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    Clinical Trial Results:
    Efficacy and Safety of Eslicarbazepine Acetate (Bia 2-093) as Adjunctive Therapy for Refractory Partial Seizures in a Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicentre Clinical Trial

    Summary
    EudraCT number
    		 2008-002455-25
    Trial protocol
    		 FR   IT   DE   GR   CY   HU   RO  
    Global end of trial date
    16 May 2018

    Results information
    Results version number
    		 v3(current)
    This version publication date
    03 Jul 2021
    First version publication date
    20 Apr 2016
    Other versions
    		 v1 , v2
    Version creation reason
    Summary report(s)
    		 BIA-2093-304 Synopsis
    amendment

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BIA-2093-304
    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
    Joana Moreira, BIAL - Portela & Cª, S.A., 00351 229866100, joana.moreira@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
    13 Mar 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jan 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary: To evaluate the efficacy of Eslicarbazepine acetate (ESL) administered once daily (QD) at doses of 800 mg and 1200 mg compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period. The primary objective was evaluated in Part I of the study and is reported in the Part I Clinical Study Report (CSR). Secondary: The secondary objectives evaluated in Part II and Part III were: - To evaluate the safety and tolerability of ESL at doses titrated to an efficacy or safety endpoint over a 1-year open-label period (Part II). - To assess the maintenance of therapeutic effects of ESL over a 1-year open-label period (Part II). - To assess the drug-drug pharmacokinetic (PK) interactions between ESL and concomitant anti-epileptic drugs (AEDs) in Part II of the study. - To assess the health-related quality-of-life and depressive symptoms in Part II of the study. - To study the effects of long-term use of ESL in Part III of the
    Protection of trial subjects
    This study was conducted in compliance with the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice, including the archiving of essential documents.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 43
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Brazil: 111
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Cyprus: 7
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    France: 24
    Country: Number of subjects enrolled
    Greece: 12
    Country: Number of subjects enrolled
    Hungary: 11
    Country: Number of subjects enrolled
    India: 91
    Country: Number of subjects enrolled
    Italy: 33
    Country: Number of subjects enrolled
    Korea, Republic of: 85
    Country: Number of subjects enrolled
    Poland: 22
    Country: Number of subjects enrolled
    Romania: 26
    Country: Number of subjects enrolled
    Turkey: 4
    Country: Number of subjects enrolled
    Ukraine: 60
    Country: Number of subjects enrolled
    United States: 365
    Country: Number of subjects enrolled
    South Africa: 15
    Worldwide total number of subjects
    936
    EEA total number of subjects
    143
    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)
    19
    Adults (18-64 years)
    896
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Approximately 615 patients in approximately 200 sites within Argentina, Australia, Brazil, Belgium, Canada, Cyprus, France, Germany, Greece, Hungary, India, Italy, Poland, Russia, Turkey, South Korea, Romania, South Africa, Ukraine and the United States needed. Recruitment closed as soon as the required number of randomised patients was achieved.

    Pre-assignment
    Screening details
    		 Subjects who met all the inclusion criteria and none of the exclusion criteria. 936 subjects were screened. For283 subjects were stated Screen Failure, 653 subjects were randomised.

    Pre-assignment period milestones
    Number of subjects started
    		 936
    Number of subjects completed
    		 653

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 1
    Reason: Number of subjects
    		 Adverse event, serious non-fatal: 10
    Reason: Number of subjects
    		 Consent withdrawn by subject: 31
    Reason: Number of subjects
    		 Physician decision: 2
    Reason: Number of subjects
    		 Protocol deviation: 202
    Reason: Number of subjects
    		 Lack of Efficacy: 1
    Reason: Number of subjects
    		 Sponsor's decision: 2
    Reason: Number of subjects
    		 Patient Non-Compliance: 14
    Reason: Number of subjects
    		 Missing: 3
    Reason: Number of subjects
    		 Other: 17
    Period 1
    Period 1 title
    Part I: double-blind
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part I - Placebo
    Arm description
    		 Age ≥16 8-week observation baseline period (Week -8 to Week -1), randomization of eligible subjects at the end of the 8-week observational baseline period. 2-week, double-blind, up-titration period (Week 1 to Week 2) with placebo QD. 12-week, double-blind, maintenance period (Week 3 to Week 14), where subjects received placebo QD. After maintenance subjects were down-titraded by receiving placebo QD for 2 weeks if not entered Part II. Concomitant AEDs were allowed in this study and were to be kept stable during the course of the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablets QD orally during Part 1, the 2-week, double-blind, up-titration period (Week 1 to Week 2), and the 12-week double-blind maintenance period (Week 3 to Week 14). All patients received ESL in Part II and Part III. For Part II and Part III, scored 800 mg tablets will be supplied. The tablets were taken QD by mouth, swallowed at approximately the same time each day, Patients were instructed not to chew or crush the study medication. In Part II, the starting dose had to be kept stable at 800 mg QD for 1 month. After that titration upwards or downwards was done at 400 mg increments by Investigator’s judgement. Maximum dose allowed was 1600 mg QD and the minimum dose was 400 mg QD. In additional open-label extension Part III, patients started with Part II dose with the option to titrate this dose within a 400−1600 mg QD dose range, in no more than 400 increments. If not entering Part III down-titration in dependance of last dose level was done.

    Arm title
    		 Part I - Eslicarbazepine Acetate 800 mg
    Arm description
    		 Age ≥16 8-week observation baseline period (Week -8 to Week -1), randomization of eligible subjects at the end of the 8-week observational baseline period. 2-week, double-blind, up-titration period (Week 1 to Week 2) with ESL 400 mg QD. 12-week, double-blind, maintenance period (Week 3 to Week 14), where subjects received ESL 800 mg QD. After maintenance subjects were down-titraded to 400 mg for a duration of 2 weeks if not entered Part II. Concomitant AEDs were allowed in this study and were to be kept stable during the course of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2‑093
    Other name
    Zebinix
    Pharmaceutical forms
    Tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg tablets QD orally during Part 1, the 2-week, double-blind, up-titration period (Week 1 to Week 2), and the 12-week double-blind maintenance period (Week 3 to Week 14). For Part II and Part III, scored 800 mg tablets will be supplied. The tablets were taken QD by mouth, swallowed at approximately the same time each day, Patients were instructed not to chew or crush the study medication. In Part II, the starting dose had to be kept stable at 800 mg QD for 1 month. After that titration upwards or downwards was done at 400 mg increments by Investigator’s judgement. Maximum dose allowed was 1600 mg QD and the minimum dose was 400 mg QD. In additional open-label extension Part III, patients started with Part II dose with the option to titrate this dose within a 400−1600 mg QD dose range, in no more than 400 increments. If not entering Part III down-titration in dependance of last dose level was done (see synopsis).

    Arm title
    		 Part I - Eslicarbazepine Acetate 1200 mg
    Arm description
    		 Age ≥16 8-week observation baseline period (Week -8 to Week -1), randomization of eligible subjects at the end of the 8-week observational baseline period. 2-week, double-blind, up-titration period (Week 1 to Week 2) with ESL 800 mg QD. 12-week, double-blind, maintenance period (Week 3 to Week 14), where subjects received ESL 120 mg QD. After maintenance subjects were down-titraded to 800 mg for a duration of 2 weeks if not entered Part II. Concomitant AEDs were allowed in this study and were to be kept stable during the course of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2‑093
    Other name
    Zebinix
    Pharmaceutical forms
    Tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg and 400 mg tablets QD orally during Part 1, the 2-week, double-blind, up-titration period (Week 1 to Week 2), and the 12-week double-blind maintenance period (Week 3 to Week 14). For Part II and Part III, scored 800 mg tablets will be supplied. The tablets were taken QD by mouth, swallowed at approximately the same time each day, Patients were instructed not to chew or crush the study medication. In Part II, the starting dose had to be kept stable at 800 mg QD for 1 month. After that titration upwards or downwards was done at 400 mg increments by Investigator’s judgement. Maximum dose allowed was 1600 mg QD and the minimum dose was 400 mg QD. In additional open-label extension Part III, patients started with Part II dose with the option to titrate this dose within a 400−1600 mg QD dose range, in no more than 400 increments. If not entering Part III down-titration in dependance of last dose level was done (see synopsis).

