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    Clinical Trial Results:
    Maintenance of Response After Open-Label Treatment with Atomoxetine Hydrochloride in Adult Outpatients with Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study

    Summary
    EudraCT number
    		 2007-007672-41
    Trial protocol
    		 GB   NL   DE   ES   FR   PT   SE   AT   FI   BE   DK   IT  
    Global end of trial date
    02 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jul 2016
    First version publication date
    02 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B4Z-MC-LYDO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00700427
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Alias: B4Z-MC-LYDO, Trial Number: 9655
    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
    02 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of Study LYDO is to test the hypothesis that atomoxetine is superior to placebo in maintaining a satisfactory response at the end of double-blind treatment in adult outpatients with ADHD who show a satisfactory response to acute atomoxetine treatment, as measured by the proportion of patients who meet predefined response criteria.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (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
    16 Jun 2008
    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
    Netherlands: 71
    Country: Number of subjects enrolled
    Portugal: 3
    Country: Number of subjects enrolled
    Spain: 153
    Country: Number of subjects enrolled
    Sweden: 112
    Country: Number of subjects enrolled
    United Kingdom: 27
    Country: Number of subjects enrolled
    Austria: 109
    Country: Number of subjects enrolled
    Belgium: 137
    Country: Number of subjects enrolled
    Denmark: 15
    Country: Number of subjects enrolled
    Finland: 52
    Country: Number of subjects enrolled
    France: 65
    Country: Number of subjects enrolled
    Germany: 434
    Country: Number of subjects enrolled
    Italy: 32
    Country: Number of subjects enrolled
    Russian Federation: 6
    Country: Number of subjects enrolled
    Switzerland: 7
    Country: Number of subjects enrolled
    United States: 602
    Country: Number of subjects enrolled
    Mexico: 53
    Country: Number of subjects enrolled
    Argentina: 27
    Country: Number of subjects enrolled
    Canada: 60
    Country: Number of subjects enrolled
    Puerto Rico: 52
    Worldwide total number of subjects
    2017
    EEA total number of subjects
    1210
    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)
    2017
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study consisted of 4 treatment periods: 12 weeks open-label, acute-treatment (trx) phase (Study Period 2), 12 weeks double-blind maintenance phase of Study Period 3 (Study Period 3A), 25 weeks double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B) and an Open-Label Extension Period (Study Period 4) lasting up to 2.3 year

    Period 1
    Period 1 title
    Study Period 2 (Open-Label Acute Trx)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Atomoxetine (Study Period 2)
    Arm description
    		 40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    atomoxetine hydrochloride
    Investigational medicinal product code
    Other name
    Strattera, LY139603, Atomoxetine
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Starting dose 40 milligrams/day (mg/day) and target dose 80-100 mg/day atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2).

    Number of subjects in period 1
    		Atomoxetine (Study Period 2)
    Started
    2017
    Received at Least One Dose of Study Drug
    2011
    Completed
    1006
    Not completed
    1011
         Consent withdrawn by subject
    164
         Physician decision
    8
         Clinical Relapse
    7
         Adverse Event
    298
         Protocol Interim Criteria Not Met
    161
         Protocol Violation
    173
         Lost to follow-up
    108
         Entry Criteria Not Met
    2
         Lack of efficacy
    90
    Period 2
    Period 2 title
    Study Period 3A (Blinded Maintenance)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Arm title
    		 Atomoxetine (Study Period 3A)
    Arm description
    		 80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during double-blind maintenance phase (Study Period 3A).
    Arm type
    		 Experimental

    Investigational medicinal product name
    atomoxetine hydrochloride
    Investigational medicinal product code
    Other name
    Strattera, LY139603, Atomoxetine
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Starting dose 40 milligrams/day (mg/day) and target dose 80-100 mg/day atomoxetine orally, once daily or twice daily for 12 weeks during double-blind randomized withdrawal phase (Study Period 3).

    Number of subjects in period 2 [1]
    		Atomoxetine (Study Period 3A)
    Started
    1005
    Completed
    524
    Not completed
    481
         Consent withdrawn by subject
    81
         Physician decision
    2
         Missing - Not Otherwise Defined
    5
         Clinical Relapse
    49
         Adverse Event
    50
         Protocol Interim Criteria Not Met
    162
         Sponsor Decision
    3
         Protocol Violation
    56
         Lost to follow-up
    41
         Lack of efficacy
    32
    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: One participant was mistakenly recorded as completed. The reason for discontinuation is unknown.
    Period 3
    Period 3 title
    Study Period 3B (Randomized Withdrawal)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atomoxetine (Study Period 3B)
    Arm description
    		 80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
    Arm type
    		 Experimental

    Investigational medicinal product name
    atomoxetine hydrochloride
    Investigational medicinal product code
    Other name
    Strattera, LY139603, Atomoxetine
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).

    Arm title
    		 Placebo (Study Period 3B)
    Arm description
    		 Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).

    Number of subjects in period 3
    		Atomoxetine (Study Period 3B) Placebo (Study Period 3B)
    Started
    266
    258
    Completed
    184
    165
    Not completed
    82
    93
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    25
    34
         Physician decision
    2
    -
         Missing - Not Otherwise Defined
    1
    1
         Clinical Relapse
    -
    3
         Adverse Event
    8
    5
         Protocol Interim Criteria Not Met
    -
    5
         Protocol Violation
    23
    25
         Lost to follow-up
    19
    9
         Lack of efficacy
    3
    11
    Period 4
    Period 4 title
    Study Period 4 (Open-Label Extension)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Atomoxetine (Study Period 4)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    atomoxetine hydrochloride
    Investigational medicinal product code
    Other name
    Strattera, LY139603, Atomoxetine
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants who received either atomoxetine or placebo and completed the last visit of Study Period 3 who were in countries where the adult ADHD indication for atomoxetine was not approved were allowed to participant in Study Period 4 (Open-label Extension). Participants received 40 mg/day atomoxetine orally for at least 7 days after which it was increased to 80-100 mg/day atomoxetine orally for up to 2.3 years.

    Number of subjects in period 4
    		Atomoxetine (Study Period 4)
    Started
    349
    Completed
    96
    Not completed
    253
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    38
         Physician decision
    2
         Clinical Relapse
    1
         Adverse Event
    16
         Only available in Europe, subject not in Europe
    169
         Sponsor Decision
    2
         Protocol Violation
    12
         Lost to follow-up
    11
         Lack of efficacy
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study Period 2 (Open-Label Acute Trx)
    Reporting group description
    		 -

    Reporting group values
    		 Study Period 2 (Open-Label Acute Trx) Total
    Number of subjects
    		 2017 2017
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.15 ± 9.09 -
    Gender categorical
    Units: Subjects
        Female
    		 833 833
        Male
    		 1184 1184
    Race/Ethnicity
    Units: Subjects
        Caucasian
    		 1765 1765
        African
    		 56 56
        Hispanic
    		 159 159
        Native American
    		 6 6
        East Asian
    		 14 14
        West Asian
    		 15 15
        Missing
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Atomoxetine (Study Period 2)
    Reporting group description
    		 40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2).
    Reporting group title
    Atomoxetine (Study Period 3A)
    Reporting group description
    		 80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during double-blind maintenance phase (Study Period 3A).
    Reporting group title
    Atomoxetine (Study Period 3B)
    Reporting group description
    		 80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).

    Reporting group title
    Placebo (Study Period 3B)
    Reporting group description
    		 Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
    Reporting group title
    Atomoxetine (Study Period 4)
    Reporting group description
    		 -

    Subject analysis set title
    Outcome Measure 1 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Primary outcome measure analysis was conducted using all randomized participants in the Double-Blind Maintenance/Randomized Withdrawal Period (Study Period 3B).

    Subject analysis set title
    Outcome Measure 1 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Primary outcome measure analysis was conducted using all randomized participants in the Double-Blind Maintenance/Randomized Withdrawal Period (Study Period 3B).

    Subject analysis set title
    Outcome Measure 2 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Analyses were conducted using all randomized participants in the Double-Blind Period (Study Period 3B).

    Subject analysis set title
    Outcome Measure 2 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Analyses were conducted using all randomized participants in the Double-Blind Period (Study Period 3B).

    Subject analysis set title
    Outcome Measure 3 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized participants with a baseline and at least 1 post-baseline AAQoL score were included in the analysis.

    Subject analysis set title
    Outcome Measure 3 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized participants with a baseline and at least 1 post-baseline AAQoL score were included in the analysis.

    Subject analysis set title
    Outcome Measure 4 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with a non-missing baseline and at least 1 post-baseline CAARS-O:SV result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.

    Subject analysis set title
    Outcome Measure 4 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with a non-missing baseline and at least 1 post-baseline CAARS-O:SV result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.

    Subject analysis set title
    Outcome Measure 5 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with a non-missing baseline and at least 1 post-baseline CAARS-S:SV result within each treatment group, Last Observation Carried Forward (LOCF).

    Subject analysis set title
    Outcome Measure 5 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with a non-missing baseline and at least 1 post-baseline CAARS-S:SV result within each treatment group, Last Observation Carried Forward (LOCF).

    Subject analysis set title
    Outcome Measure 6 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Self Report result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.

    Subject analysis set title
    Outcome Measure 6 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Self Report result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.

    Subject analysis set title
    Outcome Measure 7 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Informant result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.

    Subject analysis set title
    Outcome Measure 7 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Informant result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.

    Subject analysis set title
    Outcome Measure 8 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with a non-missing baseline and at least 1 post-baseline EQ-5D Index Score or VAS score within each group, Last Observation Carried Forward (LOCF) were included in the analysis.

    Subject analysis set title
    Outcome Measure 8 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with a non-missing baseline and at least 1 post-baseline EQ-5D Index Score or VAS score within each group, Last Observation Carried Forward (LOCF) were included in the analysis.

    Primary: Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period

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    End point title
    		 Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period
    End point description
    Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.
    End point type
    Primary
    End point timeframe
    Baseline (Week 24) up to Week 49
    End point values
    		 Outcome Measure 1 Atomoxetine Outcome Measure 1 Placebo
    Number of subjects analysed
    266
    258
    Units: percentage of responders
    64
    50
    Statistical analysis title
    		 Statistical Analysis 1 for Outcome Measure 1
    Comparison groups
    Outcome Measure 1 Atomoxetine v Outcome Measure 1 Placebo
    Number of subjects included in analysis
    524
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Number of Days Until Relapse

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    End point title
    		 Number of Days Until Relapse
    End point description
    Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed. CAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Due to limitations, values listed as 99999 represent Not Applicable
    End point type
    Secondary
    End point timeframe
    Baseline (Week 24) up to Week 49
    End point values
    		 Outcome Measure 2 Atomoxetine Outcome Measure 2 Placebo
    Number of subjects analysed
    266 [1]
    258 [2]
    Units: days
        arithmetic mean (standard deviation)
    999999 ± 999999
    999999 ± 999999
    Notes
    [1] - Mean & standard deviation couldn't be reliably estimated because of low numbers of relapsed subjects
    [2] - Mean & standard deviation couldn't be reliably estimated because of low numbers of relapsed subjects
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49

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    End point title
    		 Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49
    End point description
    The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 24), Week 49
    End point values
    		 Outcome Measure 3 Atomoxetine Outcome Measure 3 Placebo
    Number of subjects analysed
    198
    180
    Units: units on a scale
        least squares mean (standard error)
    0.4 ± 1.12
    -4 ± 1.1
    Statistical analysis title
    		 Statistical Analysis 1 for Outcome Measure 3
    Comparison groups
    Outcome Measure 3 Atomoxetine v Outcome Measure 3 Placebo
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49

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    End point title
    		 Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49
    End point description
    The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 24), Week 49
    End point values
    		 Outcome Measure 4 Atomoxetine Outcome Measure 4 Placebo
    Number of subjects analysed
    165
    153
    Units: units on a scale
    least squares mean (standard error)
        ADHD Imputed (Attributed) Index Score (N=164, 153)
    -2.6 ± 0.56
    -0.1 ± 0.57
        Hyperactivity/Impulsivity Subscale Imputed Score
    -1.9 ± 0.44
    -0.1 ± 0.44
        Inattention Subscale Imputed Score
    -1.6 ± 0.46
    -0.1 ± 0.46
        Total ADHD Symptom Imputed Score
    -3.5 ± 0.83
    -0.4 ± 0.83
    Statistical analysis title
    		 Statistical Analysis 1 for Outcome Measure 4
    Comparison groups
    Outcome Measure 4 Atomoxetine v Outcome Measure 4 Placebo
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [3] - P-value for ADHD Imputed (Attributed) Index Score.
    Statistical analysis title
    		 Statistical Analysis 2 for Outcome Measure 4
    Comparison groups
    Outcome Measure 4 Atomoxetine v Outcome Measure 4 Placebo
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002 [4]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [4] - P-value for Hyperactivity/Impulsivity Subscale Imputed Score.
    Statistical analysis title
    		 Statistical Analysis 3 for Outcome Measure 4
    Comparison groups
    Outcome Measure 4 Atomoxetine v Outcome Measure 4 Placebo
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009 [5]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [5] - P-value for Inattention Subscale Imputed Score.
    Statistical analysis title
    		 Statistical Analysis 4 for Outcome Measure 4
    Comparison groups
    Outcome Measure 4 Atomoxetine v Outcome Measure 4 Placebo
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003 [6]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [6] - P-value for Total ADHD Symptom Imputed Score.

    Secondary: Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49

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    End point title
    		 Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49
    End point description
    CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 24), Week 49
    End point values
    		 Outcome Measure 5 Atomoxetine Outcome Measure 5 Placebo
    Number of subjects analysed
    193
    178
    Units: units on a scale
    least squares mean (standard error)
        ADHD Symptom Imputed Index Score
    -1.2 ± 0.44
    0.9 ± 0.43
        Hyperactivity-Impulsivity Subscale Imputed Score
    -0.9 ± 0.33
    0.5 ± 0.32
        Inattention Subscale Imputed Score
    -0.7 ± 0.38
    1.2 ± 0.37
        Total ADHD Symptom Imputed Score
    -1.6 ± 0.65
    1.7 ± 0.64
    Statistical analysis title
    		 Statistical Analysis 1 for Outcome Measure 5
    Comparison groups
    Outcome Measure 5 Atomoxetine v Outcome Measure 5 Placebo
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [7] - P-value for ADHD Imputed (Attributed) Index Score.
    Statistical analysis title
    		 Statistical Analysis 2 for Outcome Measure 5
    Comparison groups
    Outcome Measure 5 Atomoxetine v Outcome Measure 5 Placebo
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [8] - P-value for Hyperactivity/Impulsivity Subscale Imputed Score.
    Statistical analysis title
    		 Statistical Analysis 3 for Outcome Measure 5
    Comparison groups
    Outcome Measure 5 Atomoxetine v Outcome Measure 5 Placebo
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [9] - P-value for Inattention Subscale Imputed Score.
    Statistical analysis title
    		 Statistical Analysis 4 for Outcome Measure 5
    Comparison groups
    Outcome Measure 5 Placebo v Outcome Measure 5 Atomoxetine
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [10] - P-value for Total ADHD Symptom Imputed Score.

    Secondary: Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49

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    End point title
    		 Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49
    End point description
    The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 24), Week 49
    End point values
    		 Outcome Measure 6 Atomoxetine Outcome Measure 6 Placebo
    Number of subjects analysed
    187
    173
    Units: units on a scale
        least squares mean (standard error)
    -5.7 ± 1.88
    0.9 ± 1.81
    Statistical analysis title
    		 Statistical Analysis 1 for Outcome Measure 6
    Comparison groups
    Outcome Measure 6 Atomoxetine v Outcome Measure 6 Placebo
    Number of subjects included in analysis
    360
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49

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    End point title
    		 Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49
    End point description
    BRIEF-A:Informant is a 75-item third-party observer’s view of the participants’ executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 24), Week 49
    End point values
    		 Outcome Measure 7 Atomoxetine Outcome Measure 7 Placebo
    Number of subjects analysed
    154
    147
    Units: units on a scale
        least squares mean (standard error)
    -8.4 ± 2.16
    -0.6 ± 2.17
    Statistical analysis title
    		 Statistical Analysis 1 for Outcome Measure 7
    Comparison groups
    Outcome Measure 7 Atomoxetine v Outcome Measure 7 Placebo
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49

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    End point title
    		 Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49
    End point description
    The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with <0 interpreted as a health state “worse than dead.” A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 24), Week 49
    End point values
    		 Outcome Measure 8 Atomoxetine Outcome Measure 8 Placebo
    Number of subjects analysed
    197
    180
    Units: units on a scale
    least squares mean (standard error)
        UK population-based Index Score (n=194, 180)
    0 ± 0.01
    0 ± 0.01
        US population-based Index Score (n=194, 180)
    0 ± 0.01
    0 ± 0.01
        Health State Score (N=197, 179)
    4.6 ± 1.21
    3.2 ± 1.19
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    B4Z-MC-LYDO
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Atomoxetine_Randomization Phase
    Reporting group description
    		 -

    Reporting group title
    Placebo_Randomization Phase
    Reporting group description
    		 -

    Reporting group title
    Atomoxetine_Open-label Phase
    Reporting group description
    		 -

    Reporting group title
    Atomoxetine_Open-label Extension Phase
    Reporting group description
    		 -

    Serious adverse events
    		 Atomoxetine_Randomization Phase Placebo_Randomization Phase Atomoxetine_Open-label Phase Atomoxetine_Open-label Extension Phase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 266 (2.63%)
    3 / 258 (1.16%)
    29 / 2011 (1.44%)
    14 / 180 (7.78%)
         number of deaths (all causes)
    1
    0
    0
    1
         number of deaths resulting from adverse events
    1
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    intraductal proliferative breast lesion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    bunion operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hospitalisation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    skin neoplasm excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tonsillectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    uterine polyp
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [1]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    0 / 827 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    dyspnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    alcohol abuse
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    depressive symptom
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hallucination, auditory
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    restlessness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicidal ideation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    accidental overdose
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diaphragmatic injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    foot fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intentional overdose
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lower limb fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    meniscus injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    2 / 180 (1.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    splenic injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    toxicity to various agents
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Cardiac disorders
    myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    palpitations
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebellar infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    convulsion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypoaesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intestinal obstruction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    umbilical hernia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholecystitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    2 / 180 (1.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hepatitis alcoholic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    angioedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pain in extremity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    erysipelas
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peritonsillar abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Atomoxetine_Randomization Phase Placebo_Randomization Phase Atomoxetine_Open-label Phase Atomoxetine_Open-label Extension Phase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    120 / 266 (45.11%)
    96 / 258 (37.21%)
    1611 / 2011 (80.11%)
    119 / 180 (66.11%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    uterine leiomyoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [2]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    1 / 827 (0.12%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vascular disorders
    flushing
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    14 / 2011 (0.70%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    15
    0
    haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hot flush
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 266 (1.13%)
    0 / 258 (0.00%)
    56 / 2011 (2.78%)
    1 / 180 (0.56%)
         occurrences all number
    3
    0
    61
    1
    hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    27 / 2011 (1.34%)
    2 / 180 (1.11%)
         occurrences all number
    1
    0
    28
    2
    hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    5
    0
    lymphoedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    orthostatic hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    pallor
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    peripheral coldness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    16 / 2011 (0.80%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    19
    1
    varicose vein
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    Surgical and medical procedures
    abdominal hernia repair
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    abscess drainage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    angioplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    artificial crown procedure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    breast prosthesis implantation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    central nervous system stimulation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    cleft palate repair
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    dental care
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    dental implantation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    dental operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    gastritis prophylaxis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    intervertebral disc operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    knee operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    1
    1
    lipoma excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    nasal septal operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    renal artery angioplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    renal stone removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    sinus operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    skin neoplasm excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    surgery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    tooth extraction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    5 / 2011 (0.25%)
    2 / 180 (1.11%)
         occurrences all number
    0
    1
    7
    2
    wisdom teeth removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    1
    0
    1
    1
    Pregnancy, puerperium and perinatal conditions
    pregnancy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [3]
    0 / 115 (0.00%)
    1 / 103 (0.97%)
    7 / 827 (0.85%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    7
    0
    vomiting in pregnancy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [4]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    1 / 827 (0.12%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    17 / 2011 (0.85%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    20
    0
    chest discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    8 / 2011 (0.40%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    9
    0
    chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    12 / 2011 (0.60%)
    1 / 180 (0.56%)
         occurrences all number
    0
    1
    12
    1
    chills
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    57 / 2011 (2.83%)
    2 / 180 (1.11%)
         occurrences all number
    0
    0
    60
    2
    crying
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    5 / 2011 (0.25%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    5
    0
    device extrusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    drug ineffective
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    fatigue
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    3 / 258 (1.16%)
    262 / 2011 (13.03%)
    4 / 180 (2.22%)
         occurrences all number
    1
    3
    292
    5
    feeling abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    7 / 2011 (0.35%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    7
    0
    feeling cold
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    16 / 2011 (0.80%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    18
    1
    feeling hot
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    6 / 2011 (0.30%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    6
    0
    feeling jittery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    19 / 2011 (0.94%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    20
    0
    feeling of body temperature change
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    feeling of relaxation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hernia pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    1
    1
    hunger
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    3
    1
    influenza like illness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    1 / 258 (0.39%)
    11 / 2011 (0.55%)
    2 / 180 (1.11%)
         occurrences all number
    3
    1
    11
    2
    irritability
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 258 (0.00%)
    80 / 2011 (3.98%)
    0 / 180 (0.00%)
         occurrences all number
    2
    0
    87
    0
    malaise
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    46 / 2011 (2.29%)
    1 / 180 (0.56%)
         occurrences all number
    1
    0
    57
    1
    oedema peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    2 / 258 (0.78%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    2
    4
    0
    pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    4
    0
    pyrexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 266 (1.50%)
    2 / 258 (0.78%)
    16 / 2011 (0.80%)
    1 / 180 (0.56%)
         occurrences all number
    4
    2
    17
    1
    secretion discharge
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    sense of oppression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    sluggishness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    5
    1
    temperature intolerance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    temperature regulation disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    therapeutic response unexpected
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    thirst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    20 / 2011 (0.99%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    20
    0
    thirst decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    xerosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Immune system disorders
    allergy to arthropod sting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    allergy to chemicals
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    food allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    house dust allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hypersensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    7 / 2011 (0.35%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    7
    0
    multiple allergies
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    seasonal allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    1 / 258 (0.39%)
    16 / 2011 (0.80%)
    1 / 180 (0.56%)
         occurrences all number
    2
    1
    16
    1
    smoke sensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Social circumstances
    corrective lens user
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    denture wearer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    educational problem
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    job dissatisfaction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    miscarriage of partner
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    stress at work
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    1
    1
    tobacco user
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Reproductive system and breast disorders
    amenorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [5]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    1 / 827 (0.12%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    1
    0
    breast disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    breast pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    breast tenderness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    dysmenorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [6]
    1 / 115 (0.87%)
    1 / 103 (0.97%)
    19 / 827 (2.30%)
    2 / 85 (2.35%)
         occurrences all number
    2
    1
    23
    2
    dyspareunia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    7
    0
    ejaculation delayed
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [7]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    7 / 1184 (0.59%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    8
    0
    ejaculation disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [8]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    25 / 1184 (2.11%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    29
    0
    ejaculation failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [9]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    1 / 1184 (0.08%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    1
    0
    epididymitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [10]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    2 / 1184 (0.17%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    2
    0
    erectile dysfunction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [11]
    3 / 151 (1.99%)
    0 / 155 (0.00%)
    99 / 1184 (8.36%)
    2 / 95 (2.11%)
         occurrences all number
    3
    0
    103
    2
    erection increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [12]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    1 / 1184 (0.08%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    1
    0
    genital pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    6 / 2011 (0.30%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    7
    0
    haematospermia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [13]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    1 / 1184 (0.08%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    1
    0
    menorrhagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [14]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    4 / 827 (0.48%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    4
    1
    menstrual disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [15]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    2 / 827 (0.24%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    3
    7
    menstruation delayed
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [16]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    2 / 827 (0.24%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    2
    0
    menstruation irregular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [17]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    1 / 827 (0.12%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    1
    0
    metrorrhagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [18]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    2 / 827 (0.24%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    2
    0
    nipple disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    oligomenorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [19]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    1 / 827 (0.12%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    1
    0
    ovarian cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [20]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    1 / 827 (0.12%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    1
    0
    painful erection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [21]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    4 / 1184 (0.34%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    4
    0
    penile size reduced
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [22]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    1 / 1184 (0.08%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    1
    0
    penile swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [23]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    0 / 1184 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    0
    0
    1
    penis disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [24]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    1 / 1184 (0.08%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    1
    0
    polymenorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [25]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    1 / 827 (0.12%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    1
    0
    premenstrual cramps
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [26]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    1 / 827 (0.12%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    1
    0
    prostatic pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [27]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    1 / 1184 (0.08%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    1
    0
    prostatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [28]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    1 / 1184 (0.08%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    1
    0
    retrograde ejaculation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [29]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    3 / 1184 (0.25%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    5
    0
    scrotal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [30]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    3 / 1184 (0.25%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    4
    0
    scrotal swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [31]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    1 / 1184 (0.08%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    1
    0
    sexual dysfunction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    16 / 2011 (0.80%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    16
    0
    spermatorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [32]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    2 / 1184 (0.17%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    3
    0
    testicular pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [33]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    20 / 1184 (1.69%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    21
    0
    testicular swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [34]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    1 / 1184 (0.08%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    2
    0
    testicular torsion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [35]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    1 / 1184 (0.08%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    1
    0
    vaginal discharge
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [36]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    2 / 827 (0.24%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    2
    0
    vaginal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [37]
    1 / 115 (0.87%)
    0 / 103 (0.00%)
    2 / 827 (0.24%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    2
    0
    vulvovaginal dryness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [38]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    0 / 827 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    asphyxia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    asthma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    6 / 2011 (0.30%)
    2 / 180 (1.11%)
         occurrences all number
    0
    0
    7
    2
    bronchospasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 266 (1.88%)
    1 / 258 (0.39%)
    22 / 2011 (1.09%)
    2 / 180 (1.11%)
         occurrences all number
    6
    1
    23
    2
    dry throat
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    dysphonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    dyspnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    11 / 2011 (0.55%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    12
    0
    epistaxis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    7
    0
    hyperventilation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    increased upper airway secretion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    nasal congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    2 / 258 (0.78%)
    17 / 2011 (0.85%)
    0 / 180 (0.00%)
         occurrences all number
    1
    2
    18
    0
    nasal discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    nasal dryness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    nasal obstruction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    nasal polyps
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 266 (1.88%)
    4 / 258 (1.55%)
    20 / 2011 (0.99%)
    6 / 180 (3.33%)
         occurrences all number
    5
    5
    20
    6
    pharyngeal inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    pharyngeal oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    pleurisy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    1
    1
    pneumothorax
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    productive cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    respiratory disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    1
    1
    respiratory tract congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    2
    0
    rhinitis allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    5 / 2011 (0.25%)
    2 / 180 (1.11%)
         occurrences all number
    1
    1
    5
    2
    rhinitis seasonal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    rhinorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    19 / 2011 (0.94%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    23
    0
    sinus congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    5
    0
    sneezing
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    5
    0
    snoring
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    tachypnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    throat irritation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    throat tightness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    upper-airway cough syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    yawning
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    8 / 2011 (0.40%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    9
    0
    Psychiatric disorders
    abnormal behaviour
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    abnormal dreams
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    34 / 2011 (1.69%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    35
    0
    adjustment disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    affect lability
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    12 / 2011 (0.60%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    12
    0
    affective disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    1
    0
    aggression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    14 / 2011 (0.70%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    14
    1
    agitation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    28 / 2011 (1.39%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    32
    1
    alcohol abuse
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    alcohol problem
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    alcoholic hangover
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    alcoholism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    anger
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    anorgasmia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    anxiety
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 266 (1.13%)
    3 / 258 (1.16%)
    60 / 2011 (2.98%)
    2 / 180 (1.11%)
         occurrences all number
    3
    3
    62
    2
    apathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    14 / 2011 (0.70%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    16
    0
    attention deficit/hyperactivity disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    1 / 180 (0.56%)
         occurrences all number
    1
    0
    4
    1
    bradyphrenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    bruxism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    burnout syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    confusional state
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    5
    1
    daydreaming
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    decreased activity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    decreased interest
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    depressed mood
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    2 / 258 (0.78%)
    56 / 2011 (2.78%)
    4 / 180 (2.22%)
         occurrences all number
    0
    2
    62
    5
    depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    3 / 258 (1.16%)
    34 / 2011 (1.69%)
    1 / 180 (0.56%)
         occurrences all number
    2
    4
    34
    1
    depressive symptom
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    4 / 2011 (0.20%)
    1 / 180 (0.56%)
         occurrences all number
    0
    1
    4
    1
    derealisation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    disinhibition
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    disorientation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    dissociation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    distractibility
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    disturbance in sexual arousal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    drug dependence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    dysphemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    dysphoria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    3
    1
    eating disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    emotional disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    5
    1
    euphoric mood
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    fear
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    feelings of worthlessness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    hallucination, auditory
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hallucination, visual
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hypersexuality
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hypomania
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    illusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    impatience
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    impulsive behaviour
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    4
    1
    inappropriate affect
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    initial insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 266 (1.50%)
    0 / 258 (0.00%)
    34 / 2011 (1.69%)
    1 / 180 (0.56%)
         occurrences all number
    4
    0
    40
    1
    insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 266 (1.13%)
    1 / 258 (0.39%)
    177 / 2011 (8.80%)
    4 / 180 (2.22%)
         occurrences all number
    3
    1
    209
    6
    intentional self-injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    laziness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    libido decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    2 / 258 (0.78%)
    61 / 2011 (3.03%)
    1 / 180 (0.56%)
         occurrences all number
    2
    2
    65
    1
    libido increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    listless
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    5
    1
    logorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    loss of libido
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    9 / 2011 (0.45%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    9
    1
    magical thinking
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    major depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    middle insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 258 (0.00%)
    33 / 2011 (1.64%)
    3 / 180 (1.67%)
         occurrences all number
    2
    0
    35
    3
    mood altered
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    mood swings
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    12 / 2011 (0.60%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    12
    0
    mutism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    nervousness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    9 / 2011 (0.45%)
    2 / 180 (1.11%)
         occurrences all number
    1
    0
    9
    3
    nightmare
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    11 / 2011 (0.55%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    11
    0
    orgasm abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    7 / 2011 (0.35%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    7
    0
    orgasmic sensation decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    panic attack
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    8 / 2011 (0.40%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    8
    0
    panic disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    post-traumatic stress disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    poverty of speech
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    premature ejaculation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [39]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    20 / 1184 (1.69%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    24
    0
    pressure of speech
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    psychiatric symptom
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    psychomotor retardation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    restlessness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    27 / 2011 (1.34%)
    2 / 180 (1.11%)
         occurrences all number
    1
    0
    34
    3
    self-injurious ideation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    sleep attacks
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    sleep disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    71 / 2011 (3.53%)
    5 / 180 (2.78%)
         occurrences all number
    1
    1
    82
    5
    sleep talking
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    staring
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    stress
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    6 / 2011 (0.30%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    7
    0
    suicidal ideation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    7 / 2011 (0.35%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    7
    0
    tachyphrenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    tearfulness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    tension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    7 / 2011 (0.35%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    7
    0
    terminal insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    18 / 2011 (0.90%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    21
    0
    tic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    3
    0
    trance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    violence-related symptom
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatobiliary disorders
    biliary colic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    cholecystitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    cholelithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hepatic cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    arthroscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    blood cholesterol increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    blood glucose increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    blood pressure decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    blood pressure diastolic increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    blood pressure increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 266 (1.50%)
    0 / 258 (0.00%)
    13 / 2011 (0.65%)
    3 / 180 (1.67%)
         occurrences all number
    6
    0
    13
    3
    blood pressure orthostatic decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    blood urine present
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    body temperature decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    colonoscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    2
    0
    electrocardiogram pr interval
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    electrocardiogram qrs complex prolonged
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    electrocardiogram abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    gastric ph decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    hiv test positive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    heart rate increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    21 / 2011 (1.04%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    24
    1
    heart rate irregular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    intraocular pressure increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    qrs axis abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    1
    0
    0
    1
    respiratory rate increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    serum ferritin
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    weight decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    39 / 2011 (1.94%)
    2 / 180 (1.11%)
         occurrences all number
    1
    1
    39
    2
    weight increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 266 (1.13%)
    1 / 258 (0.39%)
    13 / 2011 (0.65%)
    2 / 180 (1.11%)
         occurrences all number
    3
    1
    13
    2
    Injury, poisoning and procedural complications
    animal bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    ankle fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    arthropod bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    2 / 180 (1.11%)
         occurrences all number
    1
    0
    2
    2
    arthropod sting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    bone contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    burns first degree
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    chest injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    clavicle fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    concussion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 266 (1.88%)
    0 / 258 (0.00%)
    8 / 2011 (0.40%)
    0 / 180 (0.00%)
         occurrences all number
    5
    0
    8
    0
    craniocerebral injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    electric shock
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    epicondylitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    2
    0
    1
    0
    excoriation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    2
    0
    exposure during pregnancy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    exposure via father
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    eye injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    foot fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    foreign body in eye
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    frostbite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hand fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    2 / 258 (0.78%)
    6 / 2011 (0.30%)
    0 / 180 (0.00%)
         occurrences all number
    0
    2
    6
    0
    heat stroke
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    joint injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    laceration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    7 / 2011 (0.35%)
    1 / 180 (0.56%)
         occurrences all number
    0
    1
    11
    1
    ligament injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    ligament rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    ligament sprain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    2 / 258 (0.78%)
    5 / 2011 (0.25%)
    1 / 180 (0.56%)
         occurrences all number
    1
    2
    5
    1
    limb injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    meniscus injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    1
    0
    muscle rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    muscle strain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    4 / 2011 (0.20%)
    1 / 180 (0.56%)
         occurrences all number
    1
    1
    4
    1
    nail injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    overdose
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    periorbital haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    post procedural complication
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    post-traumatic neck syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    3 / 2011 (0.15%)
    2 / 180 (1.11%)
         occurrences all number
    0
    1
    3
    2
    procedural pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    4
    1
    rib fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    road traffic accident
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    3 / 2011 (0.15%)
    1 / 180 (0.56%)
         occurrences all number
    1
    1
    3
    1
    scar
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    soft tissue injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    thermal burn
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    tooth fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    tooth injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    wound
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    wrist fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    3 / 180 (1.67%)
         occurrences all number
    2
    0
    2
    3
    bradycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    cardiac disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    cardiovascular disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    extrasystoles
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    5
    0
    palpitations
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    83 / 2011 (4.13%)
    2 / 180 (1.11%)
         occurrences all number
    1
    1
    90
    2
    sinus arrhythmia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    sinus bradycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    sinus tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 266 (1.13%)
    1 / 258 (0.39%)
    70 / 2011 (3.48%)
    2 / 180 (1.11%)
         occurrences all number
    4
    1
    73
    2
    Nervous system disorders
    ageusia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    akathisia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    akinesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    apallic syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    aphasia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    autonomic nervous system imbalance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    balance disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    burning sensation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    2 / 180 (1.11%)
         occurrences all number
    0
    0
    0
    2
    circadian rhythm sleep disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    clumsiness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    6
    0
    cognitive disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    convulsion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    coordination abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    depressed level of consciousness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    disturbance in attention
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 258 (0.00%)
    11 / 2011 (0.55%)
    0 / 180 (0.00%)
         occurrences all number
    2
    0
    12
    0
    dizziness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    2 / 258 (0.78%)
    170 / 2011 (8.45%)
    3 / 180 (1.67%)
         occurrences all number
    1
    2
    195
    3
    dizziness postural
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    drooling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    dysaesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    dysarthria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    dysgeusia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    20 / 2011 (0.99%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    22
    0
    dyskinesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    formication
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    2
    1
    head discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    head titubation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    13 / 266 (4.89%)
    11 / 258 (4.26%)
    347 / 2011 (17.26%)
    17 / 180 (9.44%)
         occurrences all number
    15
    11
    482
    38
    hypersomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    6 / 2011 (0.30%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    6
    1
    hypertonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    3 / 2011 (0.15%)
    1 / 180 (0.56%)
         occurrences all number
    0
    1
    3
    1
    hypoaesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    11 / 2011 (0.55%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    12
    0
    hypogeusia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hypotonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    irregular sleep phase
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    lethargy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    11 / 2011 (0.55%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    11
    0
    loss of consciousness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    1
    0
    memory impairment
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    10 / 2011 (0.50%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    10
    0
    mental impairment
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    5
    0
    migraine
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    26 / 2011 (1.29%)
    3 / 180 (1.67%)
         occurrences all number
    3
    1
    46
    3
    muscle contractions involuntary
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    myoclonus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    neurological symptom
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    orthostatic intolerance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    paraesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    74 / 2011 (3.68%)
    2 / 180 (1.11%)
         occurrences all number
    1
    0
    76
    2
    parosmia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    poor quality sleep
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    15 / 2011 (0.75%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    15
    0
    psychomotor hyperactivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    2
    0
    psychomotor skills impaired
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    restless legs syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    sciatica
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    2 / 258 (0.78%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    0
    2
    1
    1
    sedation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    26 / 2011 (1.29%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    27
    0
    sensory disturbance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    sinus headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    5
    0
    somnolence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    112 / 2011 (5.57%)
    1 / 180 (0.56%)
         occurrences all number
    1
    1
    126
    2
    speech disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    syncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    1 / 180 (0.56%)
         occurrences all number
    1
    0
    3
    1
    tension headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    8 / 2011 (0.40%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    8
    0
    tremor
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    25 / 2011 (1.24%)
    3 / 180 (1.67%)
         occurrences all number
    0
    1
    26
    3
    trigeminal neuralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    tunnel vision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    1
    1
    leukopenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    lymphadenitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    lymphadenopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    2
    0
    3
    0
    splenic cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear and labyrinth disorders
    ear discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    ear pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    external ear inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hyperacusis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    hypoacusis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    inner ear inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    motion sickness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    sudden hearing loss
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    tinnitus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    11 / 2011 (0.55%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    11
    0
    vertigo
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    38 / 2011 (1.89%)
    3 / 180 (1.67%)
         occurrences all number
    0
    1
    46
    4
    Eye disorders
    abnormal sensation in eye
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    accommodation disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    blepharitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    blepharospasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    blindness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    conjunctivitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    8 / 2011 (0.40%)
    2 / 180 (1.11%)
         occurrences all number
    0
    1
    8
    2
    diplopia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    dry eye
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    4
    1
    excessive eye blinking
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    eye discharge
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    eye irritation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    eye pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    1
    0
    glaucoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    iridocyclitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    lacrimation increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    4
    1
    miosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    mydriasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    ocular discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    ocular hyperaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    photophobia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    vision blurred
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    32 / 2011 (1.59%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    32
    1
    visual acuity reduced
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    5
    0
    visual impairment
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    29 / 2011 (1.44%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    30
    0
    abdominal distension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    7 / 2011 (0.35%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    7
    0
    abdominal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    38 / 2011 (1.89%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    41
    0
    abdominal pain lower
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    1
    1
    3
    0
    abdominal pain upper
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    2 / 258 (0.78%)
    61 / 2011 (3.03%)
    3 / 180 (1.67%)
         occurrences all number
    2
    2
    73
    3
    abdominal rigidity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    aphthous stomatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    barrett's oesophagus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    breath odour
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    3
    1
    chapped lips
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    constipation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    93 / 2011 (4.62%)
    2 / 180 (1.11%)
         occurrences all number
    1
    0
    99
    2
    crohn's disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    defaecation urgency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    dental caries
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    2
    0
    1
    1
    diarrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 266 (1.50%)
    5 / 258 (1.94%)
    53 / 2011 (2.64%)
    8 / 180 (4.44%)
         occurrences all number
    4
    5
    60
    10
    dry mouth
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 266 (1.13%)
    2 / 258 (0.78%)
    342 / 2011 (17.01%)
    6 / 180 (3.33%)
         occurrences all number
    4
    2
    368
    6
    dyspepsia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    65 / 2011 (3.23%)
    6 / 180 (3.33%)
         occurrences all number
    1
    0
    72
    6
    dysphagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    epigastric discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    eructation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    faeces hard
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    flatulence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    10 / 2011 (0.50%)
    1 / 180 (0.56%)
         occurrences all number
    1
    0
    11
    1
    food poisoning
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    frequent bowel movements
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    gastric disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    7 / 2011 (0.35%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    8
    1
    gastritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    6 / 180 (3.33%)
         occurrences all number
    1
    0
    4
    6
    gastrointestinal disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    6
    1
    gastrointestinal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    4 / 2011 (0.20%)
    1 / 180 (0.56%)
         occurrences all number
    0
    1
    5
    1
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    12 / 2011 (0.60%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    14
    0
    gingival bleeding
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    gingival inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    gingival pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    haematochezia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    haemorrhoidal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    haemorrhoids
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    2 / 180 (1.11%)
         occurrences all number
    1
    0
    5
    2
    hyperchlorhydria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    hypoaesthesia oral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    inguinal hernia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    irritable bowel syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    nausea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 266 (2.26%)
    3 / 258 (1.16%)
    552 / 2011 (27.45%)
    9 / 180 (5.00%)
         occurrences all number
    6
    4
    707
    9
    oesophagitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    oral disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    oral mucosal blistering
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    oral pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    paraesthesia oral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    periodontal disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    reflux gastritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    saliva altered
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    salivary hypersecretion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    stomatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    tooth disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    1
    1
    toothache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    2 / 258 (0.78%)
    23 / 2011 (1.14%)
    1 / 180 (0.56%)
         occurrences all number
    1
    2
    25
    2
    umbilical hernia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    vomiting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    3 / 258 (1.16%)
    82 / 2011 (4.08%)
    1 / 180 (0.56%)
         occurrences all number
    1
    3
    96
    1
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    12 / 2011 (0.60%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    12
    0
    alopecia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    1 / 180 (0.56%)
         occurrences all number
    1
    0
    5
    1
    cold sweat
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    5
    0
    dandruff
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    dermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    dermatitis acneiform
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    dermatitis allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    1 / 180 (0.56%)
         occurrences all number
    1
    0
    3
    1
    dermatitis atopic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    dermatitis contact
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    dry skin
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    6 / 2011 (0.30%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    6
    0
    eczema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    6 / 2011 (0.30%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    6
    1
    erythema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    guttate psoriasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    heat rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hyperhidrosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 258 (0.00%)
    180 / 2011 (8.95%)
    8 / 180 (4.44%)
         occurrences all number
    2
    0
    196
    8
    hyperkeratosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hypertrichosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    lichen planus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    neurodermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    night sweats
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    2 / 258 (0.78%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    2
    3
    0
    pain of skin
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    photosensitivity reaction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    piloerection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    23 / 2011 (1.14%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    25
    0
    pityriasis rosea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    16 / 2011 (0.80%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    16
    0
    pruritus generalised
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    psoriasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    12 / 2011 (0.60%)
    2 / 180 (1.11%)
         occurrences all number
    1
    0
    12
    2
    rash erythematous
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    rash pruritic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    rosacea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    skin atrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    skin burning sensation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    skin disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    skin lesion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    skin odour abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    solar dermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    urticaria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    1
    0
    1
    1
    Renal and urinary disorders
    bladder dysfunction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    chromaturia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    dysuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    49 / 2011 (2.44%)
    2 / 180 (1.11%)
         occurrences all number
    1
    0
    54
    2
    haematuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    incontinence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    micturition disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    6 / 2011 (0.30%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    6
    0
    micturition urgency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    3
    0
    nocturia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    pollakiuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    13 / 2011 (0.65%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    13
    1
    polyuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    renal colic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    2
    1
    renal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    semenuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [40]
    0 / 151 (0.00%)
    0 / 155 (0.00%)
    3 / 1184 (0.25%)
    0 / 95 (0.00%)
         occurrences all number
    0
    0
    3
    0
    urethral discharge
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    urinary hesitation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 258 (0.00%)
    43 / 2011 (2.14%)
    1 / 180 (0.56%)
         occurrences all number
    2
    0
    46
    1
    urinary incontinence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    urinary retention
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    21 / 2011 (1.04%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    22
    1
    urinary tract disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    urinary tract obstruction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    urine abnormality
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    urine flow decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    14 / 2011 (0.70%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    14
    0
    urine odour abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Endocrine disorders
    goitre
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    2 / 258 (0.78%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    2
    1
    0
    hyperthyroidism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hypothyroidism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    thyroid pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    1 / 258 (0.39%)
    15 / 2011 (0.75%)
    8 / 180 (4.44%)
         occurrences all number
    2
    1
    15
    8
    arthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    back pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 266 (1.13%)
    7 / 258 (2.71%)
    30 / 2011 (1.49%)
    7 / 180 (3.89%)
         occurrences all number
    3
    7
    30
    9
    bursitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    chondropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    coccydynia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    compartment syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    groin pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    3
    0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    2 / 180 (1.11%)
         occurrences all number
    0
    0
    2
    2
    joint contracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    limb discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    monarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    muscle contracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    muscle fatigue
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    muscle spasms
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    8 / 2011 (0.40%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    8
    0
    muscle tightness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    10 / 2011 (0.50%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    10
    0
    muscular weakness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    musculoskeletal discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    musculoskeletal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    9 / 2011 (0.45%)
    1 / 180 (0.56%)
         occurrences all number
    0
    1
    9
    1
    musculoskeletal stiffness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    2
    0
    myalgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    16 / 2011 (0.80%)
    1 / 180 (0.56%)
         occurrences all number
    1
    1
    20
    1
    myosclerosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    1
    1
    myositis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    neck pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    6 / 2011 (0.30%)
    2 / 180 (1.11%)
         occurrences all number
    1
    1
    6
    2
    osteitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    osteoarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    1
    0
    0
    1
    pain in extremity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    2 / 258 (0.78%)
    5 / 2011 (0.25%)
    1 / 180 (0.56%)
         occurrences all number
    2
    2
    5
    1
    pain in jaw
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    periostitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    plantar fasciitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    rotator cuff syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    scoliosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    sensation of heaviness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    spinal osteoarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    2
    1
    tendon pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    tendonitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    3 / 2011 (0.15%)
    1 / 180 (0.56%)
         occurrences all number
    0
    1
    3
    1
    tenosynovitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    torticollis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    1
    0
    acarodermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    acute sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    acute tonsillitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    1
    0
    0
    2
    body tinea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 266 (1.13%)
    2 / 258 (0.78%)
    18 / 2011 (0.90%)
    5 / 180 (2.78%)
         occurrences all number
    3
    2
    19
    7
    candidiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    chlamydial cervicitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [41]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    1 / 827 (0.12%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    1
    0
    chronic sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    cystitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    8 / 2011 (0.40%)
    5 / 180 (2.78%)
         occurrences all number
    1
    1
    8
    8
    ear infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    2 / 180 (1.11%)
         occurrences all number
    2
    0
    2
    2
    enteritis infectious
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    erythema migrans
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    fungal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    gastroenteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 266 (1.88%)
    2 / 258 (0.78%)
    24 / 2011 (1.19%)
    5 / 180 (2.78%)
         occurrences all number
    5
    2
    24
    7
    gastroenteritis norovirus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    gastroenteritis viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    16 / 2011 (0.80%)
    1 / 180 (0.56%)
         occurrences all number
    0
    1
    16
    1
    gastrointestinal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    4 / 2011 (0.20%)
    2 / 180 (1.11%)
         occurrences all number
    0
    0
    4
    2
    gastrointestinal viral infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    genital herpes
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    genital infection fungal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    gingivitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    3
    0
    gonorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    helicobacter infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    herpes simplex
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    2
    1
    herpes virus infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    herpes zoster
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    2 / 180 (1.11%)
         occurrences all number
    0
    0
    0
    2
    hordeolum
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    1
    0
    infected bites
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    infection parasitic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    influenza
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 266 (3.01%)
    6 / 258 (2.33%)
    52 / 2011 (2.59%)
    10 / 180 (5.56%)
         occurrences all number
    8
    6
    55
    10
    laryngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    localised infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    lower respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    lyme disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    mycoplasma infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    0
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    18 / 266 (6.77%)
    13 / 258 (5.04%)
    137 / 2011 (6.81%)
    22 / 180 (12.22%)
         occurrences all number
    26
    16
    153
    39
    oral herpes
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    4
    0
    otitis media
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 258 (0.00%)
    6 / 2011 (0.30%)
    0 / 180 (0.00%)
         occurrences all number
    2
    0
    6
    0
    peritonsillar abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    pertussis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    pharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 258 (0.00%)
    8 / 2011 (0.40%)
    1 / 180 (0.56%)
         occurrences all number
    2
    0
    8
    1
    pharyngitis streptococcal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    4 / 2011 (0.20%)
    1 / 180 (0.56%)
         occurrences all number
    0
    1
    4
    1
    pharyngotonsillitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    2 / 180 (1.11%)
         occurrences all number
    2
    0
    1
    2
    pyelonephritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    1
    0
    respiratory tract infection viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    rhinitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    2 / 258 (0.78%)
    13 / 2011 (0.65%)
    4 / 180 (2.22%)
         occurrences all number
    1
    2
    13
    4
    rhinovirus infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    salpingo-oophoritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [42]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    1 / 827 (0.12%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    1
    0
    scarlet fever
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 266 (0.75%)
    3 / 258 (1.16%)
    23 / 2011 (1.14%)
    4 / 180 (2.22%)
         occurrences all number
    2
    4
    24
    4
    skin infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    subcutaneous abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    tinea pedis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    tinea versicolour
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    3
    0
    tonsillitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    2 / 258 (0.78%)
    9 / 2011 (0.45%)
    3 / 180 (1.67%)
         occurrences all number
    1
    2
    9
    4
    tooth abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    3 / 2011 (0.15%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    3
    0
    tooth infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    5
    0
    tracheitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 266 (4.14%)
    7 / 258 (2.71%)
    57 / 2011 (2.83%)
    1 / 180 (0.56%)
         occurrences all number
    13
    7
    62
    2
    urethritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    urinary tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    12 / 2011 (0.60%)
    2 / 180 (1.11%)
         occurrences all number
    2
    0
    12
    2
    vaginal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [43]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    3 / 827 (0.36%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    3
    0
    viral infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    6 / 2011 (0.30%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    6
    0
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    5 / 2011 (0.25%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    5
    0
    vulvovaginal candidiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [44]
    0 / 115 (0.00%)
    0 / 103 (0.00%)
    0 / 827 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    0
    1
    wound infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    0 / 180 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metabolism and nutrition disorders
    acidosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    decreased appetite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 258 (0.39%)
    294 / 2011 (14.62%)
    1 / 180 (0.56%)
         occurrences all number
    1
    1
    319
    1
    dehydration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hypercholesterolaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 258 (0.39%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    1
    2
    0
    hyperphagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    2 / 2011 (0.10%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    2
    0
    hypertriglyceridaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hypoglycaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    increased appetite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 266 (0.38%)
    3 / 258 (1.16%)
    10 / 2011 (0.50%)
    0 / 180 (0.00%)
         occurrences all number
    1
    3
    10
    0
    polydipsia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    tetany
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    vitamin b12 deficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    0 / 2011 (0.00%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    0
    1
    vitamin d deficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 266 (0.00%)
    0 / 258 (0.00%)
    1 / 2011 (0.05%)
    0 / 180 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly
    [44] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly

    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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