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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Parallel Study with an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men

    Summary
    EudraCT number
    		 2012-004866-16
    Trial protocol
    		 DE   IT   GB   ES  
    Global end of trial date
    30 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2016
    First version publication date
    15 May 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I5E-MC-TSAT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01816295
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    30 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.
    Protection of trial subjects
    This study was conducted in accordance with ICH Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 May 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
    Argentina: 58
    Country: Number of subjects enrolled
    Canada: 24
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Spain: 40
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Italy: 52
    Country: Number of subjects enrolled
    Korea, Republic of: 74
    Country: Number of subjects enrolled
    Puerto Rico: 7
    Country: Number of subjects enrolled
    United States: 432
    Worldwide total number of subjects
    715
    EEA total number of subjects
    120
    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)
    572
    From 65 to 84 years
    141
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 No text entered.

    Pre-assignment
    Screening details
    		 Total testosterone level <300 nanograms per deciliter (ng/dL) [10.4 nanomole/liter (nmol/L)] obtained at each of the 2 screening visits, Screening Visit 1 and Screening Visit 2, performed at least 1 week apart

    Period 1
    Period 1 title
    Double Blind Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Solution
    Arm description
    		 Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal solution
    Routes of administration
    Topical use
    Dosage and administration details
    Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period.

    Arm title
    		 Testosterone Solution
    Arm description
    		 Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Testosterone Solution
    Investigational medicinal product code
    Other name
    Axiron, Testosterone Solution 2%
    Pharmaceutical forms
    Transdermal solution
    Routes of administration
    Topical use
    Dosage and administration details
    Testosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks.

    Number of subjects in period 1
    		Placebo Solution Testosterone Solution
    Started
    357
    358
    Received Study Drug
    356
    354
    Completed
    294
    302
    Not completed
    63
    56
         Physician decision
    2
    2
         Consent withdrawn by subject
    22
    20
         Adverse event, non-fatal
    11
    8
         Sponsor Decision
    8
    8
         Lost to follow-up
    3
    5
         Entry Criteria Not Met
    -
    2
         Protocol deviation
    17
    11
    Period 2
    Period 2 title
    Open Label Extension
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Solution
    Arm description
    		 Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal solution
    Routes of administration
    Topical use
    Dosage and administration details
    Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period.

    Arm title
    		 Testosterone Solution
    Arm description
    		 Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Testosterone Solution
    Investigational medicinal product code
    Other name
    Axiron, Testosterone Solution 2%
    Pharmaceutical forms
    Transdermal solution
    Routes of administration
    Topical use
    Dosage and administration details
    Testosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks.

    Number of subjects in period 2 [1]
    		Placebo Solution Testosterone Solution
    Started
    275
    283
    Completed
    222
    227
    Not completed
    53
    56
         Adverse event, serious fatal
    1
    -
         Physician decision
    3
    1
         Consent withdrawn by subject
    10
    10
         Adverse event, non-fatal
    17
    15
         Sponsor Decision
    7
    9
         Lost to follow-up
    5
    5
         Entry Criteria Not Met
    3
    5
         Protocol deviation
    4
    4
         Lack of efficacy
    3
    7
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participants who completed the Double Blind Phase and still met eligibility criteria had the option to enroll in the Open Label Extension.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo Solution
    Reporting group description
    		 Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.

    Reporting group title
    Testosterone Solution
    Reporting group description
    		 Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.

    Reporting group values
    		 Placebo Solution Testosterone Solution Total
    Number of subjects
    		 357 358 715
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.9 ( 11.35 ) 54.7 ( 10.58 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 0 0 0
        Male
    		 357 358 715
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 51 57 108
        Not Hispanic or Latino
    		 280 279 559
        Unknown or Not Reported
    		 26 22 48
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 3 1 4
        Asian
    		 38 45 83
        Native Hawaiian or Other Pacific Islander
    		 2 0 2
        Black or African American
    		 26 24 50
        White
    		 282 281 563
        More than one race
    		 6 7 13
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        East Asia
    		 34 40 74
        Europe
    		 63 57 120
        South America
    		 28 30 58
        North America
    		 232 231 463
    Symptoms of Hypogonadism
    Units: Subjects
        Only Low Energy
    		 49 47 96
        Only Decreased Sexual Drive
    		 39 40 79
        Both Symptoms Present
    		 269 271 540
    Body Mass Index (BMI)
    BMI is an estimate of body fat based on body weight divided by height squared.
    Units: kilogram per square meter (kg/m²)
        arithmetic mean (standard deviation)
    		 30.9 ( 4.21 ) 30.3 ( 4.06 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo Solution
    Reporting group description
    		 Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.

