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    Clinical Trial Results:
    A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures. Followed by an Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2008-005098-37
    Trial protocol
    		 BE   FI   DE   SE   NL   ES   IT  
    Global end of trial date
    31 Aug 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    02 Jun 2016
    First version publication date
    06 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    CARISEPY3013/CARISEPY3014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Cilag International, NV
    Sponsor organisation address
    Archimedsweg 29-2333CM, Leiden, Netherlands,
    Public contact
    Clinical Registry Group, Clinical Registry Group, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000360-PIP01-08
    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
    31 Aug 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study (CARISEPY3013) was to evaluate the effectiveness, safety, and tolerability of carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy. The Primary objective of this study study (CARISEPY3014) was to provide long-term safety and tolerability information on carisbamate as add-on therapy for the treatment of partial onset seizures in subjects with epilepsy. CARISEPY3014/CARISEPY3013 is the open-label extension study that follows the double-blind study .
    Protection of trial subjects
    The safety assessments included the incidence and severity of Adverse events (AEs),laboratory safety (hematology, serum chemistry and urinalysis), 12-lead Electrocardiogram (ECG),vital signs, physical and neurological examinations, and seizure rates, Quality of Life in Epilepsy-31 Problems (QOLIE-31-P) and Medical Resource Utilization (MRU) responses were assessed throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Nov 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 22
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    Croatia: 12
    Country: Number of subjects enrolled
    Finland: 8
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Hong Kong: 15
    Country: Number of subjects enrolled
    India: 49
    Country: Number of subjects enrolled
    Italy: 31
    Country: Number of subjects enrolled
    Lithuania: 12
    Country: Number of subjects enrolled
    Mexico: 21
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 93
    Country: Number of subjects enrolled
    Russian Federation: 68
    Country: Number of subjects enrolled
    Serbia: 12
    Country: Number of subjects enrolled
    Singapore: 8
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    Sweden: 5
    Country: Number of subjects enrolled
    Taiwan: 28
    Country: Number of subjects enrolled
    Thailand: 37
    Country: Number of subjects enrolled
    United States: 52
    Worldwide total number of subjects
    547
    EEA total number of subjects
    142
    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)
    518
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 547 subjects were assigned into 3 groups in a 1:1:1 ratio to receive either 800 milligram per day [mg/day] carisbamate, 1,200 mg/day carisbamate, or placebo for 14 weeks in Phase 1 of study and Total of 402 Subjects were enrolled into the Phase 2 (open-label extension) of the study, received study drug, and were included in the safety population

    Period 1
    Period 1 title
    Double-Blind Treatment (Day 1 to 99)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo to carisbamate [CRS] for 14 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for 14 weeks

    Arm title
    		 Carisbamate [CRS] 800 mg
    Arm description
    		 In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 to 14, the dosage was increase to 800 mg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 to 14, the dosage was increase to 800 mg/day.

    Arm title
    		 Carisbamate [CRS] 1200 mg
    Arm description
    		 In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day],and in Week 2 the dosage was increase to 800 mg/day. In Weeks 3 to 14 of the maintenance period, dosage increased to 1,200 mg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 the dosage was increase to 800 mg/day. In Weeks 3 to 14 of the maintenance period, dosage increased to 1,200 mg/day.

    Number of subjects in period 1
    		Placebo Carisbamate [CRS] 800 mg Carisbamate [CRS] 1200 mg
    Started
    185
    180
    182
    Completed
    164
    144
    126
    Not completed
    21
    36
    56
         Consent withdrawn by subject
    5
    9
    9
         Adverse event, non-fatal
    6
    14
    30
         Other
    5
    3
    6
         Adverse event, serious non-fatal
    1
    3
    5
         Lost to follow-up
    2
    1
    1
         Protocol deviation
    2
    5
    4
         Lack of efficacy
    -
    1
    1
    Period 2
    Period 2 title
    Open-Label Phase
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Carisbamate less than (<) 400 milligram (mg)
    Arm description
    		 subjects received modal dose of Carisbamate less than 400 milligram (mg) per day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    subjects who received carisbamate less than (<) 400 milligram (mg) in double blind phase.