    Number of subjects in period 1 [1]
    		Part I - Placebo Part I - Eslicarbazepine Acetate 800 mg Part I - Eslicarbazepine Acetate 1200 mg
    Started
    226
    216
    211
    Completed
    189
    173
    142
    Not completed
    37
    43
    69
         Sponsor's decision
    1
    2
    1
         Consent withdrawn by subject
    7
    7
    12
         Physician decision
    1
    -
    3
         Lack of Efficacy
    -
    -
    1
         Adverse event, non-fatal
    9
    20
    44
         Patient Non-Compliance
    5
    1
    3
         Other
    8
    8
    1
         Pregnancy
    2
    1
    -
         Adverse event, serious non-fatal
    -
    1
    1
         Protocol deviation
    4
    3
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: During observation pretime, 653 of 936 subjects enrolled turned out to be eligible for randomisation and started part I.
    Period 2
    Period 2 title
    Part II: one-year open-label extension
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part II - Placebo
    Arm description
    		 patients who completed placebo treatment in Part I and were willing to participate in the extension part Part II respectively
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2‑093
    Other name
    Zebinix
    Pharmaceutical forms
    Tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    For Part II, scored 800 mg tablets will be supplied. The tablets were taken QD by mouth, swallowed at approximately the same time each day, Patients were instructed not to chew or crush the study medication. In Part II, the starting dose had to be kept stable at 800 mg QD for 1 month. After that titration upwards or downwards was done at 400 mg increments by Investigator’s judgement. Maximum dose allowed was 1600 mg QD and the minimum dose was 400 mg QD.

    Arm title
    		 Part II - Eslicarbazepine Acetate 800 mg
    Arm description
    		 patients who completed ESL 800 mg QD treatment in Part I and were willing to participate in the extension part Part II respectively
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2‑093
    Other name
    Zebinix
    Pharmaceutical forms
    Tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    For Part II, scored 800 mg tablets will be supplied. The tablets were taken QD by mouth, swallowed at approximately the same time each day, Patients were instructed not to chew or crush the study medication. In Part II, the starting dose had to be kept stable at 800 mg QD for 1 month. After that titration upwards or downwards was done at 400 mg increments by Investigator’s judgement. Maximum dose allowed was 1600 mg QD and the minimum dose was 400 mg QD.

    Arm title
    		 Part II - Eslicarbazepine Acetate 1200 mg
    Arm description
    		 patients who completed ESL 1200 mg QD treatment in Part I and were willing to participate in the extension part Part II respectively
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2‑093
    Other name
    Zebinix
    Pharmaceutical forms
    Tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    For Part II, scored 800 mg tablets will be supplied. The tablets were taken QD by mouth, swallowed at approximately the same time each day, Patients were instructed not to chew or crush the study medication. In Part II, the starting dose had to be kept stable at 800 mg QD for 1 month. After that titration upwards or downwards was done at 400 mg increments by Investigator’s judgement. Maximum dose allowed was 1600 mg QD and the minimum dose was 400 mg QD.

    Number of subjects in period 2 [2]
    		Part II - Placebo Part II - Eslicarbazepine Acetate 800 mg Part II - Eslicarbazepine Acetate 1200 mg
    Started
    186
    170
    140
    Completed
    118
    127
    101
    Not completed
    68
    43
    39
         Sponsor's decision
    3
    2
    2
         Consent withdrawn by subject
    22
    13
    11
         Physician decision
    3
    2
    2
         Lack of Efficacy
    3
    1
    2
         Adverse event, non-fatal
    15
    3
    5
         Other
    17
    18
    16
         Pregnancy
    2
    1
    -
         Adverse event, serious non-fatal
    3
    2
    1
         Protocol deviation
    -
    1
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The prerequisite for participating in Part II was the completion of Part I. In addition, separate consent from the subject was required. 496 of 504 completers of Part I gave their consent to participate in Part II.
    Period 3
    Period 3 title
    Part III: open-label additioal extension
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part III - Placebo
    Arm description
    		 patients who completed placebo treatment in Part I, completed Part II and were willing to participate in the extension part Part III respectively
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2‑093
    Other name
    Zebinix
    Pharmaceutical forms
    Tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    For Part III, scored 800 mg tablets will be supplied. The tablets were taken QD by mouth, swallowed at approximately the same time each day, Patients were instructed not to chew or crush the study medication. In additional open-label extension Part III, patients started with Part II dose with the option to titrate this dose within a 400−1600 mg QD dose range, in no more than 400 increments. If not entering Part III down-titration in dependance of last dose level was done (see synopsis).

    Arm title
    		 Part III - Eslicarbazepine Acetate 800 mg
    Arm description
    		 patients who completed ESL 800 mg QD treatment in Part I, completed Part II and were willing to participate in the extension part Part III respectively
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2‑093
    Other name
    Zebinix
    Pharmaceutical forms
    Tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    For Part III, scored 800 mg tablets will be supplied. The tablets were taken QD by mouth, swallowed at approximately the same time each day, Patients were instructed not to chew or crush the study medication. In additional open-label extension Part III, patients started with Part II dose with the option to titrate this dose within a 400−1600 mg QD dose range, in no more than 400 increments. If not entering Part III down-titration in dependance of last dose level was done (see synopsis).

    Arm title
    		 Part III - Eslicarbazepine Acetate 1200 mg
    Arm description
    		 patients who completed ESL 1200 mg QD treatment in Part I, completed Part II and were willing to participate extension part Part III respectively
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2‑093
    Other name
    Zebinix
    Pharmaceutical forms
    Tablet, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    For Part III, scored 800 mg tablets will be supplied. The tablets were taken QD by mouth, swallowed at approximately the same time each day, Patients were instructed not to chew or crush the study medication. In additional open-label extension Part III, patients started with Part II dose with the option to titrate this dose within a 400−1600 mg QD dose range, in no more than 400 increments. If not entering Part III down-titration in dependance of last dose level was done (see synopsis).

    Number of subjects in period 3 [3]
    		Part III - Placebo Part III - Eslicarbazepine Acetate 800 mg Part III - Eslicarbazepine Acetate 1200 mg
    Started
    78
    87
    75
    Completed
    20
    18
    17
    Not completed
    58
    69
    58
         Sponsor's decision
    11
    8
    12
         Consent withdrawn by subject
    10
    18
    14
         Physician decision
    1
    4
    3
         Lack of Efficacy
    1
    1
    -
         Adverse event, non-fatal
    3
    3
    -
         Other
    31
    34
    27
         Pregnancy
    -
    -
    1
         Adverse event, serious non-fatal
    1
    -
    -
         Missing
    -
    1
    -
         Protocol deviation
    -
    -
    1
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The prerequisite for participating in Part III was the completion of Part II. In addition, separate consent from the subject was required. 240 of 346 completers of Part II gave their consent to participate in Part III.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part I - Placebo
    Reporting group description
    		 Age ≥16 8-week observation baseline period (Week -8 to Week -1), randomization of eligible subjects at the end of the 8-week observational baseline period. 2-week, double-blind, up-titration period (Week 1 to Week 2) with placebo QD. 12-week, double-blind, maintenance period (Week 3 to Week 14), where subjects received placebo QD. After maintenance subjects were down-titraded by receiving placebo QD for 2 weeks if not entered Part II. Concomitant AEDs were allowed in this study and were to be kept stable during the course of the study.

    Reporting group title
    Part I - Eslicarbazepine Acetate 800 mg
    Reporting group description
    		 Age ≥16 8-week observation baseline period (Week -8 to Week -1), randomization of eligible subjects at the end of the 8-week observational baseline period. 2-week, double-blind, up-titration period (Week 1 to Week 2) with ESL 400 mg QD. 12-week, double-blind, maintenance period (Week 3 to Week 14), where subjects received ESL 800 mg QD. After maintenance subjects were down-titraded to 400 mg for a duration of 2 weeks if not entered Part II. Concomitant AEDs were allowed in this study and were to be kept stable during the course of the study.

    Reporting group title
    Part I - Eslicarbazepine Acetate 1200 mg
    Reporting group description
    		 Age ≥16 8-week observation baseline period (Week -8 to Week -1), randomization of eligible subjects at the end of the 8-week observational baseline period. 2-week, double-blind, up-titration period (Week 1 to Week 2) with ESL 800 mg QD. 12-week, double-blind, maintenance period (Week 3 to Week 14), where subjects received ESL 120 mg QD. After maintenance subjects were down-titraded to 800 mg for a duration of 2 weeks if not entered Part II. Concomitant AEDs were allowed in this study and were to be kept stable during the course of the study.

    Reporting group values
    		 Part I - Placebo Part I - Eslicarbazepine Acetate 800 mg Part I - Eslicarbazepine Acetate 1200 mg Total
    Number of subjects
    		 226 216 211 653
    Age Categorical
    Age Categorical Characteristic
    Units: Subjects
        In Utero
    		 0 0 0 0
        Preterm newborn- gestational age < 37 wk
    		 0 0 0 0
        Newborns (0-27days)
    		 0 0 0 0
        Infants and toddlers (28days – 23months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 year)
    		 5 4 6 15
        From 18 - 64 years
    		 217 207 203 627
        From 65 – 84 years
    		 3 5 2 10
        Over 85 years
    		 0 0 0 0
        Missing
    		 1 0 0 1
    Age Continuous
    Age Continuous Characteristic
    Units: Years
        arithmetic mean (standard deviation)
    		 39.1 ( 12.71 ) 38.8 ( 12.11 ) 38.0 ( 11.98 ) -
    Gender Categorical
    Gender Categorical Characteristic
    Units: Subjects
        Female
    		 114 109 106 329
        Male
    		 112 107 105 324

    End points

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    End points reporting groups
    Reporting group title
    Part I - Placebo
    Reporting group description
    		 Age ≥16 8-week observation baseline period (Week -8 to Week -1), randomization of eligible subjects at the end of the 8-week observational baseline period. 2-week, double-blind, up-titration period (Week 1 to Week 2) with placebo QD. 12-week, double-blind, maintenance period (Week 3 to Week 14), where subjects received placebo QD. After maintenance subjects were down-titraded by receiving placebo QD for 2 weeks if not entered Part II. Concomitant AEDs were allowed in this study and were to be kept stable during the course of the study.

    Reporting group title
    Part I - Eslicarbazepine Acetate 800 mg
    Reporting group description
    		 Age ≥16 8-week observation baseline period (Week -8 to Week -1), randomization of eligible subjects at the end of the 8-week observational baseline period. 2-week, double-blind, up-titration period (Week 1 to Week 2) with ESL 400 mg QD. 12-week, double-blind, maintenance period (Week 3 to Week 14), where subjects received ESL 800 mg QD. After maintenance subjects were down-titraded to 400 mg for a duration of 2 weeks if not entered Part II. Concomitant AEDs were allowed in this study and were to be kept stable during the course of the study.

    Reporting group title
    Part I - Eslicarbazepine Acetate 1200 mg
    Reporting group description
    		 Age ≥16 8-week observation baseline period (Week -8 to Week -1), randomization of eligible subjects at the end of the 8-week observational baseline period. 2-week, double-blind, up-titration period (Week 1 to Week 2) with ESL 800 mg QD. 12-week, double-blind, maintenance period (Week 3 to Week 14), where subjects received ESL 120 mg QD. After maintenance subjects were down-titraded to 800 mg for a duration of 2 weeks if not entered Part II. Concomitant AEDs were allowed in this study and were to be kept stable during the course of the study.
    Reporting group title
    Part II - Placebo
    Reporting group description
    		 patients who completed placebo treatment in Part I and were willing to participate in the extension part Part II respectively

    Reporting group title
    Part II - Eslicarbazepine Acetate 800 mg
    Reporting group description
    		 patients who completed ESL 800 mg QD treatment in Part I and were willing to participate in the extension part Part II respectively

    Reporting group title
    Part II - Eslicarbazepine Acetate 1200 mg
    Reporting group description
    		 patients who completed ESL 1200 mg QD treatment in Part I and were willing to participate in the extension part Part II respectively
    Reporting group title
    Part III - Placebo
    Reporting group description
    		 patients who completed placebo treatment in Part I, completed Part II and were willing to participate in the extension part Part III respectively

    Reporting group title
    Part III - Eslicarbazepine Acetate 800 mg
    Reporting group description
    		 patients who completed ESL 800 mg QD treatment in Part I, completed Part II and were willing to participate in the extension part Part III respectively

    Reporting group title
    Part III - Eslicarbazepine Acetate 1200 mg
    Reporting group description
    		 patients who completed ESL 1200 mg QD treatment in Part I, completed Part II and were willing to participate extension part Part III respectively

    Subject analysis set title
    Part I - Placebo x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized subjects who received at least one dose of study drug after randomization

    Subject analysis set title
    Part I - Eslicarbazepine Acetate 800 mg x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized subjects who received at least one dose of study drug after randomization

    Subject analysis set title
    Part I - Eslicarbazepine Acetate 1200 mg x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized subjects who received at least one dose of study drug after randomization

    Subject analysis set title
    Part I - Placebo x Intent-to-treat Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized subjects who received at least one dose of study drug after randomization and had at least one post-baseline seizure frequency assessment

    Subject analysis set title
    Part I - Eslicarbazepine Acetate 800 mg x Intent-to-treat Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized subjects who received at least one dose of study drug after randomization and had at least one post-baseline seizure frequency assessment

    Subject analysis set title
    Part I - Eslicarbazepine Acetate 1200 mg x Intent-to-treat Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized subjects who received at least one dose of study drug after randomization and had at least one post-baseline seizure frequency assessment

    Subject analysis set title
    Part I - Placebo x DE ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects in the ITT population who completed the DE diary

    Subject analysis set title
    Part I - Eslicarbazepine Acetate 800 mg x DE ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects in the ITT population who completed the DE diary

    Subject analysis set title
    Part I - Eslicarbazepine Acetate 1200 mg x DE ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects in the ITT population who completed the DE diary

    Subject analysis set title
    Part I - Placebo x EE ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects in the ITT population who completed the EE diary

    Subject analysis set title
    Part I - Eslicarbazepine Acetate 800 mg x EE ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects in the ITT population who completed the EE diary

    Subject analysis set title
    Part I - Eslicarbazepine Acetate 1200 mg x EE ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects in the ITT population who completed the EE diary

    Subject analysis set title
    Part I - Placebo x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in ITT population without any important protocol deviation

    Subject analysis set title
    Part I - Eslicarbazepine Acetate 800 mg x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in ITT population without any important protocol deviation

    Subject analysis set title
    Part I - Eslicarbazepine Acetate 1200 mg x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in ITT population without any important protocol deviation

    Subject analysis set title
    Part II - Placebo x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients in Part I Safety population who entered Part II

    Subject analysis set title
    Part II - Eslicarbazepine Acetate 800 mg x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients in Part I Safety population who entered Part II

    Subject analysis set title
    Part II - Eslicarbazepine Acetate 1200 mg x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients in Part I Safety population who entered Part II

    Subject analysis set title
    Part III - Placebo x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients in Part I Safety population who entered Part III

    Subject analysis set title
    Part III - Eslicarbazepine Acetate 800 mg x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients in Part I Safety population who entered Part III

    Subject analysis set title
    Part III - Eslicarbazepine Acetate 1200 mg x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients in Part I Safety population who entered Part III

    Primary: Standardized Seizure Frequency During the Maintenance Period

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    End point title
    		 Standardized Seizure Frequency During the Maintenance Period
    End point description
    Mean
    End point type
    Primary
    End point timeframe
    During the Maintenance Period
    End point values
    		 Part I - Placebo x Intent-to-treat Set Part I - Eslicarbazepine Acetate 800 mg x Intent-to-treat Set Part I - Eslicarbazepine Acetate 1200 mg x Intent-to-treat Set
    Number of subjects analysed
    212
    200
    184
    Units: Seizures
    number (not applicable)
        Seizures
    12.99
    13.7
    12.05
    Statistical analysis title
    		 ANCOVA analysis, ITT pop. strat by treatment.
    Statistical analysis description
    Results are based on an ANCOVA model with log-transformed baseline standardized frequency and diary version as covariates and treatment as a fixed effect. The pairwise comparisons are each ESL dose versus placebo. LS means and CIs are back-transformed via the exponential function and subtracting 0.333. SEs for LS means are back-transformed via the Delta Method. Subjects who discontinued from the study during the titration period are not included.
    Comparison groups
    Part I - Placebo x Intent-to-treat Set v Part I - Eslicarbazepine Acetate 800 mg x Intent-to-treat Set
    Number of subjects included in analysis
    412
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.058
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 ANCOVA analysis, ITT pop. strat by treatment.
    Statistical analysis description
    Results are based on an ANCOVA model with log-transformed baseline standardized frequency and diary version as covariates and treatment as a fixed effect. The pairwise comparisons are each ESL dose versus placebo. LS means and CIs are back-transformed via the exponential function and subtracting 0.333. SEs for LS means are back-transformed via the Delta Method. Subjects who discontinued from the study during the titration period are not included.
    Comparison groups
    Part I - Placebo x Intent-to-treat Set v Part I - Eslicarbazepine Acetate 1200 mg x Intent-to-treat Set
    Number of subjects included in analysis
    396
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent until the date of the EOT visit/EDV.
    Adverse event reporting additional description
    AEs monitored at each visit from V1 throughout the study (including at early discontinuation and at the PSV). The investigator inquired generally about the patient’s well being since the last visit. Details of any reported AEs were recorded at all scheduled and unscheduled visits as well as those reported during any telephone contact.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Placebo x Safety Set
    Reporting group description
    		 Subjects in the Safety Set treated with Placebo

    Reporting group title
    Eslicarbazepine Acetate 800 mg x Safety Set
    Reporting group description
    		 Subjects in the Safety Set treated with ESL

    Reporting group title
    Eslicarbazepine Acetate 1200 mg x Safety Set
    Reporting group description
    		 Subjects in the Safety Set treated with ESL

    Serious adverse events
    		 Placebo x Safety Set Eslicarbazepine Acetate 800 mg x Safety Set Eslicarbazepine Acetate 1200 mg x Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    33 / 226 (14.60%)
    42 / 216 (19.44%)
    29 / 211 (13.74%)
         number of deaths (all causes)
    1
    3
    2
         number of deaths resulting from adverse events
    1
    3
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain neoplasm
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebellar tumour
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemangioma
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial haemorrhage
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden unexplained death in epilepsy
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute psychosis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Affective disorder
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination, auditory
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mood altered
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Anticonvulsant drug level below therapeutic
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood chloride decreased
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood urea decreased
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood urea nitrogen/creatinine ratio decreased
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug level decreased
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Near drowning
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Therapeutic agent toxicity
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital anomaly
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve prolapse
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebellar syndrome
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Complex partial seizures
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myoclonus
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    2 / 226 (0.88%)
    6 / 216 (2.78%)
    6 / 211 (2.84%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Partial seizures with secondary generalisation
         subjects affected / exposed
    1 / 226 (0.44%)
    6 / 216 (2.78%)
    2 / 211 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postictal state
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Simple partial seizures
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    2 / 226 (0.88%)
    2 / 216 (0.93%)
    3 / 211 (1.42%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dental caries
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Leukocytoclastic vasculitis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vaginal abscess
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    3 / 226 (1.33%)
    3 / 216 (1.39%)
    0 / 211 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo x Safety Set Eslicarbazepine Acetate 800 mg x Safety Set Eslicarbazepine Acetate 1200 mg x Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    193 / 226 (85.40%)
    184 / 216 (85.19%)
    196 / 211 (92.89%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acrochordon
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Angiofibroma
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    3
    0
    Angiomyolipoma
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    1
    2
    0
    Benign neoplasm
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Breast cancer
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Cervicitis human papilloma virus
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Haemangioma of skin
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Carotidynia
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Diastolic hypertension
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Flushing
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    1
    1
    2
    Haematoma
         subjects affected / exposed
    0 / 226 (0.00%)
    4 / 216 (1.85%)
    1 / 211 (0.47%)
         occurrences all number
    0
    5
    2
    Hot flush
         subjects affected / exposed
    3 / 226 (1.33%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    5
    1
    0
    Hyperaemia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertension
         subjects affected / exposed
    8 / 226 (3.54%)
    4 / 216 (1.85%)
    7 / 211 (3.32%)
         occurrences all number
    13
    5
    15
    Hypertensive crisis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    0
    0
    2
    Hypotension
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    2 / 211 (0.95%)
         occurrences all number
    1
    2
    3
    Labile blood pressure
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    2
    0
    Peripheral coldness
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Varicose vein
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Varicose vein ruptured
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Venous insufficiency
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Surgical and medical procedures
    Sinus operation
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Suture insertion
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    3
    1
    0
    Asthenia
         subjects affected / exposed
    7 / 226 (3.10%)
    9 / 216 (4.17%)
    11 / 211 (5.21%)
         occurrences all number
    11
    16
    12
    Chest discomfort
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    2
    1
    1
    Chest pain
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    2
    0
    3
    Chills
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Drug intolerance
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Facial pain
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Fatigue
         subjects affected / exposed
    21 / 226 (9.29%)
    10 / 216 (4.63%)
    20 / 211 (9.48%)
         occurrences all number
    28
    20
    32
    Feeling abnormal
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Feeling drunk
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Feeling hot
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    3
    Feeling jittery
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    3
    0
    Gait disturbance
         subjects affected / exposed
    6 / 226 (2.65%)
    4 / 216 (1.85%)
    4 / 211 (1.90%)
         occurrences all number
    7
    4
    4
    Generalised oedema
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperthermia
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Implant site pain
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Inflammation
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    2
    Influenza like illness
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    2
    1
    2
    Injection site reaction
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Irritability
         subjects affected / exposed
    4 / 226 (1.77%)
    5 / 216 (2.31%)
    3 / 211 (1.42%)
         occurrences all number
    7
    9
    4
    Malaise
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    1
    1
    Oedema
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    0
    0
    5
    Oedema peripheral
         subjects affected / exposed
    3 / 226 (1.33%)
    3 / 216 (1.39%)
    4 / 211 (1.90%)
         occurrences all number
    9
    4
    5
    Pain
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    3
    1
    3
    Pyrexia
         subjects affected / exposed
    9 / 226 (3.98%)
    6 / 216 (2.78%)
    5 / 211 (2.37%)
         occurrences all number
    12
    10
    6
    Sluggishness
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Thirst
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    2
    4
    0
    Vessel puncture site haemorrhage
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Hypersensitivity
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    1
    2
    2
    Seasonal allergy
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    2
    0
    2
    Social circumstances
    Physical assault
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    0
    0
    2
    Breast cyst
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Breast disorder
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Cervical dysplasia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    5
    0
    2
    Cervix haemorrhage uterine
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Dysfunctional uterine bleeding
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Dysmenorrhoea
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    1
    1
    3
    Ejaculation disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Epididymitis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    5
    0
    0
    Fibrocystic breast disease
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Galactorrhoea
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Gynaecomastia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Menorrhagia
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Menstruation delayed
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Menstruation irregular
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Metrorrhagia
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    1
    2
    0
    Ovarian cyst
         subjects affected / exposed
    2 / 226 (0.88%)
    3 / 216 (1.39%)
    0 / 211 (0.00%)
         occurrences all number
    4
    4
    0
    Pelvic pain
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Prostatitis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Testicular pain
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    2
    0
    Vaginal cyst
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Vaginal inflammation
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Varicocele
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    3 / 211 (1.42%)
         occurrences all number
    0
    0
    3
    Atelectasis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchospasm
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Cough
         subjects affected / exposed
    6 / 226 (2.65%)
    6 / 216 (2.78%)
    4 / 211 (1.90%)
         occurrences all number
    7
    7
    5
    Dyspnoea
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    4 / 211 (1.90%)
         occurrences all number
    4
    1
    5
    Dyspnoea exertional
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Emphysema
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    2
    1
    Epistaxis
         subjects affected / exposed
    4 / 226 (1.77%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    4
    2
    1
    Hiccups
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Lung disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    3 / 226 (1.33%)
    4 / 216 (1.85%)
    0 / 211 (0.00%)
         occurrences all number
    3
    6
    0
    Oropharyngeal pain
         subjects affected / exposed
    3 / 226 (1.33%)
    2 / 216 (0.93%)
    2 / 211 (0.95%)
         occurrences all number
    3
    3
    3
    Paranasal sinus hypersecretion
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    2
    1
    2
    Pharyngeal oedema
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Pleural effusion
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Pleuritic pain
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary congestion
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 216 (0.93%)
    2 / 211 (0.95%)
         occurrences all number
    0
    2
    5
    Rhinorrhoea
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Sinus congestion
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    1
    4
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    3
    1
    0
    Snoring
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Throat tightness
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    1
    1
    Abnormal dreams
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    4 / 211 (1.90%)
         occurrences all number
    0
    0
    5
    Affective disorder
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Aggression
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    2
    1
    3
    Agitation
         subjects affected / exposed
    2 / 226 (0.88%)
    4 / 216 (1.85%)
    1 / 211 (0.47%)
         occurrences all number
    3
    5
    1
    Anger
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Anxiety
         subjects affected / exposed
    12 / 226 (5.31%)
    18 / 216 (8.33%)
    6 / 211 (2.84%)
         occurrences all number
    17
    32
    16
    Apathy
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    3
    0
    1
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    0
    0
    2
    Bradyphrenia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Bruxism
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Communication disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Confusional state
         subjects affected / exposed
    4 / 226 (1.77%)
    2 / 216 (0.93%)
    2 / 211 (0.95%)
         occurrences all number
    5
    4
    2
    Conversion disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Daydreaming
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Depressed mood
         subjects affected / exposed
    0 / 226 (0.00%)
    3 / 216 (1.39%)
    2 / 211 (0.95%)
         occurrences all number
    0
    4
    3
    Depression
         subjects affected / exposed
    11 / 226 (4.87%)
    10 / 216 (4.63%)
    11 / 211 (5.21%)
         occurrences all number
    23
    13
    19
    Disorientation
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Emotional disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Flat affect
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Hallucination, visual
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Inappropriate affect
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Initial insomnia
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    3
    0
    1
    Insomnia
         subjects affected / exposed
    7 / 226 (3.10%)
    8 / 216 (3.70%)
    7 / 211 (3.32%)
         occurrences all number
    11
    9
    9
    Intermittent explosive disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Laziness
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Libido decreased
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    3
    2
    0
    Libido increased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Mental status changes
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    1
    1
    Mood altered
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    0
    1
    2
    Mood swings
         subjects affected / exposed
    2 / 226 (0.88%)
    3 / 216 (1.39%)
    2 / 211 (0.95%)
         occurrences all number
    2
    6
    3
    Negative thoughts
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Nervousness
         subjects affected / exposed
    2 / 226 (0.88%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    2
    2
    1
    Nightmare
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Obsessive-compulsive disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Panic attack
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Panic disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Phonophobia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Postictal psychosis
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    0
    4
    0
    Rapid eye movements sleep abnormal
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    3
    Restlessness
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Self esteem decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Sleep disorder
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Social avoidant behaviour
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Somnambulism
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    0
    0
    2
    Staring
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Stress
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    2
    1
    0
    Suicidal behaviour
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Suicidal ideation
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    1
    0
    2
    Suspiciousness
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    3 / 211 (1.42%)
         occurrences all number
    1
    3
    4
    Ammonia
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 226 (1.33%)
    1 / 216 (0.46%)
    3 / 211 (1.42%)
         occurrences all number
    3
    2
    3
    Bacterial test positive
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Blood 1,25-dihydroxycholecalciferol decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    4
    2
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    3
    0
    2
    Blood bilirubin increased
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    4
    0
    0
    Blood chloride decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    1
    1
    Blood cholesterol increased
         subjects affected / exposed
    4 / 226 (1.77%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    7
    4
    0
    Blood creatine increased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    5 / 226 (2.21%)
    3 / 216 (1.39%)
    2 / 211 (0.95%)
         occurrences all number
    7
    4
    2
    Blood creatinine increased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    2
    0
    1
    Blood iron decreased
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Blood parathyroid hormone decreased
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    0
    4
    0
    Blood parathyroid hormone increased
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    2
    5
    2
    Blood phosphorus increased
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Blood potassium decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Blood potassium increased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Blood pressure diastolic increased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    3
    0
    Blood pressure systolic increased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Blood sodium decreased
         subjects affected / exposed
    4 / 226 (1.77%)
    4 / 216 (1.85%)
    5 / 211 (2.37%)
         occurrences all number
    4
    6
    5
    Blood testosterone decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    2
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    3 / 226 (1.33%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    5
    3
    2
    Blood triglycerides increased
         subjects affected / exposed
    3 / 226 (1.33%)
    3 / 216 (1.39%)
    1 / 211 (0.47%)
         occurrences all number
    5
    4
    1
    Blood urea increased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Body temperature increased
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac murmur
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    0
    0
    3
    Colonoscopy
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Crystal urine present
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Electrocardiogram repolarisation abnormality
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Electroencephalogram
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Eosinophil count increased
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Grip strength decreased
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Haemoglobin increased
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    High density lipoprotein decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Low density lipoprotein increased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Monocyte count decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    N-telopeptide urine increased
         subjects affected / exposed
    2 / 226 (0.88%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    4
    4
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Neutrophil count increased
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    2
    1
    Osteocalcin increased
         subjects affected / exposed
    2 / 226 (0.88%)
    3 / 216 (1.39%)
    1 / 211 (0.47%)
         occurrences all number
    4
    6
    2
    Platelet count decreased
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    2
    1
    0
    Platelet count increased
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    QRS axis abnormal
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Red blood cells urine positive
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Thyroid function test abnormal
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Thyroxine decreased
         subjects affected / exposed
    3 / 226 (1.33%)
    1 / 216 (0.46%)
    3 / 211 (1.42%)
         occurrences all number
    6
    2
    5
    Thyroxine free decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    3 / 211 (1.42%)
         occurrences all number
    1
    6
    6
    Thyroxine free increased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Thyroxine increased
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    0
    1
    2
    Tri-iodothyronine decreased
         subjects affected / exposed
    3 / 226 (1.33%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    13
    0
    0
    Tri-iodothyronine free decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    2
    0
    3
    Tri-iodothyronine free increased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Tri-iodothyronine increased
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Urinary sediment present
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Urine analysis abnormal
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Vitamin D decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    2
    1
    Vitamin D increased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    6 / 211 (2.84%)
         occurrences all number
    2
    1
    8
    Weight increased
         subjects affected / exposed
    7 / 226 (3.10%)
    7 / 216 (3.24%)
    5 / 211 (2.37%)
         occurrences all number
    12
    12
    7
    White blood cell count decreased
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    1
    0
    2
    White blood cell count increased
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    0
    4
    1
    White blood cells urine positive
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Accidental overdose
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    2
    0
    1
    Animal bite
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Arthropod bite
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    2
    4
    1
    Arthropod sting
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Avulsion fracture
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Back injury
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Burns first degree
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Burns second degree
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    2
    0
    1
    Clavicle fracture
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    1
    1
    Concussion
         subjects affected / exposed
    3 / 226 (1.33%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    4
    1
    0
    Contusion
         subjects affected / exposed
    8 / 226 (3.54%)
    6 / 216 (2.78%)
    7 / 211 (3.32%)
         occurrences all number
    16
    10
    8
    Drug dose omission
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Drug toxicity
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Excoriation
         subjects affected / exposed
    4 / 226 (1.77%)
    3 / 216 (1.39%)
    2 / 211 (0.95%)
         occurrences all number
    6
    5
    5
    Eye injury
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    0
    0
    3
    Eyelid injury
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    1
    0
    3
    Face injury
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Facial bones fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Fall
         subjects affected / exposed
    11 / 226 (4.87%)
    8 / 216 (3.70%)
    5 / 211 (2.37%)
         occurrences all number
    18
    15
    5
    Fibula fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    0
    3
    0
    Foot fracture
         subjects affected / exposed
    2 / 226 (0.88%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    2
    2
    0
    Forearm fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Fracture
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Hand fracture
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    2
    1
    Head injury
         subjects affected / exposed
    7 / 226 (3.10%)
    5 / 216 (2.31%)
    6 / 211 (2.84%)
         occurrences all number
    12
    8
    11
    Incision site pain
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Injury
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Intentional overdose
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Jaw fracture
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Joint dislocation
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    2
    1
    0
    Joint injury
         subjects affected / exposed
    5 / 226 (2.21%)
    7 / 216 (3.24%)
    1 / 211 (0.47%)
         occurrences all number
    7
    7
    1
    Joint sprain
         subjects affected / exposed
    2 / 226 (0.88%)
    3 / 216 (1.39%)
    3 / 211 (1.42%)
         occurrences all number
    2
    4
    4
    Laceration
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    6
    1
    Ligament injury
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Ligament rupture
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Ligament sprain
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Limb injury
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    3 / 211 (1.42%)
         occurrences all number
    3
    1
    4
    Lip injury
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Multiple injuries
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle strain
