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    Clinical Trial Results:
    An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2 Anti-Epileptic Drugs

    Summary
    EudraCT number
    2014-004335-39
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    24 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Jun 2016
    First version publication date
    25 Apr 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    N01223
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01063764
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Japan Co. Ltd.
    Sponsor organisation address
    8-17-1 Nishi-Shinjuku, Tokyo, Japan, 160-0023
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 4815 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    First Period: The primary objective was to evaluate the efficacy of Levetiracetam (LEV) dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric subjects aged ≥4 to <16 years and with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drugs (AEDs). Second Period: To provide LEV treatment to subjects who were judged by the investigators to benefit from long-term treatment and who are willing to continuously receive this drug and to continuously evaluate the safety of long-term administration of LEV at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the First Period of this study.
    Protection of trial subjects
    Not applicable
    Background therapy
    One or two anti-epileptic drug(s)
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    29 Jan 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 73
    Worldwide total number of subjects
    73
    EEA total number of subjects
    0
    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)
    44
    Adolescents (12-17 years)
    29
    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
    Full Analysis Set (FAS) includes all subjects taking at least one dose of study medication. Per-Protocol Set (PPS) is a subset of the FAS, consisting of subjects without major protocol violations affecting the primary efficacy variable.

    Pre-assignment
    Screening details
    Participant Flow refers to the Full Analysis Set. First Period started after Baseline (Week 0 to Week 8).

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Levetiracetam
    Arm description
    •First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. •Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted. •Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.
    Arm type
    Experimental

    Investigational medicinal product name
    Levetiracetam tablet
    Investigational medicinal product code
    ucb L059
    Other name
    Keppra
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.

    Investigational medicinal product name
    Levetiracetam dry syrup
    Investigational medicinal product code
    ucb L059
    Other name
    EKeppra
    Pharmaceutical forms
    Powder for syrup
    Routes of administration
    Oral use
    Dosage and administration details
    First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.

    Number of subjects in period 1
    Levetiracetam
    Started
    73
    Completed
    35
    Not completed
    38
         Protocol deviation
    1
         Lack of efficacy
    20
         SAE, non-fatal
    1
         AE, serious fatal
    1
         AE, non-serious non-fatal
    5
         Consent withdrawn by subject
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    •First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. •Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted. •Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.

    Reporting group values
    Levetiracetam Total
    Number of subjects
    73 73
    Age Categorical
    Units: Subjects
        >=4 - <8 years
    22 22
        >=8 - <12 years
    22 22
        >=12 - <16 years
    29 29
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    10.1 ± 3.4 -
    Gender Categorical
    Units: Subjects
        Female
    32 32
        Male
    41 41
    Region of Enrollment
    Units: Subjects
        Japan
    73 73
    Hospitalization Status
    Units: Subjects
        Yes
    0 0
        No
    73 73
    Body Weight
    Units: kilogram (kg)
        arithmetic mean (standard deviation)
    32.43 ± 13.2 -
    Height
    Units: centimeter (cm)
        arithmetic mean (standard deviation)
    134.55 ± 20.69 -
    Body Mass Index (BMI)
    Units: kilogram / meter^2 (kg/m^2)
        arithmetic mean (standard deviation)
    17.15 ± 2.99 -

    End points

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    End points reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    •First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. •Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted. •Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.

    Primary: Change from Baseline in partial seizure frequency per week over the 14-weeks Treatment Period

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    End point title
    Change from Baseline in partial seizure frequency per week over the 14-weeks Treatment Period [1]
    End point description
    The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as: (B values- T values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. Partial seizures can be classified into: - Simple partial seizures - Complex partial seizures - Partial seizures evolving to secondarily generalized seizures.
    End point type
    Primary
    End point timeframe
    From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The efficacy of LEV in this study was considered positive if the lower limit of the 2-sided 95 % CI of the median percentage reduction in the partial seizure frequency per week was greater than 16.3 %. This was based on the median percentage reduction of the seizure frequency per week in the placebo in N159. Furthermore, a percentage reduction greater than 16.3 % was considered clinically relevant. Descriptive statistics with 95 % CI of the median percentage reduction were presented.
    End point values
    Levetiracetam
    Number of subjects analysed
    73
    Units: Percent reduction
    median (confidence interval 95%)
        median (95 % confidence interval)
    43.21 (26.19 to 52.14)
    No statistical analyses for this end point

    Primary: Incidence of Treatment-Emergent Adverse Events (TEAEs) during the Second Period (up to three years until the time of approval granted)

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    End point title
    Incidence of Treatment-Emergent Adverse Events (TEAEs) during the Second Period (up to three years until the time of approval granted) [2]
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE.
    End point type
    Primary
    End point timeframe
    During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no statistical analysis for this endpoint in this open-label study.
    End point values
    Levetiracetam
    Number of subjects analysed
    55
    Units: percentage of participants
    number (not applicable)
        percentage of participants
    98.2
    No statistical analyses for this end point

    Secondary: Change from Baseline in partial seizure frequency per week over the 10-week Evaluation Period

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    End point title
    Change from Baseline in partial seizure frequency per week over the 10-week Evaluation Period
    End point description
    The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as: (B values- E values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline to the 10-week Evaluation Period. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7. Partial seizures can be classified into: - Simple partial seizures - Complex partial seizures - Partial seizures evolving to secondarily generalized seizures.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
    End point values
    Levetiracetam
    Number of subjects analysed
    68
    Units: Percent reduction
    median (confidence interval 95%)
        median (95 % confidence interval)
    39.02 (26.67 to 52.07)
    No statistical analyses for this end point

    Secondary: Partial seizure frequency per week over the 14-weeks Treatment Period

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    End point title
    Partial seizure frequency per week over the 14-weeks Treatment Period
    End point description
    The seizure frequency per week was calculated as: Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7. Partial seizures can be classified into one of the following three groups: - Simple partial seizures - Complex partial seizures - Partial seizures evolving to secondarily generalized seizures.
    End point type
    Secondary
    End point timeframe
    14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
    End point values
    Levetiracetam
    Number of subjects analysed
    73
    Units: Seizures per week
    median (inter-quartile range (Q1-Q3))
        median (95 % confidence interval)
    3.92 (0.93 to 17.08)
    No statistical analyses for this end point

    Secondary: Partial seizure frequency per week over the 10-weeks Evaluation Period

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    End point title
    Partial seizure frequency per week over the 10-weeks Evaluation Period
    End point description
    The seizure frequency per week was calculated as: Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7. Partial seizures can be classified into one of the following three groups: - Simple partial seizures - Complex partial seizures - Partial seizures evolving to secondarily generalized seizures.
    End point type
    Secondary
    End point timeframe
    10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
    End point values
    Levetiracetam
    Number of subjects analysed
    68
    Units: Seizures per week
    median (inter-quartile range (Q1-Q3))
        median (95 % confidence interval)
    3.9 (0.86 to 17.26)
    No statistical analyses for this end point

    Secondary: Percentage of partial seizures 50 % responders over the 14-weeks Treatment Period

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    End point title
    Percentage of partial seizures 50 % responders over the 14-weeks Treatment Period
    End point description
    50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders. Partial seizures can be classified into one of the following three groups: - Simple partial seizures - Complex partial seizures - Partial seizures evolving to secondarily generalized seizures.
    End point type
    Secondary
    End point timeframe
    14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
    End point values
    Levetiracetam
    Number of subjects analysed
    73
    Units: percentage of participants
    number (confidence interval 95%)
        number (95% confidence interval)
    38.4 (27.2 to 50.5)
    No statistical analyses for this end point

    Secondary: Percentage of partial seizures 50 % responders over the 10-weeks Evaluation Period

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    End point title
    Percentage of partial seizures 50 % responders over the 10-weeks Evaluation Period
    End point description
    50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders. Partial seizures can be classified into one of the following three groups: - Simple partial seizures - Complex partial seizures - Partial seizures evolving to secondarily generalized seizures.
    End point type
    Secondary
    End point timeframe
    10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
    End point values
    Levetiracetam
    Number of subjects analysed
    68
    Units: percentage of participants
    number (confidence interval 95%)
        number (95% confidence interval)
    38.2 (26.7 to 50.8)
    No statistical analyses for this end point

    Secondary: Number of seizure-free subjects over the 14-weeks Treatment Period

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    End point title
    Number of seizure-free subjects over the 14-weeks Treatment Period
    End point description
    Seizure-free means not having a seizure of type I (Partial seizure). Partial seizures can be classified into one of the following three groups: - Simple partial seizures - Complex partial seizures - Partial seizures evolving to secondarily generalized seizures.
    End point type
    Secondary
    End point timeframe
    14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
    End point values
    Levetiracetam
    Number of subjects analysed
    73
    Units: participants
        participants
    2
    No statistical analyses for this end point

    Secondary: Number of seizure-free subjects over the 10-weeks Evaluation Period

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    End point title
    Number of seizure-free subjects over the 10-weeks Evaluation Period
    End point description
    Seizure-free means not having a seizure of type I (Partial seizure). Partial seizures can be classified into one of the following three groups: - Simple partial seizures - Complex partial seizures - Partial seizures evolving to secondarily generalized seizures.
    End point type
    Secondary
    End point timeframe
    10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
    End point values
    Levetiracetam
    Number of subjects analysed
    68
    Units: participants
        participants
    3
    No statistical analyses for this end point

    Secondary: Incidence of treatment-emergent Adverse Drug Reactions (ADRs) during the Second Period (up to three years until the time of approval granted)

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    End point title
    Incidence of treatment-emergent Adverse Drug Reactions (ADRs) during the Second Period (up to three years until the time of approval granted)
    End point description
    An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR.
    End point type
    Secondary
    End point timeframe
    During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)
    End point values
    Levetiracetam
    Number of subjects analysed
    55
    Units: participants
        participants
    15
    No statistical analyses for this end point

    Secondary: Change from Baseline in partial seizure frequency per week for the Second Period (up to three years from informed consent until the time of approval granted)

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    End point title
    Change from Baseline in partial seizure frequency per week for the Second Period (up to three years from informed consent until the time of approval granted)
    End point description
    The outcome was also calculated for each 3-month Period but here only the result for the total Second Evaluation Period (Second Period without following 6-weeks Withdrawal Period for withdrawers) is presented. Change in partial seizure frequency from Baseline (B) over Second Evaluation Period (E) is given as a percentage reduction computed as: (B values- E values) / B values x 100. Positive values in percent reduction show a decrease from Baseline. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.
    End point type
    Secondary
    End point timeframe
    From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period)
    End point values
    Levetiracetam
    Number of subjects analysed
    55
    Units: Percent reduction
    median (inter-quartile range (Q1-Q3))
        median (inter-quartile range)
    41.32 (15.37 to 82.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected over the whole study from Baseline (Visit 2) over the complete First Period (14 weeks plus up to 6-week Down-titration and Follow-up) and the Second Period (Week 22 to the end of study).
    Adverse event reporting additional description
    AEs refer to the Full Analysis Set (FAS). FAS includes all subjects which received at least one dose of study medication.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    •First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. •Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted. •Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped.

    Serious adverse events
    Levetiracetam
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 73 (10.96%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Near drowning
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Strabismus
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Conversion disorder
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acetonaemic vomiting
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Dental caries
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Levetiracetam
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 73 (90.41%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    8 / 73 (10.96%)
         occurrences all number
    11
    Excoriation
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    8
    Wound
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    10
    Arthropod bite
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    21
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    10
    Epistaxis
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    8
    Rhinitis allergic
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Cough
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    5
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    34 / 73 (46.58%)
         occurrences all number
    48
    Convulsion
         subjects affected / exposed
    7 / 73 (9.59%)
         occurrences all number
    8
    Headache
         subjects affected / exposed
    10 / 73 (13.70%)
         occurrences all number
    20
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    5
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    17 / 73 (23.29%)
         occurrences all number
    32
    Irritability
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 73 (12.33%)
         occurrences all number
    16
    Abdominal Pain
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    7
    Nausea
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    5
    Constipation
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    7
    Dental Caries
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    11
    Skin and subcutaneous tissue disorders
    Heat rash
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    5
    Acne
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    6
    Pruritus
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    6
    Eczema
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    5
    Rash
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    6
    Urticaria
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    54 / 73 (73.97%)
         occurrences all number
    205
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 73 (16.44%)
         occurrences all number
    37
    Influenza
         subjects affected / exposed
    20 / 73 (27.40%)
         occurrences all number
    24
    Impetigo
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Gastroenteritis
         subjects affected / exposed
    7 / 73 (9.59%)
         occurrences all number
    13
    Pharyngitis
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/24018745
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