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    Clinical Trial Results:
    A Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1- to 11-Year Old Pediatric Subjects With Endoscopically Proven GERD

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2008-004837-54
    Trial protocol
    		 DK   BE   FR   NL   IT   BG  
    Global end of trial date
    25 Jan 2011

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RABGRD3003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00787891
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Johnson & Johnson Pharmaceutical Research & Development, LLC
    Sponsor organisation address
    920 US Route 202 , Raritan, New Jersey 08869-0602, United States,
    Public contact
    Janssen Research & Development, Clinical Registry Group, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Janssen Research & Development, Clinical Registry Group, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000055-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jan 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jan 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the efficacy (endoscopic/histological healing) and safety of 2 dose levels (0.5 milligram per kilogram (mg/kg) [10 mg max dose] and 1.0 mg/kg [20 mg max dose]) of a pediatric bead formulation of rabeprazole sodium (which can be administered orally mixed with food as needed) in a 12-week, parallel-group, double-blind design followed by a long-term safety and efficacy assessment in a 24-week, double-blind maintenance treatment phase in subjects, 1 to11 years of age, with endoscopically proven Gastroesophageal Reflux Disease (GERD).
    Protection of trial subjects
    An Independent Data Safety Monitoring Board (DSMB) was commissioned for the study as well as for the whole pediatric program, and monitored serious adverse events (SAEs), subject withdrawals, and other safety data. Safety variables included adverse events (AEs), clinical laboratory tests, and urinalysis, vital sign measurements (Oral or tympanic temperature, pulse and respiration rate, diastolic and systolic blood pressure measurement), physical examinations (including body weight and height), and Tanner Staging.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jan 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Denmark: 4
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    India: 3
    Country: Number of subjects enrolled
    Israel: 10
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    United States: 74
    Country: Number of subjects enrolled
    South Africa: 7
    Worldwide total number of subjects
    127
    EEA total number of subjects
    33
    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)
    14
    Children (2-11 years)
    113
    Adolescents (12-17 years)
    0
    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
    		 In the study, 127 subjects were enrolled at 30 sites from 8 countries.

    Pre-assignment
    Screening details
    		 In the study, 108 subjects completed the 12-week phase (Part 1) and were counted for the primary outcome measure (OM). Subjects with healing at Week 12 had the option to continue the treatment for 24 weeks. Among the 87 with healing, 64 enrolled into Part 2. Only 52 had the primary efficacy endpoint available and were included in the primary OM

    Period 1
    Period 1 title
    Short-term Double-blind Phase (Part 1)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rabeprazole Sodium 0.5 mg/kg
    Arm description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rabeprazole sodium
    Investigational medicinal product code
    R128546
    Other name
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Pediatric micro-bead formulation of rabeprazole sodium 0.5 mg/kg orally administered.

    Arm title
    		 Rabeprazole Sodium 1.0 mg/kg
    Arm description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rabeprazole sodium
    Investigational medicinal product code
    R128546
    Other name
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Pediatric micro-bead formulation of rabeprazole sodium 1.0 mg/kg orally administered.

    Number of subjects in period 1
    		Rabeprazole Sodium 0.5 mg/kg Rabeprazole Sodium 1.0 mg/kg
    Started
    65
    62
    Completed
    55
    53
    Not completed
    10
    9
         Physician decision
    1
    -
         Consent withdrawn by subject
    6
    2
         Other
    -
    2
         Adverse event
    1
    2
         Lost to follow-up
    2
    2
         Protocol deviation
    -
    1
    Period 2
    Period 2 title
    Maintenance Double-blind Phase (Part 2)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Rabeprazole Sodium 0.5 mg/kg
    Arm description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rabeprazole sodium
    Investigational medicinal product code
    R128546
    Other name
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Pediatric micro-bead formulation of rabeprazole sodium 0.5 mg/kg orally administered.

    Arm title
    		 Rabeprazole Sodium 1.0 mg/kg
    Arm description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rabeprazole sodium
    Investigational medicinal product code
    R128546
    Other name
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Pediatric micro-bead formulation of rabeprazole sodium 1.0 mg/kg orally administered.

    Number of subjects in period 2
    		Rabeprazole Sodium 0.5 mg/kg Rabeprazole Sodium 1.0 mg/kg
    Started
    33
    31
    Completed
    26
    24
    Not completed
    7
    7
         Consent withdrawn by subject
    1
    3
         Other
    5
    2
         Adverse event
    -
    1
         Noncompliance with study drug
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rabeprazole Sodium 0.5 mg/kg
    Reporting group description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.

    Reporting group title
    Rabeprazole Sodium 1.0 mg/kg
    Reporting group description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.

    Reporting group values
    		 Rabeprazole Sodium 0.5 mg/kg Rabeprazole Sodium 1.0 mg/kg Total
    Number of subjects
    		 65 62 127
    Title for AgeCategorical
    Units: subjects
        infants and toddlers(28 days-23 months)
    		 5 9 14
        Children (2-11 years)
    		 60 53 113
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 5.9 ± 3.49 5.4 ± 3.26 -
    Title for Gender
    Units: subjects
        Female
    		 31 25 56
        Male
    		 34 37 71

    End points

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    End points reporting groups
    Reporting group title
    Rabeprazole Sodium 0.5 mg/kg
    Reporting group description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.

    Reporting group title
    Rabeprazole Sodium 1.0 mg/kg
    Reporting group description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.
    Reporting group title
    Rabeprazole Sodium 0.5 mg/kg
    Reporting group description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.

    Reporting group title
    Rabeprazole Sodium 1.0 mg/kg
    Reporting group description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.

    Primary: The Percentage of Participants With Healing by Week 12 (Short-term Double-blind Treatment Phase)

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    End point title
    		 The Percentage of Participants With Healing by Week 12 (Short-term Double-blind Treatment Phase) [1]
    End point description
    Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa. ITT (Intent-to-treat) analysis set included all participants randomized into the study and who had at least 1 postbaseline efficacy measurement.
    End point type
    Primary
    End point timeframe
    12 weeks
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Rabeprazole Sodium 0.5 mg/kg Rabeprazole Sodium 1.0 mg/kg
    Number of subjects analysed
    55
    53
    Units: percentage of participants
        number (confidence interval 95%)
    78 (67 to 89)
    83 (73 to 93)
    No statistical analyses for this end point

    Primary: The Percentage of Participants With Healing by Week 36 (Double-blind Maintenance Treatment Phase)

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    End point title
    		 The Percentage of Participants With Healing by Week 36 (Double-blind Maintenance Treatment Phase) [2]
    End point description
    Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa. ITT analysis set included all participants randomized into the study and who had at least 1 postbaseline efficacy measurement.
    End point type
    Primary
    End point timeframe
    36 weeks
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Rabeprazole Sodium 0.5 mg/kg Rabeprazole Sodium 1.0 mg/kg
    Number of subjects analysed
    26
    26
    Units: percentage of participants
        number (confidence interval 95%)
    92 (82 to 100)
    88 (76 to 100)
    No statistical analyses for this end point

    Secondary: The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Short-term Double-blind Treatment Phase)

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    End point title
    		 The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Short-term Double-blind Treatment Phase)
    End point description
    The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement. ITT analysis set included all participants randomized into the study and who had at least 1 postbaseline efficacy measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Rabeprazole Sodium 0.5 mg/kg Rabeprazole Sodium 1.0 mg/kg
    Number of subjects analysed
    55
    53
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -1.3 ± 0.85
    -1 ± 0.81
    No statistical analyses for this end point

    Secondary: The Change From Baseline in the Total Gastroesophageal Reflux Disease (GERD) Symptom and Severity Score (Short-term Double-blind Treatment Phase)

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    End point title
    		 The Change From Baseline in the Total Gastroesophageal Reflux Disease (GERD) Symptom and Severity Score (Short-term Double-blind Treatment Phase)
    End point description
    The GERD symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening and negative score indicates improvement. ITT analysis set included all participants randomized into the study and who had at least 1 postbaseline efficacy measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Rabeprazole Sodium 0.5 mg/kg Rabeprazole Sodium 1.0 mg/kg
    Number of subjects analysed
    61
    59
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -11.5 ± 11.7
    -8.5 ± 9.75
    No statistical analyses for this end point

    Secondary: The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Double-blind Maintenance Treatment Phase)

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    End point title
    		 The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Double-blind Maintenance Treatment Phase)
    End point description
    The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening and a negative score indicates an improvement. ITT analysis set included all participants randomized into the study and who had at least 1 postbaseline efficacy measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 36
    End point values
    		 Rabeprazole Sodium 0.5 mg/kg Rabeprazole Sodium 1.0 mg/kg
    Number of subjects analysed
    26
    26
    Units: scores on a scale
        arithmetic mean (standard deviation)
    0.2 ± 0.49
    0.2 ± 0.54
    No statistical analyses for this end point

    Secondary: The Change From Baseline in the Total Gastroesophageal Reflux Disease (GERD) Symptom and Severity Score (Double-blind Maintenance Treatment Phase)

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    End point title
    		 The Change From Baseline in the Total Gastroesophageal Reflux Disease (GERD) Symptom and Severity Score (Double-blind Maintenance Treatment Phase)
    End point description
    The GERD symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening and a negative score indicates improvement. ITT analysis set included all participants randomized into the study and who had at least 1 postbaseline efficacy measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 36
    End point values
    		 Rabeprazole Sodium 0.5 mg/kg Rabeprazole Sodium 1.0 mg/kg
    Number of subjects analysed
    32
    29
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -2.9 ± 4.82
    -1.4 ± 9.59
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 30 days after the last dose of study drug
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Rabeprazole Sodium 0.5 mg/kg ( Short-term Double-blind Phase)
    Reporting group description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.

    Reporting group title
    Rabeprazole Sodium 1.0 mg/kg ( Short-term Double-blind Phase)
    Reporting group description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.

    Reporting group title
    Rabeprazole Sodium 1.0 mg/kg ( Double-blind Maintenance Phase)
    Reporting group description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.

    Reporting group title
    Rabeprazole Sodium 0.5 mg/kg ( Double-blind Maintenance Phase)
    Reporting group description
    		 Pediatric micro-bead formulation of rabeprazole sodium orally administered.

    Serious adverse events
    		 Rabeprazole Sodium 0.5 mg/kg ( Short-term Double-blind Phase) Rabeprazole Sodium 1.0 mg/kg ( Short-term Double-blind Phase) Rabeprazole Sodium 1.0 mg/kg ( Double-blind Maintenance Phase) Rabeprazole Sodium 0.5 mg/kg ( Double-blind Maintenance Phase)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 65 (7.69%)
    1 / 62 (1.61%)
    3 / 31 (9.68%)
    2 / 33 (6.06%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Head Injury
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Partial Seizures with Secondary Generalisation
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Conversion Disorder
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Infection
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Rabeprazole Sodium 0.5 mg/kg ( Short-term Double-blind Phase) Rabeprazole Sodium 1.0 mg/kg ( Short-term Double-blind Phase) Rabeprazole Sodium 1.0 mg/kg ( Double-blind Maintenance Phase) Rabeprazole Sodium 0.5 mg/kg ( Double-blind Maintenance Phase)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 65 (72.31%)
    47 / 62 (75.81%)
    21 / 31 (67.74%)
    18 / 33 (54.55%)
    Surgical and medical procedures
    Suture Insertion
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tooth Extraction
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Chills
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Influenza Like Illness
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    8 / 65 (12.31%)
    5 / 62 (8.06%)
    3 / 31 (9.68%)
    0 / 33 (0.00%)
         occurrences all number
    9
    9
    3
    0
    Immune system disorders
    Atopy
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    1
    Hypersensitivity
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Social circumstances
    Menarche
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Breast Mass
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal Hypertrophy
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Asthma
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 62 (3.23%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Asthma Exercise Induced
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bronchial Hyperreactivity
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Choking
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Cough
         subjects affected / exposed
    9 / 65 (13.85%)
    9 / 62 (14.52%)
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    10
    11
    0
    2
    Dysphonia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperventilation
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Increased Upper Airway Secretion
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasal Congestion
         subjects affected / exposed
    4 / 65 (6.15%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    6
    1
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    2 / 65 (3.08%)
    6 / 62 (9.68%)
    2 / 31 (6.45%)
    0 / 33 (0.00%)
         occurrences all number
    2
    8
    2
    0
    Pharyngeal Erythema
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Postnasal Drip
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Productive Cough
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Rhinitis Allergic
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mental Disorder
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sleep Disorder
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    0
    1
    Investigations
    Beta 2 Microglobulin Urine Increased
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    1
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Body Temperature Increased
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood Iron Decreased
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Serum Ferritin Decreased
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod Sting
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Concussion
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Contusion
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Excoriation
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Fall
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Humerus Fracture
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    1
    Procedural Vomiting
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    1
    Skin Laceration
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ulna Fracture
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dysgeusia
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Febrile Convulsion
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    4 / 65 (6.15%)
    7 / 62 (11.29%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    4
    10
    0
    1
    Lethargy
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Ear and labyrinth disorders
    Ear Pain
         subjects affected / exposed
    0 / 65 (0.00%)
    3 / 62 (4.84%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Eustachian Tube Obstruction
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tympanic Membrane Perforation
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 62 (3.23%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Vision Blurred
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    7 / 65 (10.77%)
    8 / 62 (12.90%)
    2 / 31 (6.45%)
    3 / 33 (9.09%)
         occurrences all number
    11
    8
    2
    4
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    1
    1
    Diarrhoea
         subjects affected / exposed
    7 / 65 (10.77%)
    7 / 62 (11.29%)
    3 / 31 (9.68%)
    1 / 33 (3.03%)
         occurrences all number
    8
    7
    3
    1
    Dyspepsia
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 62 (1.61%)
    2 / 31 (6.45%)
    0 / 33 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Eosinophilic Oesophagitis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eructation
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 62 (3.23%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Gastritis
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Haematochezia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hiatus Hernia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Irritable Bowel Syndrome
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mouth Ulceration
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 65 (0.00%)
    3 / 62 (4.84%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Regurgitation
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Toothache
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    8 / 65 (12.31%)
    10 / 62 (16.13%)
    3 / 31 (9.68%)
    4 / 33 (12.12%)
         occurrences all number
    9
    13
    3
    4
    Skin and subcutaneous tissue disorders
    Dermatitis Allergic
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    1
    Dermatitis Contact
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatitis Diaper
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eczema
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Prurigo
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash Pruritic
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin Exfoliation
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Back Pain
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Pain in Extremity
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Infections and infestations
    Acute Tonsillitis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 62 (3.23%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    2
    0
    1
    Conjunctivitis Infective
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Coxsackie Viral Infection
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Croup Infectious
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    0
    2
    Ear Infection
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 62 (3.23%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    2
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fungal Oesophagitis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    0
    1
    Gastroenteritis Rotavirus
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 62 (3.23%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Localised Infection
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    0
    1
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    1
    Lower Respiratory Tract Infection Viral
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Molluscum Contagiosum
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 65 (4.62%)
    3 / 62 (4.84%)
    1 / 31 (3.23%)
    2 / 33 (6.06%)
         occurrences all number
    3
    3
    2
    2
    Pharyngitis
         subjects affected / exposed
    3 / 65 (4.62%)
    1 / 62 (1.61%)
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    3
    1
    2
    2
    Otitis Media
         subjects affected / exposed
    3 / 65 (4.62%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    3
    0
    0
    3
    Pharyngitis Streptococcal
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 62 (1.61%)
    1 / 31 (3.23%)
    2 / 33 (6.06%)
         occurrences all number
    1
    1
    1
    2
    Pneumonia
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 62 (3.23%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Rash Pustular
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    3 / 65 (4.62%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    3
    1
    0
    2
    Sinusitis
         subjects affected / exposed
    2 / 65 (3.08%)
    3 / 62 (4.84%)
    1 / 31 (3.23%)
    2 / 33 (6.06%)
         occurrences all number
    2
    3
    1
    2
    Tooth Abscess
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tracheitis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    6 / 65 (9.23%)
    4 / 62 (6.45%)
    4 / 31 (12.90%)
    4 / 33 (12.12%)
         occurrences all number
    7
    4
    4
    4
    Urinary Tract Infection
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Viral Infection
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 62 (3.23%)
    1 / 31 (3.23%)
    1 / 33 (3.03%)
         occurrences all number
    1
    2
    1
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 62 (1.61%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Acidosis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Iron Deficiency
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2008
    The overall reason for the amendment INT-1 was to allow assent to the informed consent process (as minors were included in the study), to add updated information, and to correct textual inconsistencies within the protocol.
    05 Mar 2009
    The overall reason for the amendment INT-2 was to extend the end of study visit window and to expand the list of antacids allowed during the study; several sections also were revised to provide further text clarification.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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