported. Question 47 was following: "Has weight loss been a problem for you?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 820 | 399 |
| Baseline: a little | 48 | 25 |
| Baseline: quite a bit | 10 | 10 |
| Baseline: very much | 6 | 5 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 733 | 375 |
| Week 17: a little | 81 | 28 |
| Week 17: quite a bit | 15 | 13 |
| Week 17: very much | 10 | 3 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 643 | 296 |
| Week 33: a little | 72 | 35 |
| Week 33: quite a bit | 13 | 5 |
| Week 33: very much | 9 | 5 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 553 | 215 |
| Week 49: a little | 61 | 29 |
| Week 49: quite a bit | 15 | 3 |
| Week 49: very much | 6 | 3 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 479 | 168 |
| Week 65: a little | 39 | 20 |
| Week 65: quite a bit | 11 | 4 |
| Week 65: very much | 7 | 1 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 371 | 136 |
| Week 81: a little | 46 | 10 |
| Week 81: quite a bit | 14 | 1 |
| Week 81: very much | 3 | 1 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 314 | 84 |
| Week 97: a little | 36 | 10 |
| Week 97: quite a bit | 10 | 0 |
| Week 97: very much | 5 | 1 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 235 | 62 |
| Week 113: a little | 27 | 8 |
| Week 113: quite a bit | 9 | 1 |
| Week 113: very much | 4 | 2 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 169 | 37 |
| Week 129: a little | 17 | 4 |
| Week 129: quite a bit | 5 | 0 |
| Week 129: very much | 1 | 0 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 95 | 20 |
| Week 145: a little | 17 | 1 |
| Week 145: quite a bit | 4 | 0 |
| Week 145: very much | 0 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 34 | 8 |
| Week 161: a little | 5 | 0 |
| Week 161: quite a bit | 1 | 0 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 5 | 1 |
| Week 177: a little | 0 | 0 |
| Week 177: quite a bit | 1 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 48 are reported. Question 48 was following: "Has weight gain been a problem for you?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 677 | 315 |
| Baseline: a little | 153 | 95 |
| Baseline: quite a bit | 40 | 16 |
| Baseline: very much | 14 | 13 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 674 | 316 |
| Week 17: a little | 118 | 74 |
| Week 17: quite a bit | 30 | 19 |
| Week 17: very much | 17 | 10 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 570 | 259 |
| Week 33: a little | 133 | 59 |
| Week 33: quite a bit | 21 | 18 |
| Week 33: very much | 13 | 5 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 479 | 193 |
| Week 49: a little | 125 | 44 |
| Week 49: quite a bit | 18 | 10 |
| Week 49: very much | 13 | 3 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 410 | 155 |
| Week 65: a little | 92 | 27 |
| Week 65: quite a bit | 26 | 9 |
| Week 65: very much | 8 | 2 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 327 | 115 |
| Week 81: a little | 71 | 27 |
| Week 81: quite a bit | 28 | 5 |
| Week 81: very much | 8 | 1 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 267 | 76 |
| Week 97: a little | 70 | 16 |
| Week 97: quite a bit | 24 | 2 |
| Week 97: very much | 4 | 1 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 200 | 60 |
| Week 113: a little | 56 | 10 |
| Week 113: quite a bit | 10 | 3 |
| Week 113: very much | 9 | 0 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 156 | 32 |
| Week 129: a little | 27 | 8 |
| Week 129: quite a bit | 5 | 1 |
| Week 129: very much | 4 | 0 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 89 | 16 |
| Week 145: a little | 18 | 5 |
| Week 145: quite a bit | 7 | 0 |
| Week 145: very much | 2 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 31 | 6 |
| Week 161: a little | 6 | 2 |
| Week 161: quite a bit | 1 | 0 |
| Week 161: very much | 2 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 2 | 0 |
| Week 177: a little | 3 | 1 |
| Week 177: quite a bit | 1 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 49 are reported. Question 49 was following: "Have you felt less masculine as a result of your illness or treatment?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 435 | 214 |
| Baseline: a little | 234 | 131 |
| Baseline: quite a bit | 138 | 59 |
| Baseline: very much | 77 | 35 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 400 | 210 |
| Week 17: a little | 244 | 115 |
| Week 17: quite a bit | 109 | 57 |
| Week 17: very much | 86 | 37 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 345 | 167 |
| Week 33: a little | 207 | 107 |
| Week 33: quite a bit | 109 | 38 |
| Week 33: very much | 76 | 29 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 302 | 127 |
| Week 49: a little | 187 | 68 |
| Week 49: quite a bit | 84 | 36 |
| Week 49: very much | 62 | 19 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 263 | 90 |
| Week 65: a little | 142 | 57 |
| Week 65: quite a bit | 71 | 24 |
| Week 65: very much | 60 | 22 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 206 | 74 |
| Week 81: a little | 124 | 38 |
| Week 81: quite a bit | 57 | 17 |
| Week 81: very much | 47 | 19 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 175 | 46 |
| Week 97: a little | 98 | 28 |
| Week 97: quite a bit | 47 | 10 |
| Week 97: very much | 45 | 11 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 136 | 31 |
| Week 113: a little | 78 | 27 |
| Week 113: quite a bit | 30 | 8 |
| Week 113: very much | 31 | 7 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 91 | 18 |
| Week 129: a little | 49 | 16 |
| Week 129: quite a bit | 27 | 5 |
| Week 129: very much | 25 | 2 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 59 | 9 |
| Week 145: a little | 31 | 9 |
| Week 145: quite a bit | 18 | 1 |
| Week 145: very much | 8 | 2 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 18 | 2 |
| Week 161: a little | 15 | 3 |
| Week 161: quite a bit | 3 | 1 |
| Week 161: very much | 4 | 2 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 3 | 0 |
| Week 177: a little | 3 | 1 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 50 are reported. Question 50 was following: "To what extent were you interested in sex?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 586 | 291 |
| Baseline: a little | 204 | 101 |
| Baseline: quite a bit | 67 | 32 |
| Baseline: very much | 27 | 15 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 637 | 293 |
| Week 17: a little | 136 | 92 |
| Week 17: quite a bit | 45 | 20 |
| Week 17: very much | 21 | 14 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 542 | 251 |
| Week 33: a little | 136 | 66 |
| Week 33: quite a bit | 37 | 18 |
| Week 33: very much | 22 | 6 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 483 | 180 |
| Week 49: a little | 106 | 50 |
| Week 49: quite a bit | 33 | 12 |
| Week 49: very much | 13 | 8 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 417 | 143 |
| Week 65: a little | 78 | 37 |
| Week 65: quite a bit | 27 | 9 |
| Week 65: very much | 14 | 4 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 320 | 114 |
| Week 81: a little | 76 | 24 |
| Week 81: quite a bit | 26 | 9 |
| Week 81: very much | 12 | 1 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 286 | 65 |
| Week 97: a little | 52 | 19 |
| Week 97: quite a bit | 20 | 8 |
| Week 97: very much | 7 | 3 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 218 | 59 |
| Week 113: a little | 36 | 11 |
| Week 113: quite a bit | 14 | 1 |
| Week 113: very much | 7 | 2 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 156 | 33 |
| Week 129: a little | 24 | 6 |
| Week 129: quite a bit | 9 | 2 |
| Week 129: very much | 3 | 0 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 92 | 14 |
| Week 145: a little | 16 | 3 |
| Week 145: quite a bit | 7 | 4 |
| Week 145: very much | 1 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 30 | 5 |
| Week 161: a little | 5 | 2 |
| Week 161: quite a bit | 4 | 1 |
| Week 161: very much | 1 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 4 | 1 |
| Week 177: a little | 1 | 0 |
| Week 177: quite a bit | 1 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 51 are reported. Question 51 was following: "To what extent were you sexually active (with or without intercourse)?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 735 | 374 |
| Baseline: a little | 98 | 38 |
| Baseline: quite a bit | 41 | 19 |
| Baseline: very much | 10 | 8 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 734 | 354 |
| Week 17: a little | 71 | 44 |
| Week 17: quite a bit | 24 | 13 |
| Week 17: very much | 10 | 8 |
| Week 17: not answered | 0 | 0 |
| Week 33: not at all | 642 | 299 |
| Week 33: a little | 68 | 28 |
| Week 33: quite a bit | 20 | 9 |
| Week 33: very much | 7 | 5 |
| Week 33: not answered | 0 | 0 |
| Week 49: not at all | 569 | 214 |
| Week 49: a little | 46 | 26 |
| Week 49: quite a bit | 15 | 6 |
| Week 49: very much | 5 | 4 |
| Week 49: not answered | 0 | 0 |
| Week 65: not at all | 485 | 170 |
| Week 65: a little | 37 | 14 |
| Week 65: quite a bit | 12 | 7 |
| Week 65: very much | 2 | 2 |
| Week 65: not answered | 0 | 0 |
| Week 81: not at all | 381 | 130 |
| Week 81: a little | 32 | 13 |
| Week 81: quite a bit | 15 | 5 |
| Week 81: very much | 6 | 0 |
| Week 81: not answered | 0 | 0 |
| Week 97: not at all | 333 | 79 |
| Week 97: a little | 20 | 12 |
| Week 97: quite a bit | 9 | 4 |
| Week 97: very much | 3 | 0 |
| Week 97: not answered | 0 | 0 |
| Week 113: not at all | 250 | 68 |
| Week 113: a little | 16 | 3 |
| Week 113: quite a bit | 6 | 2 |
| Week 113: very much | 3 | 0 |
| Week 113: not answered | 0 | 0 |
| Week 129: not at all | 176 | 37 |
| Week 129: a little | 8 | 3 |
| Week 129: quite a bit | 5 | 1 |
| Week 129: very much | 3 | 0 |
| Week 129: not answered | 0 | 0 |
| Week 145: not at all | 106 | 17 |
| Week 145: a little | 4 | 3 |
| Week 145: quite a bit | 5 | 1 |
| Week 145: very much | 1 | 0 |
| Week 145: not answered | 0 | 0 |
| Week 161: not at all | 35 | 6 |
| Week 161: a little | 3 | 2 |
| Week 161: quite a bit | 1 | 0 |
| Week 161: very much | 1 | 0 |
| Week 161: not answered | 0 | 0 |
| Week 177: not at all | 5 | 1 |
| Week 177: a little | 0 | 0 |
| Week 177: quite a bit | 1 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 0 | 0 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 52 are reported. Question 52 was following: "To what extent was sex enjoyable for you?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 5 | 6 |
| Baseline: a little | 23 | 11 |
| Baseline: quite a bit | 14 | 5 |
| Baseline: very much | 8 | 2 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 7 | 3 |
| Week 17: a little | 13 | 9 |
| Week 17: quite a bit | 16 | 11 |
| Week 17: very much | 3 | 4 |
| Week 17: not answered | 800 | 392 |
| Week 33: not at all | 8 | 4 |
| Week 33: a little | 17 | 8 |
| Week 33: quite a bit | 11 | 5 |
| Week 33: very much | 4 | 0 |
| Week 33: not answered | 697 | 324 |
| Week 49: not at all | 3 | 4 |
| Week 49: a little | 6 | 5 |
| Week 49: quite a bit | 9 | 5 |
| Week 49: very much | 3 | 4 |
| Week 49: not answered | 614 | 232 |
| Week 65: not at all | 4 | 2 |
| Week 65: a little | 6 | 4 |
| Week 65: quite a bit | 9 | 4 |
| Week 65: very much | 3 | 0 |
| Week 65: not answered | 514 | 183 |
| Week 81: not at all | 5 | 2 |
| Week 81: a little | 7 | 3 |
| Week 81: quite a bit | 4 | 2 |
| Week 81: very much | 5 | 1 |
| Week 81: not answered | 413 | 140 |
| Week 97: not at all | 2 | 2 |
| Week 97: a little | 5 | 0 |
| Week 97: quite a bit | 3 | 3 |
| Week 97: very much | 3 | 0 |
| Week 97: not answered | 352 | 90 |
| Week 113: not at all | 0 | 1 |
| Week 113: a little | 5 | 1 |
| Week 113: quite a bit | 2 | 0 |
| Week 113: very much | 2 | 0 |
| Week 113: not answered | 266 | 71 |
| Week 129: not at all | 1 | 0 |
| Week 129: a little | 1 | 0 |
| Week 129: quite a bit | 1 | 0 |
| Week 129: very much | 1 | 0 |
| Week 129: not answered | 188 | 41 |
| Week 145: not at all | 1 | 0 |
| Week 145: a little | 0 | 0 |
| Week 145: quite a bit | 1 | 1 |
| Week 145: very much | 0 | 0 |
| Week 145: not answered | 114 | 20 |
| Week 161: not at all | 1 | 0 |
| Week 161: a little | 1 | 0 |
| Week 161: quite a bit | 0 | 0 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 38 | 8 |
| Week 177: not at all | 0 | 0 |
| Week 177: a little | 0 | 0 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 6 | 1 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 53 are reported. Question 53 was following: "Did you have difficulty getting or maintaining an erection?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 6 | 4 |
| Baseline: a little | 19 | 5 |
| Baseline: quite a bit | 4 | 4 |
| Baseline: very much | 21 | 11 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 10 | 8 |
| Week 17: a little | 8 | 8 |
| Week 17: quite a bit | 8 | 4 |
| Week 17: very much | 13 | 7 |
| Week 17: not answered | 800 | 392 |
| Week 33: not at all | 6 | 2 |
| Week 33: a little | 8 | 6 |
| Week 33: quite a bit | 8 | 3 |
| Week 33: very much | 18 | 6 |
| Week 33: not answered | 697 | 324 |
| Week 49: not at all | 4 | 6 |
| Week 49: a little | 6 | 5 |
| Week 49: quite a bit | 0 | 1 |
| Week 49: very much | 11 | 6 |
| Week 49: not answered | 614 | 232 |
| Week 65: not at all | 3 | 1 |
| Week 65: a little | 4 | 4 |
| Week 65: quite a bit | 4 | 2 |
| Week 65: very much | 11 | 3 |
| Week 65: not answered | 514 | 183 |
| Week 81: not at all | 7 | 3 |
| Week 81: a little | 2 | 2 |
| Week 81: quite a bit | 3 | 2 |
| Week 81: very much | 9 | 1 |
| Week 81: not answered | 413 | 140 |
| Week 97: not at all | 2 | 1 |
| Week 97: a little | 5 | 1 |
| Week 97: quite a bit | 1 | 1 |
| Week 97: very much | 5 | 2 |
| Week 97: not answered | 352 | 90 |
| Week 113: not at all | 1 | 0 |
| Week 113: a little | 3 | 1 |
| Week 113: quite a bit | 1 | 0 |
| Week 113: very much | 4 | 1 |
| Week 113: not answered | 266 | 71 |
| Week 129: not at all | 0 | 0 |
| Week 129: a little | 1 | 0 |
| Week 129: quite a bit | 0 | 0 |
| Week 129: very much | 3 | 0 |
| Week 129: not answered | 188 | 41 |
| Week 145: not at all | 1 | 0 |
| Week 145: a little | 0 | 1 |
| Week 145: quite a bit | 0 | 0 |
| Week 145: very much | 1 | 0 |
| Week 145: not answered | 114 | 20 |
| Week 161: not at all | 1 | 0 |
| Week 161: a little | 0 | 0 |
| Week 161: quite a bit | 1 | 0 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 38 | 8 |
| Week 177: not at all | 0 | 0 |
| Week 177: a little | 0 | 0 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 6 | 1 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 54 are reported. Question 54 was following: "Did you have ejaculation problems (e.g, dry ejaculation)?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 11 | 7 |
| Baseline: a little | 14 | 4 |
| Baseline: quite a bit | 3 | 2 |
| Baseline: very much | 22 | 11 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 13 | 11 |
| Week 17: a little | 5 | 5 |
| Week 17: quite a bit | 3 | 1 |
| Week 17: very much | 18 | 10 |
| Week 17: not answered | 800 | 392 |
| Week 33: not at all | 12 | 10 |
| Week 33: a little | 9 | 1 |
| Week 33: quite a bit | 5 | 0 |
| Week 33: very much | 14 | 6 |
| Week 33: not answered | 697 | 324 |
| Week 49: not at all | 7 | 6 |
| Week 49: a little | 3 | 5 |
| Week 49: quite a bit | 1 | 1 |
| Week 49: very much | 10 | 6 |
| Week 49: not answered | 614 | 232 |
| Week 65: not at all | 8 | 3 |
| Week 65: a little | 2 | 1 |
| Week 65: quite a bit | 1 | 2 |
| Week 65: very much | 11 | 4 |
| Week 65: not answered | 514 | 183 |
| Week 81: not at all | 7 | 4 |
| Week 81: a little | 0 | 0 |
| Week 81: quite a bit | 3 | 0 |
| Week 81: very much | 11 | 4 |
| Week 81: not answered | 413 | 140 |
| Week 97: not at all | 5 | 2 |
| Week 97: a little | 3 | 0 |
| Week 97: quite a bit | 0 | 1 |
| Week 97: very much | 5 | 2 |
| Week 97: not answered | 352 | 90 |
| Week 113: not at all | 3 | 2 |
| Week 113: a little | 1 | 0 |
| Week 113: quite a bit | 0 | 0 |
| Week 113: very much | 5 | 0 |
| Week 113: not answered | 266 | 71 |
| Week 129: not at all | 1 | 0 |
| Week 129: a little | 0 | 0 |
| Week 129: quite a bit | 0 | 0 |
| Week 129: very much | 3 | 0 |
| Week 129: not answered | 188 | 41 |
| Week 145: not at all | 2 | 0 |
| Week 145: a little | 0 | 1 |
| Week 145: quite a bit | 0 | 0 |
| Week 145: very much | 0 | 0 |
| Week 145: not answered | 114 | 20 |
| Week 161: not at all | 1 | 0 |
| Week 161: a little | 0 | 0 |
| Week 161: quite a bit | 1 | 0 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 38 | 8 |
| Week 177: not at all | 0 | 0 |
| Week 177: a little | 0 | 0 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 6 | 1 |
The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 55 are reported. Question 55 was following: "Have you felt uncomfortable about being sexually intimate?"
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Baseline: not at all | 31 | 13 |
| Baseline: a little | 13 | 8 |
| Baseline: quite a bit | 4 | 0 |
| Baseline: very much | 2 | 3 |
| Baseline: not answered | 0 | 0 |
| Week 17: not at all | 23 | 14 |
| Week 17: a little | 11 | 7 |
| Week 17: quite a bit | 2 | 3 |
| Week 17: very much | 3 | 3 |
| Week 17: not answered | 800 | 392 |
| Week 33: not at all | 24 | 10 |
| Week 33: a little | 6 | 4 |
| Week 33: quite a bit | 6 | 2 |
| Week 33: very much | 4 | 1 |
| Week 33: not answered | 697 | 324 |
| Week 49: not at all | 16 | 10 |
| Week 49: a little | 4 | 6 |
| Week 49: quite a bit | 1 | 1 |
| Week 49: very much | 0 | 1 |
| Week 49: not answered | 614 | 232 |
| Week 65: not at all | 13 | 5 |
| Week 65: a little | 7 | 3 |
| Week 65: quite a bit | 1 | 2 |
| Week 65: very much | 1 | 0 |
| Week 65: not answered | 514 | 183 |
| Week 81: not at all | 13 | 5 |
| Week 81: a little | 6 | 1 |
| Week 81: quite a bit | 1 | 1 |
| Week 81: very much | 1 | 1 |
| Week 81: not answered | 413 | 140 |
| Week 97: not at all | 8 | 3 |
| Week 97: a little | 3 | 2 |
| Week 97: quite a bit | 1 | 0 |
| Week 97: very much | 1 | 0 |
| Week 97: not answered | 352 | 90 |
| Week 113: not at all | 7 | 2 |
| Week 113: a little | 0 | 0 |
| Week 113: quite a bit | 1 | 0 |
| Week 113: very much | 1 | 0 |
| Week 113: not answered | 266 | 71 |
| Week 129: not at all | 3 | 0 |
| Week 129: a little | 0 | 0 |
| Week 129: quite a bit | 1 | 0 |
| Week 129: very much | 0 | 0 |
| Week 129: not answered | 188 | 41 |
| Week 145: not at all | 2 | 1 |
| Week 145: a little | 0 | 0 |
| Week 145: quite a bit | 0 | 0 |
| Week 145: very much | 0 | 0 |
| Week 145: not answered | 114 | 20 |
| Week 161: not at all | 1 | 0 |
| Week 161: a little | 0 | 0 |
| Week 161: quite a bit | 1 | 0 |
| Week 161: very much | 0 | 0 |
| Week 161: not answered | 38 | 8 |
| Week 177: not at all | 0 | 0 |
| Week 177: a little | 0 | 0 |
| Week 177: quite a bit | 0 | 0 |
| Week 177: very much | 0 | 0 |
| Week 177: not answered | 6 | 1 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first). AEs included both non-serious adverse events (AEs) and SAEs.
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| AEs | 808 | 360 |
| SAEs | 226 | 85 |
An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first).Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0 | 292 | 109 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious adverse events (AEs) and SAEs.
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs) | 87 | 28 |
Hematology parameters: Haemoglobin (grams per liter \[g/L\]); leukocytes (log 10 raised to power 9 per liter \[10\*9/L\]); lymphocytes (log 10 raised to power 6 per liter \[10\*6/L\]); neutrophils (log 10 raised to power 6 per liter \[10\*6/L\]); platelets (log 10 raised to power 9 per litre \[10\*9/L\]).
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Haemoglobin (Low) | 12 | 7 |
| Leukocytes (Low) | 7 | 7 |
| Lymphocytes (High) | 4 | 2 |
| Lymphocytes (Low) | 44 | 26 |
| Neutrophils (Low) | 13 | 4 |
| Platelets (Low) | 3 | 2 |
Chemistry parameters: Alanine aminotransferase (units per liter \[U/L\]); albumin (g/L); alkaline phosphatase (U/L); bilirubin (micromoles per liter \[umol/L\]); calcium (millimoles per liter \[mmol/L\]); creatine kinase (U/L); creatinine (umol/L); glucose, magnesium, phosphate, potassium, sodium (mmol/L).
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| Alanine Aminotransferase (High) | 4 | 1 |
| Albumin (Low) | 7 | 0 |
| Alkaline Phosphatase (High) | 3 | 6 |
| Aspartate Aminotransferase (High) | 3 | 1 |
| Bilirubin (High) | 4 | 1 |
| Calcium (High) | 1 | 1 |
| Calcium (Low) | 2 | 1 |
| Creatine Kinase (High) | 4 | 3 |
| Creatinine (High) | 1 | 7 |
| Glucose (High) | 26 | 8 |
| Glucose (Low) | 5 | 1 |
| Magnesium (High) | 1 | 0 |
| Magnesium (Low) | 1 | 0 |
| Phosphate (Low) | 30 | 13 |
| Potassium (High) | 14 | 5 |
| Potassium (Low) | 0 | 3 |
| Sodium (High) | 2 | 1 |
| Sodium (Low) | 12 | 7 |
Vital signs included Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and heart rate.
| Participants | Enzalutamide 160 mg | Placebo |
|---|---|---|
| SBP | 738 | 328 |
| DBP | 563 | 229 |
| Heart rate | 7 | 4 |
Collected over Baseline up to 30 days after last dose of study drug or till death, whichever occurred first (up to a maximum duration of 69.8 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enzalutamide 160 mg | 285/930 (30.6%) | 372/930 (40%) | 762/930 (81.9%) |
| Placebo | 173/465 (37.2%) | 100/465 (21.5%) | 299/465 (64.3%) |
| Placebo Patients Crossover to Enzalutamide 160 mg | 4/87 (4.6%) | 12/87 (13.8%) | 45/87 (51.7%) |
| Event | Enzalutamide 160 mg | Placebo | Placebo Patients Crossover to Enzalutamide 160 mg |
|---|---|---|---|
| HaematuriaRenal and urinary disorders | 31/930 | 15/465 | 1/87 |
| Urinary retentionRenal and urinary disorders | 13/930 | 12/465 | 0/87 |
| PneumoniaInfections and infestations | 20/930 | 2/465 | 0/87 |
| Renal failure acuteRenal and urinary disorders | 7/930 | 8/465 | 0/87 |
| Urinary tract infectionInfections and infestations | 11/930 | 6/465 | 0/87 |
| FallInjury, poisoning and procedural complications | 12/930 | 2/465 | 0/87 |
| AnaemiaBlood and lymphatic system disorders | 10/930 | 1/465 | 1/87 |
| Acute myocardial infarctionCardiac disorders | 10/930 | 2/465 | 1/87 |
| Disease progressionGeneral disorders | 3/930 | 0/465 | 1/87 |
| General physical health deteriorationGeneral disorders | 3/930 | 0/465 | 1/87 |
| Event | Enzalutamide 160 mg | Placebo | Placebo Patients Crossover to Enzalutamide 160 mg |
|---|---|---|---|
| FatigueGeneral disorders | 348/930 | 73/465 | 13/87 |
| FallInjury, poisoning and procedural complications | 164/930 | 25/465 | 2/87 |
| HypertensionVascular disorders | 161/930 | 27/465 | 6/87 |
| Hot flushVascular disorders | 132/930 | 38/465 | 3/87 |
| NauseaGastrointestinal disorders | 125/930 | 42/465 | 3/87 |
| ConstipationGastrointestinal disorders | 121/930 | 39/465 | 1/87 |
| Back painMusculoskeletal and connective tissue disorders | 120/930 | 38/465 | 4/87 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 119/930 | 36/465 | 3/87 |
| DiarrhoeaGastrointestinal disorders | 112/930 | 47/465 | 3/87 |
| DizzinessNervous system disorders | 112/930 | 27/465 | 6/87 |
The intent-to-treat (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.
| Age, Continuous(years) | Enzalutamide 160 mg | Placebo | Total |
|---|---|---|---|
| Mean | 73.8 ± 7.83 | 72.9 ± 7.63 | 73.5 ± 7.77 |
| Sex: Female, Male(Participants) | Enzalutamide 160 mg | Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 933 | 468 | 1401 |
| Race/Ethnicity, Customized(Participants) | Enzalutamide 160 mg | Placebo | Total |
|---|---|---|---|
| Asian | 142 | 88 | 230 |
| Black or African American | 21 | 10 | 31 |
| Native Hawaiian or Other Pacific Islander | 3 | 2 | 5 |
| White | 671 | 320 | 991 |
| Multiple | 4 | 4 | 8 |
| Other | 15 | 5 | 20 |
| Missing | 77 | 39 | 116 |
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Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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