    Reporting group title
    Testosterone Solution
    Reporting group description
    		 Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
    Reporting group title
    Placebo Solution
    Reporting group description
    		 Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.

    Reporting group title
    Testosterone Solution
    Reporting group description
    		 Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.

    Primary: Number of Participants with Total Serum Testosterone Concentration within Normal Range at Week 12

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    End point title
    		 Number of Participants with Total Serum Testosterone Concentration within Normal Range at Week 12
    End point description
    Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL) or 10.4-36.4 nmol/L.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo Solution Testosterone Solution
    Number of subjects analysed
    287
    297
    Units: participants
        number (not applicable)
    43
    217
    Statistical analysis title
    		 Statistical Analysis for Primary Endpoint
    Comparison groups
    Placebo Solution v Testosterone Solution
    Number of subjects included in analysis
    584
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Change from Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores

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    End point title
    		 Change from Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores
    End point description
    The SAID Scale is a self-administered instrument used to assess sexual arousal, interest, and sex drive in men with symptomatic hypogonadism. The SAID consists of 5 questions that were scored on a scale from 1 to 5, with "5" corresponding to greater levels of sexual arousal, interest, or drive. The SAID Scale total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater sexual arousal, interest, and drive. Least squares (LS) mean change from baseline was calculated using an analysis of covariance (ANCOVA) with treatment group and the baseline value as covariates.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo Solution Testosterone Solution
    Number of subjects analysed
    257
    244
    Units: units on a scale
        least squares mean (standard error)
    6.3 ( 0.99 )
    11.4 ( 1.02 )
    Statistical analysis title
    		 Statistical Analysis for SAID Scale Scores
    Comparison groups
    Placebo Solution v Testosterone Solution
    Number of subjects included in analysis
    501
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    5.1
    Confidence interval
         level
    		 99.5%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 9.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.42

    Secondary: Change from Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores

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    End point title
    		 Change from Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores
    End point description
    The HED is a self-administered instrument used to assess real-time energy levels in men with symptomatic hypogonadism. It consists of 2 questions that were scored on a scale from 0 to 10, with “10” corresponding to "Full of Energy" or "Not Tired at All" (The Tiredness scale was reverse-mapped, as it was collected with “10” corresponding to "Extreme Tiredness"). The questionnaire was completed 3 times daily (forming 6 unique items) for 7 consecutive days. Item scores were computed by averaging the values for each item across 7 days. If more than 2 days were missing for an item, the item score was missing. The total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater energy. If any item score was missing, the total score was missing. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo Solution Testosterone Solution
    Number of subjects analysed
    243
    230
    Units: units on a scale
        least squares mean (standard error)
    7.5 ( 0.87 )
    10.5 ( 0.89 )
    Statistical analysis title
    		 Statistical Analysis for HED Scores
    Comparison groups
    Placebo Solution v Testosterone Solution
    Number of subjects included in analysis
    473
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    2.9
    Confidence interval
         level
    		 99.5%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 6.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.25

    Secondary: Number of Participants with Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)

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    End point title
    		 Number of Participants with Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    Double Blind Baseline, Week 12, Open Label Baseline, Week 36
    End point values
    		 Placebo Solution Testosterone Solution
    Number of subjects analysed
    350
    347
    Units: participants
    number (not applicable)
        Double-Blind Baseline (n=350, 347)
    1
    0
        Week 12 (n=289, 299)
    3
    4
        Open Label Baseline (n=269, 278)
    0
    0
        Week 36 (n=219, 223)
    4
    4
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline in Total International Prostate Symptom Score (IPSS)

