Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Efficacy and safety of eslicarbazepine acetate (BIA 2-093) as monotherapy for patients with newly diagnosed partial-onset seizures: a double-blind, randomized, active-controlled, parallel-group, multicenter clinical study

    Summary
    EudraCT number
    		 2009-011135-13
    Trial protocol
    		 DE   IE   AT   FI   LT   PT   GB   SK   ES   IT   CZ   LV   BE   EE   HU   BG  
    Global end of trial date
    08 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Sep 2017
    First version publication date
    24 Sep 2017
    Other versions
    Summary report(s)
    		 bia-2093-311

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BIA-2093-311
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BIAL - Portela & CA, S.A.
    Sponsor organisation address
    À Av. Siderurgia Nacional, Coronado, Portugal, 4745-457
    Public contact
    André Garrido, BIAL - Portela & Cª, S.A., 00351 229866100, andre.garrido@bial.com
    Scientific contact
    José Francisco Rocha, BIAL - Portela & Cª, S.A., 00351 229866100, jose.rocha@bial.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary: To demonstrate that monotherapy with eslicarbazepine acetate (ESL; 800 to 1600 mg once daily [QD]) is not inferior to monotherapy with controlled-release carbamazepine (CBZ-CR; 200 to 600 mg twice daily [BID]) in adults (≥18 years) with newly diagnosed epilepsy experiencing partial-onset seizures.
    Protection of trial subjects
    The trial was conducted in accordance with the International Conference on Harmonisation (ICH), Good Clinical Practices (GCP), Good Manufacturing Practice (GMP), the ethical principles of the Declaration of Helsinki and with applicable local regulations. This trial was conducted by qualified persons who respected the rights and welfare of the subjects and after the review and approval of the protocol by IEC.
    Background therapy
    		 Concomitant AED therapy (1 or 2 AEDs).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jan 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 35
    Country: Number of subjects enrolled
    Australia: 23
    Country: Number of subjects enrolled
    Austria: 13
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Bulgaria: 54
    Country: Number of subjects enrolled
    Brazil: 26
    Country: Number of subjects enrolled
    Chile: 16
    Country: Number of subjects enrolled
    Czech Republic: 42
    Country: Number of subjects enrolled
    Germany: 27
    Country: Number of subjects enrolled
    Spain: 35
    Country: Number of subjects enrolled
    Estonia: 11
    Country: Number of subjects enrolled
    Finland: 36
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    United Kingdom: 30
    Country: Number of subjects enrolled
    Croatia: 6
    Country: Number of subjects enrolled
    Hungary: 40
    Country: Number of subjects enrolled
    India: 67
    Country: Number of subjects enrolled
    Ireland: 8
    Country: Number of subjects enrolled
    Israel: 11
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Lithuania: 5
    Country: Number of subjects enrolled
    Latvia: 28
    Country: Number of subjects enrolled
    Peru: 13
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Portugal: 17
    Country: Number of subjects enrolled
    Romania: 44
    Country: Number of subjects enrolled
    Russian Federation: 104
    Country: Number of subjects enrolled
    Serbia: 21
    Country: Number of subjects enrolled
    Slovakia: 20
    Country: Number of subjects enrolled
    Sweden: 13
    Country: Number of subjects enrolled
    Ukraine: 43
    Worldwide total number of subjects
    815
    EEA total number of subjects
    456
    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)
    753
    From 65 to 84 years
    61
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The patient recruitment period lasted 41 months. First subject was recruited on 27JAN2011, the last subject on 09JUN2014.

    Pre-assignment
    Screening details
    		 Subjects who met all the inclusion criteria and none of the exclusion criteria. 929 subjects were enrolled to the trial and 114 subjects were screening failures including 36 who met all the inclusion criteria and none of the exclusion criteria but were not randomised. 2 subjects were randomised but not treated.

    Pre-assignment period milestones
    Number of subjects started
    		 929 [1]
    Number of subjects completed
    		 813 [2]

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 1
    Reason: Number of subjects
    		 Consent withdrawn by subject: 25
    Reason: Number of subjects
    		 Pregnancy: 1
    Reason: Number of subjects
    		 Ineligibility: 72
    Reason: Number of subjects
    		 Subject's non compliance: 2
    Reason: Number of subjects
    		 Sponsor's discretion: 3
    Reason: Number of subjects
    		 Progressive disease: 1
    Reason: Number of subjects
    		 Randomised, but not treated: 2
    Reason: Number of subjects
    		 Other reason: 9
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to have started the pre-assignment period is the number of enrolled subjects; The worldwide number of subjects enrolled in the trial is number of randomised subjects. 2 randomised subjects were not treated.
    [2] - The number of subjects reported to be in the pre-assignment period is not consistent with the number starting period 1. It is expected that the number completing the pre-assignment period are also present in the arms in period 1.
    Justification: The arms are not mutually exclusive and number starting period 1 should be calculated as sum of the Eslicarbazepine acetate and CBZ-CR or as sum of ESL 800 mg QD, ESL 1200 mg QD, ESL 1600 mg QD, CBZ-CR 200 mg BID, CBZ-CR 400 mg BID, CBZ-CR 600 mg BID and not as sum of all arms groups. Therefore, the number of subjects starting period 1 consist with the number of subjects completing the pre-assignment period.
    Period 1
    Period 1 title
    DOUBLE-BLIND TREATMENT (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Eslicarbazepine acetate
    Arm description
    		 Patients will receive the study treatment in the form of 400-800 mg Eslicarbazepine Acetate capsules. The study treatment should be administered once daily. The maximum absolute daily dosage will be 1600 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2-093
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The study treatment should be administered once daily in the evening. The maximum absolute dosage will be 1600 mg once daily. Dose Level A0 (during Titration Period): ESL 400 mg once daily Dose Level A: ESL 800 mg once daily Dose Level B0 (during Titration Period): ESL 1200 mg once daily Dose Level B: ESL 1200 mg once daily Dose Level C0 (during Titration Period): ESL 1600 mg once daily Dose Level C: ESL 1600 mg once daily

    Arm title
    		 CBZ-CR
    Arm description
    		 Patients will receive the study treatment in the form of 200-400 mg Carbamazepine controlled-release (Tegretal®-CR) capsules. The study treatment should be administered twice daily. The maximum absolute daily dosage will be 1200 mg. Carbatrol-XR (100 mg) capsules will be used during the 1-week Titration Period, when needed, because Tegretal-CR does not have a 100 mg capsule.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Carbamazepine controlled-release
    Investigational medicinal product code
    Other name
    Tegretal®-CR, Carbatrol®-XR
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The study treatment should be administered twice daily in the morning and in the evening except for Dose Level A0 where morning dose is Placebo. The maximum absolute daily dosage will be 1200 mg. Dose Level A0 (during Titration Period): CBZ-CR 200 mg once daily Dose Level A: CBZ-CR 200 mg twice daily Dose Level B0 (during Titration Period): CBZ-CR 300 mg twice daily Dose Level B: CBZ-CR 400 mg twice daily Dose Level C0 (during Titration Period): CBZ-CR 500 mg twice daily Dose Level C: CBZ-CR 600 mg twice daily

    Arm title
    		 ESL 800 mg QD
    Arm description
    		 Patients with last evaluated dose 800 mg QD of Eslicarbazepine Acetate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2-093
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The study treatment should be administered once daily in the evening.

    Arm title
    		 ESL 1200 mg QD
    Arm description
    		 Patients with last evaluated dose 1200 mg QD of Eslicarbazepine Acetate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2-093
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The study treatment should be administered once daily in the evening.

    Arm title
    		 ESL 1600 mg QD
    Arm description
    		 Patients with last evaluated dose 1600 mg QD of Eslicarbazepine Acetate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2-093
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The study treatment should be administered once daily in the evening.

    Arm title
    		 CBZ-CR 200 mg BID
    Arm description
    		 Patients with last evaluated dose 200 mg BID of Carbamazepine controlled-release.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Carbamazepine controlled-release
    Investigational medicinal product code
    Other name
    Tegretal®-CR
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The study treatment should be administered twice daily in the morning and in the evening.

    Arm title
    		 CBZ-CR 400 mg BID
    Arm description
    		 Patients with last evaluated dose 400 mg BID of Carbamazepine controlled-release.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Carbamazepine controlled-release
    Investigational medicinal product code
    Other name
    Tegretal®-CR
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The study treatment should be administered twice daily in the morning and in the evening.

    Arm title
    		 CBZ-CR 600 mg BID
    Arm description
    		 Patients with last evaluated dose 600 mg BID of Carbamazepine controlled-release.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Carbamazepine controlled-release
    Investigational medicinal product code
    Other name
    Tegretal®-CR
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The study treatment should be administered twice daily in the morning and in the evening.

    Number of subjects in period 1
    		Eslicarbazepine acetate CBZ-CR ESL 800 mg QD ESL 1200 mg QD ESL 1600 mg QD CBZ-CR 200 mg BID CBZ-CR 400 mg BID CBZ-CR 600 mg BID
    Started
    401
    412
    271
    70
    60
    317
    61
    34
    Completed
    132
    148
    103
    21
    8
    114
    25
    9
    Not completed
    269
    264
    168
    49
    52
    203
    36
    25
         Adverse event, serious fatal
    2
    2
    2
    -
    -
    2
    -
    -
         Other reason
    46
    67
    35
    8
    3
    59
    7
    1
         Adverse event, serious non-fatal
    7
    12
    3
    3
    1
    11
    1
    -
         Ineligibility
    1
    1
    1
    -
    -
    1
    -
    -
         Consent withdrawn by subject
    55
    41
    44
    8
    3
    35
    5
    1
         Investigator or sponsor discretion
    10
    12
    7
    2
    1
    9
    3
    -
         Subject non compliance
    10
    14
    8
    2
    -
    10
    2
    2
         Adverse event, non-fatal
    32
    48
    21
    9
    2
    36
    8
    4
         Pregnancy
    7
    4
    2
    2
    3
    3
    1
    -
         Progressive disease
    5
    6
    3
    1
    1
    6
    -
    -
         Unblinding of the IMP
    1
    1
    1
    -
    -
    1
    -
    -
         Lack of efficacy
    90
    56
    38
    14
    38
    30
    9
    17
         Protocol deviation
    3
    -
    3
    -
    -
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups [1]
    Reporting group title
    Eslicarbazepine acetate
    Reporting group description
    		 Patients will receive the study treatment in the form of 400-800 mg Eslicarbazepine Acetate capsules. The study treatment should be administered once daily. The maximum absolute daily dosage will be 1600 mg.

    Reporting group title
    CBZ-CR
    Reporting group description
    		 Patients will receive the study treatment in the form of 200-400 mg Carbamazepine controlled-release (Tegretal®-CR) capsules. The study treatment should be administered twice daily. The maximum absolute daily dosage will be 1200 mg. Carbatrol-XR (100 mg) capsules will be used during the 1-week Titration Period, when needed, because Tegretal-CR does not have a 100 mg capsule.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number reported to be in the baseline period is the number of treated subjects; The worldwide number of subjects enrolled in the trial is number of randomised subjects. Baseline period does not include 2 subjects who were randomised but not treated.
    Reporting group values
    		 Eslicarbazepine acetate CBZ-CR Total
    Number of subjects
    		 401 412 813
    Age Categorical
    Age Categorical Characteristic
    Units: Subjects
        In Utero
    		 0 0 0
        Preterm newborn- gestational age < 37 wk
    		 0 0 0
        Newborns (0-27days)
    		 0 0 0
        Infants and toddlers (28days – 23months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 year)
    		 0 0 0
        From 18 - 64 years
    		 374 377 751
        From 65 – 84 years
    		 26 35 61
        Over 85 years
    		 1 0 1
    Age Continuous
    Age Continuous Characteristic
    Units: Years
        arithmetic mean (standard deviation)
    		 37.6 ( 15.79 ) 38.7 ( 16.29 ) -
    Gender Categorical
    Gender Categorical Characteristic
    Units: Subjects
        Female
    		 173 192 365
        Male
    		 228 220 448

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Eslicarbazepine acetate
    Reporting group description
    		 Patients will receive the study treatment in the form of 400-800 mg Eslicarbazepine Acetate capsules. The study treatment should be administered once daily. The maximum absolute daily dosage will be 1600 mg.

    Reporting group title
    CBZ-CR
    Reporting group description
    		 Patients will receive the study treatment in the form of 200-400 mg Carbamazepine controlled-release (Tegretal®-CR) capsules. The study treatment should be administered twice daily. The maximum absolute daily dosage will be 1200 mg. Carbatrol-XR (100 mg) capsules will be used during the 1-week Titration Period, when needed, because Tegretal-CR does not have a 100 mg capsule.

    Reporting group title
    ESL 800 mg QD
    Reporting group description
    		 Patients with last evaluated dose 800 mg QD of Eslicarbazepine Acetate.

    Reporting group title
    ESL 1200 mg QD
    Reporting group description
    		 Patients with last evaluated dose 1200 mg QD of Eslicarbazepine Acetate.

    Reporting group title
    ESL 1600 mg QD
    Reporting group description
    		 Patients with last evaluated dose 1600 mg QD of Eslicarbazepine Acetate.

    Reporting group title
    CBZ-CR 200 mg BID
    Reporting group description
    		 Patients with last evaluated dose 200 mg BID of Carbamazepine controlled-release.

    Reporting group title
    CBZ-CR 400 mg BID
    Reporting group description
    		 Patients with last evaluated dose 400 mg BID of Carbamazepine controlled-release.

    Reporting group title
    CBZ-CR 600 mg BID
    Reporting group description
    		 Patients with last evaluated dose 600 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    ESL x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of study treatment.

    Subject analysis set title
    CBZ-CR x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of study treatment.

    Subject analysis set title
    ESL 800 mg QD x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of study treatment and the last evaluated dose was 800 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    ESL 1200 mg QD x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of study treatment and the last evaluated dose was 1200 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    ESL 1600 mg QD x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of study treatment and the last evaluated dose was 1600 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    CBZ-CR 200 mg BID x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of study treatment and the last evaluated dose was 200 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    CBZ-CR 400 mg BID x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of study treatment and the last evaluated dose was 400 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    CBZ-CR 600 mg BID x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of study treatment and the last evaluated dose was 600 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    ESL x Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients randomised and treated with at least one dose of study treatment after randomisation.

    Subject analysis set title
    CBZ-CR x Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients randomised and treated with at least one dose of study treatment after randomisation.

    Subject analysis set title
    ESL 800 mg QD x Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients randomised and treated with at least one dose of study treatment after randomisation and the last evaluated dose was 800 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    ESL 1200 mg QD x Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients randomised and treated with at least one dose of study treatment after randomisation and the last evaluated dose was 1200 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    ESL 1600 mg QD x Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients who received at least one dose of study treatment and the last evaluated dose was 1600 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    CBZ-CR 200 mg BID x Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients randomised and treated with at least one dose of study treatment after randomisation and the last evaluated dose was 200 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    CBZ-CR 400 mg BID x Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients randomised and treated with at least one dose of study treatment after randomisation and the last evaluated dose was 400 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    CBZ-CR 600 mg BID x Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients randomised and treated with at least one dose of study treatment after randomisation and the last evaluated dose was 600 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    ESL x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the FAS without any major protocol deviations

    Subject analysis set title
    CBZ-CR x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the FAS without any major protocol deviations

    Subject analysis set title
    ESL 800 mg QD x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the FAS without any major protocol deviations and the last evaluated dose was 800 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    ESL 1200 mg QD x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the FAS without any major protocol deviations and the last evaluated dose was 1200 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    ESL 1600 mg QD x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the FAS without any major protocol deviations and the last evaluated dose was 1600 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    CBZ-CR 200 mg BID x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the FAS without any major protocol deviations and the last evaluated dose was 200 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    CBZ-CR 400 mg BID x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the FAS without any major protocol deviations and the last evaluated dose was 400 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    CBZ-CR 600 mg BID x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the FAS without any major protocol deviations and the last evaluated dose was 600 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    ESL x Corrected Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PPS based on data corrections identified after the snapshot for the primary statistical analysis.

    Subject analysis set title
    CBZ-CR x Corrected Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PPS based on data corrections identified after the snapshot for the primary statistical analysis.

    Subject analysis set title
    ESL 800 mg QD x Corrected Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PPS based on data corrections identified after the snapshot for the primary statistical analysis and the last evaluated dose for patient was 800 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    ESL 1200 mg QD x Corrected Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PPS based on data corrections identified after the snapshot for the primary statistical analysis and the last evaluated dose for patient was 1200 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    ESL 1600 mg QD x Corrected Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PPS based on data corrections identified after the snapshot for the primary statistical analysis and the last evaluated dose for patient was 1600 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    CBZ-CR 200 mg BID x Corrected Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PPS based on data corrections identified after the snapshot for the primary statistical analysis and the last evaluated dose for patient was 200 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    CBZ-CR 400 mg BID x Corrected Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PPS based on data corrections identified after the snapshot for the primary statistical analysis and the last evaluated dose for patient was 400 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    CBZ-CR 600 mg BID x Corrected Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    PPS based on data corrections identified after the snapshot for the primary statistical analysis and the last evaluated dose for patient was 600 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    ESL x Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the PP Set excluding all subjects discontinuing the study before reaching the end of the 26-week Evaluation Period for any reasons not linked to efficacy.

    Subject analysis set title
    CBZ-CR x Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the PP Set excluding all subjects discontinuing the study before reaching the end of the 26-week Evaluation Period for any reasons not linked to efficacy.

    Subject analysis set title
    ESL 800 mg QD x Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the PP Set excluding all subjects discontinuing the study before reaching the end of the 26-week Evaluation Period for any reasons not linked to efficacy and the last evaluated dose was 800 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    ESL 1200 mg QD x Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the PP Set excluding all subjects discontinuing the study before reaching the end of the 26-week Evaluation Period for any reasons not linked to efficacy and the last evaluated dose was 1200 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    ESL 1600 mg QD x Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the PP Set excluding all subjects discontinuing the study before reaching the end of the 26-week Evaluation Period for any reasons not linked to efficacy and the last evaluated dose was 1600 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    CBZ-CR 200 mg BID x Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the PP Set excluding all subjects discontinuing the study before reaching the end of the 26-week Evaluation Period for any reasons not linked to efficacy and the last evaluated dose was 200 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    CBZ-CR 400 mg BID x Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the PP Set excluding all subjects discontinuing the study before reaching the end of the 26-week Evaluation Period for any reasons not linked to efficacy and the last evaluated dose was 400 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    CBZ-CR 600 mg BID x Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients of the PP Set excluding all subjects discontinuing the study before reaching the end of the 26-week Evaluation Period for any reasons not linked to efficacy and the last evaluated dose was 600 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    ESL x Corrected Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Subset (SPP) based on data corrections identified after the snapshot for the primary statistical analysis.

    Subject analysis set title
    CBZ-CR x Corrected Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Subset (SPP) based on data corrections identified after the snapshot for the primary statistical analysis.

    Subject analysis set title
    ESL 800 mg QD x Corrected Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Subset (SPP) based on data corrections identified after the snapshot for the primary statistical analysis and the last evaluated dose for patient was 800 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    ESL 1200 mg QD x Corrected Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Subset (SPP) based on data corrections identified after the snapshot for the primary statistical analysis and the last evaluated dose for patient was 1200 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    ESL 1600 mg QD x Corrected Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Subset (SPP) based on data corrections identified after the snapshot for the primary statistical analysis and the last evaluated dose for patient was 1600 mg QD of Eslicarbazepine Acetate.

    Subject analysis set title
    CBZ-CR 200 mg BID x Corrected Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Subset (SPP) based on data corrections identified after the snapshot for the primary statistical analysis and the last evaluated dose for patient was 200 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    CBZ-CR 400 mg BID x Corrected Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Subset (SPP) based on data corrections identified after the snapshot for the primary statistical analysis and the last evaluated dose for patient was 400 mg BID of Carbamazepine controlled-release.

    Subject analysis set title
    CBZ-CR 600 mg BID x Corrected Per Protocol Subset
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Subset (SPP) based on data corrections identified after the snapshot for the primary statistical analysis and the last evaluated dose for patient was 600 mg BID of Carbamazepine controlled-release.

    Primary: Seizure freedom

    		 Close Top of page
    End point title
    		 Seizure freedom
    End point description
    Proportion of subjects who are seizure free (seizure freedom) for the entire 26-week Evaluation Period (ESD 182) at the last evaluated dose level.
    End point type
    Primary
    End point timeframe
    26-week Evaluation Period of the last evaluated dose level
    End point values
    		 ESL x Full Analysis Set CBZ-CR x Full Analysis Set ESL x Per Protocol Set CBZ-CR x Per Protocol Set ESL x Corrected Per Protocol Set CBZ-CR x Corrected Per Protocol Set ESL x Per Protocol Subset CBZ-CR x Per Protocol Subset ESL x Corrected Per Protocol Subset CBZ-CR x Corrected Per Protocol Subset
    Number of subjects analysed
    401
    412
    388
    397
    389
    397
    316
    326
    317
    326
    Units: Subjects
    number (not applicable)
        Western Europe
    46
    57
    44
    55
    44
    55
    44
    55
    44
    55
        Central Europe
    62
    67
    62
    65
    62
    65
    62
    65
    62
    65
        Eastern Europe
    58
    68
    57
    67
    57
    67
    57
    67
    57
    67
        Russia
    45
    46
    44
    46
    44
    46
    44
    46
    44
    46
        GBR+Ireland+Australia
    18
    16
    17
    16
    17
    16
    17
    16
    17
    16
        South America
    30
    24
    29
    24
    29
    24
    29
    24
    29
    24
        India
    25
    27
    23
    27
    24
    27
    23
    27
    24
    27
        Total
    284
    305
    276
    300
    277
    300
    276
    300
    277
    300
    Statistical analysis title
    		 Average risk difference PP
    Statistical analysis description
    The difference in proportions stratified by region etimated by the average risk difference (ARD) over the different regions and estimated from the coefficients of the logistic regression.
    Comparison groups
    ESL x Per Protocol Set v CBZ-CR x Per Protocol Set
    Number of subjects included in analysis
    785
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 P-value was not provided
    Parameter type
    		 Average Risk Difference (ARD)
    Point estimate
    -4.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.3
         upper limit
    		 1.74
    Notes
    [1] - Non-inferiority margin = -12%
    Statistical analysis title
    		 Average risk difference FAS
    Statistical analysis description
    The difference in proportions stratified by region etimated by the average risk difference (ARD) over the different regions and estimated from the coefficients of the logistic regression.
    Comparison groups
    ESL x Full Analysis Set v CBZ-CR x Full Analysis Set
    Number of subjects included in analysis
    813
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    Method
    		 P-value was not provided
    Parameter type
    		 Average Risk Difference (ARD)
    Point estimate
    -3.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.04
         upper limit
    		 2.89
    Notes
    [2] - ESL is assumed to be superior to CBZ-CR if the lower limit of the CI > 0%
    Statistical analysis title
    		 Average risk difference SPP
    Statistical analysis description
    The difference in proportions stratified by region etimated by the average risk difference (ARD) over the different regions and estimated from the coefficients of the logistic regression.
    Comparison groups
    ESL x Per Protocol Subset v CBZ-CR x Per Protocol Subset
    Number of subjects included in analysis
    642
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    		 P-value was not provided
    Parameter type
    		 Average Risk Difference (ARD)
    Point estimate
    -4.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.13
         upper limit
    		 0.1
    Notes
    [3] - Non-inferiority margin = -12%
    Statistical analysis title
    		 Average risk difference PPcor
    Statistical analysis description
    The difference in proportions stratified by region etimated by the average risk difference (ARD) over the different regions and estimated from the coefficients of the logistic regression.
    Comparison groups
    ESL x Corrected Per Protocol Set v CBZ-CR x Corrected Per Protocol Set
    Number of subjects included in analysis
    786
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    		 P-value was not provided
    Parameter type
    		 Average Risk Difference (ARD)
    Point estimate
    -4.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.23
         upper limit
    		 1.8
    Notes
    [4] - Non-inferiority margin = -12%
    Statistical analysis title
    		 Average risk difference SPPcor
    Statistical analysis description
    The difference in proportions stratified by region etimated by the average risk difference (ARD) over the different regions and estimated from the coefficients of the logistic regression.
    Comparison groups
    ESL x Corrected Per Protocol Subset v CBZ-CR x Corrected Per Protocol Subset
    Number of subjects included in analysis
    643
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    		 P-value was not provided
    Parameter type
    		 Average Risk Difference (ARD)
    Point estimate
    -4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.1
         upper limit
    		 0.11
    Notes
    [5] - Non-inferiority margin = -12%

    Secondary: 1-year treatment effect

    		 Close Top of page
    End point title
    		 1-year treatment effect
    End point description
    The proportion of seizure-free subjects during 1 year of treatment at the last evaluated dose
    End point type
    Secondary
    End point timeframe
    1 year after first day of Evaluation period
    End point values
    		 ESL x Full Analysis Set CBZ-CR x Full Analysis Set ESL x Per Protocol Set CBZ-CR x Per Protocol Set
    Number of subjects analysed
    401
    412
    388
    397
    Units: Subjects
    number (not applicable)
        Western Europe
    40
    55
    38
    54
        Central Europe
    58
    62
    58
    60
        Eastern Europe
    56
    58
    55
    57
        Russia
    38
    43
    37
    43
        GBR+Ireland+Australia
    15
    15
    15
    15
        South America
    26
    23
    26
    23
        India
    23
    27
    22
    27
        Total
    256
    283
    251
    279
    Statistical analysis title
    		 Average risk difference PP
    Statistical analysis description
    The difference in proportions stratified by region etimated by the average risk difference (ARD) over the different regions and estimated from the coefficients of the logistic regression.
    Comparison groups
    ESL x Per Protocol Set v CBZ-CR x Per Protocol Set
    Number of subjects included in analysis
    785
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    		 P-value was not provided
    Parameter type
    		 Average Risk Difference (ARD)
    Point estimate
    -5.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.88
         upper limit
    		 0.97
    Notes
    [6] - Non-inferiority margin = -12%
    Statistical analysis title
    		 Average risk difference FAS
    Statistical analysis description
    The difference in proportions stratified by region etimated by the average risk difference (ARD) over the different regions and estimated from the coefficients of the logistic regression.
    Comparison groups
    ESL x Full Analysis Set v CBZ-CR x Full Analysis Set
    Number of subjects included in analysis
    813
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    		 P-value was not provided
    Parameter type
    		 Average Risk Difference (ARD)
    Point estimate
    -4.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.07
         upper limit
    		 1.64
    Notes
    [7] - Non-inferiority margin = -12%

    Secondary: Treatment failure time

    		 Close Top of page
    End point title
    		 Treatment failure time
    End point description
    The time to first seizure at the last evaluated dose.
    End point type
    Secondary
    End point timeframe
    From the first day of Evaluation period till the last IMP intake of the target dose + 1 day
    End point values
    		 ESL x Full Analysis Set CBZ-CR x Full Analysis Set ESL x Per Protocol Set CBZ-CR x Per Protocol Set
    Number of subjects analysed
    401
    412
    388
    397
    Units: Days
    number (not applicable)
        25% Quartile
    572
    1217
    576
    1217
    Statistical analysis title
    		 Log-Rank Test for treatment failure time PP
    Comparison groups
    ESL x Per Protocol Set v CBZ-CR x Per Protocol Set
    Number of subjects included in analysis
    785
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0005 [8]
    Method
    		 Logrank
    Confidence interval
    Notes
    [8] - p-value (Log-Rank Test) - startified by region: 0.0003
    Statistical analysis title
    		 Log-Rank Test for treatment failure time FAS
    Comparison groups
    ESL x Full Analysis Set v CBZ-CR x Full Analysis Set
    Number of subjects included in analysis
    813
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0004 [9]
    Method
    		 Logrank
    Confidence interval
    Notes
    [9] - p-value (Log-Rank Test) - startified by region: 0.0003

    Secondary: Treatment retention time

    		 Close Top of page
    End point title
    		 Treatment retention time
    End point description
    The time of the first occurrence of one of the following: Withdrawal of IMP due to AEs. Withdrawal of IMP due to lack of efficacy.
    End point type
    Secondary
    End point timeframe
    From the first dose of IMP till the last IMP intake of the target dose + 1day
    End point values
    		 ESL x Full Analysis Set CBZ-CR x Full Analysis Set ESL x Per Protocol Set CBZ-CR x Per Protocol Set
    Number of subjects analysed
    401
    412
    388
    397
    Units: Days
    number (confidence interval)
        25% Quartile
    398 (293 to 546)
    477 (384 to 723)
    420 (298 to 563)
    517 (392 to 790)
    Statistical analysis title
    		 Log-Rank Test for treatment retention time PP
    Comparison groups
    ESL x Per Protocol Set v CBZ-CR x Per Protocol Set
    Number of subjects included in analysis
    785
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1299 [10]
    Method
    		 Logrank
    Confidence interval
    Notes
    [10] - p-value (Log-Rank Test) - startified by region: 0.1151
    Statistical analysis title
    		 Log-Rank Test for retention failure time FAS
    Comparison groups
    ESL x Full Analysis Set v CBZ-CR x Full Analysis Set
    Number of subjects included in analysis
    813
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1438 [11]
    Method
    		 Logrank
    Confidence interval
    Notes
    [11] - p-value (Log-Rank Test) - startified by region: 0.1249

    Secondary: Dose-response relationship

    		 Close Top of page
    End point title
    		 Dose-response relationship
    End point description
    The seizure frequency adjusted for the exposure time until end of evaluation, maintenance, and extension period
    End point type
    Secondary
    End point timeframe
    Evaluation, Maintenance and Extension periods
    End point values
    		 ESL 800 mg QD x Full Analysis Set ESL 1200 mg QD x Full Analysis Set ESL 1600 mg QD x Full Analysis Set CBZ-CR 200 mg BID x Full Analysis Set CBZ-CR 400 mg BID x Full Analysis Set CBZ-CR 600 mg BID x Full Analysis Set ESL 800 mg QD x Per Protocol Set ESL 1200 mg QD x Per Protocol Set ESL 1600 mg QD x Per Protocol Set CBZ-CR 200 mg BID x Per Protocol Set CBZ-CR 400 mg BID x Per Protocol Set CBZ-CR 600 mg BID x Per Protocol Set
    Number of subjects analysed
    271
    70
    60
    317
    61
    34
    262
    69
    57
    304
    60
    33
    Units: Subjects
    number (not applicable)
        Evaluation Period
    8
    8
    26
    5
    4
    12
    8
    8
    25
    4
    3
    12
        Maintenance Period
    12
    5
    7
    9
    6
    3
    11
    5
    6
    8
    5
    3
        Extension Phase
    28
    10
    3
    26
    4
    2
    26
    10
    3
    26
    3
    2
    No statistical analyses for this end point

    Secondary: Seizure occurrence

    		 Close Top of page
    End point title
    		 Seizure occurrence
    End point description
    Number of subjects with at least 1 seizure during the respective phase / period of the last evaluated dose.
    End point type
    Secondary
    End point timeframe
    From Titration period till Extension phase
    End point values
    		 ESL x Full Analysis Set CBZ-CR x Full Analysis Set ESL x Per Protocol Set CBZ-CR x Per Protocol Set
    Number of subjects analysed
    401
    412
    388
    397
    Units: Subjects
    number (not applicable)
        Main Treatment Phase
    104
    74
    100
    71
        Titration Period
    35
    36
    34
    36
        Stabilization Period
    21
    21
    21
    21
        Evaluation Period
    42
    21
    41
    19
        Maintenance Period
    24
    16
    22
    15
        Extension Phase
    39
    31
    37
    30
    No statistical analyses for this end point

    Secondary: Quality of life

    		 Close Top of page
    End point title
    		 Quality of life
    End point description
    The scores of the QOLIE-31
    End point type
    Secondary
    End point timeframe
    From Visit A1 (start of double-blind period) till the last Extension Phase Visit
    End point values
    		 ESL x Full Analysis Set CBZ-CR x Full Analysis Set ESL x Per Protocol Set CBZ-CR x Per Protocol Set
    Number of subjects analysed
    401
    412
    388
    397
    Units: Scale
    arithmetic mean (standard deviation)
        Final score: Screening
    64.5 ( 15.26 )
    63.9 ( 15.42 )
    64.6 ( 15.18 )
    63.9 ( 15.56 )
        Final score: Baseline
    65.4 ( 15.03 )
    66 ( 15.63 )
    65.7 ( 14.94 )
    65.9 ( 15.69 )
        Final score: Visit 4
    72 ( 14.27 )
    71.6 ( 14.78 )
    72.3 ( 14.1 )
    71.7 ( 14.82 )
        Final score: MPV2
    72.8 ( 14.21 )
    74.5 ( 14.62 )
    72.8 ( 14.09 )
    74.5 ( 14.71 )
        Final score: FEV
    72.7 ( 13.9 )
    75.5 ( 14.23 )
    72.8 ( 13.93 )
    75.5 ( 14.23 )
        Final score: EDV
    66.1 ( 17.42 )
    66.3 ( 18.48 )
    66.2 ( 17.61 )
    66.2 ( 18.58 )
        T-score: Screening
    51 ( 9.36 )
    50.6 ( 9.45 )
    51.1 ( 9.31 )
    50.7 ( 9.54 )
        T-score: Baseline
    51.6 ( 9.22 )
    51.9 ( 9.59 )
    51.7 ( 9.16 )
    51.8 ( 9.62 )
        T-score: Visit 4
    55.6 ( 8.75 )
    55.3 ( 9.06 )
    55.8 ( 8.64 )
    55.4 ( 9.09 )
        T-score: MPV2
    56.1 ( 8.71 )
    57.1 ( 8.96 )
    56.1 ( 8.64 )
    57.1 ( 9.02 )
        T-score: FEV
    56 ( 8.52 )
    57.8 ( 8.73 )
    56.1 ( 8.54 )
    57.8 ( 8.73 )
        T-score: EDV
    52 ( 10.68 )
    52.1 ( 11.33 )
    52.1 ( 10.8 )
    52 ( 11.39 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From the date of first study treatment up to 28 days after the last intake of the last evaluated dose of study medication.
    Adverse event reporting additional description
    Each AE has to be documented with reference to intensity, date of occurrence, duration, frequency, treatment, and outcome. Furthermore, each AE has to be classified as serious or non-serious. Additionally, the investigator has to assess whether the AE is drug related or not. Changes of AEs and dates of ending have to be documented.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    ESL x Safety Set
    Reporting group description
    		 All patients who received at least one dose of study treatment.

    Reporting group title
    CBZ-CR x Safety Set
    Reporting group description
    		 All patients who received at least one dose of study treatment.

    Reporting group title
    ESL 800 mg QD x Safety Set
    Reporting group description
    		 All patients who received at least one dose of study treatment and the last evaluated dose was 800 mg QD of Eslicarbazepine Acetate.

    Reporting group title
    ESL 1200 mg QD x Safety Set
    Reporting group description
    		 All patients who received at least one dose of study treatment and the last evaluated dose was 1200 mg QD of Eslicarbazepine Acetate.

    Reporting group title
    ESL 1600 mg QD x Safety Set
    Reporting group description
    		 All patients who received at least one dose of study treatment and the last evaluated dose was 1600 mg QD of Eslicarbazepine Acetate.

    Reporting group title
    CBZ-CR 200 mg BID x Safety Set
    Reporting group description
    		 All patients who received at least one dose of study treatment and the last evaluated dose was 200 mg BID of Carbamazepine controlled-release.

    Reporting group title
    CBZ-CR 400 mg BID x Safety Set
    Reporting group description
    		 All patients who received at least one dose of study treatment and the last evaluated dose was 400 mg BID of Carbamazepine controlled-release.

    Reporting group title
    CBZ-CR 600 mg BID x Safety Set
    Reporting group description
    		 All patients who received at least one dose of study treatment and the last evaluated dose was 600 mg BID of Carbamazepine controlled-release.

    Serious adverse events
    		 ESL x Safety Set CBZ-CR x Safety Set ESL 800 mg QD x Safety Set ESL 1200 mg QD x Safety Set ESL 1600 mg QD x Safety Set CBZ-CR 200 mg BID x Safety Set CBZ-CR 400 mg BID x Safety Set CBZ-CR 600 mg BID x Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 401 (11.47%)
    50 / 412 (12.14%)
    24 / 271 (8.86%)
    9 / 70 (12.86%)
    13 / 60 (21.67%)
    45 / 317 (14.20%)
    4 / 61 (6.56%)
    1 / 34 (2.94%)
         number of deaths (all causes)
    2
    2
    2
    0
    0
    2
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain neoplasm
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholesteatoma
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioma
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectosigmoid cancer
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion late
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    High risk pregnancy
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion site inflammation
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hydrothorax
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Depressive symptom
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychogenic seizure
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme abnormal
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dislocation of vertebra
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus lesion
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural vomiting
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column injury
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Adams-stokes syndrome
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sick sinus syndrome
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral circulatory failure
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complex partial seizures
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    3 / 401 (0.75%)
    4 / 412 (0.97%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    2 / 60 (3.33%)
    3 / 317 (0.95%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 0
    0 / 1
    0 / 2
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    2 / 60 (3.33%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epileptic psychosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Monoparesis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures with secondary generalisation
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Simple partial seizures
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    3 / 401 (0.75%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 2
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis necrotising
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash generalised
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ESL x Safety Set CBZ-CR x Safety Set ESL 800 mg QD x Safety Set ESL 1200 mg QD x Safety Set ESL 1600 mg QD x Safety Set CBZ-CR 200 mg BID x Safety Set CBZ-CR 400 mg BID x Safety Set CBZ-CR 600 mg BID x Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    318 / 401 (79.30%)
    342 / 412 (83.01%)
    212 / 271 (78.23%)
    55 / 70 (78.57%)
    51 / 60 (85.00%)
    258 / 317 (81.39%)
    55 / 61 (90.16%)
    29 / 34 (85.29%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acoustic neuroma
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Haemangioma
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Haemangioma of liver
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Lipoma
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Lung neoplasm
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    Melanocytic naevus
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    3
    0
    0
    0
    0
    0
    Osteoma
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Ovarian granulosa-theca cell tumour
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Skin papilloma
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    0
    1
    0
    Uterine leiomyoma
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    2
    1
    1
    0
    2
    0
    0
    Vascular disorders
    Aortic arteriosclerosis
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Aortic disorder
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Blood pressure fluctuation
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Flushing
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Haematoma
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    3
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    3
    0
    0
    0
    2
    0
    1
    Hypertension
         subjects affected / exposed
    25 / 401 (6.23%)
    28 / 412 (6.80%)
    17 / 271 (6.27%)
    4 / 70 (5.71%)
    4 / 60 (6.67%)
    22 / 317 (6.94%)
    4 / 61 (6.56%)
    2 / 34 (5.88%)
         occurrences all number
    27
    31
    19
    4
    4
    24
    5
    2
    Hypertensive angiopathy
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Hypertensive crisis
         subjects affected / exposed
    3 / 401 (0.75%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    4
    2
    0
    1
    4
    0
    0
    Hypotension
         subjects affected / exposed
    6 / 401 (1.50%)
    3 / 412 (0.73%)
    5 / 271 (1.85%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    7
    3
    6
    1
    0
    3
    0
    0
    Thrombophlebitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    3
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Gestational diabetes
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Vomiting in pregnancy
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Asthenia
         subjects affected / exposed
    16 / 401 (3.99%)
    16 / 412 (3.88%)
    8 / 271 (2.95%)
    3 / 70 (4.29%)
    5 / 60 (8.33%)
    11 / 317 (3.47%)
    2 / 61 (3.28%)
    3 / 34 (8.82%)
         occurrences all number
    19
    17
    11
    3
    5
    11
    2
    4
    Axillary pain
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Chest pain
         subjects affected / exposed
    6 / 401 (1.50%)
    8 / 412 (1.94%)
    3 / 271 (1.11%)
    1 / 70 (1.43%)
    2 / 60 (3.33%)
    5 / 317 (1.58%)
    2 / 61 (3.28%)
    1 / 34 (2.94%)
         occurrences all number
    9
    11
    3
    1
    5
    6
    4
    1
    Chills
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    3
    0
    0
    0
    2
    0
    1
    Crying
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    3
    0
    0
    0
    2
    0
    1
    Energy increased
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    37 / 401 (9.23%)
    38 / 412 (9.22%)
    22 / 271 (8.12%)
    6 / 70 (8.57%)
    9 / 60 (15.00%)
    27 / 317 (8.52%)
    5 / 61 (8.20%)
    6 / 34 (17.65%)
         occurrences all number
    47
    52
    30
    6
    11
    34
    7
    11
    Feeling abnormal
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    0
    1
    Feeling cold
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    2
    0
    0
    Feeling hot
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    1
    0
    1
    0
    0
    0
    Gait disturbance
         subjects affected / exposed
    3 / 401 (0.75%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    6
    2
    1
    0
    6
    0
    0
    Generalised oedema
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Hangover
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Hyperthermia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    5
    0
    0
    Inflammation
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    1 / 401 (0.25%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    6
    0
    0
    1
    6
    0
    0
    Irritability
         subjects affected / exposed
    7 / 401 (1.75%)
    3 / 412 (0.73%)
    3 / 271 (1.11%)
    2 / 70 (2.86%)
    2 / 60 (3.33%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    7
    4
    3
    2
    2
    4
    0
    0
    Localised oedema
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    Malaise
         subjects affected / exposed
    7 / 401 (1.75%)
    5 / 412 (1.21%)
    3 / 271 (1.11%)
    1 / 70 (1.43%)
    3 / 60 (5.00%)
    3 / 317 (0.95%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    10
    6
    3
    1
    6
    4
    1
    1
    Mucosal dryness
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    4 / 401 (1.00%)
    7 / 412 (1.70%)
    4 / 271 (1.48%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    7 / 317 (2.21%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    4
    9
    4
    0
    0
    9
    0
    0
    Pain
         subjects affected / exposed
    2 / 401 (0.50%)
    5 / 412 (1.21%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    3
    7
    2
    1
    0
    6
    0
    1
    Pyrexia
         subjects affected / exposed
    8 / 401 (2.00%)
    12 / 412 (2.91%)
    4 / 271 (1.48%)
    2 / 70 (2.86%)
    2 / 60 (3.33%)
    12 / 317 (3.79%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    10
    14
    5
    2
    3
    14
    0
    0
    Spinal pain
         subjects affected / exposed
    2 / 401 (0.50%)
    3 / 412 (0.73%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    2
    4
    1
    1
    0
    3
    1
    0
    Thirst
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Hypersensitivity
         subjects affected / exposed
    2 / 401 (0.50%)
    8 / 412 (1.94%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    5 / 317 (1.58%)
    2 / 61 (3.28%)
    1 / 34 (2.94%)
         occurrences all number
    2
    9
    1
    0
    1
    6
    2
    1
    Multiple allergies
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    3 / 401 (0.75%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    4
    2
    2
    0
    2
    0
    0
    2
    Social circumstances
    Menopause
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Breast pain
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Cervical dysplasia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Dysmenorrhoea
         subjects affected / exposed
    1 / 401 (0.25%)
    4 / 412 (0.97%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    5
    1
    0
    0
    5
    0
    0
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    1
    0
    1
    1
    0
    0
    Fibrocystic breast disease
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Genital haemorrhage
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Menorrhagia
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    1
    0
    0
    Menstruation irregular
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    3
    2
    0
    0
    3
    0
    0
    Metrorrhagia
         subjects affected / exposed
    5 / 401 (1.25%)
    1 / 412 (0.24%)
    3 / 271 (1.11%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    5
    1
    3
    2
    0
    1
    0
    0
    Oligomenorrhoea
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Ovarian cyst
         subjects affected / exposed
    4 / 401 (1.00%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    4
    3
    2
    2
    0
    3
    0
    0
    Prostatitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Prostatomegaly
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Pruritus genital
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Rectocele
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Scrotal cyst
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Scrotal swelling
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Sexual dysfunction
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    Spermatocele
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Testicular cyst
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Testicular microlithiasis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Uterine polyp
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Vaginal discharge
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    2 / 61 (3.28%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    2
    0
    Varicocele
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Allergic sinusitis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Asthma
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    2
    2
    2
    0
    0
    1
    1
    0
    Atelectasis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Bronchospasm
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    10 / 401 (2.49%)
    11 / 412 (2.67%)
    8 / 271 (2.95%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    8 / 317 (2.52%)
    2 / 61 (3.28%)
    1 / 34 (2.94%)
         occurrences all number
    12
    11
    9
    3
    0
    8
    2
    1
    Dysphonia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    6 / 401 (1.50%)
    3 / 412 (0.73%)
    3 / 271 (1.11%)
    2 / 70 (2.86%)
    1 / 60 (1.67%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    8
    3
    4
    2
    2
    3
    0
    0
    Epistaxis
         subjects affected / exposed
    5 / 401 (1.25%)
    6 / 412 (1.46%)
    4 / 271 (1.48%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    5 / 317 (1.58%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    10
    11
    8
    0
    2
    9
    2
    0
    Hiccups
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Hyperventilation
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Lung disorder
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    1
    0
    Nasal oedema
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Nasal septum deviation
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    6 / 401 (1.50%)
    7 / 412 (1.70%)
    4 / 271 (1.48%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    3 / 317 (0.95%)
    2 / 61 (3.28%)
    2 / 34 (5.88%)
         occurrences all number
    10
    11
    7
    2
    1
    3
    2
    6
    Pleurisy
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Pulmonary fibrosis
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    Pulmonary vascular disorder
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Reversible airways obstruction
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    2 / 401 (0.50%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    4
    3
    4
    0
    0
    2
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 401 (0.25%)
    5 / 412 (1.21%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    1
    5
    1
    0
    0
    3
    1
    1
    Stridor
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Vasomotor rhinitis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Psychiatric disorders
    Acute stress disorder
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Adjustment disorder
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Affect lability
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    1
    Affective disorder
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Aggression
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Agitation
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    2
    0
    0
    Alcohol abuse
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Anxiety
         subjects affected / exposed
    20 / 401 (4.99%)
    19 / 412 (4.61%)
    8 / 271 (2.95%)
    9 / 70 (12.86%)
    3 / 60 (5.00%)
    11 / 317 (3.47%)
    3 / 61 (4.92%)
    5 / 34 (14.71%)
         occurrences all number
    24
    23
    10
    11
    3
    12
    6
    5
    Anxiety disorder
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Apathy
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Bradyphrenia
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Bulimia nervosa
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Claustrophobia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Confusional state
         subjects affected / exposed
    4 / 401 (1.00%)
    7 / 412 (1.70%)
    3 / 271 (1.11%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    6 / 317 (1.89%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    4
    9
    3
    1
    0
    8
    1
    0
    Deja vu
         subjects affected / exposed
    3 / 401 (0.75%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    6
    1
    5
    0
    1
    0
    1
    0
    Delirium
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Depressed mood
         subjects affected / exposed
    7 / 401 (1.75%)
    6 / 412 (1.46%)
    3 / 271 (1.11%)
    1 / 70 (1.43%)
    3 / 60 (5.00%)
    4 / 317 (1.26%)
    0 / 61 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    9
    6
    4
    1
    4
    4
    0
    2
    Depression
         subjects affected / exposed
    7 / 401 (1.75%)
    8 / 412 (1.94%)
    2 / 271 (0.74%)
    4 / 70 (5.71%)
    1 / 60 (1.67%)
    6 / 317 (1.89%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    7
    11
    2
    4
    1
    9
    1
    1
    Disorientation
         subjects affected / exposed
    3 / 401 (0.75%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    3
    6
    2
    1
    0
    1
    0
    5
    Drug abuse
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Dysphemia
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    2 / 60 (3.33%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    0
    0
    2
    0
    0
    0
    Dysphoria
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Emotional disorder
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Hallucination, auditory
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Hypervigilance
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    1
    0
    1
    0
    0
    0
    Impaired reasoning
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Initial insomnia
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    2 / 61 (3.28%)
    0 / 34 (0.00%)
         occurrences all number
    1
    4
    1
    0
    0
    0
    4
    0
    Insomnia
         subjects affected / exposed
    14 / 401 (3.49%)
    12 / 412 (2.91%)
    8 / 271 (2.95%)
    4 / 70 (5.71%)
    2 / 60 (3.33%)
    10 / 317 (3.15%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    15
    13
    9
    4
    2
    11
    1
    1
    Libido decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    3
    0
    0
    Mental disorder
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Mood altered
         subjects affected / exposed
    3 / 401 (0.75%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    1
    1
    1
    1
    1
    0
    0
    Mood disorder due to a general medical condition
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Mood swings
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Nervousness
         subjects affected / exposed
    7 / 401 (1.75%)
    10 / 412 (2.43%)
    6 / 271 (2.21%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    6 / 317 (1.89%)
    0 / 61 (0.00%)
    4 / 34 (11.76%)
         occurrences all number
    8
    11
    7
    0
    1
    7
    0
    4
    Nightmare
         subjects affected / exposed
    3 / 401 (0.75%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    1
    1
    1
    0
    0
    0
    Panic attack
         subjects affected / exposed
    1 / 401 (0.25%)
    4 / 412 (0.97%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    5
    0
    1
    0
    5
    0
    0
    Panic disorder
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Personality change
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Personality disorder
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Psychogenic seizure
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Psychotic disorder
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Restlessness
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    3
    1
    1
    0
    3
    0
    0
    Sleep disorder
         subjects affected / exposed
    4 / 401 (1.00%)
    4 / 412 (0.97%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    4 / 317 (1.26%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    5
    4
    3
    0
    2
    4
    0
    0
    Sleep talking
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    1
    0
    Social avoidant behaviour
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Staring
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Stress
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Suicidal ideation
         subjects affected / exposed
    3 / 401 (0.75%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    3
    2
    1
    2
    0
    1
    0
    1
    Tachyphrenia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Tension
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Tic
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Biliary dyskinesia
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    0
    2
    0
    1
    0
    0
    Cholangitis acute
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Cholelithiasis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Drug-induced liver injury
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Hepatic pain
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Hepatic steatosis
         subjects affected / exposed
    4 / 401 (1.00%)
    5 / 412 (1.21%)
    3 / 271 (1.11%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    4
    5
    3
    1
    0
    4
    1
    0
    Hepatitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Hepatitis acute
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Hepatomegaly
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Hepatotoxicity
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    Liver disorder
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Post cholecystectomy syndrome
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    4 / 401 (1.00%)
    3 / 412 (0.73%)
    4 / 271 (1.48%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    4
    3
    4
    0
    0
    2
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    9 / 401 (2.24%)
    10 / 412 (2.43%)
    5 / 271 (1.85%)
    2 / 70 (2.86%)
    2 / 60 (3.33%)
    9 / 317 (2.84%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    9
    11
    5
    2
    2
    10
    1
    0
    Anti-gad antibody positive
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Anti-islet cell antibody positive
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 401 (1.50%)
    9 / 412 (2.18%)
    2 / 271 (0.74%)
    2 / 70 (2.86%)
    2 / 60 (3.33%)
    8 / 317 (2.52%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    6
    9
    2
    2
    2
    8
    1
    0
    Biopsy endometrium
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Blood 25-hydroxycholecalciferol decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Blood alkaline phosphatase decreased
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 401 (0.25%)
    5 / 412 (1.21%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    3
    9
    3
    0
    0
    6
    0
    3
    Blood bilirubin increased
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Blood calcium decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    4 / 412 (0.97%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    5
    0
    0
    0
    3
    0
    2
    Blood calcium increased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    2
    Blood chloride decreased
         subjects affected / exposed
    5 / 401 (1.25%)
    1 / 412 (0.24%)
    5 / 271 (1.85%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    5
    1
    5
    0
    0
    0
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    1 / 401 (0.25%)
    6 / 412 (1.46%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    5 / 317 (1.58%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    6
    1
    0
    0
    5
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    19 / 401 (4.74%)
    19 / 412 (4.61%)
    12 / 271 (4.43%)
    4 / 70 (5.71%)
    3 / 60 (5.00%)
    14 / 317 (4.42%)
    3 / 61 (4.92%)
    2 / 34 (5.88%)
         occurrences all number
    22
    20
    14
    4
    4
    15
    3
    2
    Blood creatinine decreased
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    1
    0
    1
    0
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Blood folate decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    2
    Blood glucose decreased
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Blood glucose increased
         subjects affected / exposed
    4 / 401 (1.00%)
    3 / 412 (0.73%)
    4 / 271 (1.48%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    4
    3
    4
    0
    0
    2
    1
    0
    Blood lactate dehydrogenase decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    7 / 401 (1.75%)
    2 / 412 (0.49%)
    5 / 271 (1.85%)
    0 / 70 (0.00%)
    2 / 60 (3.33%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    13
    2
    11
    0
    2
    2
    0
    0
    Blood parathyroid hormone decreased
         subjects affected / exposed
    4 / 401 (1.00%)
    1 / 412 (0.24%)
    4 / 271 (1.48%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    4
    1
    4
    0
    0
    1
    0
    0
    Blood parathyroid hormone increased
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    4
    0
    0
    Blood phosphorus increased
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    1
    Blood potassium decreased
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    1
    0
    0
    Blood potassium increased
         subjects affected / exposed
    3 / 401 (0.75%)
    2 / 412 (0.49%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    3
    2
    2
    1
    0
    0
    0
    2
    Blood pressure decreased
         subjects affected / exposed
    3 / 401 (0.75%)
    1 / 412 (0.24%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    1
    3
    0
    0
    1
    0
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    3
    1
    0
    0
    1
    0
    2
    Blood sodium decreased
         subjects affected / exposed
    5 / 401 (1.25%)
    2 / 412 (0.49%)
    4 / 271 (1.48%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    5
    2
    4
    0
    1
    0
    1
    1
    Blood sodium increased
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    3
    0
    0
    0
    2
    0
    1
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 401 (0.25%)
    3 / 412 (0.73%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    1
    3
    1
    0
    0
    1
    1
    1
    Blood triglycerides
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Blood triglycerides increased
         subjects affected / exposed
    5 / 401 (1.25%)
    7 / 412 (1.70%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    2 / 60 (3.33%)
    6 / 317 (1.89%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    8
    16
    6
    0
    2
    12
    0
    4
    Blood urea increased
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Blood urine present
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    1
    1
    0
    1
    0
    0
    Body mass index decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Body mass index increased
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    1
    3
    0
    0
    1
    0
    0
    Body temperature increased
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    2
    2
    0
    0
    2
    0
    0
    Bone density increased
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    2
    2
    0
    0
    1
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    16 / 401 (3.99%)
    20 / 412 (4.85%)
    11 / 271 (4.06%)
    4 / 70 (5.71%)
    1 / 60 (1.67%)
    17 / 317 (5.36%)
    3 / 61 (4.92%)
    0 / 34 (0.00%)
         occurrences all number
    20
    26
    14
    5
    1
    22
    4
    0
    Coagulation test abnormal
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    Coagulation time prolonged
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Colonoscopy
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Electrocardiogram qrs complex prolonged
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Electrocardiogram qt prolonged
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    0
    1
    Eosinophil count decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Eosinophil count increased
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    2
    2
    0
    0
    0
    0
    2
    Gamma-glutamyltransferase abnormal
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    21 / 401 (5.24%)
    65 / 412 (15.78%)
    13 / 271 (4.80%)
    6 / 70 (8.57%)
    2 / 60 (3.33%)
    48 / 317 (15.14%)
    9 / 61 (14.75%)
    8 / 34 (23.53%)
         occurrences all number
    26
    76
    14
    10
    2
    53
    11
    12
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Haematocrit decreased
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    2
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    4 / 401 (1.00%)
    4 / 412 (0.97%)
    3 / 271 (1.11%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    8
    6
    6
    2
    0
    5
    1
    0
    Heart rate decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Heart rate increased
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    4 / 401 (1.00%)
    4 / 412 (0.97%)
    3 / 271 (1.11%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    2 / 61 (3.28%)
    0 / 34 (0.00%)
         occurrences all number
    5
    4
    4
    1
    0
    2
    2
    0
    High density lipoprotein decreased
         subjects affected / exposed
    1 / 401 (0.25%)
    4 / 412 (0.97%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    1
    5
    1
    0
    0
    3
    1
    1
    International normalised ratio decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    6 / 401 (1.50%)
    6 / 412 (1.46%)
    6 / 271 (2.21%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    5 / 317 (1.58%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    6
    7
    6
    0
    0
    6
    1
    0
    Intraocular pressure increased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Low density lipoprotein increased
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    2
    1
    1
    0
    1
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Monocyte count decreased
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    N-telopeptide
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    N-telopeptide urine increased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Neutrophil count increased
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    2
    0
    Osteocalcin decreased
         subjects affected / exposed
    4 / 401 (1.00%)
    2 / 412 (0.49%)
    4 / 271 (1.48%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    4
    2
    4
    0
    0
    2
    0
    0
    Osteocalcin increased
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    2
    1
    0
    0
    1
    0
    1
    Positive rombergism
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Protein total decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Protein total increased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Red blood cell count decreased
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Serum ferritin increased
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Tandem gait test abnormal
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Thyroid function test abnormal
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Thyroxine decreased
         subjects affected / exposed
    4 / 401 (1.00%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    4
    1
    2
    2
    0
    1
    0
    0
    Thyroxine free decreased
         subjects affected / exposed
    7 / 401 (1.75%)
    5 / 412 (1.21%)
    4 / 271 (1.48%)
    2 / 70 (2.86%)
    1 / 60 (1.67%)
    4 / 317 (1.26%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    7
    6
    4
    2
    1
    5
    0
    1
    Transaminases increased
         subjects affected / exposed
    3 / 401 (0.75%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    3
    2
    1
    0
    3
    0
    0
    Tri-iodothyronine free increased
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Tri-iodothyronine increased
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Urine analysis abnormal
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Vitamin d decreased
         subjects affected / exposed
    1 / 401 (0.25%)
    3 / 412 (0.73%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    3
    1
    0
    0
    2
    0
    1
    Weight decreased
         subjects affected / exposed
    4 / 401 (1.00%)
    6 / 412 (1.46%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    5 / 317 (1.58%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    4
    6
    3
    0
    1
    5
    1
    0
    Weight increased
         subjects affected / exposed
    13 / 401 (3.24%)
    19 / 412 (4.61%)
    10 / 271 (3.69%)
    3 / 70 (4.29%)
    0 / 60 (0.00%)
    14 / 317 (4.42%)
    2 / 61 (3.28%)
    3 / 34 (8.82%)
         occurrences all number
    13
    19
    10
    3
    0
    14
    2
    3
    White blood cell count decreased
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    White blood cells urine positive
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    2
    0
    0
    Animal bite
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    0
    0
    Ankle fracture
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Arthropod bite
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    1
    0
    Arthropod sting
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Brain contusion
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Clavicle fracture
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Concussion
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Contusion
         subjects affected / exposed
    8 / 401 (2.00%)
    5 / 412 (1.21%)
    5 / 271 (1.85%)
    1 / 70 (1.43%)
    2 / 60 (3.33%)
    2 / 317 (0.63%)
    2 / 61 (3.28%)
    1 / 34 (2.94%)
         occurrences all number
    10
    5
    7
    1
    2
    2
    2
    1
    Craniocerebral injury
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    0
    0
    1
    2
    0
    0
    Ear injury
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Excoriation
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    2
    0
    1
    1
    2
    0
    0
    Expired drug administered
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Face injury
         subjects affected / exposed
    3 / 401 (0.75%)
    2 / 412 (0.49%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    3
    2
    2
    0
    1
    1
    0
    1
    Facial bones fracture
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Fall
         subjects affected / exposed
    5 / 401 (1.25%)
    12 / 412 (2.91%)
    3 / 271 (1.11%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    8 / 317 (2.52%)
    1 / 61 (1.64%)
    3 / 34 (8.82%)
         occurrences all number
    7
    20
    5
    1
    1
    16
    1
    3
    Foot fracture
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    Hand fracture
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Head injury
         subjects affected / exposed
    3 / 401 (0.75%)
    2 / 412 (0.49%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    3
    2
    2
    0
    1
    1
    0
    1
    Injury
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    0
    1
    Joint dislocation
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Joint injury
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Laceration
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    3
    0
    0
    Ligament rupture
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    1
    0
    0
    Ligament sprain
         subjects affected / exposed
    1 / 401 (0.25%)
    3 / 412 (0.73%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    3
    1
    0
    0
    2
    1
    0
    Limb injury
         subjects affected / exposed
    5 / 401 (1.25%)
    5 / 412 (1.21%)
    3 / 271 (1.11%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    4 / 317 (1.26%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    5
    5
    3
    1
    1
    4
    0
    1
    Lip injury
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Muscle rupture
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Muscle strain
         subjects affected / exposed
    4 / 401 (1.00%)
    0 / 412 (0.00%)
    3 / 271 (1.11%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    7
    0
    3
    4
    0
    0
    0
    0
    Nail injury
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Overdose
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Procedural pain
         subjects affected / exposed
    0 / 401 (0.00%)
    5 / 412 (1.21%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    5
    1
    0
    Scratch
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Skeletal injury
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Soft tissue injury
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    1
    2
    0
    0
    1
    0
    1
    1
    Thermal burn
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    1
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Tooth fracture
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Wound
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Wrist fracture
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Congenital, familial and genetic disorders
    Bruton's agammaglobulinaemia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Congenital cerebrovascular anomaly
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Cortical dysplasia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Gilbert's syndrome
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Hydrocele
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    3 / 401 (0.75%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    3
    3
    2
    1
    0
    2
    0
    1
    Aortic valve incompetence
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Arrhythmia
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    3 / 401 (0.75%)
    2 / 412 (0.49%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    4
    3
    4
    0
    0
    3
    0
    0
    Atrial flutter
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Atrioventricular block
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 401 (0.25%)
    5 / 412 (1.21%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    5 / 317 (1.58%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    5
    1
    0
    0
    5
    0
    0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Bradycardia
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Bundle branch block left
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    Bundle branch block right
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    1
    1
    0
    1
    0
    0
    Cardiac disorder
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Cardiac failure
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Cardiomyopathy
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Cardiovascular disorder
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    2
    1
    1
    0
    2
    0
    0
    Hypertensive heart disease
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Left atrial dilatation
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Left ventricular hypertrophy
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    0
    0
    Mitral valve incompetence
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    Mitral valve prolapse
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    Palpitations
         subjects affected / exposed
    4 / 401 (1.00%)
    5 / 412 (1.21%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    4 / 317 (1.26%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    6
    5
    4
    0
    2
    4
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    3 / 401 (0.75%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    3
    3
    2
    1
    0
    2
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    1 / 401 (0.25%)
    5 / 412 (1.21%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    5
    1
    0
    0
    4
    0
    1
    Tachycardia paroxysmal
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    3 / 401 (0.75%)
    0 / 412 (0.00%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    3
    0
    0
    0
    0
    0
    Nervous system disorders
    Action tremor
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Altered state of consciousness
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Amnesia
         subjects affected / exposed
    4 / 401 (1.00%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    2 / 60 (3.33%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    4
    1
    1
    1
    2
    0
    0
    1
    Aphasia
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    1
    Arachnoid cyst
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    3
    0
    0
    Areflexia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Ataxia
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    3
    0
    0
    0
    2
    0
    1
    Autonomic nervous system imbalance
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Balance disorder
         subjects affected / exposed
    2 / 401 (0.50%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    6
    2
    0
    0
    4
    0
    2
    Burning sensation
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    4
    0
    0
    Cognitive disorder
         subjects affected / exposed
    2 / 401 (0.50%)
    4 / 412 (0.97%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    4
    2
    0
    0
    3
    0
    1
    Complex partial seizures
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    3
    2
    3
    0
    0
    1
    0
    1
    Convulsion
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Coordination abnormal
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    2
    1
    0
    Dementia alzheimer's type
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Disturbance in attention
         subjects affected / exposed
    11 / 401 (2.74%)
    6 / 412 (1.46%)
    8 / 271 (2.95%)
    3 / 70 (4.29%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    12
    6
    8
    4
    0
    4
    1
    1
    Dizziness
         subjects affected / exposed
    79 / 401 (19.70%)
    65 / 412 (15.78%)
    43 / 271 (15.87%)
    17 / 70 (24.29%)
    19 / 60 (31.67%)
    38 / 317 (11.99%)
    14 / 61 (22.95%)
    13 / 34 (38.24%)
         occurrences all number
    146
    120
    85
    24
    37
    54
    27
    39
    Dysarthria
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Dysgeusia
         subjects affected / exposed
    3 / 401 (0.75%)
    0 / 412 (0.00%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    4
    0
    4
    0
    0
    0
    0
    0
    Dystonia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Epilepsy
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    2
    2
    1
    0
    1
    0
    1
    1
    Epileptic aura
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Grand mal convulsion
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    1
    0
    0
    2
    0
    0
    1
    Head discomfort
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    119 / 401 (29.68%)
    116 / 412 (28.16%)
    75 / 271 (27.68%)
    20 / 70 (28.57%)
    24 / 60 (40.00%)
    82 / 317 (25.87%)
    22 / 61 (36.07%)
    12 / 34 (35.29%)
         occurrences all number
    254
    262
    159
    38
    57
    159
    46
    57
    Hemiparesis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Hippocampal sclerosis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Hyperreflexia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    Hypersomnia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    3 / 401 (0.75%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    3
    3
    2
    1
    0
    2
    0
    1
    Idiopathic generalised epilepsy
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Incoherent
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Lethargy
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    Loss of consciousness
         subjects affected / exposed
    1 / 401 (0.25%)
    4 / 412 (0.97%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    4
    1
    0
    0
    3
    1
    0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    2
    0
    0
    Lumbosacral plexus lesion
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Memory impairment
         subjects affected / exposed
    10 / 401 (2.49%)
    12 / 412 (2.91%)
    4 / 271 (1.48%)
    2 / 70 (2.86%)
    4 / 60 (6.67%)
    9 / 317 (2.84%)
    0 / 61 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    10
    13
    4
    2
    4
    10
    0
    3
    Mental impairment
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Migraine
         subjects affected / exposed
    6 / 401 (1.50%)
    7 / 412 (1.70%)
    5 / 271 (1.85%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    6 / 317 (1.89%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    11
    16
    10
    1
    0
    13
    0
    3
    Monoparesis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Muscle spasticity
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Myoclonus
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Neurotoxicity
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Nystagmus
         subjects affected / exposed
    1 / 401 (0.25%)
    3 / 412 (0.73%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    4
    1
    0
    0
    3
    0
    1
    Paraesthesia
         subjects affected / exposed
    6 / 401 (1.50%)
    11 / 412 (2.67%)
    4 / 271 (1.48%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    5 / 317 (1.58%)
    3 / 61 (4.92%)
    3 / 34 (8.82%)
         occurrences all number
    7
    34
    4
    2
    1
    5
    15
    14
    Parosmia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Partial seizures with secondary generalisation
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    2
    1
    0
    1
    2
    0
    0
    Peripheral nerve paresis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Poor quality sleep
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Postictal headache
         subjects affected / exposed
    3 / 401 (0.75%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    2 / 60 (3.33%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    4
    1
    0
    1
    3
    0
    0
    1
    Postictal paralysis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Postictal state
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    2
    0
    Presyncope
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    3
    2
    2
    1
    0
    1
    1
    0
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Reflexes abnormal
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    3
    0
    0
    1
    3
    0
    0
    Sedation
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Sensory disturbance
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    0
    0
    1
    1
    1
    0
    Simple partial seizures
         subjects affected / exposed
    1 / 401 (0.25%)
    4 / 412 (0.97%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    2 / 61 (3.28%)
    1 / 34 (2.94%)
         occurrences all number
    1
    5
    0
    0
    1
    1
    3
    1
    Slow speech
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    34 / 401 (8.48%)
    43 / 412 (10.44%)
    16 / 271 (5.90%)
    13 / 70 (18.57%)
    5 / 60 (8.33%)
    28 / 317 (8.83%)
    8 / 61 (13.11%)
    7 / 34 (20.59%)
         occurrences all number
    52
    57
    22
    18
    12
    34
    8
    15
    Syncope
         subjects affected / exposed
    6 / 401 (1.50%)
    14 / 412 (3.40%)
    3 / 271 (1.11%)
    1 / 70 (1.43%)
    2 / 60 (3.33%)
    9 / 317 (2.84%)
    2 / 61 (3.28%)
    3 / 34 (8.82%)
         occurrences all number
    13
    17
    3
    1
    9
    11
    3
    3
    Tension headache
         subjects affected / exposed
    2 / 401 (0.50%)
    5 / 412 (1.21%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    5
    7
    0
    2
    3
    4
    0
    3
    Tongue biting
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Tremor
         subjects affected / exposed
    10 / 401 (2.49%)
    6 / 412 (1.46%)
    5 / 271 (1.85%)
    2 / 70 (2.86%)
    3 / 60 (5.00%)
    3 / 317 (0.95%)
    1 / 61 (1.64%)
    2 / 34 (5.88%)
         occurrences all number
    26
    6
    8
    14
    4
    3
    1
    2
    Vascular encephalopathy
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    2
    0
    Anaemia
         subjects affected / exposed
    9 / 401 (2.24%)
    11 / 412 (2.67%)
    5 / 271 (1.85%)
    2 / 70 (2.86%)
    2 / 60 (3.33%)
    8 / 317 (2.52%)
    3 / 61 (4.92%)
    0 / 34 (0.00%)
         occurrences all number
    11
    11
    6
    3
    2
    8
    3
    0
    Bicytopenia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Eosinophilia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Haemorrhagic anaemia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Hypochromic anaemia
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    1
    0
    Leukocytosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Leukopenia
         subjects affected / exposed
    4 / 401 (1.00%)
    6 / 412 (1.46%)
    2 / 271 (0.74%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    4
    8
    2
    2
    0
    4
    3
    1
    Lymph node pain
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    3 / 401 (0.75%)
    5 / 412 (1.21%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    3
    5
    2
    1
    0
    3
    1
    1
    Lymphopenia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    0
    2
    0
    0
    0
    0
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Pancytopenia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 401 (0.00%)
    5 / 412 (1.21%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    5 / 317 (1.58%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    5
    0
    0
    Thrombocytosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Deafness neurosensory
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Ear congestion
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Ear discomfort
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Ear pain
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    2
    1
    0
    2
    2
    0
    0
    Hearing impaired
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Hyperacusis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Hypoacusis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Mastoid disorder
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Neurosensory hypoacusis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Sudden hearing loss
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Tinnitus
         subjects affected / exposed
    6 / 401 (1.50%)
    6 / 412 (1.46%)
    3 / 271 (1.11%)
    2 / 70 (2.86%)
    1 / 60 (1.67%)
    5 / 317 (1.58%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    6
    6
    3
    2
    1
    5
    1
    0
    Vertigo
         subjects affected / exposed
    16 / 401 (3.99%)
    26 / 412 (6.31%)
    10 / 271 (3.69%)
    4 / 70 (5.71%)
    2 / 60 (3.33%)
    18 / 317 (5.68%)
    5 / 61 (8.20%)
    3 / 34 (8.82%)
         occurrences all number
    25
    46
    16
    7
    2
    30
    6
    10
    Vertigo positional
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    1
    0
    0
    Vestibular ataxia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Vestibular disorder
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    4
    0
    3
    1
    0
    0
    0
    0
    Eye disorders
    Asthenopia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Astigmatism
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Blepharitis
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    0
    0
    Blindness transient
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Cataract
         subjects affected / exposed
    3 / 401 (0.75%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    2
    1
    0
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    2
    0
    0
    Diplopia
         subjects affected / exposed
    2 / 401 (0.50%)
    4 / 412 (0.97%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    2
    5
    1
    0
    1
    1
    0
    4
    Dry eye
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Eczema eyelids
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Eye haemorrhage
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Eye movement disorder
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Eye oedema
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Eye pain
         subjects affected / exposed
    1 / 401 (0.25%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    2 / 317 (0.63%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    4
    0
    0
    1
    3
    1
    0
    Eyelid oedema
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    2
    0
    1
    0
    1
    0
    1
    Eyelids pruritus
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Glaucoma
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Keratoconus
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Myopia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Pterygium
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    8 / 401 (2.00%)
    11 / 412 (2.67%)
    6 / 271 (2.21%)
    0 / 70 (0.00%)
    2 / 60 (3.33%)
    5 / 317 (1.58%)
    2 / 61 (3.28%)
    4 / 34 (11.76%)
         occurrences all number
    8
    12
    6
    0
    2
    5
    2
    5
    Visual impairment
         subjects affected / exposed
    3 / 401 (0.75%)
    4 / 412 (0.97%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    2 / 317 (0.63%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    3
    4
    1
    1
    1
    2
    1
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    3
    0
    0
    Abdominal distension
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    1
    1
    0
    Abdominal pain
         subjects affected / exposed
    9 / 401 (2.24%)
    13 / 412 (3.16%)
    2 / 271 (0.74%)
    3 / 70 (4.29%)
    4 / 60 (6.67%)
    9 / 317 (2.84%)
    1 / 61 (1.64%)
    3 / 34 (8.82%)
         occurrences all number
    15
    16
    8
    3
    4
    10
    2
    4
    Abdominal pain upper
         subjects affected / exposed
    17 / 401 (4.24%)
    21 / 412 (5.10%)
    10 / 271 (3.69%)
    4 / 70 (5.71%)
    3 / 60 (5.00%)
    12 / 317 (3.79%)
    5 / 61 (8.20%)
    4 / 34 (11.76%)
         occurrences all number
    45
    24
    11
    29
    5
    13
    7
    4
    Aphthous stomatitis
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    1
    0
    0
    Breath odour
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Coeliac disease
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Colitis ulcerative
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Colonic polyp
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    4 / 401 (1.00%)
    6 / 412 (1.46%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    6 / 317 (1.89%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    5
    6
    2
    1
    2
    6
    0
    0
    Dental caries
         subjects affected / exposed
    2 / 401 (0.50%)
    5 / 412 (1.21%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    3 / 317 (0.95%)
    2 / 61 (3.28%)
    0 / 34 (0.00%)
         occurrences all number
    2
    7
    1
    0
    1
    4
    3
    0
    Diarrhoea
         subjects affected / exposed
    20 / 401 (4.99%)
    19 / 412 (4.61%)
    14 / 271 (5.17%)
    3 / 70 (4.29%)
    3 / 60 (5.00%)
    15 / 317 (4.73%)
    3 / 61 (4.92%)
    1 / 34 (2.94%)
         occurrences all number
    33
    29
    19
    9
    5
    24
    4
    1
    Diverticulum intestinal
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    3 / 401 (0.75%)
    9 / 412 (2.18%)
    1 / 271 (0.37%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    6 / 317 (1.89%)
    1 / 61 (1.64%)
    2 / 34 (5.88%)
         occurrences all number
    3
    11
    1
    2
    0
    7
    2
    2
    Duodenal ulcer
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Duodenogastric reflux
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    7 / 401 (1.75%)
    9 / 412 (2.18%)
    7 / 271 (2.58%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    7 / 317 (2.21%)
    2 / 61 (3.28%)
    0 / 34 (0.00%)
         occurrences all number
    9
    11
    9
    0
    0
    8
    3
    0
    Enteritis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Enterocolitis
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    Erosive duodenitis
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    Eructation
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    2
    2
    0
    0
    2
    0
    0
    Flatulence
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    1
    2
    0
    0
    0
    0
    Food poisoning
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    1
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Gastric mucosa erythema
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Gastric ulcer
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Gastritis
         subjects affected / exposed
    4 / 401 (1.00%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    2 / 70 (2.86%)
    1 / 60 (1.67%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    4
    3
    1
    2
    1
    3
    0
    0
    Gastritis erosive
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    Gastroduodenitis
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 401 (1.25%)
    1 / 412 (0.24%)
    4 / 271 (1.48%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    5
    1
    4
    1
    0
    1
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    1
    1
    0
    Hiatus hernia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    2
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    4
    0
    0
    Irritable bowel syndrome
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    0
    0
    Leukoplakia oral
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Mouth ulceration
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    0
    2
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    41 / 401 (10.22%)
    50 / 412 (12.14%)
    18 / 271 (6.64%)
    10 / 70 (14.29%)
    13 / 60 (21.67%)
    34 / 317 (10.73%)
    5 / 61 (8.20%)
    11 / 34 (32.35%)
         occurrences all number
    79
    84
    37
    20
    22
    49
    9
    26
    Odynophagia
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Oesophagitis
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    1
    0
    Oral mucosal blistering
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Oral pain
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Pancreatic steatosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Paraesthesia oral
         subjects affected / exposed
    3 / 401 (0.75%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    3
    2
    1
    1
    1
    1
    0
    1
    Periodontal disease
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Polyp colorectal
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Proctalgia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    Reflux gastritis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Salivary hypersecretion
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Tongue ulceration
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Tooth loss
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Toothache
         subjects affected / exposed
    9 / 401 (2.24%)
    11 / 412 (2.67%)
    8 / 271 (2.95%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    10 / 317 (3.15%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    9
    14
    8
    1
    0
    13
    1
    0
    Vomiting
         subjects affected / exposed
    20 / 401 (4.99%)
    23 / 412 (5.58%)
    10 / 271 (3.69%)
    5 / 70 (7.14%)
    5 / 60 (8.33%)
    12 / 317 (3.79%)
    5 / 61 (8.20%)
    6 / 34 (17.65%)
         occurrences all number
    28
    39
    14
    7
    7
    21
    8
    10
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    5 / 401 (1.25%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    2 / 70 (2.86%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    5
    3
    2
    2
    1
    1
    1
    1
    Alopecia
         subjects affected / exposed
    3 / 401 (0.75%)
    5 / 412 (1.21%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    6
    5
    3
    0
    3
    3
    0
    2
    Blister
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Dermal cyst
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    1 / 401 (0.25%)
    5 / 412 (1.21%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    2 / 61 (3.28%)
    0 / 34 (0.00%)
         occurrences all number
    2
    6
    2
    0
    0
    4
    2
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    2 / 401 (0.50%)
    9 / 412 (2.18%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    7 / 317 (2.21%)
    2 / 61 (3.28%)
    0 / 34 (0.00%)
         occurrences all number
    2
    9
    2
    0
    0
    7
    2
    0
    Drug eruption
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Dry skin
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    Eczema
         subjects affected / exposed
    2 / 401 (0.50%)
    5 / 412 (1.21%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    2
    5
    2
    0
    0
    4
    1
    0
    Erythema
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    1
    0
    1
    1
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    3 / 401 (0.75%)
    6 / 412 (1.46%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    4 / 317 (1.26%)
    2 / 61 (3.28%)
    0 / 34 (0.00%)
         occurrences all number
    3
    9
    2
    0
    1
    7
    2
    0
    Night sweats
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    1
    1
    0
    Photosensitivity reaction
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    1
    0
    0
    Pigmentation disorder
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    4 / 401 (1.00%)
    4 / 412 (0.97%)
    2 / 271 (0.74%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    4
    4
    2
    2
    0
    4
    0
    0
    Pruritus generalised
         subjects affected / exposed
    1 / 401 (0.25%)
    4 / 412 (0.97%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    1
    4
    0
    1
    0
    3
    1
    0
    Psoriasis
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Rash
         subjects affected / exposed
    17 / 401 (4.24%)
    15 / 412 (3.64%)
    9 / 271 (3.32%)
    6 / 70 (8.57%)
    2 / 60 (3.33%)
    10 / 317 (3.15%)
    2 / 61 (3.28%)
    3 / 34 (8.82%)
         occurrences all number
    18
    18
    10
    6
    2
    11
    3
    4
    Rash generalised
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Rash papular
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    1
    Rash pruritic
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    1
    1
    0
    1
    0
    0
    Scar
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Seborrhoea
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    1
    Skin depigmentation
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Skin irritation
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Skin lesion
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    1
    0
    1
    1
    0
    0
    Skin reaction
         subjects affected / exposed
    3 / 401 (0.75%)
    0 / 412 (0.00%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    3
    0
    0
    0
    0
    0
    Skin striae
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Subcutaneous nodule
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Sunburn
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Sweat gland disorder
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Swelling face
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Toxic skin eruption
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Urticaria
         subjects affected / exposed
    4 / 401 (1.00%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    4
    0
    2
    1
    1
    0
    0
    0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Dysuria
         subjects affected / exposed
    3 / 401 (0.75%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    1
    2
    1
    0
    1
    0
    0
    Haematuria
         subjects affected / exposed
    4 / 401 (1.00%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    4
    3
    2
    2
    0
    1
    1
    1
    Leukocyturia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Nephrolithiasis
         subjects affected / exposed
    1 / 401 (0.25%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    4
    0
    3
    0
    4
    0
    0
    Nocturia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Pollakiuria
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Proteinuria
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Pyuria
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Renal colic
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    2
    2
    1
    1
    0
    1
    1
    0
    Renal cyst
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Renal impairment
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Renal pain
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    3
    1
    0
    0
    3
    0
    0
    Urethral pain
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Urinary hesitation
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Urinary tract disorder
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Endocrine disorders
    Empty sella syndrome
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    Hyperparathyroidism
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Hyperparathyroidism secondary
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Hyperthyroidism
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Hypothyroidism
         subjects affected / exposed
    14 / 401 (3.49%)
    11 / 412 (2.67%)
    9 / 271 (3.32%)
    2 / 70 (2.86%)
    3 / 60 (5.00%)
    8 / 317 (2.52%)
    0 / 61 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    15
    11
    10
    2
    3
    8
    0
    3
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    7 / 401 (1.75%)
    12 / 412 (2.91%)
    3 / 271 (1.11%)
    3 / 70 (4.29%)
    1 / 60 (1.67%)
    9 / 317 (2.84%)
    2 / 61 (3.28%)
    1 / 34 (2.94%)
         occurrences all number
    8
    17
    3
    4
    1
    11
    2
    4
    Arthritis
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    3
    2
    0
    0
    0
    0
    3
    Arthropathy
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Back pain
         subjects affected / exposed
    26 / 401 (6.48%)
    21 / 412 (5.10%)
    15 / 271 (5.54%)
    8 / 70 (11.43%)
    3 / 60 (5.00%)
    14 / 317 (4.42%)
    4 / 61 (6.56%)
    3 / 34 (8.82%)
         occurrences all number
    31
    23
    17
    9
    5
    15
    5
    3
    Bone pain
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    2
    2
    2
    0
    0
    0
    1
    1
    Bursitis
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    1
    0
    1
    0
    0
    0
    Costochondritis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Exostosis
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    3 / 401 (0.75%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    1 / 60 (1.67%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    2
    1
    1
    1
    2
    0
    0
    Joint crepitation
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Limb asymmetry
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    8 / 401 (2.00%)
    6 / 412 (1.46%)
    4 / 271 (1.48%)
    2 / 70 (2.86%)
    2 / 60 (3.33%)
    2 / 317 (0.63%)
    3 / 61 (4.92%)
    1 / 34 (2.94%)
         occurrences all number
    10
    6
    4
    2
    4
    2
    3
    1
    Muscle tightness
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    0
    2
    Muscle twitching
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    2
    1
    0
    0
    1
    0
    1
    Muscular weakness
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    2
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    5 / 401 (1.25%)
    6 / 412 (1.46%)
    2 / 271 (0.74%)
    2 / 70 (2.86%)
    1 / 60 (1.67%)
    4 / 317 (1.26%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    5
    7
    2
    2
    1
    5
    1
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    3 / 401 (0.75%)
    6 / 412 (1.46%)
    0 / 271 (0.00%)
    2 / 70 (2.86%)
    1 / 60 (1.67%)
    3 / 317 (0.95%)
    2 / 61 (3.28%)
    1 / 34 (2.94%)
         occurrences all number
    4
    10
    0
    3
    1
    3
    6
    1
    Myokymia
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    2
    0
    0
    2
    2
    0
    0
    Myositis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Neck pain
         subjects affected / exposed
    6 / 401 (1.50%)
    9 / 412 (2.18%)
    5 / 271 (1.85%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    6 / 317 (1.89%)
    1 / 61 (1.64%)
    2 / 34 (5.88%)
         occurrences all number
    6
    9
    5
    1
    0
    6
    1
    2
    Osteoarthritis
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    2
    2
    0
    0
    2
    0
    0
    Osteochondritis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Osteochondrosis
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Osteoporosis
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    3
    0
    0
    Pain in extremity
         subjects affected / exposed
    6 / 401 (1.50%)
    13 / 412 (3.16%)
    6 / 271 (2.21%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    9 / 317 (2.84%)
    3 / 61 (4.92%)
    1 / 34 (2.94%)
         occurrences all number
    9
    15
    9
    0
    0
    10
    4
    1
    Periostitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Sle arthritis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Soft tissue mass
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Spinal osteoarthritis
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    4
    0
    1
    3
    0
    0
    0
    0
    Spondylolisthesis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Sympathetic posterior cervical syndrome
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Tendonitis
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Tenosynovitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Acarodermatitis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Acute sinusitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Acute tonsillitis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Body tinea
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    8 / 401 (2.00%)
    12 / 412 (2.91%)
    6 / 271 (2.21%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    11 / 317 (3.47%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    10
    13
    8
    2
    0
    12
    1
    0
    Bronchopneumonia
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Cellulitis
         subjects affected / exposed
    3 / 401 (0.75%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    2
    1
    0
    0
    0
    0
    Cervicitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Cystitis
         subjects affected / exposed
    5 / 401 (1.25%)
    5 / 412 (1.21%)
    5 / 271 (1.85%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    5
    6
    5
    0
    0
    3
    2
    1
    Diverticulitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Ear infection
         subjects affected / exposed
    4 / 401 (1.00%)
    2 / 412 (0.49%)
    4 / 271 (1.48%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    7
    2
    7
    0
    0
    1
    0
    1
    Enterovirus infection
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Erysipelas
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Eye infection viral
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Eyelid infection
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Folliculitis
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    1
    0
    0
    Fungal infection
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    3
    0
    0
    Gardnerella infection
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    5 / 401 (1.25%)
    9 / 412 (2.18%)
    4 / 271 (1.48%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    7 / 317 (2.21%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    7
    10
    6
    0
    1
    8
    1
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    3
    0
    1
    0
    2
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Genital abscess
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Gingival abscess
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Gingivitis
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    3
    0
    0
    Helicobacter infection
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Helminthic infection
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Hepatitis c
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Hepatitis viral
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Herpes dermatitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Herpes simplex
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Influenza
         subjects affected / exposed
    20 / 401 (4.99%)
    25 / 412 (6.07%)
    15 / 271 (5.54%)
    5 / 70 (7.14%)
    0 / 60 (0.00%)
    19 / 317 (5.99%)
    5 / 61 (8.20%)
    1 / 34 (2.94%)
         occurrences all number
    26
    27
    20
    6
    0
    20
    5
    2
    Laryngitis
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    1
    0
    0
    Lobar pneumonia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    37 / 401 (9.23%)
    47 / 412 (11.41%)
    22 / 271 (8.12%)
    8 / 70 (11.43%)
    7 / 60 (11.67%)
    37 / 317 (11.67%)
    5 / 61 (8.20%)
    5 / 34 (14.71%)
         occurrences all number
    56
    67
    32
    10
    14
    56
    5
    6
    Oesophagitis bacterial
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Onychomycosis
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    1
    0
    0
    Oral infection
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    0
    1
    Orchitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Otitis media acute
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    Parotitis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Periodontitis
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 412 (0.49%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    2 / 61 (3.28%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    3
    0
    Pharyngitis
         subjects affected / exposed
    5 / 401 (1.25%)
    6 / 412 (1.46%)
    3 / 271 (1.11%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    6 / 317 (1.89%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    6
    12
    4
    2
    0
    12
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    2 / 401 (0.50%)
    3 / 412 (0.73%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    2
    3
    2
    0
    0
    2
    1
    0
    Proctitis chlamydial
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Pulpitis dental
         subjects affected / exposed
    3 / 401 (0.75%)
    4 / 412 (0.97%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    3
    5
    3
    0
    0
    4
    1
    0
    Pyelonephritis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    9 / 401 (2.24%)
    8 / 412 (1.94%)
    6 / 271 (2.21%)
    2 / 70 (2.86%)
    1 / 60 (1.67%)
    5 / 317 (1.58%)
    2 / 61 (3.28%)
    1 / 34 (2.94%)
         occurrences all number
    10
    10
    7
    2
    1
    5
    4
    1
    Respiratory tract infection viral
         subjects affected / exposed
    6 / 401 (1.50%)
    9 / 412 (2.18%)
    3 / 271 (1.11%)
    2 / 70 (2.86%)
    1 / 60 (1.67%)
    8 / 317 (2.52%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    6
    9
    3
    2
    1
    8
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 401 (0.25%)
    3 / 412 (0.73%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    3
    1
    0
    0
    3
    0
    0
    Salmonellosis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Salpingo-oophoritis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    6 / 401 (1.50%)
    8 / 412 (1.94%)
    4 / 271 (1.48%)
    0 / 70 (0.00%)
    2 / 60 (3.33%)
    4 / 317 (1.26%)
    4 / 61 (6.56%)
    0 / 34 (0.00%)
         occurrences all number
    6
    9
    4
    0
    2
    5
    4
    0
    Skin infection
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Staphylococcal infection
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Tinea cruris
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Tinea manuum
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Tinea versicolour
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    4 / 401 (1.00%)
    7 / 412 (1.70%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    3 / 317 (0.95%)
    3 / 61 (4.92%)
    1 / 34 (2.94%)
         occurrences all number
    4
    11
    3
    0
    1
    3
    7
    1
    Tonsillitis streptococcal
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Tooth abscess
         subjects affected / exposed
    2 / 401 (0.50%)
    5 / 412 (1.21%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    2
    5
    2
    0
    0
    3
    1
    1
    Tooth infection
         subjects affected / exposed
    1 / 401 (0.25%)
    6 / 412 (1.46%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    1
    10
    1
    0
    0
    6
    3
    1
    Tracheitis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Tuberculosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 401 (2.49%)
    10 / 412 (2.43%)
    7 / 271 (2.58%)
    2 / 70 (2.86%)
    1 / 60 (1.67%)
    7 / 317 (2.21%)
    2 / 61 (3.28%)
    1 / 34 (2.94%)
         occurrences all number
    10
    16
    7
    2
    1
    11
    4
    1
    Urethritis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    8 / 401 (2.00%)
    13 / 412 (3.16%)
    6 / 271 (2.21%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    11 / 317 (3.47%)
    2 / 61 (3.28%)
    0 / 34 (0.00%)
         occurrences all number
    8
    13
    6
    2
    0
    11
    2
    0
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Vaginal infection
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Viral infection
         subjects affected / exposed
    8 / 401 (2.00%)
    9 / 412 (2.18%)
    8 / 271 (2.95%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    7 / 317 (2.21%)
    2 / 61 (3.28%)
    0 / 34 (0.00%)
         occurrences all number
    11
    13
    11
    0
    0
    10
    3
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 401 (0.75%)
    0 / 412 (0.00%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    3
    0
    0
    0
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 401 (1.50%)
    1 / 412 (0.24%)
    3 / 271 (1.11%)
    2 / 70 (2.86%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    6
    1
    3
    2
    1
    1
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Diabetes mellitus
         subjects affected / exposed
    3 / 401 (0.75%)
    1 / 412 (0.24%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    6
    1
    4
    2
    0
    1
    0
    0
    Dyslipidaemia
         subjects affected / exposed
    3 / 401 (0.75%)
    8 / 412 (1.94%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    2 / 61 (3.28%)
    2 / 34 (5.88%)
         occurrences all number
    3
    9
    2
    1
    0
    4
    2
    3
    Folate deficiency
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Gout
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    6 / 401 (1.50%)
    6 / 412 (1.46%)
    4 / 271 (1.48%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    5 / 317 (1.58%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    7
    6
    5
    2
    0
    5
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 401 (0.25%)
    4 / 412 (0.97%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    4 / 317 (1.26%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    5
    0
    2
    0
    5
    0
    0
    Hyperinsulinism
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    3 / 401 (0.75%)
    3 / 412 (0.73%)
    3 / 271 (1.11%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    3
    3
    0
    0
    3
    0
    0
    Hyperphagia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    5 / 401 (1.25%)
    4 / 412 (0.97%)
    4 / 271 (1.48%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    2 / 317 (0.63%)
    1 / 61 (1.64%)
    1 / 34 (2.94%)
         occurrences all number
    5
    5
    4
    0
    1
    3
    1
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    2
    0
    0
    Hypochloraemia
         subjects affected / exposed
    3 / 401 (0.75%)
    0 / 412 (0.00%)
    2 / 271 (0.74%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    2
    1
    0
    0
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    13 / 401 (3.24%)
    4 / 412 (0.97%)
    4 / 271 (1.48%)
    6 / 70 (8.57%)
    3 / 60 (5.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    14
    5
    4
    7
    3
    3
    0
    2
    Increased appetite
         subjects affected / exposed
    2 / 401 (0.50%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    2 / 70 (2.86%)
    0 / 60 (0.00%)
    3 / 317 (0.95%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    2
    3
    0
    2
    0
    3
    0
    0
    Metabolic disorder
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 412 (0.00%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    0 / 317 (0.00%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Obesity
         subjects affected / exposed
    2 / 401 (0.50%)
    6 / 412 (1.46%)
    1 / 271 (0.37%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    5 / 317 (1.58%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    2
    6
    1
    1
    0
    5
    1
    0
    Overweight
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 412 (0.49%)
    1 / 271 (0.37%)
    0 / 70 (0.00%)
    1 / 60 (1.67%)
    1 / 317 (0.32%)
    1 / 61 (1.64%)
    0 / 34 (0.00%)
         occurrences all number
    2
    2
    1
    0
    1
    1
    1
    0
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 412 (0.24%)
    0 / 271 (0.00%)
    1 / 70 (1.43%)
    0 / 60 (0.00%)
    1 / 317 (0.32%)
    0 / 61 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    Vitamin d deficiency
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 412 (0.73%)
    0 / 271 (0.00%)
    0 / 70 (0.00%)
    0 / 60 (0.00%)
    2 / 317 (0.63%)
    0 / 61 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    3
    0
    0
    0
    2
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2012
    Amendment#1 This Amendment No. 1 was prepared based on the experience made thus far in the study with investigators and patients which led the sponsor to reconsider some points in the protocol.
    27 Mar 2015
    Amendment #2 The objective of this amendment is to clarify the end of the double-blind study, permitting some subjects to early terminate or even skip their maintenance phase, so that the openlabel extension study (BIA-2093-311/EXT).

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

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

    European Medicines Agency © 1995-Sat Nov 22 22:42:10 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA