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    Clinical Trial Results:
    Long-Term Eslicarbazepine Acetate Extension Study

    Summary
    EudraCT number
    		 2010-019000-22
    Trial protocol
    		 CZ   ES   PL   BG  
    Global end of trial date
    15 Apr 2017

    Results information
    Results version number
    		 v3(current)
    This version publication date
    24 Aug 2018
    First version publication date
    29 Apr 2018
    Other versions
    		 v1 , v2
    Version creation reason
    • New data added to full data set
    updating with new information
    Summary report(s)
    		 update results to match ct.gov

    Trial information

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    Trial identification
    Sponsor protocol code
    093-050
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00910247
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sunovion Pharmaceuticals Inc.
    Sponsor organisation address
    84 Waterford Drive, Marlboro, United States, 01752
    Public contact
    CNS Medical Director, Sunovion Pharmaceuticals Inc., 1 866-503-6351, clinicaltrialsdisclosure@sunovion.com
    Scientific contact
    CNS Medical Direcctor, Sunovion Pharmaceuticals Inc., 1 866-503-6351, clinicaltrialsdisclosure@sunovion.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
    15 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the 1-year and post-1-year safety and tolerability of eslicarbazepine acetate flexible dosing within the range of 800 mg to 2400 mg in subjects with partial epilepsy who have participated in an 18-week double-blind eslicarbazepine acetate monotherapy study (Protocols 093-045 or 093-046).
    Protection of trial subjects
    This study was conducted according to the protocol, ICH Good Clinical Practice (GCP), ICH guidelines and the ethical principles that have their origin in the Declaration of Helsinki
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2009
    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
    Bulgaria: 18
    Country: Number of subjects enrolled
    Czech Republic: 27
    Country: Number of subjects enrolled
    United States: 167
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Serbia: 2
    Country: Number of subjects enrolled
    Ukraine: 57
    Worldwide total number of subjects
    274
    EEA total number of subjects
    45
    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)
    12
    Adults (18-64 years)
    258
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who participated in either study 093-045 (NCT00866775)or study 093-046 (NCT01091662) were eligible to participate in study 093-050

    Pre-assignment
    Screening details
    		 Subjects who completed the 18-week treatment period or exited the study per protocol may be eligible to participate. Subjects who discontinued for reasons other than reaching the exit criteria may be eligible if there is no safety concern, however, subjects must have completed at least the first 3 weeks of the 18-week doubleblind treatment

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 eslicarbazepine acetate
    Arm description
    		 Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
    Arm type
    		 Experimental

    Investigational medicinal product name
    eslicarbazepine acetate
    Investigational medicinal product code
    Other name
    DRP-0002093, BIA 2-093
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800 to 2400 mg once daily (QD)

    Number of subjects in period 1
    		eslicarbazepine acetate
    Started
    274
    Completed
    205
    Not completed
    69
         Adverse event, serious fatal
    2
         Physician decision
    3
         Consent withdrawn by subject
    25
         Adverse event, non-fatal
    15
         Not Collected
    4
         Lost to follow-up
    10
         Protocol deviation
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 274 274
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 12 12
        Adults (18-64 years)
    		 258 258
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.9 ( 12.70 ) -
    Gender categorical
    Units: Subjects
        Female
    		 134 134
        Male
    		 140 140

    End points

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    End points reporting groups
    Reporting group title
    eslicarbazepine acetate
    Reporting group description
    		 Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

    Primary: Number and percent of subjects with treatment emergent adverse events

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    End point title
    		 Number and percent of subjects with treatment emergent adverse events [1]
    End point description
    Number and percent of subjects with treatment emergent adverse events
    End point type
    Primary
    End point timeframe
    One year
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no statistical analysis is required for this endpoint
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    274
    Units: subjects
    220
    No statistical analyses for this end point

    Secondary: Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations

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    End point title
    		 Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations
    End point description
    End point type
    Secondary
    End point timeframe
    One Year
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    274
    Units: subjects
    186
    No statistical analyses for this end point

    Secondary: Number and percent of subjects with normal baseline sodium reaching blood sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L

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    End point title
    		 Number and percent of subjects with normal baseline sodium reaching blood sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L
    End point description
    Number and percentage of subjects who had normal sodium value (i.e. >135 mEq/L) at baseline but reached <=135 mEq/L and >130 mEq/L, <=130 mEq/L and >125 mEq/L, or <=125 mEq/L at any post baseline.
    End point type
    Secondary
    End point timeframe
    One year
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    261
    Units: subjects
        ≤135 mmol/L
    48
        ≤130 mmol/L
    22
        ≤125 mmol/L
    4
    No statistical analyses for this end point

    Secondary: Proportion (%) of subjects with increase of body weight ≥7%

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    End point title
    		 Proportion (%) of subjects with increase of body weight ≥7%
    End point description
    End point type
    Secondary
    End point timeframe
    One year
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    274
    Units: percentage of participants
    27
    No statistical analyses for this end point

    Secondary: Number and percentage of subjects with orthostatic effects

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    End point title
    		 Number and percentage of subjects with orthostatic effects
    End point description
    End point type
    Secondary
    End point timeframe
    One year
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    274
    Units: subjects
    67
    No statistical analyses for this end point

    Secondary: Number and percentage of subjects with QTc-F changes (in categories) from baseline.

