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    Clinical Trial Results:
    Reporting and Analysis Plan for FDC116115: A prospective study of sexual function in sexually active men treated for BPH

    Summary
    EudraCT number
    		 2012-002047-26
    Trial protocol
    		 GR   NL   HU   ES   DE  
    Global end of trial date
    05 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Dec 2016
    First version publication date
    01 Dec 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    116115
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 866 435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 866 435-7343,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH (international prostate symptom score - IPSS = or > 12) who are treated with DUODART, compared to men treated with placebo
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Feb 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 32
    Country: Number of subjects enrolled
    France: 54
    Country: Number of subjects enrolled
    Germany: 72
    Country: Number of subjects enrolled
    Greece: 65
    Country: Number of subjects enrolled
    Hungary: 81
    Country: Number of subjects enrolled
    Netherlands: 74
    Country: Number of subjects enrolled
    Spain: 111
    Worldwide total number of subjects
    489
    EEA total number of subjects
    457
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    210
    From 65 to 84 years
    278
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 This is a European double-blind, placebo-controlled, parallel-group study to assess the impact of dutasteride treatment on sexual function in men with moderate/severe Benign Prostatic Hyperplasia (BPH)

    Pre-assignment
    Screening details
    		 Eligible participants (par.) entered a 4-week Placebo Run-in Phase, and were randomised in 1:1 ratio to receive DUODART (fixed dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg) and placebo one capsule daily for 52 weeks. Follow-up was performed 6 months after the last dose of study medication

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Sugar capsule was administered once daily

    Arm title
    		 Duodart
    Arm description
    		 Participants received a combination of dutasteride 0.5 milligrams (mg) and tamsulosin 0.4 mg plus lifestyle advice for 12 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duodart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    DUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg) was administered once daily

    Number of subjects in period 1
    		Placebo Duodart
    Started
    246
    243
    Completed
    191
    184
    Not completed
    55
    59
         Consent withdrawn by subject
    9
    9
         Physician decision
    5
    2
         Adverse event, non-fatal
    24
    33
         Participants reached stopping criteria
    1
    1
         Lost to follow-up
    4
    -
         Lack of efficacy
    8
    10
         Protocol deviation
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a matching placebo for Duodart plus lifestyle advice for 12 months

    Reporting group title
    Duodart
    Reporting group description
    		 Participants received a combination of dutasteride 0.5 milligrams (mg) and tamsulosin 0.4 mg plus lifestyle advice for 12 months

    Reporting group values
    		 Placebo Duodart Total
    Number of subjects
    		 246 243
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 65.4 ± 6.49 65.7 ± 6.59 -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 246 243 489
    Race/Ethnicity, Customized
    Units: Subjects
        African American/African Heritage
    		 1 2 3
        American Indian or Alaska Native
    		 2 3 5
        Asian - East Asian Heritage
    		 1 0 1
        White - Arabic/North African Heritage
    		 3 0 3
        White - White/Caucasian/European Heritage
    		 239 237 476
        Mixed Race
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a matching placebo for Duodart plus lifestyle advice for 12 months

    Reporting group title
    Duodart
    Reporting group description
    		 Participants received a combination of dutasteride 0.5 milligrams (mg) and tamsulosin 0.4 mg plus lifestyle advice for 12 months

    Primary: Changes from Baseline (BL) in total score from the full Men’s Sexual Health Questionnaire (MSHQ) at 12 months

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    End point title
    		 Changes from Baseline (BL) in total score from the full Men’s Sexual Health Questionnaire (MSHQ) at 12 months
    End point description
    Total MSHQ score is composed of 3 domain scores: Erection score(ES)=sum of score for Questions (Q) 1 to 3(ranges from 0 to 15), Ejaculation score(EjS)=sum of scores for Q5 to 11(ranges from 1 to 35), Satisfaction score(SS)=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS. The total MSHQ score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analyzed using a mixed model repeated measures (MMRM) analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest double-blind (DB) treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s)
    End point type
    Primary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo Duodart
    Number of subjects analysed
    162 [1]
    151
    Units: Scores on a scale
        least squares mean (standard error)
    -0.7 ± 0.78
    -8.7 ± 0.81
    Notes
    [1] - Intent-to-Treat (ITT): All randomized par. regardless of whether or not treatment was administered
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    313
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.22
         upper limit
    		 -5.79