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Open wound
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Overdose
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Periorbital haematoma
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Post procedural complication
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Post procedural swelling
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Post-traumatic pain
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Procedural pain
         subjects affected / exposed
    2 / 226 (0.88%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    2
    3
    0
    Radius fracture
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Rib fracture
         subjects affected / exposed
    3 / 226 (1.33%)
    3 / 216 (1.39%)
    0 / 211 (0.00%)
         occurrences all number
    4
    3
    0
    Road traffic accident
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Scratch
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Skeletal injury
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Skin laceration
         subjects affected / exposed
    8 / 226 (3.54%)
    8 / 216 (3.70%)
    4 / 211 (1.90%)
         occurrences all number
    12
    11
    4
    Skull fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Spinal compression fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Thermal burn
         subjects affected / exposed
    5 / 226 (2.21%)
    6 / 216 (2.78%)
    3 / 211 (1.42%)
         occurrences all number
    6
    7
    3
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Tongue injury
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    0
    3
    2
    Traumatic brain injury
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    2
    0
    1
    Traumatic haematoma
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Wrist fracture
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    2
    1
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac arrest
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Conduction disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Dilatation ventricular
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Palpitations
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Right ventricular hypertrophy
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus bradycardia
         subjects affected / exposed
    1 / 226 (0.44%)
    4 / 216 (1.85%)
    2 / 211 (0.95%)
         occurrences all number
    1
    6
    4
    Tachycardia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    1
    0
    2
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    3 / 226 (1.33%)
    6 / 216 (2.78%)
    3 / 211 (1.42%)
         occurrences all number
    5
    8
    4
    Aphasia
         subjects affected / exposed
    0 / 226 (0.00%)
    3 / 216 (1.39%)
    1 / 211 (0.47%)
         occurrences all number
    0
    3
    2
    Ataxia
         subjects affected / exposed
    4 / 226 (1.77%)
    10 / 216 (4.63%)
    11 / 211 (5.21%)
         occurrences all number
    4
    16
    16
    Balance disorder
         subjects affected / exposed
    4 / 226 (1.77%)
    8 / 216 (3.70%)
    8 / 211 (3.79%)
         occurrences all number
    5
    12
    14
    Basal ganglia infarction
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Burning sensation
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Carotid arteriosclerosis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Carpal tunnel syndrome
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    4
    3
    0
    Cerebellar syndrome
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    6
    1
    2
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Cognitive disorder
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    2 / 211 (0.95%)
         occurrences all number
    5
    3
    2
    Coordination abnormal
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    4 / 211 (1.90%)
         occurrences all number
    0
    2
    4
    Crying
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Decreased vibratory sense
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Disturbance in attention
         subjects affected / exposed
    5 / 226 (2.21%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    8
    2
    2
    Dizziness
         subjects affected / exposed
    62 / 226 (27.43%)
    60 / 216 (27.78%)
    67 / 211 (31.75%)
         occurrences all number
    110
    114
    122
    Dizziness postural
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Drooling
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Dysarthria
         subjects affected / exposed
    0 / 226 (0.00%)
    3 / 216 (1.39%)
    8 / 211 (3.79%)
         occurrences all number
    0
    5
    9
    Dysgeusia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Dysgraphia
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Dyskinesia
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    0
    0
    2
    Grand mal convulsion
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Head discomfort
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    0
    0
    4
    Headache
         subjects affected / exposed
    45 / 226 (19.91%)
    37 / 216 (17.13%)
    50 / 211 (23.70%)
         occurrences all number
    74
    73
    87
    Hemianopia homonymous
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Hemicephalalgia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperaesthesia
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Hypersomnia
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    0
    1
    3
    Hypoaesthesia
         subjects affected / exposed
    3 / 226 (1.33%)
    3 / 216 (1.39%)
    2 / 211 (0.95%)
         occurrences all number
    4
    6
    2
    Intention tremor
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Lethargy
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    3 / 211 (1.42%)
         occurrences all number
    2
    1
    3
    Loss of consciousness
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    1
    3
    1
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Memory impairment
         subjects affected / exposed
    5 / 226 (2.21%)
    3 / 216 (1.39%)
    6 / 211 (2.84%)
         occurrences all number
    8
    3
    9
    Migraine
         subjects affected / exposed
    3 / 226 (1.33%)
    1 / 216 (0.46%)
    3 / 211 (1.42%)
         occurrences all number
    16
    1
    6
    Monoparesis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Motor dysfunction
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    3
    0
    Myoclonus
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Nerve compression
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Neuralgia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Nystagmus
         subjects affected / exposed
    2 / 226 (0.88%)
    3 / 216 (1.39%)
    5 / 211 (2.37%)
         occurrences all number
    3
    5
    6
    Paraesthesia
         subjects affected / exposed
    3 / 226 (1.33%)
    2 / 216 (0.93%)
    6 / 211 (2.84%)
         occurrences all number
    4
    3
    9
    Partial seizures
         subjects affected / exposed
    20 / 226 (8.85%)
    10 / 216 (4.63%)
    12 / 211 (5.69%)
         occurrences all number
    21
    16
    15
    Partial seizures with secondary generalisation
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    1
    3
    0
    Peripheral nerve lesion
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Petit mal epilepsy
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Postictal headache
         subjects affected / exposed
    1 / 226 (0.44%)
    3 / 216 (1.39%)
    3 / 211 (1.42%)
         occurrences all number
    1
    6
    3
    Presyncope
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    2
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Sciatica
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    5
    0
    0
    Sedation
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    1
    2
    3
    Simple partial seizures
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Sinus headache
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Somnolence
         subjects affected / exposed
    35 / 226 (15.49%)
    30 / 216 (13.89%)
    44 / 211 (20.85%)
         occurrences all number
    50
    43
    66
    Speech disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    3
    1
    Status epilepticus
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Syncope
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    3 / 211 (1.42%)
         occurrences all number
    0
    1
    3
    Tension headache
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    2
    0
    1
    Tongue biting
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Toxic encephalopathy
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Tremor
         subjects affected / exposed
    10 / 226 (4.42%)
    10 / 216 (4.63%)
    12 / 211 (5.69%)
         occurrences all number
    14
    13
    21
    Tunnel vision
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Visual field defect
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    4
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 226 (2.21%)
    4 / 216 (1.85%)
    3 / 211 (1.42%)
         occurrences all number
    8
    4
    4
    Eosinophilia
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Granulocytopenia
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Leukocytosis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Lymphadenitis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Lymphocytosis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Lymphopenia
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Macrocytosis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Neutropenia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Pancytopenia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Polycythaemia
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Splenomegaly
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    0
    1
    2
    Deafness bilateral
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Deafness neurosensory
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Deafness unilateral
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Ear pain
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Hearing impaired
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Mastoid disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Motion sickness
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Tinnitus
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    1
    1
    3
    Vertigo
         subjects affected / exposed
    15 / 226 (6.64%)
    8 / 216 (3.70%)
    18 / 211 (8.53%)
         occurrences all number
    23
    14
    30
    Vertigo positional
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    2
    0
    Vestibular disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Eye disorders
    Abnormal sensation in eye
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Blepharitis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Cataract
         subjects affected / exposed
    2 / 226 (0.88%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    3
    4
    0
    Conjunctival ulcer
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 226 (0.00%)
    4 / 216 (1.85%)
    2 / 211 (0.95%)
         occurrences all number
    0
    5
    2
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Diplopia
         subjects affected / exposed
    17 / 226 (7.52%)
    26 / 216 (12.04%)
    28 / 211 (13.27%)
         occurrences all number
    23
    64
    51
    Dry eye
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Episcleritis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Eye irritation
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Eye pain
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    2
    Eye pruritus
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    2
    1
    1
    Eye swelling
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Eyelid oedema
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Glaucoma
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Keratitis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Macular degeneration
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Metamorphopsia
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Mydriasis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Ocular discomfort
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Oscillopsia
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Panophthalmitis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Photophobia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Pterygium
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Vision blurred
         subjects affected / exposed
    9 / 226 (3.98%)
    16 / 216 (7.41%)
    13 / 211 (6.16%)
         occurrences all number
    10
    26
    19
    Visual acuity reduced
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    1
    2
    2
    Visual impairment
         subjects affected / exposed
    4 / 226 (1.77%)
    4 / 216 (1.85%)
    1 / 211 (0.47%)
         occurrences all number
    5
    5
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 226 (0.00%)
    3 / 216 (1.39%)
    3 / 211 (1.42%)
         occurrences all number
    0
    5
    4
    Abdominal distension
         subjects affected / exposed
    1 / 226 (0.44%)
    3 / 216 (1.39%)
    2 / 211 (0.95%)
         occurrences all number
    1
    3
    2
    Abdominal pain
         subjects affected / exposed
    7 / 226 (3.10%)
    4 / 216 (1.85%)
    6 / 211 (2.84%)
         occurrences all number
    9
    10
    8
    Abdominal pain upper
         subjects affected / exposed
    8 / 226 (3.54%)
    5 / 216 (2.31%)
    6 / 211 (2.84%)
         occurrences all number
    11
    7
    6
    Anal fissure
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Colitis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    3
    0
    Colonic polyp
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    11 / 226 (4.87%)
    10 / 216 (4.63%)
    11 / 211 (5.21%)
         occurrences all number
    14
    12
    15
    Defaecation urgency
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Dental caries
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    1
    2
    0
    Diarrhoea
         subjects affected / exposed
    15 / 226 (6.64%)
    14 / 216 (6.48%)
    8 / 211 (3.79%)
         occurrences all number
    22
    24
    11
    Dry mouth
         subjects affected / exposed
    2 / 226 (0.88%)
    3 / 216 (1.39%)
    5 / 211 (2.37%)
         occurrences all number
    3
    5
    6
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    8 / 226 (3.54%)
    3 / 216 (1.39%)
    6 / 211 (2.84%)
         occurrences all number
    14
    5
    8
    Enteritis
         subjects affected / exposed
    3 / 226 (1.33%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Frequent bowel movements
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Gastric ulcer
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    6 / 226 (2.65%)
    5 / 216 (2.31%)
    2 / 211 (0.95%)
         occurrences all number
    7
    8
    3
    Gastrointestinal pain
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 226 (0.88%)
    3 / 216 (1.39%)
    2 / 211 (0.95%)
         occurrences all number
    2
    6
    3
    Gingival hyperplasia
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Gingivitis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Glossodynia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    2 / 226 (0.88%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    2
    3
    1
    Hypoaesthesia oral
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    2
    2
    2
    Infrequent bowel movements
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    2
    1
    Inguinal hernia
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Intestinal polyp
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Loose tooth
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    25 / 226 (11.06%)
    31 / 216 (14.35%)
    39 / 211 (18.48%)
         occurrences all number
    31
    41
    51
    Odynophagia
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Oesophagitis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Oral dysaesthesia
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Pancreatic atrophy
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Paraesthesia oral
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    2
    Periodontal disease
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    2
    1
    0
    Periodontitis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Retching
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Salivary gland calculus
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Sensitivity of teeth
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Tongue ulceration
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth loss
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Toothache
         subjects affected / exposed
    7 / 226 (3.10%)
    4 / 216 (1.85%)
    8 / 211 (3.79%)
         occurrences all number
    9
    5
    8
    Umbilical hernia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    14 / 226 (6.19%)
    16 / 216 (7.41%)
    29 / 211 (13.74%)
         occurrences all number
    19
    28
    37
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Liver disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    1
    4
    3
    Alopecia
         subjects affected / exposed
    2 / 226 (0.88%)
    4 / 216 (1.85%)
    1 / 211 (0.47%)
         occurrences all number
    3
    5
    1
    Blister
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Chloasma
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Dandruff
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    4
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    1
    1
    2
    Drug eruption
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Ecchymosis
         subjects affected / exposed
    2 / 226 (0.88%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    2
    3
    1
    Eczema
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    1
    2
    Erythema
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    2
    1
    0
    Hair texture abnormal
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    3
    0
    Heat rash
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    2
    2
    0
    Hypertrophic scar
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Hypoaesthesia facial
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Increased tendency to bruise
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Ingrowing nail
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Macule
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Photosensitivity reaction
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Polymorphic light eruption
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Pruritus
         subjects affected / exposed
    5 / 226 (2.21%)
    2 / 216 (0.93%)
    5 / 211 (2.37%)
         occurrences all number
    6
    3
    7
    Pruritus generalised
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Rash
         subjects affected / exposed
    6 / 226 (2.65%)
    5 / 216 (2.31%)
    8 / 211 (3.79%)
         occurrences all number
    10
    7
    8
    Rash erythematous
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Rash generalised
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Rash macular
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Rash papular
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Rash pruritic
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Rash vesicular
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Scab
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Scar
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Seborrhoea
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Skin disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Skin exfoliation
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Skin lesion
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Skin ulcer
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Swelling face
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Urticaria
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    2
    1
    0
    Renal and urinary disorders
    Bladder prolapse
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Chromaturia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Dysuria
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Haematuria
         subjects affected / exposed
    4 / 226 (1.77%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    6
    0
    1
    Hypertonic bladder
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    3
    0
    2
    Micturition urgency
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    5 / 226 (2.21%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    8
    2
    4
    Nocturia
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Pollakiuria
         subjects affected / exposed
    3 / 226 (1.33%)
    2 / 216 (0.93%)
    1 / 211 (0.47%)
         occurrences all number
    4
    4
    2
    Renal colic
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Renal failure
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    3
    0
    1
    Renal failure acute
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Urethral pain
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary hesitation
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    2
    1
    0
    Goitre
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Hyperthyroidism
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Hypogonadism
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Hypothyroidism
         subjects affected / exposed
    7 / 226 (3.10%)
    9 / 216 (4.17%)
    5 / 211 (2.37%)
         occurrences all number
    10
    16
    11
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 226 (2.65%)
    5 / 216 (2.31%)
    2 / 211 (0.95%)
         occurrences all number
    12
    9
    2
    Axillary mass
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Back pain
         subjects affected / exposed
    14 / 226 (6.19%)
    13 / 216 (6.02%)
    5 / 211 (2.37%)
         occurrences all number
    22
    24
    6
    Bone metabolism disorder
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    3 / 211 (1.42%)
         occurrences all number
    0
    0
    5
    Bone pain
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Bursitis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Coccydynia
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Finger deformity
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Flank pain
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    1
    2
    0
    Groin pain
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    0
    1
    3
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    3
    1
    2
    Joint contracture
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Joint instability
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    4 / 226 (1.77%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    6
    1
    1
    Muscular weakness
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    2 / 211 (0.95%)
         occurrences all number
    4
    4
    3
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    2
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    2
    1
    Musculoskeletal pain
         subjects affected / exposed
    9 / 226 (3.98%)
    3 / 216 (1.39%)
    2 / 211 (0.95%)
         occurrences all number
    19
    3
    2
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Myalgia
         subjects affected / exposed
    5 / 226 (2.21%)
    6 / 216 (2.78%)
    5 / 211 (2.37%)
         occurrences all number
    8
    12
    9
    Myokymia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Neck pain
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    8 / 211 (3.79%)
         occurrences all number
    2
    1
    10
    Osteoarthritis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Osteomalacia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Osteonecrosis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Osteopenia
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    2
    0
    Osteoporosis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    8 / 226 (3.54%)
    6 / 216 (2.78%)
    3 / 211 (1.42%)
         occurrences all number
    16
    12
    3
    Pain in jaw
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Periarthritis
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Posture abnormal
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Sjogren's syndrome
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    3
    0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    2
    2
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Tendon pain
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Tendonitis
         subjects affected / exposed
    3 / 226 (1.33%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    4
    0
    3
    Tenosynovitis stenosans
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Trigger finger
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Acute sinusitis
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Acute tonsillitis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Bacterial infection
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Bacteriuria
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Bronchitis
         subjects affected / exposed
    6 / 226 (2.65%)
    4 / 216 (1.85%)
    2 / 211 (0.95%)
         occurrences all number
    7
    5
    2
    Candidiasis
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    2
    1
    0
    Cellulitis
         subjects affected / exposed
    2 / 226 (0.88%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    3
    2
    0
    Cystitis
         subjects affected / exposed
    0 / 226 (0.00%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Ear infection
         subjects affected / exposed
    3 / 226 (1.33%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    6
    0
    0
    Erysipelas
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Eye infection
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    2
    Fungal infection
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    2
    0
    Furuncle
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Gastroenteritis
         subjects affected / exposed
    3 / 226 (1.33%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    4
    1
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Genital infection female
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Gingival abscess
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Gingival infection
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatitis C
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    3
    0
    Herpes zoster
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    1
    2
    0
    Hordeolum
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    1
    0
    1
    Infection
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Influenza
         subjects affected / exposed
    12 / 226 (5.31%)
    10 / 216 (4.63%)
    9 / 211 (4.27%)
         occurrences all number
    16
    11
    11
    Labyrinthitis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Laryngitis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Localised infection
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    2
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Nail infection
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    25 / 226 (11.06%)
    21 / 216 (9.72%)
    13 / 211 (6.16%)
         occurrences all number
    38
    31
    19
    Onychomycosis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    1
    1
    Otitis externa
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Papilloma viral infection
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    2
    1
    0
    Pharyngitis
         subjects affected / exposed
    9 / 226 (3.98%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    16
    2
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    1
    1
    3
    Postoperative wound infection
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    3
    1
    2
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    2 / 211 (0.95%)
         occurrences all number
    0
    1
    2
    Rhinitis
         subjects affected / exposed
    5 / 226 (2.21%)
    4 / 216 (1.85%)
    0 / 211 (0.00%)
         occurrences all number
    5
    6
    0
    Sepsis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    4 / 226 (1.77%)
    2 / 216 (0.93%)
    3 / 211 (1.42%)
         occurrences all number
    5
    2
    4
    Skin infection
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Tinea cruris
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Tinea infection
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Tinea pedis
         subjects affected / exposed
    1 / 226 (0.44%)
    2 / 216 (0.93%)
    0 / 211 (0.00%)
         occurrences all number
    3
    4
    0
    Tonsillitis
         subjects affected / exposed
    3 / 226 (1.33%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    3
    1
    1
    Tonsillitis bacterial
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    0
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 226 (3.98%)
    10 / 216 (4.63%)
    8 / 211 (3.79%)
         occurrences all number
    13
    17
    8
    Urethritis trichomonal
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    10 / 226 (4.42%)
    14 / 216 (6.48%)
    6 / 211 (2.84%)
         occurrences all number
    14
    18
    9
    Vaginal infection
         subjects affected / exposed
    3 / 226 (1.33%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    3
    2
    0
    Vaginitis bacterial
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Viral infection
         subjects affected / exposed
    4 / 226 (1.77%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    4
    0
    0
    Viral sinusitis
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    10 / 226 (4.42%)
    7 / 216 (3.24%)
    8 / 211 (3.79%)
         occurrences all number
    13
    10
    10
    Dehydration
         subjects affected / exposed
    1 / 226 (0.44%)
    3 / 216 (1.39%)
    2 / 211 (0.95%)
         occurrences all number
    1
    3
    2
    Diabetes mellitus
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    3
    0
    0
    Dyslipidaemia
         subjects affected / exposed
    2 / 226 (0.88%)
    6 / 216 (2.78%)
    7 / 211 (3.32%)
         occurrences all number
    3
    9
    13
    Food craving
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    2
    0
    Gout
         subjects affected / exposed
    0 / 226 (0.00%)
    0 / 216 (0.00%)
    1 / 211 (0.47%)
         occurrences all number
    0
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    5 / 226 (2.21%)
    2 / 216 (0.93%)
    3 / 211 (1.42%)
         occurrences all number
    10
    4
    5
    Hyperglycaemia
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperlipidaemia
         subjects affected / exposed
    2 / 226 (0.88%)
    0 / 216 (0.00%)
    3 / 211 (1.42%)
         occurrences all number
    3
    0
    6
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    2
    1
    0
    Hypochloraemia
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    1
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    0
    1
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 226 (0.44%)
    3 / 216 (1.39%)
    1 / 211 (0.47%)
         occurrences all number
    1
    3
    2
    Hyponatraemia
         subjects affected / exposed
    7 / 226 (3.10%)
    8 / 216 (3.70%)
    10 / 211 (4.74%)
         occurrences all number
    7
    11
    11
    Hypophagia
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Increased appetite
         subjects affected / exposed
    2 / 226 (0.88%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    3
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 226 (0.44%)
    0 / 216 (0.00%)
    0 / 211 (0.00%)
         occurrences all number
    2
    0
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    1 / 211 (0.47%)
         occurrences all number
    1
    1
    1
    Vitamin D deficiency
         subjects affected / exposed
    1 / 226 (0.44%)
    1 / 216 (0.46%)
    3 / 211 (1.42%)
         occurrences all number
    2
    4
    3
    Weight loss poor
         subjects affected / exposed
    0 / 226 (0.00%)
    1 / 216 (0.46%)
    0 / 211 (0.00%)
         occurrences all number
    0
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2009
    Global Protocol Amendment #1: Reason for amendment: The following parts are adapted/changed: -Inclusion Criteria -Exclusion Criteria -Volume of Blood Samples -Adverse Events -Serious Adverse Events -Pregnancies -Special cases reporting -Withdrawal Criteria -Number of Study Sites -Patient Treatment Unblinding -Laboratory tests -Introduction -Taper off strategy -First intake of medication -Warnings -Scales and questionnaires -Data collection, verification and coding -Update of Investigator Brochure -Country specific changes will be implemented as country specific protocol amendments in countries with existing country specific protocol amendments (Germany and Argentina). -Contact Details Medical Monitor changed
    01 Dec 2009
    Global Protocol Amendment #2: Reason for amendment: 1. A Sponsor for North America is introduced and additional personnel details included. “The Sponsor” now refers to either BIAL (Europe and South America) or Sepracor (North America). 2. The United States (US) and Canada are included in the list of participating countries and the number of sites increased. 3. The drug code used by the North America Sponsor is added. 4. The dosing schedule diagram is clarified. 5. Contact by telephone is added between V5 and V6. 6. The primary and secondary efficacy analyses are clarified as “change of seizure frequency” rather than “seizure frequency”. 7. In the inclusion criteria, a requirement for patients aged 16 to 18 years in North America to sign an assent is added. 8. Stratification by region (North America versus Europe and South America) is introduced in Section 5 and Section 11.2.2 is amended accordingly. 9. Section 6 is divided so that drug formulation, labelling, storage and packaging information specific to North America is included in addition to specific information for Europe and South America. 10. A fax number in the US for reporting SAEs occurring in North America is added in Section 10.7. 11. New details on objective findings are added in Section 10.9. 12. Details relating to financial disclosure are added in Section 12.2. 13. Information on computerised systems used in the US is included in Section 12.6 and Appendix I. 14. North America-specific information on patient confidentiality is added in Section 13.9. 15. Independent Ethics Committee (IEC) is amended to IEC/Institutional Review Board (IRB) throughout the protocol.
    16 Sep 2010
    "Global Protocol Amendment #3: Reason for amendment: 1. Updated guidelines for titration steps for Part III 2. Vagus nerve stimulation is not counted as anti-epileptic drug 3. Serum sodium <125 mmol/L was included as a withdrawal criterion 4. Clarification for exclusion criteria for history of schizophrenia 5. Added an option to reduce the dose of concomitant carbamazepine 6. Screening for presence of HLA-B*1502 allele in patients of Asian ancestry is exclusion criterion 7. Number of patients to be enrolled and number of sites and countries updated 8. Exclusion criteria participation in previous Eslicarbazepine acetate trials or other clinical trials is modified 9. Change in Pharmanet and Bial/Sepracor study personnel information 10. Updated wording for primary and secondary endpoints 11. Seizure diary adapted to require diary entries every day, regardless of whether a seizure had occurred 12. Changed the procedure for collecting seizure data from the diaries 13. Increased sample size 14. Updated definition of analysis populations 15. Provided specificity on definition of baseline and maintenance periods 16. Updated wording of efficacy endpoints 17. Updated statistical methodology 18. Separate analyses for patients who used Event Entry diaries and Daily Entry diaries will be performed 19. Added Columbia Suicide Severity Rating Scale assessment throughout the protocol 20. Added post-treatment assessment of withdrawal symptoms, adverse events and seizure worsening 21. Added telephone contact 3 to occur approximately 3 weeks prior to Post-study visit 22. Clarification regarding randomization patients with at least 3 partial-onset seizures in a 4-week section of the baseline period 23. Patients must have no seizure-free interval exceeding 28 consecutive days during the baseline period
    15 Feb 2011
    Global Protocol Amendment #4 Reason for amendment - Additional 2-year open-label extension (Part III) - Changes in footnotes - Added text that in Discontinuation visit/EDV dispensing of investigational product will occur for patients performing down titration only - Revised ROW Safety contact at CRO - Additional secondary objective added - Changes in maximum number of patients allowed to be recruited per site - Corrected spelling of the word preceded. - Adaption in Study Flow Chart - Inclusion criterion 7 adapted - Criterion 11 corrected - Part III to section patient enrolment and randomisation added - Clarification that “dispensed” bottles will contain sufficient Eslicarbazepine acetate tablets for the subsequent period before next visit plus 2 extra weeks. - Addition of text for rescue medication. - Clarification that seizure diaries will be kept only for Part I and Part II of the study. - Clarification when CGI ratings will be performed - Clarification that the CSSRS scale will be administered by the study personnel - Added medication accountability to Post-Study visit. - Revision of Edition and date of Bial’s Investigator’s Brochure information - Revision of Edition and date of Sepracor’s Investigator’s Brochure information - Update of name and webadress due to namechange of Sepracor Inc. - Revised telephone number for Pharmanet Project manager - Information of collected data in Part III and planned analysis updatedalysis of CGI, retention rates and AEs and that other analysis might be planned.
    28 Jul 2011
    Global Protocol Amendment #5 Reason for amendment - Modifications in section Study Drug Dosage, Administration and Schedule - Clarification of section Previous and Concomitant Therapy and Rescue Medication - Complement to section Previous and Concomitant Therapy and Rescue Medication - Complement to section Study Procedures for Safety and Efficacy Evaluations - Complement to section Evaluations and Procedures by Visit - Changes in section Criteria for Patient Withdrawal - Changes in section for Serious Adverse Events - Complement to section Statistical Methods - Changes in section Administrative revisions - Minor copy revisions to ensure proper format and consistency

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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