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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics When Administered as an A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics When Administered as an Adjunctive Therapy in Adolescents (12 to Less Than 18 Years of Age) With Inadequately Controlled Partial-onset Seizures Estudio aleatorizado, doble ciego, controlado con placebo y de grupos paralelos con una fase de extensión abierta para evaluar el efecto de perampanel (E2007) en la cognición, el crecimiento, la seguridad, la tolerabilidad y la farmacocinética cuando se administra como terapia adyuvante en adolescentes (de 12 a menos de 18 años de edad) con crisis de inicio parcial insuficientemente controladas.

    Summary
    EudraCT number
    		 2010-018518-56
    Trial protocol
    		 LV   ES   BE   HU   CZ  
    Global end of trial date
    01 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Apr 2016
    First version publication date
    13 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    E2007-G000-235
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01161524
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eisai Inc.
    Sponsor organisation address
    155 Tice Boulevard, Woodcliff Lake, New Jersey, United States, 07667
    Public contact
    Eisai Call Center, Eisai Inc., 888 422-4743,
    Scientific contact
    Eisai Call Center, Eisai Inc., 888 422-4743,
    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
    01 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents. •Comparar el efecto a corto plazo de perampanel y placebo en la cognición empleando el sistema Cognitive Drug Research (CDR) cuando se administra como tratamiento adjuvante a adolescentes (12 a menos de 18 años de edad) con crisis de inicio parcial controladas insuficientemente (con o sin crisis secundariamente generalizadas).
    Protection of trial subjects
    This study was conducted in accordance with standard operating procedures (SOPs) of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following: - Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008) - International Conference on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, International Conference on Harmonisation of Pharmaceuticals for Human Use - Title 21 of the United States (US) Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and Institutional Review Board (IRB) regulations and applicable sections of US 21 CFR Part 312 - European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states. - Article 14, Paragraph 3, and Article 80-2 of the Pharmaceutical Affairs Law (Law No. 145, 1960) for studies conducted in Japan, in addition to Japan’s GCP Subject Information and Informed Consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Sep 2010
    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
    Spain: 9
    Country: Number of subjects enrolled
    Thailand: 10
    Country: Number of subjects enrolled
    United States: 18
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Hungary: 24
    Country: Number of subjects enrolled
    India: 35
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Latvia: 19
    Country: Number of subjects enrolled
    Poland: 6
    Worldwide total number of subjects
    133
    EEA total number of subjects
    63
    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)
    133
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of the 154 participants screened for entry into the Core Study, 21 were screen failures and 133 were randomized and treated. A total of 119 participants completed the Core Study, and 114 participants entered the Extension Phase.

    Period 1
    Period 1 title
    Core Study
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo (Core Study)
    Arm description
    		 Participants received matching placebo tablets once a day (6 tablets of placebo).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Perampanel matching placebo tablets taken once daily.

    Arm title
    		 Perampanel (Core Study)
    Arm description
    		 Participants received perampanel 2 mg per day and up-titrated weekly in 2-mg increments to a target dose range of 8 to 12 mg per day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Perampanel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Perampanel 2 mg titrated up to 8-12 mg maximum, taken once daily.

    Number of subjects in period 1
    		Placebo (Core Study) Perampanel (Core Study)
    Started
    48
    85
    Completed
    43
    76
    Not completed
    5
    9
         Consent withdrawn by subject
    1
    1
         Not specified
    -
    1
         Adverse event
    -
    3
         Lost to follow-up
    2
    1
         Subject choice
    2
    3
    Period 2
    Period 2 title
    Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    During the extension phase participants received unblinded treatment.

    Arms
    Arm title
    		 Perampanel (Extension Phase)
    Arm description
    		 During the Extension Phase, participants previously assigned to perampanel arm (Core Study) continued taking study medication at the dose achieved at the end of the Core Study once daily. Participants previously assigned to a placebo arm (Core Study) started perampanel dose at 2 mg/day and up-titrated weekly in 2-mg increments up to a maximum dose of 12 mg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Perampanel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Perampanel 2 mg titrated up to 8-12mg maximum; taken once daily.

    Number of subjects in period 2 [1]
    		Perampanel (Extension Phase)
    Started
    114
    Completed
    90
    Not completed
    24
         Inadequate Therapeutic Effect
    4
         Not specified
    6
         Adverse event
    8
         Lost to follow-up
    1
         Subject choice
    5
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: A total of 133 subjects were randomized into the Core Study and 119 (43 in Placebo arm and 76 in Perampanel arm) subjects completed the Core Study. A total of 114 subjects entered the Extension Phase. A total of 90 subjects completed the Extension Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo (Core Study)
    Reporting group description
    		 Participants received matching placebo tablets once a day (6 tablets of placebo).

    Reporting group title
    Perampanel (Core Study)
    Reporting group description
    		 Participants received perampanel 2 mg per day and up-titrated weekly in 2-mg increments to a target dose range of 8 to 12 mg per day.

    Reporting group values
    		 Placebo (Core Study) Perampanel (Core Study) Total
    Number of subjects
    		 48 85 133
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.3 ( 1.88 ) 14.3 ( 1.74 ) -
    Gender categorical
    Units: Subjects
        Female
    		 20 33 53
        Male
    		 28 52 80
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 2 3
        Non-Hispanic or Latino
    		 47 82 129
        Unknown or Not Reported
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo (Core Study)
    Reporting group description
    		 Participants received matching placebo tablets once a day (6 tablets of placebo).

    Reporting group title
    Perampanel (Core Study)
    Reporting group description
    		 Participants received perampanel 2 mg per day and up-titrated weekly in 2-mg increments to a target dose range of 8 to 12 mg per day.
    Reporting group title
    Perampanel (Extension Phase)
    Reporting group description
    		 During the Extension Phase, participants previously assigned to perampanel arm (Core Study) continued taking study medication at the dose achieved at the end of the Core Study once daily. Participants previously assigned to a placebo arm (Core Study) started perampanel dose at 2 mg/day and up-titrated weekly in 2-mg increments up to a maximum dose of 12 mg/day.

    Primary: Change From Baseline to Week 19 in Cognition Drug Research (CDR) System Global Cognition Score (Core Study)

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    End point title
    		 Change From Baseline to Week 19 in Cognition Drug Research (CDR) System Global Cognition Score (Core Study)
    End point description
    The CDR System Global Cognitive score was derived from the average of 5 CDR System cognitive domain scores (Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory). The domain scores were normalized to mean of 50 and standard deviation of 10 before taking the average. The scale ranged from 0 - 100. An increase in the Global Cognitive Score indicates improvement, while a decrease indicates worsening in cognitive function.
    End point type
    Primary
    End point timeframe
    Baseline (Visit 2/Week 0 Evaluation) and Week 19 LOCF (last observation carried forward)
    End point values
    		 Placebo (Core Study) Perampanel (Core Study)
    Number of subjects analysed
    44 [1]
    79 [2]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    1.1 ( 7.14 )
    -1 ( 8.86 )
    Notes
    [1] - Full Analysis Set (FAS) for cognition (for Core Study)
    [2] - FAS for cognition (for Core Study)
    Statistical analysis title
    		 p value (for the primary outcome measure)
    Comparison groups
    Placebo (Core Study) v Perampanel (Core Study)
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.145
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline at Week 19 in the Power of Attention Score in the Randomization Phase (Core Study)

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    End point title
    		 Change From Baseline at Week 19 in the Power of Attention Score in the Randomization Phase (Core Study)
    End point description
    The Power of Attention domain (one of the 5 CDR System cognitive domains) was a measure of focused attention and information processing, comprised of the speed scores from the 3 CDR System attention tasks. The domain scores were normalized to mean of 50 and standard deviation (SD) of 10. The total score was derived by summing the 3 CDR system attention tasks. The standard norms for ‘power of attention’ score were considered as 1176 ± 130.4 (mean ± SD). A decrease in the score of Power of Attention indicated improvement in cognitive function. Change from baseline is presented as mean ± SD.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 19 LOCF
    End point values
    		 Placebo (Core Study) Perampanel (Core Study)
    Number of subjects analysed
    44 [3]
    79 [4]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    35.1 ( 237.56 )
    91.1 ( 250.51 )
    Notes
    [3] - FAS for cognition (Core Study)
    [4] - FAS for cognition (Core Study)
    No statistical analyses for this end point

    Secondary: Change From Baseline at Week 19 in the Continuity of Attention Score in the Randomization Phase (Core Study)

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    End point title
    		 Change From Baseline at Week 19 in the Continuity of Attention Score in the Randomization Phase (Core Study)
    End point description
    The Continuity of Attention domain (one of the 5 CDR System cognitive domains) was a measure of sustained attention, comprised of the accuracy scores from 2 of the CDR System attention tasks: choice reaction time and digit vigilance. The domain scores were normalized to mean of 50 and standard deviation of 10. The total score was derived by summing the 2 CDR system attention tasks. The standard norms for ‘Continuity of Attention’ score were considered as 79.75 ± 11.25 (mean ± SD). An increase in the score of Continuity of Attention indicated improvement in cognition function. Change from baseline is presented as mean ± SD.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 19 LOCF
    End point values
    		 Placebo (Core Study) Perampanel (Core Study)
    Number of subjects analysed
    44 [5]
    79 [6]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    1.1 ( 8.62 )
    -2.4 ( 9.57 )
    Notes
    [5] - FAS for cognition (Core Study)
    [6] - FAS for cognition (Core Study)
    No statistical analyses for this end point

    Secondary: Change From Baseline at Week 19 in the Quality of Episodic Secondary Memory Score in the Randomization Phase (Core Study)

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    End point title
    		 Change From Baseline at Week 19 in the Quality of Episodic Secondary Memory Score in the Randomization Phase (Core Study)
    End point description
    The Quality of Episodic Secondary Memory domain was a measure of the capability of individuals to encode, store, and subsequently retrieve verbal and nonverbal information in episodic (or declarative) memory; what was meant by memory in everyday terminology. This measure was derived by summing the scores from the 4 tasks: immediate and delayed word recall, word recognition, and picture recognition. The domain scores were normalized to mean of 50 and SD of 10 before taking the sum of the subscale scores. The standard norms for 'Quality of Episodic Secondary Memory' score were considered as 180 ± 51.6 (mean ± SD). An increase in the score of Quality of Episodic Memory indicated improvement in cognition function. Change from baseline is presented as mean ± SD.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 19 LOCF
    End point values
    		 Placebo (Core Study) Perampanel (Core Study)
    Number of subjects analysed
    44 [7]
    79 [8]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -3.4 ( 35.77 )
    17.5 ( 52.34 )
    Notes
    [7] - FAS for cognition (Core Study)
    [8] - FAS for cognition (Core Study)
    No statistical analyses for this end point

    Secondary: Change From Baseline at Week 19 in the Quality of Working Memory (Short Term) Score in the Randomization Phase (Core Study)

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    End point title
    		 Change From Baseline at Week 19 in the Quality of Working Memory (Short Term) Score in the Randomization Phase (Core Study)
    End point description
    The Quality of Working Memory domain (one of the 5 CDR System cognitive domains) was a measure of reflecting how well individuals can hold numeric and spatial information 'on line' in working memory. The domain scores were normalized to mean of 50 and SD of 10. The standard norms for 'Quality of Working Memory (Short Term)' score were considered as 1.67 ± 0.307 (mean ± SD). An increase in the score of Quality of Working Memory indicated improvement in cognition function. Change from baseline is presented as mean ± SD.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 19 LOCF
    End point values
    		 Placebo (Core Study) Perampanel (Core Study)
    Number of subjects analysed
    44 [9]
    79 [10]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    0 ( 0.39 )
    0.1 ( 0.39 )
    Notes
    [9] - FAS for cognition (Core Study)
    [10] - FAS for cognition (Core Study)
    No statistical analyses for this end point

    Secondary: Change From Baseline at Week 19 in the Speed of Memory Score in the Randomization Phase (Core Study)

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    End point title
    		 Change From Baseline at Week 19 in the Speed of Memory Score in the Randomization Phase (Core Study)
    End point description
    The Speed of Memory domain (one of the 5 CDR System cognitive domains) was a measure which reflects the time taken to accurately retrieve information from working and episodic memory. The domain scores were normalized to mean of 50 and SD of 10. The total score was derived by summing the speed scores from the two working memory tasks, plus word and picture recognition. The standard norms for 'Speed of Memory' score were considered as 3104 ± 578.8 (mean ± SD). A decrease in the score of Speed of Memory indicated improvement in cognitive function. Change from baseline is presented as mean ± SD.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 19 LOCF
    End point values
    		 Placebo (Core Study) Perampanel (Core Study)
    Number of subjects analysed
    44 [11]
    79 [12]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -311.4 ( 697.75 )
    69.6 ( 1059.75 )
    Notes
    [11] - FAS for cognition (Core Study)
    [12] - FAS for cognition (Core Study)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Experienced 50% or More Decrease in Seizure Frequency (Core Study)

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    End point title
    		 Percentage of Participants Who Experienced 50% or More Decrease in Seizure Frequency (Core Study)
    End point description
    A responder was a participant who experienced a 50% or greater reduction in seizure frequency compared to the baseline of the Randomization Phase.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 19 LOCF
    End point values
    		 Placebo (Core Study) Perampanel (Core Study)
    Number of subjects analysed
    46 [13]
    83 [14]
    Units: Percentage of Participants
        number (not applicable)
    34.8
    53
    Notes
    [13] - FAS for Efficacy
    [14] - FAS for Efficacy
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Seizure Frequency per 28 Days During the Treatment Duration of the Randomization Phase (Core Study)

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    End point title
    		 Percent Change From Baseline in Seizure Frequency per 28 Days During the Treatment Duration of the Randomization Phase (Core Study)
    End point description
    Seizure frequency was based on overall number of seizures obtained by summing the 4 seizure types (all partial seizure types, that is, simple partial without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalization) collected via the patient diary over a particular time interval and re-scaled to 28 days window.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 19 LOCF
    End point values
    		 Placebo (Core Study) Perampanel (Core Study)
    Number of subjects analysed
    46 [15]
    83 [16]
    Units: Percent change
        median (full range (min-max))
    -24 (-100 to 644.7)
    -58 (-100 to 3404)
    Notes
    [15] - FAS for efficacy
    [16] - FAS for efficacy
    No statistical analyses for this end point

    Secondary: Number of Participants Who Achieved Seizure-Free Status During the Maintenance Period and the Last 28 Days of the Maintenance Period During the Randomization Phase (Core Study)

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    End point title
    		 Number of Participants Who Achieved Seizure-Free Status During the Maintenance Period and the Last 28 Days of the Maintenance Period During the Randomization Phase (Core Study)
    End point description
    Number of Participants who were seizure free, were assessed.
    End point type
    Secondary
    End point timeframe
    13 Week Maintenenance Period
    End point values
    		 Placebo (Core Study) Perampanel (Core Study)
    Number of subjects analysed
    46 [17]
    83 [18]
    Units: Participants
        Complete Maintenance Period
    7
    18
        Last 28 Days of Maintenance Period
    13
    31
    Notes
    [17] - FAS for efficacy
    [18] - FAS for efficacy
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Seizure Frequency Per 28 Days Over the Perampanel Duration Exposure (Extension Phase)

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    End point title
    		 Percent Change From Baseline in Seizure Frequency Per 28 Days Over the Perampanel Duration Exposure (Extension Phase)
    End point description
    The median percent change in total partial onset seizure frequency per 28 days during the Extension Phase relative to the Pre-perampanel Baseline from Week 1 of perampanel treatment through successive 13-week intervals (Weeks 1 to 13 for subjects with any data, Weeks 1 to 26 for subjects with exposure of more than 13 weeks, Weeks 1 to 39 for subjects with exposure of more than 26 weeks, and Week 1 to 52 for subjects with exposure of more than 52 weeks) are presented. The perampanel exposure duration starts from the first perampanel dose (in the Core Study for subjects previously randomized to perampanel or Extension Phase for subjects previously randomized to placebo) to the last perampanel dose in the Extension Phase.
    End point type
    Secondary
    End point timeframe
    Week 1-13, Week 14-26, Week 27-39, and Week 40-52
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    114 [19]
    Units: Percent change
    median (full range (min-max))
        Week 1-13 (any exposure duration); N=114
    -59.1 (-100 to 2909.6)
        Week 1-13 (at least 13 weeks of exposure); N=109
    -60.4 (-100 to 2909.6)
        Week 1-13 (at least 26 weeks of exposure); N=107
    -60.9 (-100 to 2909.6)
        Week 1-13 (at least 39 weeks of exposure); N=90
    -54.2 (-100 to 2909.6)
        Week 1-13 (at least 52 weeks of exposure); N=67
    -60.9 (-100 to 2909.6)
        Week 14-26 (at least 26 weeks of exposure); N=107
    -63.7 (-100 to 4108.2)
        Week 14-26 (at least 39 weeks of exposure); n=90
    -58.8 (-100 to 4108.2)
        Week 14-26 (at least 52 weeks of exposure); N=67
    -61.3 (-100 to 4108.2)
        Week 27-39 (at least 39 weeks of exposure); N=90
    -73.1 (-100 to 792.3)
        Week 27-39 (at least 52 weeks of exposure); N=67
    -74.1 (-100 to 792.3)
        Week 40-52 (at least 52 weeks of exposure); N=53
    -74.1 (-100 to 3160.7)
    Notes
    [19] - FAS for efficacy (Extension Phase)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Experienced 50% or More Decrease in Seizure Frequency Over the Perampanel Duration Exposure (Extension Phase)

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    End point title
    		 Percentage of Participants Who Experienced 50% or More Decrease in Seizure Frequency Over the Perampanel Duration Exposure (Extension Phase)
    End point description
    A responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days from pre-perampanel. The percentage of responders from Week 1 of perampanel treatment through successive 13-week intervals (Weeks 1 to 13 for subjects with any data, Weeks 1 to 26 for subjects with exposure of more than 13 weeks, Weeks 1 to 39 for subjects with exposure of more than 26 weeks, and Week 1 to 52 for subjects with exposure of more than 52 weeks) are presented. The perampanel exposure duration starts from the first perampanel dose (in the Core Study for subjects previously randomized to perampanel or Extension Phase for subjects previously randomized to placebo) to the last perampanel dose in the Extension Phase.
    End point type
    Secondary
    End point timeframe
    Week 1-13, Week 14-26, Week 27-39, and Week 40-52
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    114 [20]
    Units: Percentage of participants
    number (not applicable)
        Week 1-13 (any exposure duration); N=114
    54.4
        Week 1-13 (at least 13 weeks of exposure); N=109
    55
        Week 1-13 (at least 26 weeks of exposure); N=107
    56.1
        Week 1-13 (at least 39 weeks of exposure); N=90
    51.1
        Week 1-13 (at least 52 weeks of exposure); N=67
    53.7
        Week 14-26 (at least 26 weeks of exposure); N=107
    59.8
        Week 14-26 (at least 39 weeks of exposure); N=90
    56.7
        Week 14-26 (at least 52 weeks of exposure); N=67
    55.2
        Week 27-39 (at least 39 weeks of exposure); N=90
    58.9
        Week 27-39 (at least 52 weeks of exposure); N=67
    62.7
        Week 40-52 (at least 52 weeks of exposure); N=53
    66
    Notes
    [20] - FAS for Efficacy (Extension Phase)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline to End of Treatment in Cognition Drug Research (CDR) System Global Cognition Score (Extension Phase)

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    End point title
    		 Mean Change From Baseline to End of Treatment in Cognition Drug Research (CDR) System Global Cognition Score (Extension Phase)
    End point description
    The CDR System Global Cognitive was derived from the average of 5 CDR System cognitive domain scores (Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory). Domain scores were normalized to mean of 50 and standard deviation of 10 before taking the average. The scale ranged from 0 to 100. An increase in the Global Cognitive Score indicates improvement, while a decrease indicates worsening in cognitive function. The perampanel exposure duration starts from the first perampanel dose (in the Core Study for subjects previously randomized to perampanel or Extension Phase for subjects previously randomized to placebo) to the last perampanel dose in the Extension Phase.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 9, Week 19, Week, 30, Week 39, Week 52, and End of Treatment (defined as the last nonmissing value after date of first perampanel dose up to 14 days after date of last dose)
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    112 [21]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Change from Baseline at Week 9
    -3.8 ( 9.92 )
        Change from Baseline at Week 19
    -1.1 ( 8.16 )
        Change from Baseline at Week 30
    -1.3 ( 9.41 )
        Change from Baseline at Week 39
    -2.2 ( 10.22 )
        Change from Baseline at Week 52
    -0.2 ( 10.5 )
        Change from Baseline at End of Treatment
    -1 ( 9.91 )
    Notes
    [21] - FAS for Cognition (Extension Phase)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in CDR System Global Cognition Score Over Time (Extension Phase)

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    End point title
    		 Mean Change From Baseline in CDR System Global Cognition Score Over Time (Extension Phase)
    End point description
    The CDR System Global Cognitive was derived from the average of 5 CDR System cognitive domain scores (Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory). Domain scores were normalized to mean of 50 and SD of 10 before taking the average. The scale ranged from 0 to 100. An increase in the Global Cognitive Score indicates improvement, while a decrease indicates worsening in cognitive function. The data is presented as CDR System Global Cognitive scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    112 [22]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 9 (at least 9 weeks of exposure); N=109
    -3.9 ( 10.03 )
        Week 9 (at least 19 weeks of exposure); N=107
    -3.7 ( 9.74 )
        Week 9 (at least 26 weeks of exposure); N=107
    -3.7 ( 9.74 )
        Week 9 (at least 39 weeks of exposure); N=90
    -2.6 ( 8.73 )
        Week 9 (at least 52 weeks of exposure); N=67
    -3.1 ( 8.41 )
        Week 19 (at least 19 weeks of exposure); N=105
    -1.1 ( 8.16 )
        Week 19 (at least 26 weeks of exposure); N=105
    -1.1 ( 8.16 )
        Week 19 (at least 39 weeks of exposure); N=88
    -0.8 ( 8.45 )
        Week 19 (at least 52 weeks of exposure); N=65
    -1.3 ( 8.15 )
        Week 30 (at least 26 weeks of exposure); N=105
    -1.3 ( 9.41 )
        Week 30 (at least 39 weeks of exposure); N=89
    -1 ( 9.25 )
        Week 30 (at least 52 weeks of exposure); N=66
    -1.1 ( 9.38 )
        Week 39 (at least 39 weeks of exposure); N=72
    -2.3 ( 10.28 )
        Week 39 (at least 52 weeks of exposure); N=52
    -2.3 ( 10.23 )
        Week 52 (at least 52 weeks of exposure); N=49
    -0.6 ( 9.17 )
    Notes
    [22] - FAS for Cognition (Extension Phase)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline by Visits in Cognition Drug Research (CDR) System Domain T-Scores (Extension Study)

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    End point title
    		 Mean Change From Baseline by Visits in Cognition Drug Research (CDR) System Domain T-Scores (Extension Study)
    End point description
    The Cognitive measure scores are presented as T-Scores .T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening. Wk = Week and EOT=End of Treatment. The perampanel exposure duration starts from the first perampanel dose (in the Core Study for subjects previously randomized to perampanel or Extension Phase for subjects previously randomized to placebo) to the last perampanel dose in the Extension Phase.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 2/Week 0 Evaluation), Week 9, Week 19, Week 30, Week 39, Week 52, and EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    112 [23]
    Units: T-score
    arithmetic mean (standard deviation)
        Power of Attention: Week 9 (N=112)
    -12.1 ( 22.24 )
        Power of Attention: Week 19 (N=105)
    -6.5 ( 19.39 )
        Power of Attention: Week 30 (N=105)
    -8.5 ( 23.77 )
        Power of Attention: Week 39 (N=73)
    -11.7 ( 27.04 )
        Power of Attention: Week 52 (N=62)
    -7.5 ( 26.4 )
        Power of Attention: End of treatment (N=112)
    -8 ( 25.75 )
        Continuity of Attention: Week 9 (N=112)
    -3.1 ( 8.99 )
        Continuity of Attention: Week 19 (N=105)
    -1.7 ( 8.1 )
        Continuity of Attention: Week 30 (N=105)
    -0.9 ( 8.44 )
        Continuity of Attention: Week 39 (N=73)
    -1.7 ( 8.16 )
        Continuity of Attention: Week 52 (N=62)
    -0.9 ( 8.97 )
        Continuity of Attention: End of treatment (N=112)
    -0.9 ( 7.99 )
        Quality of episodic secondary Memory:Wk 9 (N=112)
    1.3 ( 9.27 )
        Quality of episodic secondary Memory:Wk 19 (N=105)
    3 ( 9.76 )
        Quality of episodic secondary Memory:Wk 30 (N=104)
    2.5 ( 10.15 )
        Quality of episodic secondary Memory:Wk 39 (N=73)
    1.8 ( 9.78 )
        Quality of episodic secondary Memory:Wk 52 (N=63)
    2.4 ( 11.33 )
        Quality of episodic secondary Memory: EOT (N=112)
    2 ( 10 )
        Quality of working memory (short term):Wk 9(N=112)
    -1.8 ( 14.81 )
        Quality of working memory (short term):Wk19(N=105)
    1 ( 12.61 )
        Quality of working memory (short term):Wk30(N=105
    1.4 ( 11.63 )
        Quality of working memory (short term):Wk 39 (N=73
    -1.2 ( 13.31 )
        Quality of working memory (short term):Wk 52(N=63)
    1.4 ( 14.85 )
        Quality of working memory (short term):EOT (N=112)
    0.5 ( 12.85 )
        Speed of memory: Week 9 (N=111)
    -3.5 ( 21.26 )
        Speed of memory: Week 19 (N=105)
    -1.3 ( 18.23 )
        Speed of memory: Week 30 (N=104)
    -1.4 ( 20.63 )
        Speed of memory: Week 39 (N=73)
    1.8 ( 25.16 )
        Speed of memory: Week 52 (N=63)
    3.9 ( 25.34 )
        Speed of memory: Week EOT (N=112)
    1 ( 22.82 )
    Notes
    [23] - FAS for cognition (Extension Phase)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in CDR System Domain T-Score Over Time: Power of Attention (Extension Phase)

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    End point title
    		 Mean Change From Baseline in CDR System Domain T-Score Over Time: Power of Attention (Extension Phase)
    End point description
    The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 9, Week 19, Week 30, Week 39, and Week 52
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    112 [24]
    Units: T-score
    arithmetic mean (standard deviation)
        Week 9 (at least 9 weeks of exposure); N=109
    -12.3 ( 22.47 )
        Week 9 (at least 19 weeks of exposure); N=107
    -11.7 ( 22.07 )
        Week 9 (at least 26 weeks of exposure); N=107
    -11.7 ( 22.07 )
        Week 9 (at least 39 weeks of exposure); N=90
    -9.5 ( 17.49 )
        Week 9 (at least 52 weeks of exposure); N=67
    -9.2 ( 18.13 )
        Week 19 (at least 19 weeks of exposure); N=105
    -6.5 ( 19.39 )
        Week 19 (at least 26 weeks of exposure); N=105
    -6.5 ( 19.39 )
        Week 19 (at least 39 weeks of exposure); N=88
    -4.9 ( 18.82 )
        Week 19 (at least 52 weeks of exposure); N=65
    -5.5 ( 19.37 )
        Week 30 (at least 26 weeks of exposure); N=105
    -8.5 ( 23.77 )
        Week 30 (at least 39 weeks of exposure); N=89
    -7.9 ( 21.66 )
        Week 30 (at least 52 weeks of exposure); N=66
    -7.6 ( 22.39 )
        Week 39 (at least 39 weeks of exposure); N=72
    -11.8 ( 27.22 )
        Week 39 (at least 52 weeks of exposure); N=52
    -12.3 ( 28.34 )
        Week 52 (at least 52 weeks of exposure); N=48
    -8.9 ( 25.45 )
    Notes
    [24] - FAS for cognition (Extension Phase)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in CDR System Domain T-Score Over Time: Continuity of Attention (Extension Phase)

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    End point title
    		 Mean Change From Baseline in CDR System Domain T-Score Over Time: Continuity of Attention (Extension Phase)
    End point description
    The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    112 [25]
    Units: T-score
    arithmetic mean (standard deviation)
        Week 9 (at least 9 weeks of exposure); N=109
    -3.1 ( 9.11 )
        Week 9 (at least 19 weeks of exposure); N=107
    -3 ( 9.01 )
        Week 9 (at least 26 weeks of exposure); N=107
    -3 ( 9.01 )
        Week 9 (at least 39 weeks of exposure); N=90
    -2.8 ( 9.17 )
        Week 9 (at least 52 weeks of exposure); N=67
    -3.6 ( 9.53 )
        Week 19 (at least 19 weeks of exposure); N=105
    -1.7 ( 8.1 )
        Week 19 (at least 26 weeks of exposure); N=105
    -1.7 ( 8.1 )
        Week 19 (at least 39 weeks of exposure); N=88
    -1.7 ( 8.1 )
        Week 19 (at least 52 weeks of exposure); N=65
    -2.3 ( 8.49 )
        Week 30 (at least 26 weeks of exposure); N=105
    -0.9 ( 8.44 )
        Week 30 (at least 39 weeks of exposure); N=89
    -1.1 ( 8.65 )
        Week 30 (at least 52 weeks of exposure); N=66
    -1 ( 7.47 )
        Week 39 (at least 39 weeks of exposure); N=72
    -1.8 ( 8.2 )
        Week 39 (at least 52 weeks of exposure); N=52
    -1.4 ( 8.24 )
        Week 52 (at least 52 weeks of exposure); N=48
    -0.5 ( 8.6 )
    Notes
    [25] - FAS for cognition (Extension Phase)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in CDR System Domain T-Score Over Time: Quality of Episodic Secondary Memory (Extension Phase)

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    End point title
    		 Mean Change From Baseline in CDR System Domain T-Score Over Time: Quality of Episodic Secondary Memory (Extension Phase)
    End point description
    The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 9, Week 19, Week 30, Week 39, and Week 52
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    112 [26]
    Units: T-score
    arithmetic mean (standard deviation)
        Week 9 (at least 9 weeks of exposure); N=109
    1.2 ( 9.35 )
        Week 9 (at least 19 weeks of exposure); N=107
    1.4 ( 9.37 )
        Week 9 (at least 26 weeks of exposure); N=107
    1.4 ( 9.37 )
        Week 9 (at least 39 weeks of exposure); N=90
    1.9 ( 9.67 )
        Week 9 (at least 52 weeks of exposure); N=67
    2 ( 10.13 )
        Week 19 (at least 19 weeks of exposure); N=105
    3 ( 9.76 )
        Week 19 (at least 26 weeks of exposure); N=105
    3 ( 9.76 )
        Week 19 (at least 39 weeks of exposure); N=88
    2.8 ( 9.66 )
        Week 19 (at least 52 weeks of exposure); N=65
    2.6 ( 9.33 )
        Week 30 (at least 26 weeks of exposure); N=104
    2.5 ( 10.15 )
        Week 30 (at least 39 weeks of exposure); N=88
    2.5 ( 10.56 )
        Week 30 (at least 52 weeks of exposure); N=65
    2.3 ( 10.85 )
        Week 39 (at least 39 weeks of exposure); N=72
    1.9 ( 9.85 )
        Week 39 (at least 52 weeks of exposure); N=52
    2.9 ( 10.06 )
        Week 52 (at least 52 weeks of exposure); N=49
    2 ( 11.61 )
    Notes
    [26] - FAS for cognition (Extension Phase)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in CDR System Domain T-Score Over Time: Quality of Working Memory (Short Term) (Extension Phase)

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    End point title
    		 Mean Change From Baseline in CDR System Domain T-Score Over Time: Quality of Working Memory (Short Term) (Extension Phase)
    End point description
    The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    112 [27]
    Units: T-score
    arithmetic mean (standard deviation)
        Week 9 (at least 9 weeks of exposure); N=109
    -2 ( 14.95 )
        Week 9 (at least 19 weeks of exposure); N=107
    -1.9 ( 14.93 )
        Week 9 (at least 26 weeks of exposure); N=107
    -1.9 ( 14.93 )
        Week 9 (at least 39 weeks of exposure); N=90
    -1.2 ( 14.58 )
        Week 9 (at least 52 weeks of exposure); N=67
    -0.6 ( 12.03 )
        Week 19 (at least 19 weeks of exposure); N=105
    1 ( 12.61 )
        Week 19 (at least 26 weeks of exposure); N=105
    1 ( 12.61 )
        Week 19 (at least 39 weeks of exposure); N=88
    1 ( 12.24 )
        Week 19 (at least 52 weeks of exposure); N=65
    1.1 ( 8.91 )
        Week 30 (at least 26 weeks of exposure); N=105
    1.4 ( 11.63 )
        Week 30 (at least 39 weeks of exposure); N=89
    1.5 ( 11.64 )
        Week 30 (at least 52 weeks of exposure); N=66
    1.1 ( 10 )
        Week 39 (at least 39 weeks of exposure); N=72
    -1.1 ( 13.38 )
        Week 39 (at least 52 weeks of exposure); N=52
    -0.1 ( 11.77 )
        Week 52 (at least 52 weeks of exposure); N=49
    2.9 ( 10.22 )
    Notes
    [27] - FAS for cognition (Extension Phase)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in CDR System Domain T-Score Over Time: Speed of Memory (Extension Phase)

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    End point title
    		 Mean Change From Baseline in CDR System Domain T-Score Over Time: Speed of Memory (Extension Phase)
    End point description
    The Cognitive measure scores are presented as T-Scores at specific intervals (Week 9 for subjects with exposure of more than 9 weeks, Week 19 for subjects with exposure of more than 19 weeks, Week 30 for subjects with exposure of more than 26 weeks, Week 39 for subjects with exposure of more than 39 weeks, and Week 52 for subjects with exposure of more than 52 weeks). T-Scores were normalized standard scores with mean of 50 and SD of 10 with an absolute range of 0-100. The T-Scores are based on the norms from healthy age-matched controls from the CDR System database. Cohen's d-effect sizes were used to estimate the clinical relevance of a change in a parameter. A change in a score of 0.2 SD was defined by Cohen as a small effect size, 0.5 SD a medium effect size and 0.8 SD was considered a large effect size. An increase in the T-scores indicates improvement while a decrease in T-scores indicates worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    112 [28]
    Units: T-score
    arithmetic mean (standard deviation)
        Week 9 (at least 9 weeks of exposure); N=108
    -3.7 ( 21.51 )
        Week 9 (at least 19 weeks of exposure); N=106
    -3.1 ( 21.31 )
        Week 9 (at least 26 weeks of exposure); N=106
    -3.1 ( 21.31 )
        Week 9 (at least 39 weeks of exposure); N=89
    -1.6 ( 20.85 )
        Week 9 (at least 52 weeks of exposure); N=67
    -4.3 ( 15.34 )
        Week 19 (at least 19 weeks of exposure); N=105
    -1.3 ( 18.23 )
        Week 19 (at least 26 weeks of exposure); N=105
    -1.3 ( 18.23 )
        Week 19 (at least 39 weeks of exposure); N=88
    -1.1 ( 18.31 )
        Week 19 (at least 52 weeks of exposure); N=65
    -2.4 ( 15.57 )
        Week 30 (at least 26 weeks of exposure); N=104
    -1.4 ( 20.63 )
        Week 30 (at least 39 weeks of exposure); N=88
    -0.7 ( 19.74 )
        Week 30 (at least 52 weeks of exposure); N=65
    -1 ( 20.06 )
        Week 39 (at least 39 weeks of exposure); N=72
    1.6 ( 25.29 )
        Week 39 (at least 52 weeks of exposure); N=52
    -0.5 ( 24.97 )
        Week 52 (at least 52 weeks of exposure); N=49
    1.8 ( 24.05 )
    Notes
    [28] - FAS for cognition (Extension Phase)
    No statistical analyses for this end point

    Secondary: Change From Baseline to End of Treatment in Controlled Oral Word Association Test Scores (COWAT) (Extension Phase)

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    End point title
    		 Change From Baseline to End of Treatment in Controlled Oral Word Association Test Scores (COWAT) (Extension Phase)
    End point description
    The COWAT test measured the executive function of the frontal lobe and consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of 2 parts which included the Letter Fluency task and the Category Fluency task. For the Letter Fluency task, the participant was given one minute to list as many words as they could which began with a given letter from the following set of 3 letters: F, A, and L. The number of correct words from the 3 sets comprised the Letter Fluency score. For the Category Fluency task, the participant was given one minute to list as many words as they could which belonged to a given category. The number of correct words comprised the Category Fluency score. Total score was calculated as sum of acceptable words generated. The scale ranged from 0-90, with higher scores indicating improvement in language.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 52 or up to EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    112 [29]
    Units: Scale on a score
    arithmetic mean (standard deviation)
        Letter Fluency Score; N=110
    2.2 ( 7.98 )
        Category Fluency Score; N=110
    -0.3 ( 4.02 )
    Notes
    [29] - FAS for cognition (Extension Phase).
    No statistical analyses for this end point

    Secondary: Change From Baseline to End of Treatment in Time to Complete Lafayette Grooved Pegboard Test (LGPT) (Extension Phase)

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    End point title
    		 Change From Baseline to End of Treatment in Time to Complete Lafayette Grooved Pegboard Test (LGPT) (Extension Phase)
    End point description
    The LGPT test measured visuomotor skills. This test was a manipulative dexterity test that consisted of a metal matrix of 25 holes with randomly positioned slots. The participant was required to insert 25 grooved pegs into the holes. The task was completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task was timed and the scores were the time taken for the participant to complete all 25 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds were recorded for the time. An increase in score (longer time) indicated worsening of visuomotor skills. The time to complete test is presented as mean seconds +/- SD.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 52 or up to EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    112 [30]
    Units: Seconds
    arithmetic mean (standard deviation)
        Dominant Hand (N=112)
    0.5 ( 18.67 )
        Non-Dominant Hand (N=111)
    -3.3 ( 22.49 )
    Notes
    [30] - FAS for cognition (Extension Phase).
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Bone Age Minus Age (Months) From Hand X-ray (Extension Phase)

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    End point title
    		 Mean Change From Baseline in Bone Age Minus Age (Months) From Hand X-ray (Extension Phase)
    End point description
    Bone age was measured using hand X-ray. The mean change from Baseline in bone age (months) minus age (months) from the hand x-ray was assessed. "+" means bone age is older than age and "-" means bone age is younger than age.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 52 or up to EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    114 [31]
    Units: Months
    arithmetic mean (standard deviation)
        Baseline; N=110
    3.3 ( 16.21 )
        Change from Baseline at EOT; N=109
    -2 ( 9.83 )
    Notes
    [31] - Safety Analysis Set (SAS) -Extension Phase
    No statistical analyses for this end point

    Secondary: Change from Baseline to End of Treatment for the Tanner Stage

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    End point title
    		 Change from Baseline to End of Treatment for the Tanner Stage
    End point description
    The effect of perampanel on growth and development in adolescents (male and female), including sexual development, was measured using Tanner scale. The scale defined physical measurements of development based on external primary and secondary sex characteristics, such as the size of the breasts, genitals, testicular volume and development of pubic hair. Tanner scale consisted of 5 scales from I to V: Stage I (prepubertal); Stage II (increase in scrotum and testes, breast bud appears, sparse pubic hair growth; Stage III (increase in penis length, breast size and areola, amount and texture of pubic hair); Stage IV (continued increase in penis length, scrotum and testes, secondary mound formed above breast level, adult type pubic hair); Stage V (adult genitalia, mature breast, adult type pubic hair in texture and quantity). Data is reported as the number of participants with shifts in Tanner Stage from Baseline to End of Treatment.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 52 or End of treatment (EOT) (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)
    End point values
    		 Perampanel (Extension Phase)
    Number of subjects analysed
    114 [32]
    Units: Participants
        Baseline Tanner stage II to EOT Tanner stage II
    5
        Baseline Tanner stage II to EOT Tanner stage III
    2
        Baseline Tanner stage II to EOT Tanner stage IV
    3
        Baseline Tanner stage III to EOT Tanner stage III
    8
        Baseline Tanner stage III to EOT Tanner stage IV
    12
        Baseline Tanner stage III to EOT Tanner stage V
    3
        Baseline Tanner stage IV to EOT Tanner stage IV
    22
        Baseline Tanner stage IV to EOT Tanner stage V
    19
        Baseline Tanner stage V to EOT Tanner stage V
    40
    Notes
    [32] - SAS (Extension Phase)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of first dose of study drug up to approximately 23 weeks for the Core Study and up to approximately 83 weeks for the extension phase.
    Adverse event reporting additional description
    Data are presented as treatment emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication. Safety Analysis Set (SAS), defined as all subjects who took ≥ 1 study drug dose and had a postbaseline safety assessment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo (Core Study)
    Reporting group description
    		 Participants received matching placebo tablets once a day (6 tablets of placebo).

    Reporting group title
    Perampanel (Core Study)
    Reporting group description
    		 Participants received perampanel 2 mg per day and up-titrated weekly in 2-mg increments to a target dose range of 8 to 12 mg per day.

    Reporting group title
    Perampanel (Extension Phase)
    Reporting group description
    		 During the Extension Phase, participants previously assigned to perampanel arm (Core Study) continued taking study medication at the dose achieved at the end of the Core Study once daily. Participants previously assigned to a placebo arm (Core Study) started perampanel dose at 2 mg/day and up-titrated weekly in 2-mg increments up to a maximum dose of 12 mg/day.

    Serious adverse events
    		 Placebo (Core Study) Perampanel (Core Study) Perampanel (Extension Phase)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 48 (4.17%)
    5 / 85 (5.88%)
    19 / 114 (16.67%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    4 / 114 (3.51%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Partial seizures with secondary generalisation
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Simple partial seizures
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastroduodenitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular necrosis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    4 / 114 (3.51%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    4 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    0 / 114 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo (Core Study) Perampanel (Core Study) Perampanel (Extension Phase)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 48 (62.50%)
    67 / 85 (78.82%)
    95 / 114 (83.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pituitary tumour benign
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    2
    0
    2
    Fatigue
         subjects affected / exposed
    1 / 48 (2.08%)
    8 / 85 (9.41%)
    13 / 114 (11.40%)
         occurrences all number
    1
    8
    13
    Local swelling
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 85 (2.35%)
    8 / 114 (7.02%)
         occurrences all number
    1
    2
    10
    Gait disturbance
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Multiple allergies
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Drug hypersensitivity
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Menstruation irregular
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Testicular torsion
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    2
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    0 / 114 (0.00%)
         occurrences all number
    0
    4
    0
    Nasal congestion
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 85 (1.18%)
    2 / 114 (1.75%)
         occurrences all number
    1
    1
    2
    Rhinitis allergic
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 85 (2.35%)
    2 / 114 (1.75%)
         occurrences all number
    1
    2
    2
    Tachypnoea
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    0 / 114 (0.00%)
         occurrences all number
    0
    1
    0
    Diaphragmatic Spasm
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Snoring
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    1 / 48 (2.08%)
    6 / 85 (7.06%)
    7 / 114 (6.14%)
         occurrences all number
    1
    6
    7
    Adjustment disorder
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    0 / 114 (0.00%)
         occurrences all number
    0
    1
    0
    Aggression
         subjects affected / exposed
    1 / 48 (2.08%)
    6 / 85 (7.06%)
    10 / 114 (8.77%)
         occurrences all number
    1
    10
    14
    Anger
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    2 / 114 (1.75%)
         occurrences all number
    0
    3
    3
    Anxiety
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Bradyphrenia
         subjects affected / exposed
    0 / 48 (0.00%)
    3 / 85 (3.53%)
    3 / 114 (2.63%)
         occurrences all number
    0
    3
    3
    Confusional state
         subjects affected / exposed
    0 / 48 (0.00%)
    3 / 85 (3.53%)
    3 / 114 (2.63%)
         occurrences all number
    0
    3
    3
    Depressed mood
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Euphoric mood
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 85 (2.35%)
    2 / 114 (1.75%)
         occurrences all number
    1
    2
    2
    Initial insomnia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    1
    0
    1
    Insomnia
         subjects affected / exposed
    3 / 48 (6.25%)
    3 / 85 (3.53%)
    5 / 114 (4.39%)
         occurrences all number
    3
    3
    5
    Intentional self-injury
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    0 / 114 (0.00%)
         occurrences all number
    0
    1
    0
    Mood altered
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 85 (2.35%)
    1 / 114 (0.88%)
         occurrences all number
    1
    4
    3
    Mood swings
         subjects affected / exposed
    1 / 48 (2.08%)
    3 / 85 (3.53%)
    4 / 114 (3.51%)
         occurrences all number
    1
    3
    5
    Self-injurious ideation
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Tearfulness
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    1
    0
    0
    Abnormal Behaviour
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Daydreaming
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Depression
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Nervousness
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    3 / 114 (2.63%)
         occurrences all number
    0
    0
    4
    Regressive behaviour
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Somnambulism
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 48 (4.17%)
    3 / 85 (3.53%)
    4 / 114 (3.51%)
         occurrences all number
    2
    3
    4
    Blood pressure diastolic decreased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    1
    0
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    0 / 114 (0.00%)
         occurrences all number
    0
    1
    0
    Thyroxine decreased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    1
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    1
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 48 (0.00%)
    5 / 85 (5.88%)
    8 / 114 (7.02%)
         occurrences all number
    0
    5
    9
    White blood cell count decreased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    3
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    3
    Blood Cholesterol Increased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Blood Glucose Decreased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Blood Pressure Decreased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Blood Sodium Increased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Blood Triglycerides Increased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Electrocardiogram T Wave Abnormal
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    2 / 114 (1.75%)
         occurrences all number
    0
    1
    2
    Contusion
         subjects affected / exposed
    0 / 48 (0.00%)
    3 / 85 (3.53%)
    3 / 114 (2.63%)
         occurrences all number
    0
    3
    3
    Excoriation
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    2 / 114 (1.75%)
         occurrences all number
    0
    3
    4
    Joint injury
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    0 / 114 (0.00%)
         occurrences all number
    0
    1
    0
    Laceration
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Ligament rupture
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Muscle strain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Radius fracture
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    1
    0
    1
    Tongue injury
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    1
    0
    0
    Wrist fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Accidental Overdose
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    2
    Animal Bite
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    2
    Fall
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Foot fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Hand fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    2
    Head Injury
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    2
    Limb Injury
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Sunburn
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    3 / 114 (2.63%)
         occurrences all number
    0
    1
    3
    Angina pectoris
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    0 / 48 (0.00%)
    4 / 85 (4.71%)
    5 / 114 (4.39%)
         occurrences all number
    0
    5
    6
    Balance disorder
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    3 / 114 (2.63%)
         occurrences all number
    0
    2
    3
    Clumsiness
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    2 / 114 (1.75%)
         occurrences all number
    0
    2
    2
    Cognitive disorder
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    1
    0
    2
    Convulsion
         subjects affected / exposed
    4 / 48 (8.33%)
    4 / 85 (4.71%)
    10 / 114 (8.77%)
         occurrences all number
    5
    4
    28
    Depressed level of consciousness
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    0 / 114 (0.00%)
         occurrences all number
    0
    1
    0
    Disturbance in attention
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    2 / 114 (1.75%)
         occurrences all number
    0
    2
    2
    Dizziness
         subjects affected / exposed
    7 / 48 (14.58%)
    26 / 85 (30.59%)
    34 / 114 (29.82%)
         occurrences all number
    7
    43
    59
    Drooling
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Dysarthria
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    2 / 114 (1.75%)
         occurrences all number
    0
    1
    2
    Headache
         subjects affected / exposed
    7 / 48 (14.58%)
    9 / 85 (10.59%)
    13 / 114 (11.40%)
         occurrences all number
    15
    12
    21
    Hypoaesthesia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Hypotonia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Lethargy
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    4 / 114 (3.51%)
         occurrences all number
    0
    2
    4
    Memory impairment
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Partial seizures with secondary generalisation
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    1
    0
    0
    Simple partial seizures
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 85 (1.18%)
    3 / 114 (2.63%)
         occurrences all number
    4
    1
    3
    Slow speech
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    2 / 114 (1.75%)
         occurrences all number
    0
    2
    2
    Somnolence
         subjects affected / exposed
    2 / 48 (4.17%)
    13 / 85 (15.29%)
    22 / 114 (19.30%)
         occurrences all number
    2
    13
    23
    Syncope
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    2 / 114 (1.75%)
         occurrences all number
    0
    1
    2
    Tremor
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    3 / 114 (2.63%)
         occurrences all number
    0
    1
    3
    Aphasia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    2
    Complex Partial Seizures
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Coordination Abnormal
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Dyskinesia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Dyspraxia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Epilepsy
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    3 / 114 (2.63%)
         occurrences all number
    0
    0
    3
    Migraine
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Partial Seizures
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Postictal Headache
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 85 (1.18%)
    3 / 114 (2.63%)
         occurrences all number
    2
    2
    5
    Monocytosis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    1
    0
    1
    Neutropenia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    1
    0
    0
    Anaemia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    2 / 114 (1.75%)
         occurrences all number
    0
    1
    2
    Leukopenia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    6 / 114 (5.26%)
         occurrences all number
    1
    0
    12
    Tinnitus
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    1
    0
    2
    Mydriasis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Vision blurred
         subjects affected / exposed
    0 / 48 (0.00%)
    3 / 85 (3.53%)
    2 / 114 (1.75%)
         occurrences all number
    0
    3
    2
    Visual impairment
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Myopia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Visual acuity reduced
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 85 (1.18%)
    2 / 114 (1.75%)
         occurrences all number
    2
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 48 (2.08%)
    4 / 85 (4.71%)
    4 / 114 (3.51%)
         occurrences all number
    2
    5
    5
    Constipation
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    1
    1
    1
    Diarrhoea
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 85 (2.35%)
    4 / 114 (3.51%)
         occurrences all number
    1
    2
    4
    Gastritis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 48 (4.17%)
    2 / 85 (2.35%)
    6 / 114 (5.26%)
         occurrences all number
    5
    2
    9
    Abdominal discomfort
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    2 / 114 (1.75%)
         occurrences all number
    0
    2
    3
    Dry mouth
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Hyperchlorhydria
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    0 / 114 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    2 / 114 (1.75%)
         occurrences all number
    0
    2
    2
    Dyspepsia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Enterocolitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    1
    1
    2
    Dermal cyst
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Dermatitis contact
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    2 / 114 (1.75%)
         occurrences all number
    0
    1
    2
    Heat rash
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    0 / 114 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    3 / 114 (2.63%)
         occurrences all number
    0
    1
    5
    Swelling face
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Urticaria
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Acne
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    2
    Dermatitis Acneiform
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Macule
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Photosensitivity reaction
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Rash Maculo-Papular
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Seborrhoeic Dermatitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Miliaria
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Crystalluria
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    2
    Enuresis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Back pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Epiphyses premature fusion
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Joint swelling
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    0 / 114 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    2 / 114 (1.75%)
         occurrences all number
    0
    2
    2
    Myalgia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    1
    0
    0
    Myositis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Muscle Spasms
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    2
    Pain In Extremity
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    3
    Tendonitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    3 / 114 (2.63%)
         occurrences all number
    1
    0
    3
    Fungal skin infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Influenza
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    2 / 114 (1.75%)
         occurrences all number
    0
    1
    3
    Nasopharyngitis
         subjects affected / exposed
    3 / 48 (6.25%)
    3 / 85 (3.53%)
    13 / 114 (11.40%)
         occurrences all number
    4
    4
    16
    Pharyngitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Sinusitis
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    1
    1
    1
    Skin infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Tonsillitis
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    2 / 114 (1.75%)
         occurrences all number
    0
    2
    2
    Tracheitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 48 (6.25%)
    4 / 85 (4.71%)
    5 / 114 (4.39%)
         occurrences all number
    3
    5
    6
    Urinary tract infection
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 85 (2.35%)
    3 / 114 (2.63%)
         occurrences all number
    1
    2
    4
    Vaginitis bacterial
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    0 / 114 (0.00%)
         occurrences all number
    0
    1
    0
    Varicella
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 85 (2.35%)
    3 / 114 (2.63%)
         occurrences all number
    0
    2
    3
    Acarodermatitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    2 / 114 (1.75%)
         occurrences all number
    0
    0
    2
    Laryngitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Localised infection
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Oral Herpes
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Bacterial vaginosis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 85 (0.00%)
    1 / 114 (0.88%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Appetite disorder
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 85 (0.00%)
    0 / 114 (0.00%)
         occurrences all number
    1
    0
    0
    Decreased appetite
         subjects affected / exposed
    1 / 48 (2.08%)
    3 / 85 (3.53%)
    4 / 114 (3.51%)
         occurrences all number
    1
    3
    5
    Hypernatraemia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1
    Increased appetite
         subjects affected / exposed
    0 / 48 (0.00%)
    4 / 85 (4.71%)
    4 / 114 (3.51%)
         occurrences all number
    0
    4
    4
    Obesity
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 85 (1.18%)
    1 / 114 (0.88%)
         occurrences all number
    0
    1
    1

    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.
    Results were ready but could not be released before 21 July 2015 due to EudraCT System issues.
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