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    End point title
    		 Number and percentage of subjects with QTc-F changes (in categories) from baseline.
    End point description
    Based on the numbers of subjects who had at least one post-baseline assessment, the number and percentage of subjects with QTcF values in the following categories were summarized: 1. >500 millisecond (msec) at any post-baseline timepoint but not present at baseline 2. >480 msec at any post-baseline timepoint but not present at baseline 3.>450 msec at any post-baseline timepoint but not present at baseline 4. Change from Baseline >=60 ms for at least one post-baseline measurement 5. Change from Baseline >=30 ms for at least one post-baseline measurement and <60 ms for all post-baseline measurement
    End point type
    Secondary
    End point timeframe
    baseline, month 12
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    272
    Units: subjects
        >500ms at any postbaseline not present at baseline
    0
        >450ms at any postbaseline not present at baseline
    9
        >480ms at any postbaseline not present at baseline
    1
        CFB >=60 ms for at least one post-baseline
    0
        CFB>=30ms for at least one &<60ms for all PBL
    42
    No statistical analyses for this end point

    Secondary: Proportion (%) of events in each classification of the Columbia Suicide Severity Rating Scale (C SSRS)

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    End point title
    		 Proportion (%) of events in each classification of the Columbia Suicide Severity Rating Scale (C SSRS)
    End point description
    The C-SSRS is an instrument designed to systematically assess and track suicidal behavior and suicidal ideation. The C-SSRS will be completed by the Investigator or Sub-Investigator (or qualified site personnel). Suicidal ideation is collected as any occurrence of wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, active suicidal ideation with specific plan and intent. Suicidal behavior is collected as any occurrence of actual attempts, Non-Suicidal Self-Injurious Behavior, interrupted attempts, aborted attempts, or preparatory acts or behavior, suicidal behavior. Any suicidality is defined as having at least one occurrence of Suicidal Behavior or Suicidal Ideation.
    End point type
    Secondary
    End point timeframe
    One year
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    274
    Units: percentage of events
        Any Suicidality
    4
        Any suicidal behavior
    0
        any suicidal ideation
    3
    No statistical analyses for this end point

    Secondary: Responder rate (proportion [%] of subjects with a ≥50% reduction of seizure frequency from baseline)

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    End point title
    		 Responder rate (proportion [%] of subjects with a ≥50% reduction of seizure frequency from baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    One year
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    274
    Units: percentage of participants
    62
    No statistical analyses for this end point

    Secondary: Proportion (%) of subjects that are seizure-free during study

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    End point title
    		 Proportion (%) of subjects that are seizure-free during study
    End point description
    End point type
    Secondary
    End point timeframe
    One year
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    274
    Units: percentage of participants
    7
    No statistical analyses for this end point

    Secondary: Completion rate (% of subjects completing the one year treatment)

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    End point title
    		 Completion rate (% of subjects completing the one year treatment)
    End point description
    End point type
    Secondary
    End point timeframe
    One Year
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    274
    Units: percentage of participants
    74
    No statistical analyses for this end point

    Secondary: Change in total score from baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31)

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    End point title
    		 Change in total score from baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31)
    End point description
    Change in the overall score from baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31 ) The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.
    End point type
    Secondary
    End point timeframe
    baseline and month 12
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    274
    Units: change in score
        arithmetic mean (standard deviation)
    6.6 ( 15.29 )
    No statistical analyses for this end point

    Secondary: Change in total score from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)

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    End point title
    		 Change in total score from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
    End point description
    The total score of MADRS is defined as the sum of all individual item scores. Each of the 10 symptoms of depression on MADRS is measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity.
    End point type
    Secondary
    End point timeframe
    One year
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    274
    Units: change in score
        arithmetic mean (standard deviation)
    -1.5 ( 6.17 )
    No statistical analyses for this end point

    Secondary: Change in total score from baseline in MADRS in those subjects with a MADRS score of ≥14 at screening

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    End point title
    		 Change in total score from baseline in MADRS in those subjects with a MADRS score of ≥14 at screening
    End point description
    The total score of MADRS is defined as the sum of all individual item scores . Each of the 10 symptoms of depression on MADRS is measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity.
    End point type
    Secondary
    End point timeframe
    baseline and month 12
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    274
    Units: change in score
        arithmetic mean (standard deviation)
    -9.4 ( 5.69 )
    No statistical analyses for this end point

    Secondary: Completion rate (% of subjects completing each visit post-one year)

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    End point title
    		 Completion rate (% of subjects completing each visit post-one year)
    End point description
    End point type
    Secondary
    End point timeframe
    One year
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    198
    Units: percentage of participants
    67
    No statistical analyses for this end point

    Secondary: Time on esclicarbazepine acetate monotherapy

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    End point title
    		 Time on esclicarbazepine acetate monotherapy
    End point description
    The start of the monotherapy period was defined as the date of termination of all other anti-epileptic drugs while taking study medication. Time on eslicarbazepine acetate monotherapy is defined from the date of the first monotherapy dose in 093-045 or 093-046 study to the last known dose of monotherapy treatment, regardless of dose change and the time gap between the parent studies and the current study.
    End point type
    Secondary
    End point timeframe
    One year
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    238
    Units: days
        median (confidence interval 95%)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Change in seizure frequency from baseline

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    End point title
    		 Change in seizure frequency from baseline
    End point description
    Relative (%) change in standard seizure frequency(SSF) from baseline
    End point type
    Secondary
    End point timeframe
    month 12 from baseline
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    274
    Units: percent change
        median (inter-quartile range (Q1-Q3))
    -66.4 (-88.8 to -32.3)
    No statistical analyses for this end point

    Secondary: Treatment retention time (time to withdrawal due to lack of efficacy or adverse events)

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    End point title
    		 Treatment retention time (time to withdrawal due to lack of efficacy or adverse events)
    End point description
    The retention time is defined from the start of eslicarbazepine acetate monotherapy period in 093-045 or 093-046 to the last known dose of open-label eslicarbazepine acetate. The time may include taking eslicarbazepine acetate concomitantly with other anti-epileptic drugs. If a subject’s termination reason(s) includes: withdrawal of consent, lost to follow-up, physician decision or other, then it was assumed the subject terminated the study due to lack of efficacy.
    End point type
    Secondary
    End point timeframe
    One year
    End point values
    		 eslicarbazepine acetate
    Number of subjects analysed
    255
    Units: days
        median (confidence interval 95%)
    0 (0 to 0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    One year
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    eslicarbazepine acetate
    Reporting group description
    		 Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

    Serious adverse events
    		 eslicarbazepine acetate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    32 / 274 (11.68%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    fallopian tube cancer
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    non-small cel lung cancer metastatic
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    ovarian cancer
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    accelerated hypertensionaccelerated hypertension
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    irritability
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    non-cardiac chest pain
         subjects affected / exposed
    3 / 274 (1.09%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    sudden unexplained death in epilepsy
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    emphysema
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    depression
         subjects affected / exposed
    2 / 274 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    suicidal ideation
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    electroencephalogram
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    accidental overdose
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    collapse of lung
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    fall
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    post concussion syndrome
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Therapeutic agent toxicity
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    sinus tachycardia
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    akathisia
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    complex partial seizures
         subjects affected / exposed
    3 / 274 (1.09%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    grand mal convulsion
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    partial seizures with secondary generalisation
         subjects affected / exposed
    7 / 274 (2.55%)
         occurrences causally related to treatment / all
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    postictal paralysis
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    simple partial seizures
         subjects affected / exposed
    2 / 274 (0.73%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    status epilepticus
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    vertigo
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    abdominal pain upper
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    colitis
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    pancreatitis
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    vomiting
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    cholelithiasis obstructive
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    histoplasmosis
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    pneumonia
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    tooth infection
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    nephrolithiasis
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    arthritis
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    muscle twitching
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    chronic sinusitis
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    failure to thrive
         subjects affected / exposed
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 eslicarbazepine acetate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    167 / 274 (60.95%)
    Injury, poisoning and procedural complications
    fall
         subjects affected / exposed
    20 / 274 (7.30%)
         occurrences all number
    33
    Nervous system disorders
    complex partial seizures
         subjects affected / exposed
    14 / 274 (5.11%)
         occurrences all number
    18
    dizziness
         subjects affected / exposed
    46 / 274 (16.79%)
         occurrences all number
    81
    headache
         subjects affected / exposed
    64 / 274 (23.36%)
         occurrences all number
    114
    General disorders and administration site conditions
    fatigue
         subjects affected / exposed
    23 / 274 (8.39%)
         occurrences all number
    25
    Gastrointestinal disorders
    diarrhoea
         subjects affected / exposed
    15 / 274 (5.47%)
         occurrences all number
    19
    nausea
         subjects affected / exposed
    24 / 274 (8.76%)
         occurrences all number
    31
    vomiting
         subjects affected / exposed
    16 / 274 (5.84%)
         occurrences all number
    20
    Psychiatric disorders
    depression
         subjects affected / exposed
    18 / 274 (6.57%)
         occurrences all number
    19
    insomnia
         subjects affected / exposed
    15 / 274 (5.47%)
         occurrences all number
    18
    Musculoskeletal and connective tissue disorders
    back pain
         subjects affected / exposed
    16 / 274 (5.84%)
         occurrences all number
    16
    Infections and infestations
    influenza
         subjects affected / exposed
    14 / 274 (5.11%)
         occurrences all number
    15
    nasopharyngitis
         subjects affected / exposed
    24 / 274 (8.76%)
         occurrences all number
    35

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

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