Trial Outcomes & Findings for Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia (NCT NCT02058368)

NCT ID: NCT02058368

Last Updated: 2019-04-05

Results Overview

IPSS (also called IPSS total score) is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS was self administered at screening, Baseline and each time-point of Month 3, 6, 9, 12, 15, 18, 21 and 24. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). LOCF is defined as carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Month 24 is the primary timepoint and earlier timepoints are considered secondary. Change from Baseline defined as difference between Post-Baseline value and Baseline value.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

607 participants

Primary outcome timeframe

Baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months

Results posted on

2019-04-05

Participant Flow

A randomized, double-blind, parallel group trial to assess the effectiveness and safety of dutasteride (Dut) 0.5 milligram (mg) and tamsulosin (Tam) 0.2 mg combination compared to Tam 0.2 mg. The study consisted of a single-blind, placebo run-in, followed by a 2 year treatment. Eligible subjects were randomized to Dut + Tam or Dut placebo + Tam

Six hundred and fifty moderate to severe benign prostatic hyperplasia (BPH) subjects were screened with 607 participants receiving as least one dose of the study medication (China 243, Japan 135, Korea 181, Taiwan 48). Five hundred and twelve subjects completed the study with 95 subjects withdrawn.

Participant milestones

Participant milestones
Measure	Placebo +Tam 0.2mg Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Study STARTED	302	305
Overall Study COMPLETED	261	251
Overall Study NOT COMPLETED	41	54

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo +Tam 0.2mg Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Overall Study Adverse Event	15	20
Overall Study Lack of Efficacy	0	1
Overall Study Protocol Violation	0	4
Overall Study Lost to Follow-up	2	0
Overall Study Physician Decision	2	3
Overall Study Withdrawal by Subject	22	26

Baseline Characteristics

Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.	Total n=607 Participants Total of all reporting groups
Age, Continuous	66.2 Years STANDARD_DEVIATION 6.85 • n=5 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment	66.8 Years STANDARD_DEVIATION 6.82 • n=7 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment	66.5 Years STANDARD_DEVIATION 6.84 • n=5 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment
Sex: Female, Male Female	0 Participants n=5 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment	0 Participants n=7 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment	0 Participants n=5 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment
Sex: Female, Male Male	302 Participants n=5 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment	305 Participants n=7 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment	607 Participants n=5 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment
Race/Ethnicity, Customized Asian - East Asian Heritage	234 Participants n=5 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment	236 Participants n=7 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment	470 Participants n=5 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment
Race/Ethnicity, Customized Asian - Japanese Heritage	68 Participants n=5 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment	67 Participants n=7 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment	135 Participants n=5 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment
Race/Ethnicity, Customized Asian - Southeast Asian Heritage	0 Participants n=5 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment	2 Participants n=7 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment	2 Participants n=5 Participants • Intent-to-Treat Population, comprised of all randomized participants who received or did not receive study treatment

PRIMARY outcome

Timeframe: Baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months

Population: ITT Population.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months Month 15, n=300, 298	-3.95 Score on scale Standard Error 0.36	-4.90 Score on scale Standard Error 0.36
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months Month 18, n=300, 298	-3.84 Score on scale Standard Error 0.38	-4.54 Score on scale Standard Error 0.38
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months Month 21, n=300, 298	-3.94 Score on scale Standard Error 0.38	-4.66 Score on scale Standard Error 0.38
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months Month 3, n=299, 296	-4.07 Score on scale Standard Error 0.34	-3.28 Score on scale Standard Error 0.34
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months Month 6, n=300, 298	-3.73 Score on scale Standard Error 0.37	-3.36 Score on scale Standard Error 0.37
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months Month 9, n=300, 298	-4.14 Score on scale Standard Error 0.36	-4.28 Score on scale Standard Error 0.36
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months Month 12,n= 300, 298	-3.93 Score on scale Standard Error 0.36	-4.30 Score on scale Standard Error 0.36
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months Month 24, n=300, 298	-3.53 Score on scale Standard Error 0.39	-4.96 Score on scale Standard Error 0.39

SECONDARY outcome

Timeframe: Baseline,12 and 24 months

Population: ITT Population.