    Secondary: Change from baseline in scores from the full Men’s Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 months

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    End point title
    		 Change from baseline in scores from the full Men’s Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 months
    End point description
    Total MSHQ score is composed of 3 domain scores: ES=sum of score for Q 1 to 3(ranges from 0 to 15), EjS=sum of scores for Q5 to 11(ranges from 1 to 35), SS=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analysed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
    End point type
    Secondary
    End point timeframe
    Baseline and up to 9 months
    End point values
    		 Placebo Duodart
    Number of subjects analysed
    246 [2]
    243
    Units: Scores on a scale
    least squares mean (standard error)
        Month 1, n=193, 192
    -0.5 ± 0.68
    -4.6 ± 0.69
        Month 3, n= 184, 181
    -0.5 ± 0.72
    -6.9 ± 0.73
        Month 6, n=179, 164
    -0.8 ± 0.8
    -9.9 ± 0.83
        Month 9, n=166, 146
    -0.8 ± 0.76
    -9.6 ± 0.79
    Notes
    [2] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Month 1
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -4.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.01
         upper limit
    		 -2.21
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Month 3
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Adjusted mean difference
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -6.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.45
         upper limit
    		 -4.41
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -9.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.31
         upper limit
    		 -6.77
    Notes
    [3] - Month 6
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Month 9
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -8.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.96
         upper limit
    		 -6.67

    Secondary: Number of participants reaching various thresholds of change in total MSHQ from baseline at 12 months

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    End point title
    		 Number of participants reaching various thresholds of change in total MSHQ from baseline at 12 months
    End point description
    Participants reaching thresholds of change in total MSHQ were assessed. Threshold values are defined as multiplicative factor. Threshold included +10 points, +20 points, +25 points, -10 points, -20 points, -25 points; where “+” indicates improvement and “-”indicates worsening. Treatment comparisons were done based on categories defined by these thresholds using Mantel-Haenszel test
    End point type
    Secondary
    End point timeframe
    Baseline and 12 months
    End point values
    		 Placebo Duodart
    Number of subjects analysed
    162 [4]
    151
    Units: Participants
        >= 25
    0
    1
        >= 20
    3
    3
        >= 10
    16
    8
        <= -25
    3
    13
        <= -20
    3
    20
        <= -10
    24
    61
    Notes
    [4] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in erectile dysfunction (ED) at 1, 3, 6, 9 and 12 months

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    End point title
    		 Change from Baseline in erectile dysfunction (ED) at 1, 3, 6, 9 and 12 months
    End point description
    Erection scale is a domain of MSHQ to assess erectile dysfunction. ES is the sum of score for questions 1 to 3. The score ranges from 0 (no erection) to 15 (strong erection). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
    End point type
    Secondary
    End point timeframe
    Baseline and up to 12 months
    End point values
    		 Placebo Duodart
    Number of subjects analysed
    246 [5]
    243
    Units: Scores on a scale
    least squares mean (standard error)
        Month 1, n=209, 215
    -0.3 ± 0.15
    -0.5 ± 0.15
        Month 3, n= 202, 208
    -0.5 ± 0.17
    -0.7 ± 0.17
        Month 6, n= 193, 188
    -0.6 ± 0.18
    -1 ± 0.19
        Month 9, n=182, 169
    -0.5 ± 0.18
    -1.2 ± 0.19
        Month 12, n= 175, 168
    -0.5 ± 0.19
    -1 ± 0.19
    Notes
    [5] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Month 1
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.37
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.62
         upper limit
    		 0.23
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Month 3
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.33
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.71
         upper limit
    		 0.24
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Month 6
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.16
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.88
         upper limit
    		 0.15
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Month 9
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.19
         upper limit
    		 -0.17
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Month 12
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.091
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 0.07

