Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase IIb multicentre, double-blind, dose-ranging, randomised, placebo-controlled study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism

    Summary
    EudraCT number
    		 2015-005760-42
    Trial protocol
    		 GB   ES   IT  
    Global end of trial date
    15 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MBGS205
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02730169
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mereo BioPharma 2 Ltd
    Sponsor organisation address
    4th Floor, 1 Cavendish Place, London, United Kingdom, W1G 0QF
    Public contact
    William Moore, Mereo BioPharma 2 Ltd, +44 (0) 333 023 7300, enquiries@mereobiopharma.com
    Scientific contact
    Jackie Parkin, Mereo BioPharma 2 Ltd, +44 (0) 333 023 7300, enquiries@mereobiopharma.com
    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
    07 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to demonstrate the efficacy of BGS649 to normalise total testosterone levels (300-1000 ng/dL [10.4-35 nmol/L]) in ≥ 75% of subjects after 24 weeks of treatment.
    Protection of trial subjects
    This study was conducted in accordance with current applicable regulations, International Council for Harmonisation (ICH) guidelines, and local legal requirements. It complies with the ethical principles described in the 18th World Medical Assembly (Helsinki 1964) and amendments of the 29th (Tokyo 1975), 35th (Venice 1983), 41st (Hong Kong 1989), and 48th (South Africa 1996) World Medical Assemblies, Declaration of Helsinki. The risk to subjects in this study were minimised by compliance with the inclusion/exclusion criteria, close clinical monitoring, including signs and symptoms related to the potential risks of aromatase inhibitors for at least 25 weeks following the last dose of study medication. Additional stringent monitoring for inclusion in the study with specific observation for any class effects was performed throughout the study.
    Background therapy
    		 No background therapy for obesity associated hypogonadotropic hypogonadism was given as there is no approved therapy available.
    Evidence for comparator
    		 Not applicable, placebo control used.
    Actual start date of recruitment
    06 Jun 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    United States: 259
    Worldwide total number of subjects
    271
    EEA total number of subjects
    7
    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)
    271
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were recruited at 76 investigator centres in 5 countries worldwide. The target population was obese male subjects with serum testosterone concentration below the normal range and at least t2 symptoms of sexual dysfuntion.

    Pre-assignment
    Screening details
    		 Subjects were screened for up to 28 days before receiving their first dose of study treatment at the randomisation visit. Of the 2103 subjects screened for the study, 271 were randomised and received study treatment (BGS649 or placebo).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor
    Blinding implementation details
    Matched placebo used.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BGS649 0.1 mg
    Arm description
    		 Participants received 0.1 mg BGS649 orally on Day 1. Subsequent doses with 0.1 mg BGS649 were administered orally and taken once weekly to week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BGS649
    Investigational medicinal product code
    Other name
    Leflutrozole
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules of BGS649 0.1 mg, 0.3 mg, 1.0 mg or BGS649 matching placebo were taken orally by the subject, with fluids, on a weekly basis at approximately the same time of day. Treatment was self administered except on Day 1 (Baseline) and at Week 12, when it was taken by the subject at the study site.

    Arm title
    		 BGS649 0.3 mg
    Arm description
    		 Participants received 0.3 mg BGS649 orally on Day 1. Subsequent doses with 0.3 mg BGS649 were administered orally and taken once weekly to week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BGS649
    Investigational medicinal product code
    Other name
    Leflutrozole
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules of BGS649 0.1 mg, 0.3 mg, 1.0 mg or BGS649 matching placebo were taken orally by the subject, with fluids, on a weekly basis at approximately the same time of day. Treatment was self administered except on Day 1 (Baseline) and at Week 12, when it was taken by the subject at the study site.

    Arm title
    		 BGS649 1.0 mg
    Arm description
    		 Participants received 1.0 mg BGS649 orally on Day 1. Subsequent doses with 1.0 mg BGS649 were administered orally and taken once weekly to week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BGS649
    Investigational medicinal product code
    Other name
    Leflutrozole
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules of BGS649 0.1 mg, 0.3 mg, 1.0 mg or BGS649 matching placebo were taken orally by the subject, with fluids, on a weekly basis at approximately the same time of day. Treatment was self administered except on Day 1 (Baseline) and at Week 12, when it was taken by the subject at the study site.