Prostate Volume measurements were conducted annually using Transrectal ultrasound (TRUS). The following calculation was utilized to assess the prostate volume (cc): pi/6 (Anteroposterior Width multiplied by Cephalocaudal Width multiplied by Transverse Width). Post-Baseline prostate volume was calculated at 12 and 24 months. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value and reported as a percentage.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Percent Change in Prostate Volume From Baseline Month 12, n=287, 286	0.2 Cubic centimeters (cc) Standard Error 1.28	-22.8 Cubic centimeters (cc) Standard Error 0.99
Percent Change in Prostate Volume From Baseline Month 24, n=287, 286	3.6 Cubic centimeters (cc) Standard Error 1.45	-24.8 Cubic centimeters (cc) Standard Error 1.06

SECONDARY outcome

Timeframe: Baseline and 3, 6, 9,12,15,18,21 and 24 months

Population: ITT Population.

Improvement in IPSS was categorized as improvement, no change and worsening. Improvement defined as greater than or equal to 2 points, greater than or equal to 3 points and greater than or equal to 25 percent in participants at months 3,6,9,12,15,18,21 and 24 . Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants With IPSS Improvement From Baseline Month 3,>= 25percent, n=299, 296	134 Participants	123 Participants
Number of Participants With IPSS Improvement From Baseline Month 6,>= 3 units, n=300, 298	156 Participants	156 Participants
Number of Participants With IPSS Improvement From Baseline Month 6,>= 2 units, n=300, 298	179 Participants	176 Participants
Number of Participants With IPSS Improvement From Baseline Month 12,>= 2 units, n=300, 298	179 Participants	191 Participants
Number of Participants With IPSS Improvement From Baseline Month 15,>= 25percent, n=300, 298	133 Participants	160 Participants
Number of Participants With IPSS Improvement From Baseline Month 18,>= 3 units, n=300, 298	156 Participants	171 Participants
Number of Participants With IPSS Improvement From Baseline Month 18,>= 2 units, n=300, 298	173 Participants	187 Participants
Number of Participants With IPSS Improvement From Baseline Month 21,>= 2 units, n=300, 298	186 Participants	194 Participants
Number of Participants With IPSS Improvement From Baseline Month 21,>= 25percent, n=300, 298	141 Participants	161 Participants
Number of Participants With IPSS Improvement From Baseline Month 3,>= 3 units, n=299, 296	160 Participants	157 Participants
Number of Participants With IPSS Improvement From Baseline Month 3,>= 2 units, n=299,296	190 Participants	176 Participants
Number of Participants With IPSS Improvement From Baseline Month 6,>= 25percent, n=300, 298	131 Participants	133 Participants
Number of Participants With IPSS Improvement From Baseline Month 9,>= 3 units, n=300, 298	157 Participants	177 Participants
Number of Participants With IPSS Improvement From Baseline Month 9,>= 2 units, n=300, 298	185 Participants	193 Participants
Number of Participants With IPSS Improvement From Baseline Month 9,>= 25percent, n=300, 298	128 Participants	150 Participants
Number of Participants With IPSS Improvement From Baseline Month 12,>= 3 units, n=300, 298	154 Participants	171 Participants
Number of Participants With IPSS Improvement From Baseline Month 12,>= 25percent, n=300, 298	131 Participants	154 Participants
Number of Participants With IPSS Improvement From Baseline Month 15,>= 3 units, n=300, 298	171 Participants	186 Participants
Number of Participants With IPSS Improvement From Baseline Month 15,>= 2 units, n=300, 298	186 Participants	203 Participants
Number of Participants With IPSS Improvement From Baseline Month 18,>= 25percent, n=300, 298	136 Participants	148 Participants
Number of Participants With IPSS Improvement From Baseline Month 21,>= 3 units, n=300, 298	169 Participants	178 Participants
Number of Participants With IPSS Improvement From Baseline Month 24,>= 3 units, n=300, 298	156 Participants	184 Participants
Number of Participants With IPSS Improvement From Baseline Month 24,>= 2 units, n=300, 298	175 Participants	197 Participants
Number of Participants With IPSS Improvement From Baseline Month 24,>= 25percent, n=300, 298	137 Participants	169 Participants

SECONDARY outcome

Timeframe: Baseline, 6, 12, 18 and 24 Months

Population: ITT Population

Qmax is defined as maximum urine flow. Qmax was measured with Uroflow meter (Urodyn 1000) at Screening, Baseline, and at Months 6,12,18 and 24. Change from Baseline Qmax at each scheduled post-Baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline Qmax. Baseline value was defined as the latest non-missing assessment either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach Month 18, n=287, 288	0.90 milliliter per second (mL/sec) Standard Error 0.33	2.36 milliliter per second (mL/sec) Standard Error 0.33
Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach Month 24, n=287,290	0.93 milliliter per second (mL/sec) Standard Error 0.32	2.27 milliliter per second (mL/sec) Standard Error 0.32
Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach Month 6, n=270, 274	0.62 milliliter per second (mL/sec) Standard Error 0.26	1.54 milliliter per second (mL/sec) Standard Error 0.26
Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach Month 12, n=286, 287	0.63 milliliter per second (mL/sec) Standard Error 0.28	1.62 milliliter per second (mL/sec) Standard Error 0.27

SECONDARY outcome

Timeframe: Baseline 6, 12, 18 and 24 Months

Population: ITT Population.

Qmax change from Baseline was presented using six improvement levels: \>0 milliliter per second (mL/sec) and \>=1 mL/sec through \>=5mL/sec. Qmax percentage change from Baseline was presented using six improvement levels: \>0%, \>=10%, \>=20%, \>=30%, \>=40%, and \>=50%. Here, Qmax improvement of \>= 3 mL/sec and Qmax percentage of \>= 30 % for 24 Months has been summarized. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants With Qmax Improvement From Baseline by LOCF Approach. Month 6, >= 3 mL/sec, n=270, 274	69 Participants	86 Participants
Number of Participants With Qmax Improvement From Baseline by LOCF Approach. Month 12, >= 3 mL/sec, n=286, 287	64 Participants	102 Participants
Number of Participants With Qmax Improvement From Baseline by LOCF Approach. Month 12, >= 3 %, n=286, 287	73 Participants	107 Participants
Number of Participants With Qmax Improvement From Baseline by LOCF Approach. Month 18, >= 3 mL/sec, n=287, 288	80 Participants	115 Participants
Number of Participants With Qmax Improvement From Baseline by LOCF Approach. Month 18, >= 3 %, n= 287, 288	81 Participants	111 Participants
Number of Participants With Qmax Improvement From Baseline by LOCF Approach. Month 24, >= 3 mL/sec, n=287, 290	77 Participants	121 Participants
Number of Participants With Qmax Improvement From Baseline by LOCF Approach. Month 6, >= 3 %, n=270, 274	70 Participants	86 Participants
Number of Participants With Qmax Improvement From Baseline by LOCF Approach. Month 24, >= 30 %, n=287, 290	71 Participants	119 Participants

SECONDARY outcome

Timeframe: Up to 24 Months

Population: ITT Population.

AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization. AUR or BPH-related surgery event details per participant was summarized as first occurring of either AUR or BPH-related surgery.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery Overall	15 Participants	4 Participants
Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery Year 1 subset	8 Participants	2 Participants
Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery Year 2 subset	7 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 24 Months

Population: ITT Population.

AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Subjects With AUR Overall	13 Participants	2 Participants
Number of Subjects With AUR Year 1 subset	8 Participants	2 Participants
Number of Subjects With AUR Year 2 subset	5 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 Months

Population: ITT Population.

BPH-related interventions were recorded. BPH-related interventions included adenomectomy, balloon dilatation, electroresection, thermotherapy (microwave or radiofrequency), laser resection, prostatectomy, prostatotomy, transurethral resection of the prostate, transurethral drainage of prostatic abscess, drainage of prostatic cysts, radioactive seeding of the prostate, prostatic urethral stenting, incision of periurethral stricture, ethanol injections into the prostate, transrectal high intensity focussed ultrasound, transurethral needle ablation and transurethral microwave thermotherapy.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants With BPH-related Surgery Overall	3 Participants	2 Participants
Number of Participants With BPH-related Surgery Year 1 subset	0 Participants	0 Participants
Number of Participants With BPH-related Surgery Year 2 subset	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, 3, 6, 9, 12, 15, 18, 21 and 24 Months

Population: ITT Population.