    Investigational medicinal product name
    Carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    subjects who received carisbamate less than (<) 400 milligram (mg) in double blind phase

    Arm title
    		 Carisbamate 400- less than (<) 600 milligram (mg)
    Arm description
    		 subjects received modal dose of Carisbamate 400 to less than 600 milligram (mg) per day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    subjects who received carisbamate 400 - less than (<) 600 milligram (mg) in double blind phase.

    Arm title
    		 Carisbamate 600-800 milligram (mg)
    Arm description
    		 Subjects received modal dose of Carisbamate 600 to 800 milligram (mg) per day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    subjects who received carisbamate 600 to 800 milligram (mg) in double blind phase.

    Arm title
    		 Carisbamate greater than (>) 800-1000 milligram (mg)
    Arm description
    		 subjects received modal dose of Carisbamate greater than 800 to 1000 milligram (mg) per day
    Arm type
    		 Experimental

    Investigational medicinal product name
    carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    subjects who received carisbamate greater than (>) 800-1000 milligram (mg) in double blind phase .

    Arm title
    		 Carisbamate greater than (>) 1000-1200 milligram (mg)
    Arm description
    		 subjects received modal dose of Carisbamate greater than 1000 to 1200 milligram (mg) per day
    Arm type
    		 Experimental

    Investigational medicinal product name
    carisbamate
    Investigational medicinal product code
    RWJ-333369
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    subjects who received carisbamate greater than (>) 1000-1200 milligram (mg) in double blind phase

    Number of subjects in period 2
    		Carisbamate less than (<) 400 milligram (mg) Carisbamate 400- less than (<) 600 milligram (mg) Carisbamate 600-800 milligram (mg) Carisbamate greater than (>) 800-1000 milligram (mg) Carisbamate greater than (>) 1000-1200 milligram (mg)
    Started
    4
    32
    203
    51
    112
    Completed
    4
    26
    167
    49
    94
    Not completed
    0
    6
    36
    2
    18
         Consent withdrawn by subject
    -
    2
    18
    -
    5
         Adverse event, non-fatal
    -
    3
    8
    -
    3
         Other
    -
    -
    -
    -
    1
         Pregnancy
    -
    -
    -
    -
    1
         Lost to follow-up
    -
    -
    2
    -
    -
         Lack of efficacy
    -
    1
    8
    1
    8
         Protocol deviation
    -
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to carisbamate [CRS] for 14 weeks.

    Reporting group title
    Carisbamate [CRS] 800 mg
    Reporting group description
    		 In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 to 14, the dosage was increase to 800 mg/day.

    Reporting group title
    Carisbamate [CRS] 1200 mg
    Reporting group description
    		 In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day],and in Week 2 the dosage was increase to 800 mg/day. In Weeks 3 to 14 of the maintenance period, dosage increased to 1,200 mg/day.

    Reporting group values
    		 Placebo Carisbamate [CRS] 800 mg Carisbamate [CRS] 1200 mg Total
    Number of subjects
    		 185 180 182 547
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 4 6 9 19
        Adults (18-64 years)
    		 177 171 170 518
        From 65 to 84 years
    		 4 3 3 10
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.6 ( 12.18 ) 36.8 ( 12.02 ) 36.8 ( 12.53 ) -
    Title for Gender
    Units: subjects
        Female
    		 96 92 90 278
        Male
    		 89 88 92 269

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to carisbamate [CRS] for 14 weeks.

    Reporting group title
    Carisbamate [CRS] 800 mg
    Reporting group description
    		 In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 to 14, the dosage was increase to 800 mg/day.

    Reporting group title
    Carisbamate [CRS] 1200 mg
    Reporting group description
    		 In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day],and in Week 2 the dosage was increase to 800 mg/day. In Weeks 3 to 14 of the maintenance period, dosage increased to 1,200 mg/day.
    Reporting group title
    Carisbamate less than (<) 400 milligram (mg)
    Reporting group description
    		 subjects received modal dose of Carisbamate less than 400 milligram (mg) per day

    Reporting group title
    Carisbamate 400- less than (<) 600 milligram (mg)
    Reporting group description
    		 subjects received modal dose of Carisbamate 400 to less than 600 milligram (mg) per day.

    Reporting group title
    Carisbamate 600-800 milligram (mg)
    Reporting group description
    		 Subjects received modal dose of Carisbamate 600 to 800 milligram (mg) per day.

    Reporting group title
    Carisbamate greater than (>) 800-1000 milligram (mg)
    Reporting group description
    		 subjects received modal dose of Carisbamate greater than 800 to 1000 milligram (mg) per day

    Reporting group title
    Carisbamate greater than (>) 1000-1200 milligram (mg)
    Reporting group description
    		 subjects received modal dose of Carisbamate greater than 1000 to 1200 milligram (mg) per day

    Subject analysis set title
    Intent-to-treat (ITT) population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    A total of 402 subjects were included in the intent to treat (ITT) analysis in study CARISEPY3014

    Primary: Percent Reduction From Baseline in partial onset Seizure Frequency

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    End point title
    		 Percent Reduction From Baseline in partial onset Seizure Frequency
    End point description
    The primary efficacy endpoint was the percent reduction in partial onset seizure frequency (average seizure rate per 28 days of all simple partial motor, complex partial, or secondarily generalized seizures) from the baseline phase relative to the entire double-blind treatment phase. The frequency of seizures was calculated by the actual seizure count multiplied by 28, divided by the number of days in the phase; in effect, frequency count was normalized to 28 days.
    End point type
    Primary
    End point timeframe
    Baseline up to end of double-blind treatment phase (week 14)
    End point values
    		 Placebo Carisbamate [CRS] 800 mg Carisbamate [CRS] 1200 mg
    Number of subjects analysed
    183 [1]
    176 [2]
    181 [3]
    Units: percent change
        median (full range (min-max))
    20.59 (-576 to 100)
    29.93 (-1981 to 100)
    36.3 (-140 to 100)
    Notes
    [1] - ITT population
    [2] - ITT Population
    [3] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v Carisbamate [CRS] 800 mg
    Number of subjects included in analysis
    359
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.903 [4]
    Method
    		 Wilcoxon rank sum test controlling
    Confidence interval
    Notes
    [4] - P-values from Wilcoxon rank sum test controlling for pooled country and enzyme induction group based on IVRS value.
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Carisbamate [CRS] 1200 mg v Placebo
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.041 [5]
    Method
    		 Wilcoxon rank sum test controlling
    Confidence interval
    Notes
    [5] - P-values from Wilcoxon rank sum test controlling for pooled country and enzyme induction group based on IVRS value.

    Primary: Number of subjects With greater or equal to 50% reduction in POS frequency from baseline (Responder Rate)

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    End point title
    		 Number of subjects With greater or equal to 50% reduction in POS frequency from baseline (Responder Rate)
    End point description
    End point type
    Primary
    End point timeframe
    From baseline relative to the entire double-blind treatment phase (14 weeks)
    End point values
    		 Placebo Carisbamate [CRS] 800 mg Carisbamate [CRS] 1200 mg
    Number of subjects analysed
    183 [6]
    176 [7]
    181 [8]
    Units: Number of participants
        number (not applicable)
    48
    49
    66
    Notes
    [6] - ITT Population
    [7] - ITT Population
    [8] - ITT population
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v Carisbamate [CRS] 800 mg
    Number of subjects included in analysis
    359
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.792
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.58
         upper limit
    		 10.8
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Carisbamate [CRS] 1200 mg v Placebo
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.043
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 19.71

    Primary: Percentage Change From Baseline to the Open Label (OL) Phase in partial onset seizures (POS) Frequency

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    End point title
    		 Percentage Change From Baseline to the Open Label (OL) Phase in partial onset seizures (POS) Frequency [9]
    End point description
    Percentage change in seizure frequency was calculated as 100 * (pre-treatment seizures minus Maintenance Phase seizures)/pre-treatment seizures. Partial Onset seizures are seizures that affect only a part of the brain at onset.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1 of study CARISEPY3013) up to 1 year (end of open-label phase)
    Notes
    [9] - 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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Intent-to-treat (ITT) population
    Number of subjects analysed
    402 [10]
    Units: Percentage
        median (full range (min-max))
    28.22 (-865.52 to 100)
    Notes
    [10] - ITT Population
    No statistical analyses for this end point

    Primary: Percentage of subjects With at Least a 50 Percent Reduction in Seizure Frequency

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    End point title
    		 Percentage of subjects With at Least a 50 Percent Reduction in Seizure Frequency [11]
    End point description
    Responders were defined as Participants who had at least a 50% reduction in monthly seizure rate from baseline.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1 of study CARISEPY3013) up to 1 year (end of open-label phase)
    Notes
    [11] - 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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Intent-to-treat (ITT) population
    Number of subjects analysed
    Units: Percentage
        number (not applicable)
    36.1
    No statistical analyses for this end point

    Primary: Percentage Reduction From Baseline to the Last 6 Months of the Open Label (OL) Phase in Partial Onset Seizure (POS) Frequency

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    End point title
    		 Percentage Reduction From Baseline to the Last 6 Months of the Open Label (OL) Phase in Partial Onset Seizure (POS) Frequency [12]
    End point description
    The Percentage reduction in seizure rate relative to baseline was calculated for the period preceding the final 2 visits for each participant (about 6 months for most participants).
    End point type
    Primary
    End point timeframe
    Month 6-12
    Notes
    [12] - 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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Intent-to-treat (ITT) population
    Number of subjects analysed
    Units: Percentage
        median (full range (min-max))
    37.35 (-174.2 to 100)
    No statistical analyses for this end point

    Primary: Percentage of subjects With Seizure-Free Rate of the Open Label (OL) Phase in Partial Onset Seizure (POS)

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    End point title
    		 Percentage of subjects With Seizure-Free Rate of the Open Label (OL) Phase in Partial Onset Seizure (POS) [13]
    End point description
    Percentage of Participants who are free from seizures.
    End point type
    Primary
    End point timeframe
    Month 6-12
    Notes
    [13] - 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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Intent-to-treat (ITT) population
    Number of subjects analysed
    368
    Units: Percentage
        number (not applicable)
    5.4
    No statistical analyses for this end point

    Primary: Number of subjects With Serious Adverse Events (SAEs)

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    End point title
    		 Number of subjects With Serious Adverse Events (SAEs) [14]
    End point description
    An Serious Adverse Event (SAE) was an Adverse Event (AE) resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1 of study CARISEPY3013) up to 1 year (end of open-label phase)
    Notes
    [14] - 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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Carisbamate less than (<) 400 milligram (mg) Carisbamate 400- less than (<) 600 milligram (mg) Carisbamate 600-800 milligram (mg) Carisbamate greater than (>) 800-1000 milligram (mg) Carisbamate greater than (>) 1000-1200 milligram (mg)
    Number of subjects analysed
    4
    32
    203
    51
    112
    Units: Percentage
        number (not applicable)
    0
    5
    12
    3
    8
    No statistical analyses for this end point

    Secondary: Percent Reduction from baseline in Secondarily Generalized Seizure Frequency

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    End point title
    		 Percent Reduction from baseline in Secondarily Generalized Seizure Frequency
    End point description
    Change in secondary generalized seizure frequency is given as a percent reduction computed as: [Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100. Positive values in reduction means the value decreased from Baseline during the first 16-week Period. "Number of participants Analyzed = number of participants who were evaluable for this outcome measure"
    End point type
    Secondary
    End point timeframe
    Baseline up to double-blind treatment phase (14 weeks)
    End point values
    		 Placebo Carisbamate [CRS] 800 mg Carisbamate [CRS] 1200 mg
    Number of subjects analysed
    78
    65
    81
    Units: Number of participants
        median (full range (min-max))
    11.2 (-800 to 100)
    6.7 (-800 to 100)
    40 (-800 to 100)
    No statistical analyses for this end point

    Secondary: Time of Onset of Treatment Effect on partial onset seizure frequency reduction

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    End point title
    		 Time of Onset of Treatment Effect on partial onset seizure frequency reduction
    End point description
    Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.
    End point type
    Secondary
    End point timeframe
    From baseline relative to the entire double-blind treatment phase (14 weeks)
    End point values
    		 Placebo Carisbamate [CRS] 800 mg Carisbamate [CRS] 1200 mg
    Number of subjects analysed
    183
    176
    181
    Units: Number of Subjects
        median (full range (min-max))
    20.97 (-576 to 100)
    30.01 (-1981 to 100)
    36.26 (-140 to 100)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline (Day 1 of study CARISEPY3013) up to 1 year (end of open-label phase)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Carisbamate less than (<) 400 milligram (mg)
    Reporting group description
    		 subjects received modal dose of Carisbamate less than 400 milligram (mg) per day

    Reporting group title
    Carisbamate 400 - less than (<) 600 milligram (mg)
    Reporting group description
    		 subjects received modal dose of Carisbamate 400 to less than 600 milligram (mg) per day.

    Reporting group title
    Carisbamate 600- 800 milligram (mg)
    Reporting group description
    		 Subjects received modal dose of Carisbamate 600 to 800 milligram (mg) per day.

    Reporting group title
    Carisbamate greater than (>) 1000-1200 milligram (mg)
    Reporting group description
    		 subjects received modal dose of Carisbamate greater than 1000 to 1200 milligram (mg) per day

    Reporting group title
    Carisbamate greater than (>) 800-1000 milligram (mg)
    Reporting group description
    		 subjects received modal dose of Carisbamate greater than 800 to 1000 milligram (mg) per day

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to carisbamate [CRS] for 14 weeks.

    Reporting group title
    Carisbamate [CRS] 800 mg
    Reporting group description
    		 In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day], and in Week 2 to 14, the dosage was increase to 800 mg/day.

    Reporting group title
    Carisbamate [CRS] 1200 mg
    Reporting group description
    		 In Week 1 of the titration period, the dosage of carisbamate was 400 milligram per day [mg/day],and in Week 2 the dosage was increase to 800 mg/day. In Weeks 3 to 14 of the maintenance period, dosage increased to 1,200 mg/day.

    Serious adverse events
    		 Carisbamate less than (<) 400 milligram (mg) Carisbamate 400 - less than (<) 600 milligram (mg) Carisbamate 600- 800 milligram (mg) Carisbamate greater than (>) 1000-1200 milligram (mg) Carisbamate greater than (>) 800-1000 milligram (mg) Placebo Carisbamate [CRS] 800 mg Carisbamate [CRS] 1200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 32 (15.63%)
    12 / 203 (5.91%)
    8 / 112 (7.14%)
    3 / 51 (5.88%)
    6 / 184 (3.26%)
    9 / 178 (5.06%)
    15 / 182 (8.24%)
         number of deaths (all causes)
    0
    0
    0
    1
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian Epithelial Cancer Metastatic
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden unexplained death in epilepsy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    1 / 51 (1.96%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian Cyst
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    1 / 184 (0.54%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    1 / 51 (1.96%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic Disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    2 / 182 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine Aminotransferase Increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate Aminotransferase Increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver Function Test Abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    2 / 112 (1.79%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Intentional Overdose
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist Fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    1 / 184 (0.54%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ataxia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Balance Disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral Infarction
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    1 / 184 (0.54%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical Root Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Convulsion
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    3 / 203 (1.48%)
    0 / 112 (0.00%)
    1 / 51 (1.96%)
    0 / 184 (0.00%)
    2 / 178 (1.12%)
    3 / 182 (1.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug Withdrawal Convulsions
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    1 / 51 (1.96%)
    1 / 184 (0.54%)
    0 / 178 (0.00%)
    3 / 182 (1.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 2
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lethargy
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial Seizures with Secondary Generalisation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    1 / 184 (0.54%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sensory disturbance
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postictal state
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    2 / 178 (1.12%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain Upper
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food Poisoning
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Acute
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    1 / 51 (1.96%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Stone
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug rash with eosinophilia and systemic symptoms
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    1 / 51 (1.96%)
    1 / 184 (0.54%)
    1 / 178 (0.56%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased Appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypophagia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Carisbamate less than (<) 400 milligram (mg) Carisbamate 400 - less than (<) 600 milligram (mg) Carisbamate 600- 800 milligram (mg) Carisbamate greater than (>) 1000-1200 milligram (mg) Carisbamate greater than (>) 800-1000 milligram (mg) Placebo Carisbamate [CRS] 800 mg Carisbamate [CRS] 1200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 4 (75.00%)
    28 / 32 (87.50%)
    114 / 203 (56.16%)
    63 / 112 (56.25%)
    35 / 51 (68.63%)
    73 / 184 (39.67%)
    105 / 178 (58.99%)
    109 / 182 (59.89%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    2 / 203 (0.99%)
    1 / 112 (0.89%)
    2 / 51 (3.92%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    2
    1
    2
    0
    0
    0
    Tandem gait test abnormal
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    2 / 203 (0.99%)
    0 / 112 (0.00%)
    2 / 51 (3.92%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    2
    0
    2
    0
    0
    0
    Injury, poisoning and procedural complications
    Face injury
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    1 / 51 (1.96%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    0
    0
    Medication error
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    3 / 203 (1.48%)
    3 / 112 (2.68%)
    1 / 51 (1.96%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    3
    4
    3
    0
    0
    0
    Joint sprain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    3 / 203 (1.48%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    3
    1
    0
    0
    0
    0
    Mouth injury
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    3 / 203 (1.48%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    3
    1
    0
    0
    0
    0
    Open wound
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Skin laceration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    2 / 51 (3.92%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 4 (50.00%)
    13 / 32 (40.63%)
    29 / 203 (14.29%)
    25 / 112 (22.32%)
    22 / 51 (43.14%)
    17 / 184 (9.24%)
    52 / 178 (29.21%)
    58 / 182 (31.87%)
         occurrences all number
    2
    17
    46
    32
    32
    25
    82
    85
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    9 / 32 (28.13%)
    31 / 203 (15.27%)
    16 / 112 (14.29%)
    8 / 51 (15.69%)
    31 / 184 (16.85%)
    32 / 178 (17.98%)
    43 / 182 (23.63%)
         occurrences all number
    0
    11
    71
    50
    23
    58
    64
    89
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    6 / 32 (18.75%)
    20 / 203 (9.85%)
    7 / 112 (6.25%)
    4 / 51 (7.84%)
    19 / 184 (10.33%)
    22 / 178 (12.36%)
    28 / 182 (15.38%)
         occurrences all number
    0
    6
    23
    7
    4
    20
    24
    30
    Amnesia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Ataxia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    3 / 203 (1.48%)
    4 / 112 (3.57%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    3
    4
    0
    0
    0
    0
    Convulsion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    8 / 203 (3.94%)
    0 / 112 (0.00%)
    1 / 51 (1.96%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    10
    0
    1
    0
    0
    0
    Epilepsy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    4
    1
    0
    0
    0
    0
    Partial seizures with secondary generalisation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Sensory disturbance
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 32 (9.38%)
    12 / 203 (5.91%)
    5 / 112 (4.46%)
    5 / 51 (9.80%)
    17 / 184 (9.24%)
    14 / 178 (7.87%)
    18 / 182 (9.89%)
         occurrences all number
    2
    3
    13
    6
    5
    18
    16
    18
    Asthenia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    6 / 203 (2.96%)
    1 / 112 (0.89%)
    2 / 51 (3.92%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    14
    1
    2
    0
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    1 / 112 (0.89%)
    2 / 51 (3.92%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    1
    1
    3
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 32 (6.25%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    0
    0
    Gait disturbance
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    3 / 203 (1.48%)
    1 / 112 (0.89%)
    1 / 51 (1.96%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    4
    1
    1
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 32 (3.13%)
    2 / 203 (0.99%)
    2 / 112 (1.79%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    1
    1
    2
    2
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    2 / 112 (1.79%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    0
    3
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    2 / 203 (0.99%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    4
    3
    0
    0
    0
    0
    0
    Irritability
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    4 / 203 (1.97%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    4
    1
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 32 (6.25%)
    3 / 203 (1.48%)
    5 / 112 (4.46%)
    2 / 51 (3.92%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    1
    2
    6
    7
    2
    0
    0
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    Eye disorders
    Diplopia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 32 (6.25%)
    4 / 203 (1.97%)
    9 / 112 (8.04%)
    4 / 51 (7.84%)
    3 / 184 (1.63%)
    9 / 178 (5.06%)
    14 / 182 (7.69%)
         occurrences all number
    2
    0
    7
    20
    7
    4
    19
    22
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 32 (9.38%)
    11 / 203 (5.42%)
    6 / 112 (5.36%)
    3 / 51 (5.88%)
    4 / 184 (2.17%)
    9 / 178 (5.06%)
    8 / 182 (4.40%)
         occurrences all number
    0
    5
    22
    6
    3
    4
    10
    8
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 32 (6.25%)
    19 / 203 (9.36%)
    8 / 112 (7.14%)
    2 / 51 (3.92%)
    15 / 184 (8.15%)
    11 / 178 (6.18%)
    23 / 182 (12.64%)
         occurrences all number
    0
    4
    35
    8
    3
    24
    15
    25
    Colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    2 / 203 (0.99%)
    1 / 112 (0.89%)
    2 / 51 (3.92%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    3
    2
    2
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Eosinophilia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    1 / 203 (0.49%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Psychiatric disorders
    Anxiety
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 32 (6.25%)
    5 / 203 (2.46%)
    1 / 112 (0.89%)
    0 / 51 (0.00%)
    3 / 184 (1.63%)
    9 / 178 (5.06%)
    4 / 182 (2.20%)
         occurrences all number
    0
    2
    8
    1
    0
    3
    11
    4
    Dysphoria
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Depression
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    1 / 203 (0.49%)
    0 / 112 (0.00%)
    1 / 51 (1.96%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    0
    0
    Emotional disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    1 / 112 (0.89%)
    1 / 51 (1.96%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    0
    1
    1
    0
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 32 (0.00%)
    8 / 203 (3.94%)
    7 / 112 (6.25%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    0
    10
    11
    0
    0
    0
    0
    Nail avulsion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    0 / 203 (0.00%)
    0 / 112 (0.00%)
    0 / 51 (0.00%)
    0 / 184 (0.00%)
    0 / 178 (0.00%)
    0 / 182 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 32 (3.13%)
    13 / 203 (6.40%)
    11 / 112 (9.82%)
    6 / 51 (11.76%)
    5 / 184 (2.72%)
    6 / 178 (3.37%)
    12 / 182 (6.59%)
         occurrences all number
    0
    1
    16
    13
    10
    5
    8
    12
    Metabolism and nutrition disorders
    Decreased Appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 32 (3.13%)
    5 / 203 (2.46%)
    3 / 112 (2.68%)
    0 / 51 (0.00%)
    5 / 184 (2.72%)
    9 / 178 (5.06%)
    5 / 182 (2.75%)
         occurrences all number
    1
    2
    5
    3
    0
    5
    12
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Feb 2009
    Description Added a definition in the ‘other important medical event” category to indicate that suspected transmission of an infectious agent by a medicinal product was considered a serious adverse event. The statistical procedures section was modified to indicate that physical and neurologic examination results were to be analyzed by tabulation of abnormal results, not by change from baseline at each time point. The section on the use of concomitant AEDs was updated to clarify the criteria for inadequate response to prior AEDs, and indicate that subjects with a history of 10 or more generalized seizures (of any type) per month must have exhibited inadequate response to at least 3 prior AEDs. Additional clarifications were made to the Prohibitions and Restrictions, and to the Pre-study and Concomitant The Study Protocol was also updated to specify that subject who could tolerate the dosage during the first week of the titration period, or who could not tolerate a dosage reduction during Weeks 2 through 4 as a result of side effects, were to be withdrawn from the study. Finally, the sections on Laboratory Tests, and ECG collection, were clarified to remove serum pregnancy testing (only urine pregnancy tests to be performed). The pregnancy test was added for Visit 3 (Day 1). A second ECG reading was made at visit 3 (baseline). The visit window for Visits X1 to X3 of study was changed from 2 weeks to 3 days. The statistical step-down procedure was modified for both the primary and secondary efficacy endpoints. The step-down procedure was planned to ensure the type I error rate due to multiple treatment comparisons was controlled at the 0.05 level. First, the carisbamate 800-mg/day and 1200 -mg/day dosage groups were be combined as a single group, and the combined carisbamate group compared with the placebo group for the endpoint.
    22 Sep 2009
    A change was made to specify that subjects currently receiving double-blind study medication, or who have been receiving carisbamate in the extension phase for less than 6 weeks, must be withdrawn from the study if they experience during the study, or have a history (at any time in their life) of Stevens Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, a drug-related exfoliative rash, any drug-related rash requiring hospitalization, or rash associated with an AED that involved conjunctiva or mucosae, or a maculopapular rash that required discontinuation of an antiepileptic drug [AED]. Finally an amendment was made to specify that enrolled subjects who concurrently develop two or more of the following signs and symptoms should be withdrawn from the study, unless these are clearly attributable to another documented illness (e.g.,infectious pneumonia): rash; fever (Less than [>] 38.5ºC); lymphadenopathy (must have either enlargement of nodes relative to baseline, or tenderness); eosinophilia (absolute eosinophil count greater or equal to 700/microliter, or, if elevated at baseline, an increase of more than 50%); alanine aminotransferase [ALT] greater than 2 times the upper limit of normal (ULN), confirmed by a repeat measurement; signs or symptoms of significant pulmonary, cardiac, renal, muscular or pancreatic involvement.

    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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