    Secondary: Change from Baseline in ejaculatory dysfunction (EjD) at 1, 3, 6, 9 and 12 months

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    End point title
    		 Change from Baseline in ejaculatory dysfunction (EjD) at 1, 3, 6, 9 and 12 months
    End point description
    Ejaculation scale is a domain of MSHQ to assess ejaculatory dysfunction. EjS is the sum of score for questions 5 to 11. The score ranges from 1 (could not ejaculate) to 35 (strong ejaculation). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
    End point type
    Secondary
    End point timeframe
    Baseline and up to 12 months
    End point values
    		 Placebo Duodart
    Number of subjects analysed
    246 [6]
    243
    Units: Scores on a scale
    least squares mean (standard error)
        Month 1, n=210, 208
    -0.3 ± 0.42
    -3.2 ± 0.43
        Month 3, n= 197, 196
    -0.5 ± 0.48
    -5.8 ± 0.48
        Month 6, n= 191, 179
    -0.7 ± 0.53
    -7.5 ± 0.54
        Month 9, n=177, 161
    -0.5 ± 0.52
    -7.6 ± 0.53
        Month 12, n= 173, 164
    -0.6 ± 0.55
    -7.5 ± 0.56
    Notes
    [6] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Month 1
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -2.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.07
         upper limit
    		 -1.7
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Month 3
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -5.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.59
         upper limit
    		 -3.9
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Month 6
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -6.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.3
         upper limit
    		 -5.34
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Month 9
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -7.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.51
         upper limit
    		 -5.59
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Month 12
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -6.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.47
         upper limit
    		 -5.38

    Secondary: Change from Baseline in satisfaction score at 1, 3, 6, 9 and 12 months

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    End point title
    		 Change from Baseline in satisfaction score at 1, 3, 6, 9 and 12 months
    End point description
    Satisfaction scale is a domain of MSHQ to assess sexual relationship. SS is the sum of score for questions 13 to 18. The score ranges from 6 (extremely dissatisfied) to 30 (extremely satisfied). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
    End point type
    Secondary
    End point timeframe
    Baseline and up to 12 months
    End point values
    		 Placebo Duodart
    Number of subjects analysed
    246 [7]
    243
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Month 1, n=200, 197
    0.1 ± 0.26
    -0.8 ± 0.26
        Month 3, n= 189, 182
    0.4 ± 0.27
    -0.5 ± 0.28
        Month 6, n= 185, 168
    0.2 ± 0.3
    -1.5 ± 0.31
        Month 9, n=173, 153
    0 ± 0.3
    -1.2 ± 0.32
        Month 12, n= 169, 152
    0.3 ± 0.29
    -0.6 ± 0.3
    Notes
    [7] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Month 1
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.67
         upper limit
    		 -0.21
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Month 3
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.69
         upper limit
    		 -0.17
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Month 6
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.57
         upper limit
    		 -0.88
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Month 9
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.01
         upper limit
    		 -0.3
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Month 12
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.047
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.65
         upper limit
    		 -0.01

    Secondary: Change from Baseline in International Prostate Symptom Score (IPSS) Scores using the Observed Cases approach at 2 weeks, 1, 3, 6, 9, and 12 months

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    End point title
    		 Change from Baseline in International Prostate Symptom Score (IPSS) Scores using the Observed Cases approach at 2 weeks, 1, 3, 6, 9, and 12 months
    End point description
    The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify urinary symptoms: Q1, incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. The score can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
    End point type
    Secondary
    End point timeframe
    Baseline and up to 12 months
    End point values
    		 Placebo Duodart
    Number of subjects analysed
    246 [8]
    243
    Units: Scores on a scale
    least squares mean (standard error)
        Week 2, n=232, 234
    -1.5 ± 0.29
    -3.1 ± 0.29
        Month1, n=222, 231
    -2.8 ± 0.33
    -3.4 ± 0.33
        Month 3, n=217, 224
    -2.8 ± 0.33
    -4.1 ± 0.33
        Month 6, n=206, 203
    -2.9 ± 0.36
    -4.6 ± 0.36
        Month 9, n=193, 185
    -3.2 ± 0.38
    -4.5 ± 0.38
        Month 12, n=187, 184
    -3.2 ± 0.41
    -5.2 ± 0.41
    Notes
    [8] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 2
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -1.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.45
         upper limit
    		 -0.85
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Month 1
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.24
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.47
         upper limit
    		 0.37
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Month 3
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.19
         upper limit
    		 -0.36
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Month 6
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.74
         upper limit
    		 -0.72
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Month 9
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -1.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 -0.28
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Month 12
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -1.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.12
         upper limit
    		 -0.83

    Secondary: Change From Baseline in Quality of Life (BPH Impact Index –BII scores) at 2 weeks, 1, 3, 6, 9, and 12 months

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    End point title
    		 Change From Baseline in Quality of Life (BPH Impact Index –BII scores) at 2 weeks, 1, 3, 6, 9, and 12 months
    End point description
    The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating the impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
    End point type
    Secondary
    End point timeframe
    Baseline and up to 12 months
    End point values
    		 Placebo Duodart
    Number of subjects analysed
    246 [9]
    243
    Units: Scores on a scale
    least squares mean (standard error)
        Week 2, n=226, 227
    -0.3 ± 0.14
    -0.7 ± 0.14
        Month1, n=216, 223
    -0.7 ± 0.13
    -0.7 ± 0.13
        Month 3, n=211, 217
    -0.9 ± 0.15
    -1.1 ± 0.15
        Month 6, n=201, 195
    -0.6 ± 0.17
    -1.2 ± 0.17
        Month 9, n=188, 179
    -0.7 ± 0.16
    -1.2 ± 0.17
        Month 12, n=183, 177
    -0.6 ± 0.18
    -1.2 ± 0.18
    Notes
    [9] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 2
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.036
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.78
         upper limit
    		 -0.03
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Month 1
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.37
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Month 3
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.21
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.67
         upper limit
    		 0.15
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Month 6
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.09
         upper limit
    		 -0.15
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Month 9
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.056
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.91
         upper limit
    		 0.01
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Month 12
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.08
         upper limit
    		 -0.08

    Secondary: Change from Baseline in perception of treatment benefit/satisfaction with treatment (Patient Perception of Study Medication - PPSM questionnaire scores) at 2 weeks, 1, 3, 6, 9, and 12 months

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    End point title
    		 Change from Baseline in perception of treatment benefit/satisfaction with treatment (Patient Perception of Study Medication - PPSM questionnaire scores) at 2 weeks, 1, 3, 6, 9, and 12 months
    End point description
    Patient Perception of Study Medication (PPSM) is a 12-item questionnaire designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms. The total PPSM score ranges from 7 to 49, with higher scores indicating lower satisfaction. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9, 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
    End point type
    Secondary
    End point timeframe
    Baseline and up to 12 months
    End point values
    		 Placebo Duodart
    Number of subjects analysed
    246 [10]
    243
    Units: Scores on a scale
    least squares mean (standard error)
        Week 2, n=225, 227
    -0.4 ± 0.32
    -3.4 ± 0.32
        Month1, n=216, 223
    -1.3 ± 0.38
    -3.4 ± 0.38
        Month 3, n=211, 217
    -1.7 ± 0.41
    -3.8 ± 0.41
        Month 6, n=201, 195
    -1 ± 0.44
    -3.6 ± 0.44
        Month 9, n=188, 179
    -1.6 ± 0.45
    -2.9 ± 0.45
        Month 12, n=182, 177
    -1 ± 0.49
    -4.6 ± 0.49
    Notes
    [10] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 2
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.89
         upper limit
    		 -2.1
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Month 1
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.15
         upper limit
    		 -1.06
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Month 3
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -2.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.25
         upper limit
    		 -0.98
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Month 6
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -2.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.76
         upper limit
    		 -1.3
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Month 9
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.042
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.56
         upper limit
    		 -0.05
    Statistical analysis title
    		 Statistical analysis 6
    Statistical analysis description
    Month 12
    Comparison groups
    Duodart v Placebo
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -3.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.87
         upper limit
    		 -2.14

    Secondary: Change from baseline in total MSHQ scores from Baseline at 12 months among participants with IPSS improvement of >=2 points and >=3 points

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    End point title
    		 Change from baseline in total MSHQ scores from Baseline at 12 months among participants with IPSS improvement of >=2 points and >=3 points
    End point description
    Total MSHQ score is composed of 3 domain scores: ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Par. with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed. Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
    End point type
    Secondary
    End point timeframe
    Baseline and Month 12
    End point values
    		 Placebo Duodart
    Number of subjects analysed
    246 [11]
    243
    Units: Participants
    least squares mean (standard error)
        IPSS improvement of >=2, n=152, 142
    -0.6 ± 0.81
    -8.4 ± 0.83
        IPSS improvement of >=3, n=138,136
    -0.6 ± 0.86
    -8 ± 0.86
    Notes
    [11] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Par. with IPSS change from baseline >=2 points improvement at any time post-baseline visit
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -7.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.07
         upper limit
    		 -5.49
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Par. with IPSS change from baseline >=3 points improvement at any time post-baseline visit
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -7.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.79
         upper limit
    		 -4.99

    Secondary: Change from baseline in total MSHQ scores from Baseline at 12 months among participants with IPSS improvement of >=25 percent

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    End point title
    		 Change from baseline in total MSHQ scores from Baseline at 12 months among participants with IPSS improvement of >=25 percent
    End point description
    Participants with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed.Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
    End point type
    Secondary
    End point timeframe
    Baseline and Month 12
    End point values
    		 Placebo Duodart
    Number of subjects analysed
    139 [12]
    133
    Units: Participants
        least squares mean (standard error)
    -0.6 ± 0.86
    -8.3 ± 0.88
    Notes
    [12] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Par. with IPSS change from baseline >=25 points improvement at any time post-baseline visit
    Comparison groups
    Placebo v Duodart
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 mixed-model repeated-measures
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -7.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.22
         upper limit
    		 -5.35

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to approximately 18 months).
    Adverse event reporting additional description
    On-treatment SAEs and non-serious AEs are reported for ITT Population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Duodart
    Reporting group description
    		 Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a matching placebo for Duodart plus lifestyle advice for 12 months

    Serious adverse events
    		 Duodart Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 243 (11.11%)
    9 / 246 (3.66%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal neoplasm
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular cyst
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 243 (0.41%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Joint dislocation
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 243 (0.41%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    2 / 243 (0.82%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal fistula
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamic infarction
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvi-ureteric obstruction
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 243 (0.00%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal column stenosis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 243 (0.82%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 243 (0.82%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected cyst
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 243 (0.41%)
    0 / 246 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Duodart Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 243 (27.16%)
    28 / 246 (11.38%)
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    24 / 243 (9.88%)
    16 / 246 (6.50%)
         occurrences all number
    25
    17
    Retrograde ejaculation
         subjects affected / exposed
    23 / 243 (9.47%)
    3 / 246 (1.22%)
         occurrences all number
    23
    3
    Ejaculation disorder
         subjects affected / exposed
    16 / 243 (6.58%)
    2 / 246 (0.81%)
         occurrences all number
    16
    2
    Psychiatric disorders
    Libido decreased
         subjects affected / exposed
    20 / 243 (8.23%)
    12 / 246 (4.88%)
         occurrences all number
    22
    12

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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