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    End point title
    		 Change from Baseline in Total International Prostate Symptom Score (IPSS)
    End point description
    The IPSS is a self-administered instrument used to assess for the severity of lower urinary tract symptoms. The IPSS consists of 7 questions that were scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, Week 36
    End point values
    		 Placebo Solution Testosterone Solution
    Number of subjects analysed
    320
    324
    Units: units on a scale
    least squares mean (standard error)
        Change from Baseline to Week 12
    -0.7 ( 0.24 )
    -0.9 ( 0.24 )
        Change from Baseline to Week 36 (n=247, 255)
    -0.7 ( 0.28 )
    -0.7 ( 0.27 )
    Statistical analysis title
    		 Statistical Analysis 1 for IPSS
    Statistical analysis description
    Change from Baseline to Week 36
    Comparison groups
    Placebo Solution v Testosterone Solution
    Number of subjects included in analysis
    644
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.905
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.82
         upper limit
    		 0.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.39
    Statistical analysis title
    		 Statistical Analysis 2 for IPSS
    Statistical analysis description
    Change from Baseline to Week 12
    Comparison groups
    Placebo Solution v Testosterone Solution
    Number of subjects included in analysis
    644
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.442
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.94
         upper limit
    		 0.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Double-Blind and Open-Label Treatment Periods
    Adverse event reporting additional description
    I5E-MC-TSAT
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Testosterone Solution
    Reporting group description
    		 -

    Reporting group title
    Open-Label Testosterone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Testosterone Solution Open-Label Testosterone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 354 (1.13%)
    24 / 558 (4.30%)
    8 / 356 (2.25%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    basal cell carcinoma
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    brain neoplasm
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cholangiocarcinoma
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    lentigo maligna
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    lung carcinoma cell type unspecified stage iv
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    lung neoplasm malignant
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    squamous cell carcinoma
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    venous thrombosis limb
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    non-cardiac chest pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    pneumothorax
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    respiratory failure
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    suicidal ideation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    suicide attempt
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    brachial plexus injury
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    chest injury
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    craniocerebral injury
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    foreign body
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    haematuria traumatic
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    overdose
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    rib fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    scapula fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    upper limb fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    angina pectoris
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    angina unstable
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebrovascular accident
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ischaemic stroke
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    seizure
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pancreatitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    nephrolithiasis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    musculoskeletal pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    bacterial disease carrier
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    clostridium difficile colitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    endocarditis enterococcal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    influenza
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    meningitis viral
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    septic embolus
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Testosterone Solution Open-Label Testosterone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    148 / 354 (41.81%)
    252 / 558 (45.16%)
    143 / 356 (40.17%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    acoustic neuroma
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    acrochordon
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    2 / 356 (0.56%)
         occurrences all number
    0
    0
    2
    infected neoplasm
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    melanocytic naevus
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    neoplasm prostate
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    squamous cell carcinoma
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    aortic aneurysm
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    flushing
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    2
    1
    0
    hot flush
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    hypertension
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 354 (1.13%)
    4 / 558 (0.72%)
    4 / 356 (1.12%)
         occurrences all number
    4
    4
    4
    hypertensive crisis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    hypotension
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    peripheral vascular disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    varicose vein
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    Surgical and medical procedures
    arthrodesis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    cataract operation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    corneal transplant
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    endodontic procedure
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    high frequency ablation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    inguinal hernia repair
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    knee arthroplasty
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    knee operation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    meniscus operation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    1
    2
    0
    orthodontic procedure
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    posterior lens capsulotomy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    rotator cuff repair
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    suture insertion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    umbilical hernia repair
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    vasectomy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    vitrectomy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    wisdom teeth removal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    application site acne
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    application site dryness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    application site eczema
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    application site erythema
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    4 / 558 (0.72%)
    3 / 356 (0.84%)
         occurrences all number
    1
    4
    3
    application site irritation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    3 / 558 (0.54%)
    0 / 356 (0.00%)
         occurrences all number
    2
    3
    0
    application site pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    6 / 354 (1.69%)
    2 / 558 (0.36%)
    7 / 356 (1.97%)
         occurrences all number
    6
    2
    7
    application site pruritus
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    application site rash
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    4 / 558 (0.72%)
    0 / 356 (0.00%)
         occurrences all number
    0
    4
    0
    application site reaction
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    application site warmth
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    asthenia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    axillary pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    2
    0
    0
    chills
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    cyst
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    cyst rupture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    effusion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    fatigue
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 354 (1.13%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    4
    2
    0
    haemorrhagic cyst
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    influenza like illness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    2 / 356 (0.56%)
         occurrences all number
    0
    2
    2
    local swelling
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    3 / 558 (0.54%)
    1 / 356 (0.28%)
         occurrences all number
    0
    3
    1
    oedema
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    oedema peripheral
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 354 (0.85%)
    3 / 558 (0.54%)
    0 / 356 (0.00%)
         occurrences all number
    3
    3
    0
    pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    peripheral swelling
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    pyrexia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    2
    1
    0
    therapeutic response unexpected
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    allergy to arthropod sting
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    drug hypersensitivity
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    multiple allergies
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    Social circumstances
    alcohol use
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    sexual activity increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    substance use
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    balanoposthitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    breast mass
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    breast tenderness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    erectile dysfunction
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    3 / 558 (0.54%)
    0 / 356 (0.00%)
         occurrences all number
    1
    3
    0
    genital paraesthesia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    gynaecomastia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    1
    1
    0
    nipple disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    nipple pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 354 (0.85%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    3
    1
    0
    painful erection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    prostatomegaly
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    2 / 356 (0.56%)
         occurrences all number
    1
    1
    2
    pruritus genital
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    spermatic cord pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    testicular atrophy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    testicular pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    testicular swelling
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 354 (1.13%)
    7 / 558 (1.25%)
    2 / 356 (0.56%)
         occurrences all number
    4
    7
    2
    dyspnoea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    3 / 558 (0.54%)
    4 / 356 (1.12%)
         occurrences all number
    1
    3
    4
    epistaxis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    nasal congestion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    3 / 558 (0.54%)
    0 / 356 (0.00%)
         occurrences all number
    1
    3
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    4 / 558 (0.72%)
    1 / 356 (0.28%)
         occurrences all number
    1
    5
    1
    respiratory tract congestion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    rhinitis allergic
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    1
    1
    1
    rhinorrhoea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    sinus congestion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    1
    2
    0
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    upper-airway cough syndrome
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    aggression
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    agitation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    anger
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    3 / 558 (0.54%)
    1 / 356 (0.28%)
         occurrences all number
    1
    4
    1
    anxiety
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    6 / 558 (1.08%)
    2 / 356 (0.56%)
         occurrences all number
    2
    6
    2
    bipolar disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    depression
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    3 / 558 (0.54%)
    0 / 356 (0.00%)
         occurrences all number
    2
    3
    0
    drug dependence
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    eating disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    insomnia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 354 (0.85%)
    3 / 558 (0.54%)
    2 / 356 (0.56%)
         occurrences all number
    3
    3
    2
    irritability
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    1
    2
    0
    libido decreased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    libido increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    loss of libido
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    middle insomnia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    mood swings
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    1
    1
    0
    nervousness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    personality disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    premature ejaculation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    restlessness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    sleep disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    3 / 356 (0.84%)
         occurrences all number
    0
    0
    3
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    blood creatine phosphokinase abnormal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    1
    0
    1
    blood creatinine increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    1
    1
    1
    blood follicle stimulating hormone increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    blood glucose decreased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    blood glucose increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    3 / 356 (0.84%)
         occurrences all number
    0
    1
    3
    blood insulin increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    2 / 356 (0.56%)
         occurrences all number
    0
    0
    2
    blood luteinising hormone increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    blood pressure increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    2 / 356 (0.56%)
         occurrences all number
    0
    2
    2
    blood testosterone increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    3 / 558 (0.54%)
    0 / 356 (0.00%)
         occurrences all number
    0
    3
    0
    blood triglycerides increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    blood urea increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    1
    1
    0
    electrocardiogram p wave abnormal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    electrocardiogram abnormal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    2
    0
    0
    electrocardiogram repolarisation abnormality
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    2 / 356 (0.56%)
         occurrences all number
    0
    0
    2
    glycosylated haemoglobin increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    haematocrit increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    9 / 354 (2.54%)
    28 / 558 (5.02%)
    2 / 356 (0.56%)
         occurrences all number
    9
    28
    2
    haemoglobin increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    1
    1
    0
    hepatic enzyme increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    high density lipoprotein increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    liver function test abnormal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    low density lipoprotein increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    3 / 558 (0.54%)
    0 / 356 (0.00%)
         occurrences all number
    1
    3
    0
    lymph node palpable
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    mean cell volume increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    prostatic specific antigen
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    prostatic specific antigen abnormal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    prostatic specific antigen increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 354 (1.13%)
    6 / 558 (1.08%)
    2 / 356 (0.56%)
         occurrences all number
    4
    6
    2
    red blood cell count decreased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    red blood cell count increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    1
    1
    0
    weight decreased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    2
    1
    0
    weight increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    1
    0
    1
    Injury, poisoning and procedural complications
    ankle fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    contusion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    1
    0
    1
    epicondylitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    fall
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    fibula fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    foot fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    hand fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    human bite
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    joint dislocation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    joint injury
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    laceration
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    1
    1
    1
    ligament rupture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    1
    1
    0
    ligament sprain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    limb injury
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    1
    1
    0
    meniscus injury
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    2
    2
    1
    muscle strain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    3 / 558 (0.54%)
    0 / 356 (0.00%)
         occurrences all number
    0
    3
    0
    procedural pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    rib fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    skin abrasion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    1 / 356 (0.28%)
         occurrences all number
    0
    2
    1
    stress fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    tendon injury
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    thermal burn
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    tibia fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    tooth fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    wound
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    atrial fibrillation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    atrial flutter
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    atrioventricular block first degree
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    1
    0
    1
    bradycardia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    bundle branch block left
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    bundle branch block right
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    cardiac failure congestive
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    coronary artery disease
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    palpitations
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    2 / 356 (0.56%)
         occurrences all number
    1
    1
    2
    sinus bradycardia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    1
    0
    1
    sinus tachycardia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    supraventricular extrasystoles
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    supraventricular tachycardia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    tachycardia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    ventricular extrasystoles
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    burning sensation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    6 / 354 (1.69%)
    0 / 558 (0.00%)
    4 / 356 (1.12%)
         occurrences all number
    7
    0
    5
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    cognitive disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    diabetic neuropathy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    1
    1
    0
    dizziness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    4 / 558 (0.72%)
    4 / 356 (1.12%)
         occurrences all number
    0
    4
    4
    dysgeusia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    epilepsy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    headache
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 354 (0.85%)
    7 / 558 (1.25%)
    8 / 356 (2.25%)
         occurrences all number
    3
    7
    8
    hypoaesthesia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    2
    1
    0
    lumbar radiculopathy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    memory impairment
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    mental impairment
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    neuropathy peripheral
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    paraesthesia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    2
    1
    0
    paralysis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    presyncope
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    sciatica
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    1
    1
    0
    sensory disturbance
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    sleep phase rhythm disturbance
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    syncope
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    3 / 558 (0.54%)
    0 / 356 (0.00%)
         occurrences all number
    0
    3
    0
    trigeminal nerve disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    writer's cramp
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    2
    0
    1
    leukocytosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    lymphadenopathy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    1
    1
    0
    polycythaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    cerumen impaction
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    deafness neurosensory
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    middle ear effusion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    tinnitus
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    1 / 356 (0.28%)
         occurrences all number
    0
    2
    1
    vertigo
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    Eye disorders
    blepharospasm
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    dry eye
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    abdominal pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    abdominal pain lower
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    abdominal pain upper
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    chronic gastritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    constipation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    diarrhoea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    5 / 558 (0.90%)
    4 / 356 (1.12%)
         occurrences all number
    1
    5
    4
    diverticulum
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    dyspepsia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    2
    0
    0
    food poisoning
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    gastritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    1
    1
    1
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    2
    1
    1
    gingival cyst
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    gingival pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    haemorrhoidal haemorrhage
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    haemorrhoids
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    2
    0
    0
    hypoaesthesia oral
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    inguinal hernia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    intestinal mass
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    irritable bowel syndrome
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    large intestine polyp
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    1
    2
    0
    nausea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    2
    1
    1
    oral pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    paraesthesia oral
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    rectal fissure
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    salivary duct obstruction
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    tooth impacted
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    1
    2
    0
    toothache
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    4 / 558 (0.72%)
    0 / 356 (0.00%)
         occurrences all number
    0
    4
    0
    umbilical hernia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    vomiting
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    cholecystitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    gallbladder polyp
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    hepatic cyst
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    10 / 558 (1.79%)
    3 / 356 (0.84%)
         occurrences all number
    2
    11
    3
    actinic keratosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    dermatitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    2 / 558 (0.36%)
    2 / 356 (0.56%)
         occurrences all number
    2
    3
    2
    dermatitis atopic
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    dermatitis contact
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    2 / 558 (0.36%)
    1 / 356 (0.28%)
         occurrences all number
    2
    2
    1
    dry skin
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    eczema
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    erythema
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 354 (1.13%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    4
    0
    0
    haemorrhage subcutaneous
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    hair growth abnormal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    hyperhidrosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    1
    0
    1
    night sweats
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    pruritus
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 354 (0.85%)
    3 / 558 (0.54%)
    4 / 356 (1.12%)
         occurrences all number
    3
    3
    4
    rash
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 354 (1.13%)
    2 / 558 (0.36%)
    10 / 356 (2.81%)
         occurrences all number
    4
    2
    11
    rash erythematous
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    rash papular
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    3
    0
    1
    skin burning sensation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    1
    0
    1
    skin irritation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 354 (1.13%)
    0 / 558 (0.00%)
    9 / 356 (2.53%)
         occurrences all number
    5
    0
    9
    skin lesion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    skin reaction
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    1
    0
    1
    skin ulcer
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    urticaria
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    1
    1
    0
    Renal and urinary disorders
    calculus urinary
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    diabetic nephropathy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    dysuria
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    1
    2
    0
    haematuria
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    lower urinary tract symptoms
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    micturition disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    nephrolithiasis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    nocturia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    pollakiuria
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    3 / 558 (0.54%)
    1 / 356 (0.28%)
         occurrences all number
    1
    3
    1
    polyuria
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    urinary incontinence
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    urinary retention
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    urinary tract obstruction
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    8 / 354 (2.26%)
    6 / 558 (1.08%)
    4 / 356 (1.12%)
         occurrences all number
    8
    7
    4
    axillary mass
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    2
    0
    0
    back pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    5 / 354 (1.41%)
    16 / 558 (2.87%)
    5 / 356 (1.40%)
         occurrences all number
    5
    16
    5
    exostosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    foot deformity
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    intervertebral disc degeneration
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    joint swelling
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    lumbar spinal stenosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    muscle spasms
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    2 / 558 (0.36%)
    1 / 356 (0.28%)
         occurrences all number
    2
    2
    1
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    musculoskeletal pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    3 / 558 (0.54%)
    0 / 356 (0.00%)
         occurrences all number
    1
    3
    0
    musculoskeletal stiffness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    myalgia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    2 / 558 (0.36%)
    1 / 356 (0.28%)
         occurrences all number
    1
    2
    1
    neck mass
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    neck pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    2
    2
    0
    pain in extremity
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    2 / 558 (0.36%)
    1 / 356 (0.28%)
         occurrences all number
    2
    2
    1
    plantar fasciitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    rotator cuff syndrome
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    spinal osteoarthritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    tendonitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    Infections and infestations
    abscess limb
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    acute sinusitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    1
    1
    1
    application site pustules
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    arthritis infective
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    bronchitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    7 / 558 (1.25%)
    3 / 356 (0.84%)
         occurrences all number
    1
    7
    4
    candida infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    cellulitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    3 / 558 (0.54%)
    0 / 356 (0.00%)
         occurrences all number
    0
    3
    0
    chest wall abscess
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    conjunctivitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    diarrhoea infectious
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    diverticulitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    ear infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    6 / 356 (1.69%)
         occurrences all number
    0
    0
    6
    erythema induratum
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    folliculitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    2 / 558 (0.36%)
    1 / 356 (0.28%)
         occurrences all number
    1
    2
    1
    fungal infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    1 / 356 (0.28%)
         occurrences all number
    0
    2
    1
    fungal skin infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    furuncle
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    2 / 356 (0.56%)
         occurrences all number
    0
    0
    2
    gastroenteritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    3 / 356 (0.84%)
         occurrences all number
    0
    1
    3
    gastroenteritis viral
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    5 / 558 (0.90%)
    0 / 356 (0.00%)
         occurrences all number
    2
    5
    0
    helicobacter infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    herpes zoster
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    1
    1
    1
    hordeolum
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    influenza
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 354 (0.85%)
    10 / 558 (1.79%)
    3 / 356 (0.84%)
         occurrences all number
    3
    10
    3
    kidney infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    laryngitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    localised infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    nasal vestibulitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    8 / 354 (2.26%)
    19 / 558 (3.41%)
    11 / 356 (3.09%)
         occurrences all number
    8
    21
    11
    oesophageal candidiasis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    onychomycosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    ophthalmic herpes zoster
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    oral candidiasis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    otitis media acute
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    paronychia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    periodontitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    pharyngitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    3 / 558 (0.54%)
    1 / 356 (0.28%)
         occurrences all number
    2
    3
    1
    pharyngitis streptococcal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    pneumonia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    4 / 558 (0.72%)
    0 / 356 (0.00%)
         occurrences all number
    0
    4
    0
    pneumonia mycoplasmal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    rhinitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    sinusitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 354 (0.85%)
    5 / 558 (0.90%)
    2 / 356 (0.56%)
         occurrences all number
    3
    6
    2
    tinea cruris
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0
    tinea pedis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    tooth abscess
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    2 / 558 (0.36%)
    1 / 356 (0.28%)
         occurrences all number
    1
    2
    1
    tooth infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    8 / 354 (2.26%)
    19 / 558 (3.41%)
    6 / 356 (1.69%)
         occurrences all number
    9
    20
    6
    urethritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    urinary tract infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    3 / 558 (0.54%)
    1 / 356 (0.28%)
         occurrences all number
    2
    3
    1
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    2 / 558 (0.36%)
    1 / 356 (0.28%)
         occurrences all number
    1
    2
    1
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    diabetes mellitus
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    1
    1
    1
    dyslipidaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    2 / 356 (0.56%)
         occurrences all number
    0
    0
    2
    fluid retention
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    1 / 356 (0.28%)
         occurrences all number
    0
    1
    1
    glucose tolerance impaired
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    0 / 558 (0.00%)
    1 / 356 (0.28%)
         occurrences all number
    0
    0
    1
    gout
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    4 / 558 (0.72%)
    1 / 356 (0.28%)
         occurrences all number
    1
    5
    2
    hypercalcaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    0 / 558 (0.00%)
    0 / 356 (0.00%)
         occurrences all number
    1
    0
    0
    hyperlipidaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 354 (0.85%)
    0 / 558 (0.00%)
    3 / 356 (0.84%)
         occurrences all number
    3
    0
    3
    hypertriglyceridaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 354 (0.56%)
    2 / 558 (0.36%)
    1 / 356 (0.28%)
         occurrences all number
    2
    2
    1
    hyperuricaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    1
    2
    0
    hypoglycaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    1 / 356 (0.28%)
         occurrences all number
    0
    2
    1
    increased appetite
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    3 / 558 (0.54%)
    0 / 356 (0.00%)
         occurrences all number
    0
    3
    0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 354 (0.28%)
    1 / 558 (0.18%)
    2 / 356 (0.56%)
         occurrences all number
    1
    1
    2
    vitamin b complex deficiency
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    1 / 558 (0.18%)
    0 / 356 (0.00%)
         occurrences all number
    0
    1
    0
    vitamin d deficiency
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 354 (0.00%)
    2 / 558 (0.36%)
    0 / 356 (0.00%)
         occurrences all number
    0
    2
    0

    More information

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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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