BHS was collected as Question 8 the IPSS questionnaire regarding quality of life due to urinary symptom with scores values ranging from 0 (delightful) to 6 (terrible). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from baseline BHS at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BHS.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach Month 18, n=300, 298	-0.92 Scores on scale Standard Deviation 0.08	-1.00 Scores on scale Standard Deviation 0.08
Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach Month 21, n=300, 298	-1.08 Scores on scale Standard Deviation 0.09	-1.02 Scores on scale Standard Deviation 0.09
Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach Month 3, n=299, 296	-0.88 Scores on scale Standard Deviation 0.08	-0.85 Scores on scale Standard Deviation 0.08
Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach Month 6, n=300,298	-0.89 Scores on scale Standard Deviation 0.08	-0.73 Scores on scale Standard Deviation 0.08
Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach Month 9, n=300, 298	-1.08 Scores on scale Standard Deviation 0.08	-0.95 Scores on scale Standard Deviation 0.08
Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach Month 12, n=300, 298	-0.87 Scores on scale Standard Deviation 0.08	-0.90 Scores on scale Standard Deviation 0.08
Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach Month 15, n=300, 298	-0.93 Scores on scale Standard Deviation 0.08	-1.02 Scores on scale Standard Deviation 0.08
Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach Month 24, n=300, 298	-1.00 Scores on scale Standard Deviation 0.08	-1.16 Scores on scale Standard Deviation 0.08

SECONDARY outcome

Timeframe: Baseline 3, 6, 9, 12, 15, 18, 21 and 24 Months

Population: ITT Population.

The BII consists of four questions and BII total score is the sum of four questions. Total score range is 0 (no problem) to 13 (worst value). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline BII at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BII. Change from Baseline was summarized using LOCF approaches.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Change From Baseline in BPH Impact Index (BII) by LOCF Approach Month 21, n=300, 298	-1.12 Scores on scale Standard Error 0.17	-1.27 Scores on scale Standard Error 0.17
Change From Baseline in BPH Impact Index (BII) by LOCF Approach Month 3, n=299, 296	-1.48 Scores on scale Standard Error 0.14	-1.23 Scores on scale Standard Error 0.14
Change From Baseline in BPH Impact Index (BII) by LOCF Approach Month 6, n=300, 298	-1.28 Scores on scale Standard Error 0.15	-1.08 Scores on scale Standard Error 0.16
Change From Baseline in BPH Impact Index (BII) by LOCF Approach Month 9, n=300, 298	-1.55 Scores on scale Standard Error 0.15	-1.26 Scores on scale Standard Error 0.16
Change From Baseline in BPH Impact Index (BII) by LOCF Approach Month 12, n=300, 298	-1.39 Scores on scale Standard Error 0.16	-1.24 Scores on scale Standard Error 0.16
Change From Baseline in BPH Impact Index (BII) by LOCF Approach Month 15, n=300, 298	-1.30 Scores on scale Standard Error 0.16	-1.41 Scores on scale Standard Error 0.16
Change From Baseline in BPH Impact Index (BII) by LOCF Approach Month 18, n=300, 298	-1.16 Scores on scale Standard Error 0.16	-1.28 Scores on scale Standard Error 0.16
Change From Baseline in BPH Impact Index (BII) by LOCF Approach Month 24, n=300, 298	-1.02 Scores on scale Standard Error 0.17	-1.48 Scores on scale Standard Error 0.17

SECONDARY outcome

Timeframe: Baseline, 12 and 24 Months

Population: ITT Population.

PAS SFI consists of three questions each with a range of 0 (Big Problem) to 4 (No Problem). PAS SFI was administered at screening, Baseline and at each month 12 and 24. The total PSI is the sum of the three questions; the total score range is 0 to 12. Change from Baseline PAS SFI at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline PAS SFI. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI) Month 12, n=291, 293	0.11 Scores on scale Standard Deviation 0.21	-0.91 Scores on scale Standard Deviation 0.20
Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI) Month 24, n=291, 294	-0.11 Scores on scale Standard Deviation 0.21	-0.82 Scores on scale Standard Deviation 0.21

SECONDARY outcome

Timeframe: Up to 24 Months

Population: ITT Population. Only those participants with data available at specific time point were analyzed

Duration of hospitalization days due to AUR or BPH-related surgery was recorded.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=5 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=3 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Hospitalization Days	10.0 Days Interval 6.0 to 18.0	9.0 Days Interval 7.0 to 12.0

SECONDARY outcome

Timeframe: Up to 24 Months

Population: ITT Population. Only those participants with data available at specific time point were analyzed

Details of number of participants in different types of wards was recorded. Types of wards included general ward, recovery, intensive care unit, multiple ward types and others

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=3 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=1 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants in a Hospital Ward General ward	2 Participants	0 Participants
Number of Participants in a Hospital Ward Recovery	0 Participants	1 Participants
Number of Participants in a Hospital Ward Other	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 Months

Population: ITT Population. Only those participants with data available at specific time point were analyzed.

Details of participants who were admitted to hospitals related to AUR or BPH-Related surgery has been recorded.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=11 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=3 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants With Hospital Admissions Out-patient	5 Participants	0 Participants
Number of Participants With Hospital Admissions In-patient	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 24 Months

Population: ITT Population.

An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as resulting in death, life threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation that is medically important, All events of possible drug-induced liver injury with hyperbilirubinaemia, male breast cancer and spontaneous abortion of a female partner of a male subject

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE) Any Non-serious AE	203 Participants	208 Participants
Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE) Any SAE	52 Participants	49 Participants

SECONDARY outcome

Timeframe: Baseline 6, 12 and 24 Months

Population: ITT Population.

Total serum PSA concentrations were assessed at pre-screening, month 6, 12 and 24. Change from baseline total PSA was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment at each scheduled post-baseline assessment using a general linear model with effects for treatment and baseline total PSA. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Change From Baseline in Serum Prostate Specific Antigen (PSA) Month 6, n=292, 294	0.2 nanogram/milliliter (ng/mL) Standard Deviation 0.09	-1.7 nanogram/milliliter (ng/mL) Standard Deviation 0.08
Change From Baseline in Serum Prostate Specific Antigen (PSA) Month 12, n=293, 294	0.2 nanogram/milliliter (ng/mL) Standard Deviation 0.08	-1.9 nanogram/milliliter (ng/mL) Standard Deviation 0.08
Change From Baseline in Serum Prostate Specific Antigen (PSA) Month 24, n=293, 295	0.7 nanogram/milliliter (ng/mL) Standard Deviation 0.16	-2.0 nanogram/milliliter (ng/mL) Standard Deviation 0.16

SECONDARY outcome

Timeframe: Up to 24 Months

Population: ITT Population.

Vital signs included assessment of systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. Threshold ranges for SBP ranged from \< 80 mmHg (millimeter of mercury) (lower) to \> 165 mmHg (upper); for DBP ranged from \< 40 mmHg (lower) to \> 105 mmHg (upper) and heart rate \< 40 beats per minute (bpm) (lower) to \> 100 bpm (upper).

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants With Vital Signs Exceeding Threshold Values SBP, < 80 mmHg	0 Participants	0 Participants
Number of Participants With Vital Signs Exceeding Threshold Values SBP, > 165 mmHg	10 Participants	13 Participants
Number of Participants With Vital Signs Exceeding Threshold Values SBP, either threshold	10 Participants	13 Participants
Number of Participants With Vital Signs Exceeding Threshold Values DBP, < 40 mmHg	0 Participants	0 Participants
Number of Participants With Vital Signs Exceeding Threshold Values DBP, > 105 mmHg	6 Participants	2 Participants
Number of Participants With Vital Signs Exceeding Threshold Values DBP, either threshold	6 Participants	2 Participants
Number of Participants With Vital Signs Exceeding Threshold Values Heart rate, < 40 bpm	0 Participants	0 Participants
Number of Participants With Vital Signs Exceeding Threshold Values Heart rate, > 100 bpm	11 Participants	14 Participants
Number of Participants With Vital Signs Exceeding Threshold Values Heart rate, either threshold	11 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline, 6, 12, 18 and 24 Months

Population: ITT Population.

Post void residual volume was measured suprapubically by ultrasound (immediately following the urinary flow measurement). Post void residual volume change from Baseline distribution at each scheduled post-Baseline assessment was compared with combination treatment (Dut plus Tam) versus tamsulosin treatment using a nonparametric van Elteren test. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Change From Baseline in Post Void Residual Volume Month 6, n=288, 290	-4.8 mL Standard Deviation 52.59	-3.0 mL Standard Deviation 59.56
Change From Baseline in Post Void Residual Volume Month 12, n=291, 292	1.5 mL Standard Deviation 60.94	-1.4 mL Standard Deviation 59.19
Change From Baseline in Post Void Residual Volume Month 18, n=291, 292	-2.6 mL Standard Deviation 55.67	-1.3 mL Standard Deviation 63.98
Change From Baseline in Post Void Residual Volume Month 24, n=291, 292	2.6 mL Standard Deviation 64.71	-2.6 mL Standard Deviation 62.01

SECONDARY outcome

Timeframe: Up to 24 Months

Population: ITT Population.

The threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory's normal range. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal (ULN) range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal (LLN) range is considered a low threshold value. Hematology laboratory parameters assessed included hemoglobin (Hgb), platelet count, white blood cell count (WBC) and red blood cell (RBC) count. Threshold factors are in the below table. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants With Threshold Hematology Value. Hgb, <0.75 X LLN, n=287, 291	0 Participants	0 Participants
Number of Participants With Threshold Hematology Value. Platelet count, <0.75 X LLN, n=284, 283	6 Participants	1 Participants
Number of Participants With Threshold Hematology Value. Platelet count, >1.50 X ULN, n=285, 285	0 Participants	0 Participants
Number of Participants With Threshold Hematology Value. RBC, <0.50 X LLN, n=287, 291	0 Participants	0 Participants
Number of Participants With Threshold Hematology Value. WBC, <0.50 X LLN, n=287, 291	0 Participants	0 Participants
Number of Participants With Threshold Hematology Value. WBC, >3.00 X ULN, n=287, 291	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 Months

Population: ITT Population.

Clinical chemistry laboratory parameters assessed included albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatinine, glucose, potassium, sodium, total bilirubin, total protein and urea/blood urea nitrogen (BUN). Threshold factors are in the below table. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants With Threshold Clinical Chemistry Value. ALT, >3.00 X ULN, n=289, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. albumin, <0.90 X LLN, n=289, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. albumin, >1.20 X ULN, n=289, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. ALP, > 1.50 X ULN, n=289, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. AST, >3.00 X ULN, n=288, 292	0 Participants	1 Participants
Number of Participants With Threshold Clinical Chemistry Value. creatinine, <0.50 X LLN, n=289, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. creatinine, >3.00 X ULN, n=289, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. glucose, <0.70 X LLN, n=288, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. glucose, >1.75 X ULN, n=280, 285	13 Participants	13 Participants
Number of Participants With Threshold Clinical Chemistry Value. potassium, <0.75 X LLN, n=288, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. potassium, >1.40 X ULN, n=288, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. sodium, <0.90 X LLN, n=289, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. sodium, >1.15 X ULN, n=289, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. total bilirubin, >2.50 X ULN, n=289, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. total protein, <0.80 X LLN, n=289, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. total protein, >1.15 X ULN, n=289, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. Urea/BUN, <0.50 X LLN, n=289, 292	0 Participants	0 Participants
Number of Participants With Threshold Clinical Chemistry Value. Urea/BUN, >2.00 X ULN, n=289, 292	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6, 12, 18 , 24 months and final assessment

Population: ITT Population.

DRE evaluation was carried out from normal/diffusely enlarged at Baseline to focal abnormalities at any time post-Baseline. DRE was assessed at screening visit, Month 6, 12, 18 , 24 and final assessment is the latest post-Baseline evaluation that was available. Here, participants with focal abnormalities are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants With Digital Rectal Examination (DRE) Month 6, n=287, 285	11 Participants	9 Participants
Number of Participants With Digital Rectal Examination (DRE) Month 12, n=279, 272	10 Participants	11 Participants
Number of Participants With Digital Rectal Examination (DRE) Month 18, n=267, 258	6 Participants	12 Participants
Number of Participants With Digital Rectal Examination (DRE) Month 24, n=261, 252	10 Participants	13 Participants
Number of Participants With Digital Rectal Examination (DRE) Final Assessment, n=296, 295	10 Participants	15 Participants

SECONDARY outcome

Timeframe: 6, 12, 18 , 24 months and final assessment

Population: ITT Population.

Qualitative breast examination included palpable breast tissue and nipple tenderness. Here, participants with clinically significant abnormalities for palpable breast tissue and nipple tenderness are summarized. Qualitative breast examination was done at screening visit, Month 6, 12, 18 , 24 and final assessment (latest post-Baseline evaluation that was available). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants With Clinically Significant Qualitative Breast Examination Palpable breast tissue, Month 6, n=289, 284	0 Participants	0 Participants
Number of Participants With Clinically Significant Qualitative Breast Examination Nipple tenderness,Month 6, n=289, 284	0 Participants	0 Participants
Number of Participants With Clinically Significant Qualitative Breast Examination Palpable breast tissue, Month 12, n=279, 273	1 Participants	2 Participants
Number of Participants With Clinically Significant Qualitative Breast Examination Nipple tenderness,Month 12, n=279, 273	0 Participants	1 Participants
Number of Participants With Clinically Significant Qualitative Breast Examination Palpable breast tissue, Month 18, n=267, 258	1 Participants	0 Participants
Number of Participants With Clinically Significant Qualitative Breast Examination Nipple tenderness,Month 18, n=267, 258	0 Participants	0 Participants
Number of Participants With Clinically Significant Qualitative Breast Examination Palpable breast tissue, Month 24, n=262, 252	0 Participants	0 Participants
Number of Participants With Clinically Significant Qualitative Breast Examination Nipple tenderness, Month 24, n=262, 252	0 Participants	0 Participants
Number of Participants With Clinically Significant Qualitative Breast Examination Palpable breast tissue,final assessment, n=296,296	0 Participants	0 Participants
Number of Participants With Clinically Significant Qualitative Breast Examination Nipple tenderness,final assessment, n=296, 296	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6, 12, 18 , 24 months and final assessment

Population: ITT Population.

Suicidality was assessed utilizing the Columbia Suicide Severity Rating Scale (C-SSRS). It included tabular summaries of suicidal ideation and suicidal behavior questions that were administered. Assessments were carried out at Screening, Month 6, Month 12, and Month 24 (or end of treatment) visits. C-SSRS included Question1-2 were for suicidal ideation Question 1: Passive: wish to be dead, Question 2: Active: Non-specific (no method, intent or plan). Questions 6-10 were for suicidal behavior, Question 6: Preparatory Acts or Behavior, Question 7: any aborted attempt, Question 8: Any interrupted attempts, Question 9: Any non-fatal actual suicide attempt, Question 10: Completed suicide. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo + Tam 0.2mg n=302 Participants Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	Dut 0.5 mg + Tam 0.2 mg n=305 Participants Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 24, Suicidal ideation, Q2, n=261, 251	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 6, Suicidal ideation, Q1, n=289, 285	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 6, Suicidal ideation, Q2, n=289, 285	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 6, Suicidal behavior, Q6, n=289, 285	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 6, Suicidal behavior, Q7, n=289, 285	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 6, Suicidal behavior, Q8, n=289, 285	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 6, Suicidal behavior, Q9, n=289, 285	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 6, Suicidal behavior, Q10, n=289, 285	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 12, Suicidal ideation, Q1, n=279, 273	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 12, Suicidal ideation, Q2, n=279, 273	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 12, Suicidal behavior, Q6, n=279, 273	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 12, Suicidal behavior, Q7, n=279, 273	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 12, Suicidal behavior, Q8, n=279, 273	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 12, Suicidal behavior, Q9, n=279, 273	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 12, Suicidal behavior, Q10, n=279, 273	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 24, Suicidal ideation, Q1, n=261, 251	0 Participants	1 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 12, Suicidal behavior, Q6, n=261, 251	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 12, Suicidal behavior, Q7, n=261, 251	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 12, Suicidal behavior, Q8, n=261, 251	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 12, Suicidal behavior, Q9, n=261, 251	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Month 12, Suicidal behavior, Q10, n=261, 251	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Final assessment, Suicidal ideation,Q1, n=288, 285	0 Participants	1 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Final assessment, Suicidal ideation,Q2, n=288, 285	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Final assessment, Suicidal behavior,Q6, n=288, 285	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Final assessment, Suicidal behavior,Q7, n=288, 285	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Final assessment, Suicidal behavior,Q8, n=288, 285	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Final assessment, Suicidal behavior,Q9, n=288, 285	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior Final assessment, Suicidal behavior,Q10,n=288, 285	0 Participants	0 Participants

Adverse Events

Placebo + Tam 0.2mg

Serious events: 52 serious events

Other events: 203 other events

Deaths: 1 deaths

Dut 0.5 mg + Tam 0.2 mg

Serious events: 49 serious events

Other events: 208 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER