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    Clinical Trial Results:
    A 12-MONTH OPEN-LABEL EXTENSION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF FLEXIBLE DOSES OF PREGABALIN IN PEDIATRIC PATIENTS WITH PARTIAL ONSET SEIZURES

    Summary
    EudraCT number
    		 2010-020731-39
    Trial protocol
    		 FR  
    Global end of trial date
    09 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 May 2016
    First version publication date
    23 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A0081075
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00448916
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 1-800 718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 1-800 718-1021, ClinicalTrials.gov_Inquiries@pfizer.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
    24 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of pregabalin in pediatric subjects 1 month through 16 years of age with partial onset seizures.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed; in particular, those affording greater protection to the safety of study subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 May 2007
    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
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    Mexico: 4
    Country: Number of subjects enrolled
    United States: 47
    Worldwide total number of subjects
    54
    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)
    16
    Children (2-11 years)
    27
    Adolescents (12-17 years)
    11
    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
    		 This study was a dose extension study of pediatric subjects with refractory partial-onset seizures who had completed study A0081074 (NCT00437281, Eudra CT number 2010-020730-26). Subjects were enrolled in 3 countries at 13 study centers with 13 investigators: Republic of Korea (1 center), Mexico (1 center), and the United States (11 centers).

    Pre-assignment
    Screening details
    		 Each subject was restricted to the dose levels that they had previously tolerated, or that had shown acceptable safety and tolerability in study A0081074 (NCT00437281, Eudra CT number 2010-020730-26) for the subject's age group.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pregabalin: 1-23 Months
    Arm description
    		 Age group included 1-23 months. Pregabalin was administered for 12 Months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Lyrica
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 milligram per kilogram per day (mg/kg/day) for 12 Months.

    Arm title
    		 Pregabalin: 2-6 Years
    Arm description
    		 Age group included 2-6 years. Pregabalin was administered for 12 Months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Lyrica
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.

    Arm title
    		 Pregabalin: 7-11 Years
    Arm description
    		 Age group included 7-11 years. Pregabalin was administered for 12 Months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Lyrica
    Pharmaceutical forms
    Capsule, Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Pregabalin was administered orally as capsule formulation or liquid formulation. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.

    Arm title
    		 Pregabalin: 12-16 Years
    Arm description
    		 Age group included 12-16 years. Pregabalin was administered for 12 Months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Lyrica
    Pharmaceutical forms
    Capsule, Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Pregabalin was administered orally as capsule formulation or liquid formulation. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.

    Number of subjects in period 1
    		Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Started
    16
    15
    12
    11
    Completed
    9
    9
    6
    5
    Not completed
    7
    6
    6
    6
         Consent withdrawn by subject
    3
    3
    1
    1
         Adverse Event
    2
    2
    3
    2
         Not specified
    1
    -
    -
    -
         Protocol Violation
    -
    -
    -
    1
         Lost to follow-up
    -
    1
    -
    1
         Lack of efficacy
    1
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pregabalin: 1-23 Months
    Reporting group description
    		 Age group included 1-23 months. Pregabalin was administered for 12 Months.

    Reporting group title
    Pregabalin: 2-6 Years
    Reporting group description
    		 Age group included 2-6 years. Pregabalin was administered for 12 Months.

    Reporting group title
    Pregabalin: 7-11 Years
    Reporting group description
    		 Age group included 7-11 years. Pregabalin was administered for 12 Months.

    Reporting group title
    Pregabalin: 12-16 Years
    Reporting group description
    		 Age group included 12-16 years. Pregabalin was administered for 12 Months.

    Reporting group values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years Total
    Number of subjects
    		 16 15 12 11 54
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 1.18 ± 0.57 4.14 ± 1.23 9.98 ± 1.3 14.86 ± 1.53 -
    Gender categorical
    Units: Subjects
        Female
    		 8 9 5 3 25
        Male
    		 8 6 7 8 29

    End points

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    End points reporting groups
    Reporting group title
    Pregabalin: 1-23 Months
    Reporting group description
    		 Age group included 1-23 months. Pregabalin was administered for 12 Months.

    Reporting group title
    Pregabalin: 2-6 Years
    Reporting group description
    		 Age group included 2-6 years. Pregabalin was administered for 12 Months.

    Reporting group title
    Pregabalin: 7-11 Years
    Reporting group description
    		 Age group included 7-11 years. Pregabalin was administered for 12 Months.

    Reporting group title
    Pregabalin: 12-16 Years
    Reporting group description
    		 Age group included 12-16 years. Pregabalin was administered for 12 Months.

    Primary: Number of Subjects With Adverse Events (AE)

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    End point title
    		 Number of Subjects With Adverse Events (AE) [1]
    End point description
    An AE is any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Primary
    End point timeframe
    12 Months
    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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    16
    15
    12
    11
    Units: subjects
    number (not applicable)
        Subjects with AEs
    14
    13
    11
    9
        Subjects with serious AEs
    8
    3
    0
    1
        Subjects with severe AEs
    7
    4
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up

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    End point title
    		 Number of Subjects With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up
    End point description
    Changes from previous examinations in physical examination were reported. Examination of abdomen, breasts, ears, extremities, eyes, genitourinary, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, skin, throat, thyroid and general examinations were done. Evaluation was done based on presence of abnormality which were noted as "abnormal" and no abnormalities in the sites were reported as "normal". Any change from the previous physical examination results were noted. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    16
    15
    12
    11
    Units: subjects
    number (not applicable)
        Week 1 (N=16,13,11,10)
    2
    1
    0
    0
        Month 1 (N=14,13,10,10)
    1
    1
    0
    0
        Month 6 (N=11,10,6,7)
    1
    1
    0
    0
        Month 12/Early Termination (N=16,12,12,9)
    1
    2
    1
    1
        Follow-up (N=6,4,9,6)
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up

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    End point title
    		 Number of Subjects With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up
    End point description
    Changes from previous examinations in neurological examination were reported. The neurologic exam were performed by a pediatric neurologist or qualified staff member. Coordination, cranial nerves, gait, level of consciousness, lower and upper extremity sensation, muscle strength, muscle tone, nystagmus, reflexes, Romberg test, and speech were examined. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    16
    15
    12
    11
    Units: subjects
    number (not applicable)
        Week 1 (N=16,13,11,10)
    1
    0
    0
    0
        Month 1 (N=14,13,10,10)
    0
    0
    0
    0
        Month 6 (N=11,10,6,7)
    0
    0
    0
    0
        Month 12/Early Termination (N=16,11,12,9)
    0
    0
    0
    0
        Follow-up (N=6,4,9,6)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months)

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    End point title
    		 Number of Subjects With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months)
    End point description
    Subjects with significant supine diastolic BP values with the criteria greater than or equal to (≥)20 percent (%) increase from Baseline or ≥20% decrease from Baseline or greater than (>)1.25 times upper limit of normal (ULN) or less than (<)0.9 times lower limit of normal (LLN) were identified and recorded. The categorical summary of Post-Baseline supine diastolic BP data are presented below. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    Visit 1 to 12 Months
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    16
    15
    12
    11
    Units: subjects
    number (not applicable)
        ≥ 20% increase from Baseline
    12
    5
    8
    3
        ≥ 20% decrease from Baseline
    5
    7
    3
    3
        > 1.25 * ULN
    1
    1
    0
    0
        < 0.9 * LLN
    0
    0
    3
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months)

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    End point title
    		 Number of Subjects With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months)
    End point description
    Subjects with significant supine systolic BP values with the criteria ≥30% increase from Baseline or ≥30% decrease from Baseline or >1.25 times ULN or <0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine systolic BP data are presented below. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    Visit 1 to 12 Months
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    16
    15
    12
    11
    Units: subjects
    number (not applicable)
        ≥ 30% increase from Baseline
    2
    3
    1
    1
        ≥ 30% decrease from Baseline
    2
    1
    0
    0
        > 1.25 * ULN
    0
    0
    0
    0
        < 0.9 * LLN
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months)

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    End point title
    		 Number of Subjects With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months)
    End point description
    Subjects with significant heart rate values with the criteria > 1.5 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine HR data are presented below. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    Visit 1 to 12 Months
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    16
    15
    12
    11
    Units: subjects
    number (not applicable)
        > 1.5 * ULN
    0
    0
    0
    0
        < 0.9 * LLN
    5
    2
    1
    0
    No statistical analyses for this end point

    Secondary: Derived Body Mass Index Data (BMI) at Month 12/Early Termination

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    End point title
    		 Derived Body Mass Index Data (BMI) at Month 12/Early Termination
    End point description
    BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height (meter [m])^2. Safety analysis set: All subjects who received at least one dose of study medication were included. Data was available for 15, 11, 10 and 7 subjects in Pregabalin 1-23 months group, 2-6 years group, 7-11 years group and 12-16 years group respectively.
    End point type
    Secondary
    End point timeframe
    Month 12/Early Termination
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    15
    11
    10
    7
    Units: Kg/m^2
        arithmetic mean (standard deviation)
    16.2 ± 1.73
    18 ± 3.52
    20.6 ± 6.52
    24.8 ± 7.72
    No statistical analyses for this end point

    Secondary: Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up

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    End point title
    		 Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up
    End point description
    Weight was recorded in kilograms and weight change from Baseline was reported. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    16
    15
    12
    11
    Units: Kg
    arithmetic mean (standard deviation)
        Day 9 (N=16,14,12,11)
    0.1 ± 0.16
    0.1 ± 0.29
    -0.1 ± 0.79
    0.4 ± 1.07
        Week 1 (N=16,13,11,10)
    0.3 ± 0.29
    0.4 ± 0.61
    1.5 ± 1.15
    1.2 ± 1.43
        Month 1 (N=14,13,10,10)
    0.4 ± 0.45
    0.8 ± 0.73
    2.1 ± 1.77
    2.4 ± 1.52
        Month 2 (N=11,12,8,9)
    1 ± 0.73
    1.2 ± 1.12
    3.8 ± 3.25
    3 ± 1.81
        Month 4 (N=11,10,7,9)
    1.3 ± 0.86
    1.3 ± 1.29
    5.2 ± 4.32
    4.1 ± 2.28
        Month 6 (N=11,10,6,7)
    1.8 ± 0.98
    1.4 ± 1.52
    5.9 ± 4.17
    5.9 ± 3.32
        Month 9 (N=9,10,6,5)
    2.4 ± 1.18
    2.3 ± 2.52
    6.3 ± 4.66
    7.3 ± 4.32
        Month 12/Early Termination (N=15,12,11,8)
    1.8 ± 1.33
    2.4 ± 2.71
    6 ± 4.78
    6.6 ± 4.51
    No statistical analyses for this end point

    Secondary: Height at Month 12/Early Termination

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    End point title
    		 Height at Month 12/Early Termination
    End point description
    Height was recorded in centimeters (cm). Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    Month 12/Early Termination
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    15
    11
    10
    7
    Units: cm
        arithmetic mean (standard deviation)
    83.3 ± 8.87
    109.9 ± 12.76
    145.6 ± 13.21
    167.3 ± 8.18
    No statistical analyses for this end point

    Secondary: Number of Subjects With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months)

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    End point title
    		 Number of Subjects With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months)
    End point description
    Based on the criteria for safety values of potential clinical concern, the PR interval (≥200 millisecond (msec); ≥25% increase from Baseline; ≥50% increase from Baseline), QRS complex (≥200 msec; ≥25% increase from Baseline), QT interval (≥500 msec), maximum QTcB (QTc[Bazett’s correction]) interval (450-<480; 480-<500; ≥500 msec) and maximum QTcF (QTc[Fridericia’s correction]) interval (450-<480; 480-<500; ≥500 msec) values were calculated. Baseline was defined as Day 1 of the parent study A0081074 (NCT00437281). Categorical data of the Post-Baseline vists are represented below. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    Week 1 to 12 Months
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    16
    15
    12
    11
    Units: subjects
    number (not applicable)
        PR interval: ≥ 200 msec
    0
    0
    0
    0
        PR interval: ≥50% increase from Baseline
    0
    0
    0
    0
        PR interval: ≥25% increase from Baseline
    1
    0
    1
    0
        QRS interval: ≥ 200 msec
    0
    0
    0
    0
        QRS interval: ≥25% increase from Baseline
    0
    0
    0
    0
        QT interval: ≥ 500 msec
    0
    0
    0
    0
        QTcB interval: 450-<480 msec
    1
    1
    1
    2
        QTcB interval: 480-<500 msec
    0
    0
    0
    0
        QTcB interval: ≥ 500 msec
    0
    0
    0
    0
        QTcF interval: 450-<480 msec
    0
    0
    0
    0
        QTcF interval: 480-<500 msec
    0
    0
    0
    0
        QTcF interval: ≥ 500 msec
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Hematolgical Abnormalities

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    End point title
    		 Number of Subjects With Hematolgical Abnormalities
    End point description
    Based on criteria for safety values of potential clinical concern, the subjects with abnormal values were noted. Some of the values are: platelets (10*3/ millimeter[mm]*3): <0.5 LLN or >1.75 ULN; white blood cell (WBC) count (X10E9/L): <0.6 LLN or >1.5 ULN; lymphocytes-Absolute (Abs) (10*3/mm*3): <0.8 LLN or >1.2 ULN; total neutrophils-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; and eosinophils-Abs: >1.2 ULN. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    16
    15
    12
    11
    Units: subjects
    number (not applicable)
        Platelets: <0.5xLLN (N=16,15,12,11)
    1
    1
    0
    0
        Platelets: >1.75xULN (N=16,15,12,11)
    1
    0
    0
    0
        WBC count: <0.6xLLN (N=15,15,12,11)
    1
    2
    0
    0
        WBC count: >1.5xULN (N=15,15,12,11)
    0
    0
    0
    0
        Lymphocytes-Abs: <0.8xLLN (N=15,15,12,11)
    0
    0
    0
    0
        Lymphocytes-Abs: >1.2xULN (N=15,15,12,11)
    1
    0
    0
    2
        Total neutrophils-Abs: <0.8xLLN (N=15,15,12,11)
    3
    4
    3
    3
        Total neutrophils-Abs: >1.2xULN (N=15,15,12,11)
    1
    1
    0
    0
        Eosinophils-Abs: >1.2xULN (N=15,15,12,11)
    3
    1
    1
    0
        Hemoglobin: <0.8xLLN(N=15,15,12,11)
    0
    0
    0
    0
        Hematocrit: <0.8xLLN (N=15,15,12,11)
    0
    0
    0
    0
        Red blood cell count: <0.8xLLN (N=15,15,12,11)
    0
    0
    0
    0
        Basophils: >1.2xULN (N=15,15,12,11)
    0
    0
    0
    0
        Monocytes: >1.2xULN (N=15,15,12,11)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Abnormalities in Urinalysis (Dipstick/Microscopy)

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    End point title
    		 Number of Subjects With Abnormalities in Urinalysis (Dipstick/Microscopy)
    End point description
    Based on criteria for safety values of potential clinical concern, the subjects with abnormal values were noted. Subjects with Urine Protein milligram per deciliter (mg/dL) abnormalities (≥1) were noted based on urinalysis (dipstick). No subjects with abnormalities in urinalysis (microscopy) were noted. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    11
    15
    11
    11
    Units: subjects
        number (not applicable)
    1
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Abnormalities in Endocrine Panel (Hormones)

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    End point title
    		 Number of Subjects With Abnormalities in Endocrine Panel (Hormones)
    End point description
    Based on criteria for safety values of potential clinical concern, the subjects with abnormal values were noted. Some of the criteria are: Free thyroxine (T4 free) nanogram per deciliter (ng/dL): <0.8 LLN or >1.2 ULN and Thyroid-stimulating hormone (TSH) milliunits per liter (mu/L): <0.8 LLN or >1.2 ULN. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    16
    15
    12
    11
    Units: subjects
    number (not applicable)
        T4 (free): <0.8xLLN (N=13,13,11,10)
    0
    1
    0
    0
        T4 (free): >1.2xULN (N=13,13,11,10)
    0
    0
    0
    0
        TSH: <0.8xLLN (N=14,12,11,10)
    1
    0
    0
    0
        TSH: >1.2xULN (N=14,12,11,10)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Abnormalities in Creatine Kinase

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    End point title
    		 Number of Subjects With Abnormalities in Creatine Kinase
    End point description
    Based on criteria for safety values of potential clinical concern, the subjects with abnormal values in creatine kinase (>2.0 times upper limit of the reference range) units per liter (u/L) were noted. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    15
    15
    12
    11
    Units: subjects
        number (not applicable)
    0
    1
    1
    4
    No statistical analyses for this end point

    Secondary: Seizure Frequency

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    End point title
    		 Seizure Frequency
    End point description
    Twenty-eight-day seizure frequencies were to be calculated from the seizure diaries and were to be reviewed. However, due to the nature of the data collection and due to inability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed. Hence, the seizure data was reported as AE. Safety analysis set: All subjects who received at least one dose of study medication were included. Here "99999" in the seizure frequency signifies not available (NA). Due to the nature of the data collection and due to inability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed.
    End point type
    Secondary
    End point timeframe
    28 Days
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    16
    15
    12
    11
    Units: subjects
        number (not applicable)
    99999
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Number of Subjects With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein)

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    End point title
    		 Number of Subjects With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein)
    End point description
    Based on criteria for safety values of potential clinical concern, the subjects with abnormal values in liver function tests, renal function tests, lipid profile, electrolytes, glucose, Insulin like growth factor (IGF) and IGF binding protein were noted and reported in this section. Safety analysis set: All subjects who received at least one dose of study medication were included.
    End point type
    Secondary
    End point timeframe
    12 Months
    End point values
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
    Number of subjects analysed
    15
    15
    12
    11
    Units: subjects
    number (not applicable)
        Alanine Aminotransferase: >3.0xULN (N=15,15,12,11)
    0
    1
    1
    0
        Blood Urea Nitrogen: >1.3xULN
    2
    5
    1
    0
        Albumin: <0.8xLLN (N=15,15,12,11)
    0
    0
    0
    0
        Albumin: >1.2xULN (N=15,15,12,11)
    2
    0
    0
    0
        Potassium: <0.9xLLN (N=15,15,12,11)
    0
    0
    0
    0
        Potassium: >1.1xULN (N=15,15,12,11)
    1
    0
    1
    0
        Magnesium: <0.9xLLN (N=15,15,12,11)
    0
    0
    0
    0
        Magnesium: >1.1xULN (N=15,15,12,11)
    1
    2
    0
    1
        Phosphate: <0.8xLLN (N=15,15,12,11)
    0
    0
    0
    0
        Phosphate: >1.2xULN (N=15,15,12,11)
    0
    1
    1
    0
        Bicarbonate (venous): <0.9xLLN (N=15,15,12,11)
    9
    11
    7
    3
        Bicarbonate (venous): >1.1xULN (N=15,15,12,11)
    0
    0
    0
    0
        Glucose: <0.6xLLN (N=15,15,12,11)
    1
    1
    0
    0
        Glucose: >1.5xULN (N=15,15,12,11)
    0
    0
    0
    0
        Insulin-like GrowthFactor:<0.9xLLN(N=12,13,11,10)
    0
    0
    1
    0
        Insulin-like GrowthFactor:>1.1xULN(N=12,13,11,10)
    5
    8
    4
    6
        IGF Binding Protein: <0.9xLLN (N=12,13,11,10)
    0
    0
    0
    0
        IGF Binding Protein: >1.1xULN (N=12,13,11,10)
    4
    2
    5
    0
        Lipid profile cholesterol/triglycerides(N=1,4,0,1)
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Visit 1 to Visit 9 (Follow-up visit)
    Adverse event reporting additional description
    The same event may appear as both an AE and a Serious Adverse Event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non serious in another subject, or one subject may have experienced both a serious and non serious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Pregabalin: 1-23 Months
    Reporting group description
    		 Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.

    Reporting group title
    Pregabalin: 2-6 Years
    Reporting group description
    		 Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.

    Reporting group title
    Pregabalin: 7-11 Years
    Reporting group description
    		 Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if subjects were unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.

    Reporting group title
    Pregabalin: 12-16 Years
    Reporting group description
    		 Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if subjects were unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.

    Reporting group title
    Overall
    Reporting group description
    		 This arm summarizes the AE data from all the treatment groups.

    Serious adverse events
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 16 (50.00%)
    3 / 15 (20.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    12 / 54 (22.22%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 54 (5.56%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 54 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Unresponsive to stimuli
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary hypersecretion
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Croup infectious
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 54 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 16 (87.50%)
    13 / 15 (86.67%)
    11 / 12 (91.67%)
    9 / 11 (81.82%)
    47 / 54 (87.04%)
    Surgical and medical procedures
    Adenoidectomy
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    1
    1
    Crying
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    0
    0
    1
    Irritability
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    4
    0
    0
    0
    4
    Pyrexia
         subjects affected / exposed
    9 / 16 (56.25%)
    3 / 15 (20.00%)
    0 / 12 (0.00%)
    3 / 11 (27.27%)
    15 / 54 (27.78%)
         occurrences all number
    17
    5
    0
    3
    25
    Thirst
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    4 / 16 (25.00%)
    2 / 15 (13.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    6 / 54 (11.11%)
         occurrences all number
    5
    2
    0
    0
    7
    Epistaxis
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    4 / 54 (7.41%)
         occurrences all number
    0
    3
    1
    1
    5
    Hypoxia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    2 / 16 (12.50%)
    3 / 15 (20.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    6 / 54 (11.11%)
         occurrences all number
    2
    5
    1
    0
    8
    Productive cough
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    2
    1
    0
    0
    3
    Respiratory distress
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 15 (13.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    1
    2
    0
    0
    3
    Rhonchi
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    0
    0
    1
    Snoring
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    0
    0
    1
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Anger
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    1
    1
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    1
    1
    0
    2
    Depression
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    1
    1
    Dissociation
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Dysphemia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Dyssomnia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Hallucination, visual
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    1
    0
    2
    0
    3
    Personality change
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    0
    0
    1
    Restlessness
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Anticonvulsant drug level increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    2
    0
    0
    2
    Weight increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    1
    1
    0
    2
    Injury, poisoning and procedural complications
    Anal injury
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Arthropod bite
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Arthropod sting
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Excoriation
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    2 / 11 (18.18%)
    2 / 54 (3.70%)
         occurrences all number
    0
    0
    0
    2
    2
    Fall
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Foot fracture
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    1
    1
    Laceration
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    1
    1
    Congenital, familial and genetic disorders
    Cryptorchism
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Cardiac disorders
    Bundle branch block left
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Nervous system disorders
    Cognitive disorder
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Convulsion
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
    3 / 12 (25.00%)
    1 / 11 (9.09%)
    7 / 54 (12.96%)
         occurrences all number
    5
    1
    3
    1
    10
    Dizziness
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    2 / 54 (3.70%)
         occurrences all number
    0
    0
    1
    1
    2
    Headache
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    2
    0
    2
    Lethargy
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    3 / 54 (5.56%)
         occurrences all number
    0
    2
    0
    1
    3
    Partial seizures
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Somnolence
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    4 / 54 (7.41%)
         occurrences all number
    2
    0
    1
    1
    4
    Status epilepticus
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    2
    0
    0
    2
    Blood and lymphatic system disorders
    Cyclic neutropenia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Leukocytosis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    0
    0
    1
    Neutropenia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Thrombocytosis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    2 / 54 (3.70%)
         occurrences all number
    0
    1
    0
    1
    2
    Eye disorders
    Astigmatism
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    1
    1
    0
    0
    2
    Excessive eye blinking
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Hypermetropia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    2
    0
    0
    0
    2
    Abdominal tenderness
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Constipation
         subjects affected / exposed
    5 / 16 (31.25%)
    1 / 15 (6.67%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    7 / 54 (12.96%)
         occurrences all number
    7
    1
    1
    0
    9
    Diarrhoea
         subjects affected / exposed
    3 / 16 (18.75%)
    3 / 15 (20.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    6 / 54 (11.11%)
         occurrences all number
    4
    4
    0
    0
    8
    Faeces pale
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    3
    0
    0
    0
    3
    Retching
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    0
    0
    1
    Salivary hypersecretion
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Tooth impacted
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    1
    1
    Vomiting
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    4 / 54 (7.41%)
         occurrences all number
    3
    1
    0
    1
    5
    Abdominal pain
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    3
    0
    0
    0
    3
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Dermatitis diaper
         subjects affected / exposed
    3 / 16 (18.75%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    4 / 54 (7.41%)
         occurrences all number
    3
    1
    0
    0
    4
    Pruritus
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Rash
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    0
    0
    1
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    2
    0
    1
    0
    3
    Urine odour abnormal
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle twitching
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    2
    0
    0
    2
    Infections and infestations
    Bacterial sepsis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    1
    1
    Cystitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    1
    1
    Device related infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 16 (0.00%)
    4 / 15 (26.67%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    5 / 54 (9.26%)
         occurrences all number
    0
    9
    1
    0
    10
    Eye infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    1
    1
    0
    0
    2
    Hordeolum
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    5
    0
    0
    0
    5
    Otitis media
         subjects affected / exposed
    4 / 16 (25.00%)
    4 / 15 (26.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    8 / 54 (14.81%)
         occurrences all number
    13
    6
    0
    0
    19
    Otitis media acute
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    2
    1
    0
    0
    3
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    0
    2
    1
    0
    3
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    2
    1
    0
    0
    3
    Sinusitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    1
    1
    Staphylococcal infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    0
    0
    1
    Tinea infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 16 (18.75%)
    5 / 15 (33.33%)
    2 / 12 (16.67%)
    0 / 11 (0.00%)
    10 / 54 (18.52%)
         occurrences all number
    8
    8
    2
    0
    18
    Urinary tract infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    0
    1
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    2
    1
    0
    0
    3
    Hyperkalaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Increased appetite
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    1
    1
    0
    2
    Metabolic acidosis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    0
    1
    Polydipsia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    3
    0
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Mar 2011
    1-Guidance provided to allow for reduction of blood volume required for subjects with low body weights in the 1-23 month infant cohort. 2-Language was added regarding handling of potential Hy's Law cases. Potential Hy’s Law cases were reported as serious adverse events.

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

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