    Arm title
    		 BGS649 Placebo
    Arm description
    		 Participants received BGS649 placebo orally on Day 1. Subsequent doses with BGS649 placebo were administered orally and taken once weekly to week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BGS649
    Investigational medicinal product code
    Other name
    Leflutrozole
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules of BGS649 0.1 mg, 0.3 mg, 1.0 mg or BGS649 matching placebo were taken orally by the subject, with fluids, on a weekly basis at approximately the same time of day. Treatment was self administered except on Day 1 (Baseline) and at Week 12, when it was taken by the subject at the study site.

    Number of subjects in period 1
    		BGS649 0.1 mg BGS649 0.3 mg BGS649 1.0 mg BGS649 Placebo
    Started
    67
    66
    67
    71
    Completed
    52
    41
    42
    55
    Not completed
    15
    25
    25
    16
         Consent withdrawn by subject
    5
    11
    5
    7
         Adverse event, non-fatal
    6
    8
    13
    2
         Not Specified
    2
    -
    2
    1
         Discontinuation criteria met as per protocol
    1
    1
    -
    -
         Lost to follow-up
    1
    4
    5
    5
         Protocol deviation
    -
    1
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 271 271
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 271 271
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.8 ( 8.69 ) -
    Gender categorical
    Units: Subjects
        Male
    		 271 271
    Subject analysis sets

    Subject analysis set title
    BGS649 0.1 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks

    Subject analysis set title
    BGS649 0.3 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks

    Subject analysis set title
    BGS649 1.0 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks

    Subject analysis sets values
    		 BGS649 0.1 mg BGS649 0.3 mg BGS649 1.0 mg Placebo
    Number of subjects
    67
    66
    67
    71
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    67
    66
    67
    71
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.4 ( 8.39 )
    51.6 ( 7.31 )
    49.6 ( 9.72 )
    50.9 ( 9.17 )
    Gender categorical
    Units: Subjects
        Male
    67
    66
    67
    71

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    BGS649 0.1 mg
    Reporting group description
    		 Participants received 0.1 mg BGS649 orally on Day 1. Subsequent doses with 0.1 mg BGS649 were administered orally and taken once weekly to week 24.

    Reporting group title
    BGS649 0.3 mg
    Reporting group description
    		 Participants received 0.3 mg BGS649 orally on Day 1. Subsequent doses with 0.3 mg BGS649 were administered orally and taken once weekly to week 24.

    Reporting group title
    BGS649 1.0 mg
    Reporting group description
    		 Participants received 1.0 mg BGS649 orally on Day 1. Subsequent doses with 1.0 mg BGS649 were administered orally and taken once weekly to week 24.

    Reporting group title
    BGS649 Placebo
    Reporting group description
    		 Participants received BGS649 placebo orally on Day 1. Subsequent doses with BGS649 placebo were administered orally and taken once weekly to week 24.

    Subject analysis set title
    BGS649 0.1 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks

    Subject analysis set title
    BGS649 0.3 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks

    Subject analysis set title
    BGS649 1.0 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks

    Primary: Normalisation of total testosterone levels in ≥ 75% of subjects at Week 24

    		 Close Top of page
    End point title
    		 Normalisation of total testosterone levels in ≥ 75% of subjects at Week 24
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to week 24
    End point values
    		 BGS649 0.1 mg BGS649 0.3 mg BGS649 1.0 mg Placebo
    Number of subjects analysed
    67
    66
    67
    71
    Units: Number of subjects
    59
    62
    63
    7
    Statistical analysis title
    		 Comparison of active groups to placebo
    Statistical analysis description
    Intention to Treat population using last observation carried forward imputation for missing data and analysed Fisher's exact test.
    Comparison groups
    Placebo v BGS649 0.1 mg v BGS649 0.3 mg v BGS649 1.0 mg
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [1] - For all active groups versus placebo.

    Secondary: Normalisation of total testosterone levels in ≥ 90% of subjects at Week 24

    		 Close Top of page
    End point title
    		 Normalisation of total testosterone levels in ≥ 90% of subjects at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 BGS649 0.1 mg BGS649 0.3 mg BGS649 1.0 mg Placebo
    Number of subjects analysed
    67
    66
    67
    71
    Units: Number of subjects
    59
    62
    63
    7
    Statistical analysis title
    		 Comparison of active groups to placebo
    Statistical analysis description
    Intention to Treat population using last observation carried forward imputation for missing data and analysed Fisher's exact test.
    Comparison groups
    BGS649 0.1 mg v BGS649 0.3 mg v BGS649 1.0 mg v Placebo
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [2] - For all active groups versus placebo.

    Secondary: Change of LH to 24 weeks

    		 Close Top of page
    End point title
    		 Change of LH to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 BGS649 0.1 mg BGS649 0.3 mg BGS649 1.0 mg Placebo
    Number of subjects analysed
    67
    66
    67
    71
    Units: mIU/mL
        number (not applicable)
    2.108
    3.560
    5.209
    -0.043
    Statistical analysis title
    		 Comparison of active groups to placebo
    Statistical analysis description
    A mixed model for repeated measures (MMRN) with change from baseline as the outcome and treatment, visit, treatment by visit interaction, baseline value and baseline by visit interaction as covariates.
    Comparison groups
    BGS649 0.1 mg v BGS649 0.3 mg v BGS649 1.0 mg v Placebo
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [3] - P value for all active groups versus placebo.

    Secondary: Change of FSH to 24 weeks

    		 Close Top of page
    End point title
    		 Change of FSH to 24 weeks
    End point description
    Change in FSH
    End point type
    Secondary
    End point timeframe
    Baseline to week 24
    End point values
    		 BGS649 0.1 mg BGS649 0.3 mg BGS649 1.0 mg Placebo
    Number of subjects analysed
    67
    66
    67
    71
    Units: mIU/mL
        number (not applicable)
    4.836
    6.183
    8.282
    0.038
    Statistical analysis title
    		 Comparison of active groups to placebo
    Comparison groups
    BGS649 0.1 mg v BGS649 0.3 mg v BGS649 1.0 mg v Placebo
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [4] - For all active groups versus placebo.

    Secondary: Population PK analysis

    		 Close Top of page
    End point title
    		 Population PK analysis
    End point description
    Population PK analysis (Week 12, pre-dose and 1 hour post-dose and EOT at Week 24).
    End point type
    Secondary
    End point timeframe
    Week 12, pre-dose and 1 hour post-dose and EOT at Week 24.
    End point values
    		 BGS649 0.1 mg BGS649 0.3 mg BGS649 1.0 mg
    Number of subjects analysed
    64
    59
    65
    Units: ng/mL
    geometric mean (confidence interval 95%)
        Week 12 Pre-dose
    0.73 (0.64 to 0.83)
    2.55 (2.33 to 2.80)
    8.93 (8.29 to 9.62)
        Week 12 1h Post-Dose
    1.43 (1.24 to 1.65)
    4.39 (3.89 to 4.97)
    14.91 (13.52 to 16.45)
        Week 24 EOT
    0.78 (0.64 to 0.97)
    2.76 (2.14 to 3.57)
    9.10 (7.61 to 10.89)
    No statistical analyses for this end point

    Secondary: PK analysis of semen BGS649 concentrations

    		 Close Top of page
    End point title
    		 PK analysis of semen BGS649 concentrations
    End point description
    PK analysis of semen BGS649 concentrations at Visit 8 (EOT at Week 24).
    End point type
    Secondary
    End point timeframe
    Visit 8 (EOT at Week 24).
    End point values
    		 BGS649 0.1 mg BGS649 0.3 mg BGS649 1.0 mg
    Number of subjects analysed
    64
    59
    65
    Units: ng/mL
    geometric mean (confidence interval 95%)
        Week 24 EOT
    0.49 (0.42 to 0.58)
    1.58 (1.19 to 2.08)
    5.28 (4.16 to 6.71)
    No statistical analyses for this end point

    Other pre-specified: Time to first normal testosterone level

    		 Close Top of page
    End point title
    		 Time to first normal testosterone level
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Over study period to week 24
    End point values
    		 BGS649 0.1 mg BGS649 0.3 mg BGS649 1.0 mg Placebo
    Number of subjects analysed
    67
    66
    67
    71
    Units: Days
        number (not applicable)
    7
    7
    7
    111
    Statistical analysis title
    		 Comparison of active groups to placebo
    Comparison groups
    BGS649 0.1 mg v BGS649 0.3 mg v BGS649 1.0 mg v Placebo
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [5]
    Method
    		 Kaplan-Meier
    Confidence interval
    Notes
    [5] - P less than 0.001 compared to placebo for all active arm

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were recorded from signing the informed consent to completion of the 90 day follow-up period after last administration of study drug.
    Adverse event reporting additional description
    At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    BGS649 0.1 mg
    Reporting group description
    		 Participants received 0.1 mg BGS649 orally on Day 1. Subsequent doses with 0.1 mg BGS649 were administered orally and taken once weekly to week 24.

    Reporting group title
    BGS649 0.3 mg
    Reporting group description
    		 Participants received 0.3 mg BGS649 orally on Day 1. Subsequent doses with 0.3 mg BGS649 were administered orally and taken once weekly to week 24.

    Reporting group title
    BGS649 1.0 mg
    Reporting group description
    		 Participants received 1.0 mg BGS649 orally on Day 1. Subsequent doses with 1.0 mg BGS649 were administered orally and taken once weekly to week 24.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo orally on Day 1. Subsequent doses with placebo were administered orally and taken once weekly to week 24.

    Serious adverse events
    		 BGS649 0.1 mg BGS649 0.3 mg BGS649 1.0 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 66 (3.03%)
    5 / 67 (7.46%)
    5 / 71 (7.04%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Skull fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal perforation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gouty arthritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Postoperative wound infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis infective
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 BGS649 0.1 mg BGS649 0.3 mg BGS649 1.0 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 67 (55.22%)
    39 / 66 (59.09%)
    47 / 67 (70.15%)
    41 / 71 (57.75%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Seborrhoeic keratosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Squamous cell carcinoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Vascular disorders
    Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 66 (3.03%)
    5 / 67 (7.46%)
    0 / 71 (0.00%)
         occurrences all number
    2
    2
    5
    0
    Haematoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Hot flush
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    4 / 66 (6.06%)
    1 / 67 (1.49%)
    2 / 71 (2.82%)
         occurrences all number
    1
    4
    1
    2
    Chest pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    1
    1
    Oedema peripheral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences all number
    1
    0
    1
    1
    Influenza like illness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Asthenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chest discomfort
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cyst
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Energy increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Feeling hot
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Non-cardiac chest pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oedema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gynaecomastia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Testicular pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Breast pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Erection increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Prostatic mass
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Prostatomegaly
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Spontaneous penile erection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Testicular hypertrophy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    3 / 67 (4.48%)
    1 / 71 (1.41%)
         occurrences all number
    1
    0
    3
    1
    Nasal congestion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Oropharyngeal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Asthma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Bronchial hyperreactivity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspnoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Epistaxis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pickwickian syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Productive cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinitis allergic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sinus congestion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sleep apnoea syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Psychiatric disorders
    Insomnia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 66 (0.00%)
    2 / 67 (2.99%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Depression
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    3 / 66 (4.55%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Libido decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 66 (1.52%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Irritability
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    2
    Adjustment disorder with depressed mood
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Agitation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Anxiety
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Apathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Euphoric mood
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Loss of libido
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Mood altered
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Haematocrit increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    4 / 66 (6.06%)
    5 / 67 (7.46%)
    0 / 71 (0.00%)
         occurrences all number
    2
    5
    6
    0
    Prostatic specific antigen increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 66 (1.52%)
    4 / 67 (5.97%)
    2 / 71 (2.82%)
         occurrences all number
    2
    1
    4
    2
    Blood triglycerides increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 66 (3.03%)
    1 / 67 (1.49%)
    2 / 71 (2.82%)
         occurrences all number
    0
    2
    1
    2
    Weight increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    2 / 67 (2.99%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    2
    1
    Blood creatinine increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences all number
    1
    0
    1
    1
    Blood pressure increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    2 / 67 (2.99%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Aspartate aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    0
    2
    Alanine aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatic enzyme increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blood bilirubin increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Blood glucose increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood insulin increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Blood pressure decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood prolactin increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood urine present
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    C-reactive protein increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Electrocardiogram QT prolonged
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Glycosylated haemoglobin increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Heart rate irregular
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Low density lipoprotein increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Back injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Contusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    1
    Fall
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    2 / 67 (2.99%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Limb injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    2 / 67 (2.99%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Muscle strain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    1
    0
    0
    1
    Animal bite
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Arthropod sting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Excoriation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Laceration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Procedural pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Radius fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Skin abrasion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Tendon rupture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Thermal burn
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Tooth fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Atrial fibrillation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cyanosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Extrasystoles
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Left ventricular hypertrophy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 67 (10.45%)
    3 / 66 (4.55%)
    4 / 67 (5.97%)
    2 / 71 (2.82%)
         occurrences all number
    8
    4
    4
    3
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    0 / 66 (0.00%)
    2 / 67 (2.99%)
    0 / 71 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Paraesthesia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Syncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Central nervous system lesion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Complex regional pain syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Facial paralysis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lethargy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolic encephalopathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Migraine
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Neuralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Presyncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Primary headache associated with sexual activity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Sensory loss
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tremor
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Polycythaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 66 (3.03%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    3
    2
    0
    1
    Ear and labyrinth disorders
    Tinnitus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye disorders
    Dry eye
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    2 / 67 (2.99%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Blepharitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 66 (3.03%)
    1 / 67 (1.49%)
    2 / 71 (2.82%)
         occurrences all number
    1
    2
    1
    2
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences all number
    1
    0
    1
    2
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences all number
    1
    0
    1
    1
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    1
    1
    Abdominal discomfort
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dry mouth
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Toothache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    2
    1
    Abdominal distension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Dyspepsia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Food poisoning
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Gastrooesophageal reflux disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Haematochezia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 66 (1.52%)
    2 / 67 (2.99%)
    1 / 71 (1.41%)
         occurrences all number
    1
    1
    2
    1
    Dermatitis contact
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    2
    1
    0
    1
    Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    2 / 67 (2.99%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Alopecia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Androgenetic alopecia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blister
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diabetic foot
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hidradenitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Night sweats
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Onycholysis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Penile ulceration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Seborrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal and urinary disorders
    Pollakiuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 66 (1.52%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Nephrolithiasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    1
    0
    0
    1
    Bladder outlet obstruction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Calculus urinary
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Chronic kidney disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Glycosuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haematuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Hydronephrosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Micturition urgency
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nocturia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal cyst
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Urinary retention
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary tract obstruction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    3 / 66 (4.55%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences all number
    3
    3
    1
    1
    Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 66 (3.03%)
    2 / 67 (2.99%)
    1 / 71 (1.41%)
         occurrences all number
    2
    2
    2
    1
    Muscle spasms
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 66 (3.03%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    2
    2
    0
    1
    Myalgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    2 / 71 (2.82%)
         occurrences all number
    1
    1
    0
    2
    Pain in extremity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    3 / 67 (4.48%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Osteopenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    2 / 71 (2.82%)
         occurrences all number
    0
    0
    0
    2
    Bursitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Groin pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Intervertebral disc protrusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Osteoarthritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Psoriatic arthropathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Rotator cuff syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Spinal column stenosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Trigger finger
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 67 (4.48%)
    3 / 66 (4.55%)
    2 / 67 (2.99%)
    5 / 71 (7.04%)
         occurrences all number
    4
    4
    2
    5
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 66 (3.03%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences all number
    2
    2
    1
    1
    Sinusitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    2 / 71 (2.82%)
         occurrences all number
    1
    1
    0
    2
    Influenza
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    1 / 67 (1.49%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    1
    1
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 66 (3.03%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    2
    0
    2
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    0
    1
    Osteomyelitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Sepsis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tooth abscess
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    1
    0
    0
    1
    Tooth infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Bacterial prostatitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Conjunctivitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Ear infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Folliculitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Furuncle
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastritis viral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastroenteritis norovirus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Lower respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oral herpes
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Otitis externa
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Otitis media
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Otitis media acute
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rash pustular
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tinea pedis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Viral upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Vitamin D deficiency
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 66 (3.03%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Diabetes mellitus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 66 (1.52%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Hypertriglyceridaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Type 2 diabetes mellitus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Fluid retention
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Gout
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Hypochloraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypoglycaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    0
    1
    Hypokalaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 66 (1.52%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyponatraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 66 (0.00%)
    0 / 67 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Increased appetite
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 66 (0.00%)
    1 / 67 (1.49%)
    0 / 71 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Mar 2016
    The purpose of this amendment was clarification of eligibility criteria and requirement of participants to refrain from sperm donation during the trial.
    05 May 2016
    The purpose of this amendment was a change to inclusion criteria to require two morning testosterone measurements of less than 300 ng/dL.
    26 Sep 2016
    The purpose of this amendment was a change to the interim analysis population to require approximately 100 participants.
    03 Nov 2016
    The purpose of this amendment was a change in the wash out period of topical testosterone treatments from six months prior to the first screening visit.
    10 Mar 2017
    The purpose of this amendment was to reduce the frequency of semen sampling.

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat Apr 27 01:28:48 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA