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    Clinical Trial Results:
    A Phase 4 Open Label, Prospective Study in Patients With Pompe Disease to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale

    Summary
    EudraCT number
    2015-000512-18
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    29 Dec 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    17 Jul 2016
    First version publication date
    25 Jun 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Clarification of unit of measure in endpoint analysis.

    Trial information

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    Trial identification
    Sponsor protocol code
    AGLU09411/EFC12720
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01526785
    WHO universal trial number (UTN)
    U1111-1162-8919
    Sponsors
    Sponsor organisation name
    Genzyme Corporation
    Sponsor organisation address
    500 Kendall Street, Cambridge, MA, United States, 02142
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    05 Mar 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary efficacy objective was to demonstrate comparability of treatment with alglucosidase alfa produced at the 4000L scale in subjects previously treated with 160L scale alglucosidase alfa.
    Protection of trial subjects
    Pediatric Subjects: The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimize distress and discomfort. Adult Subjects: Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Mar 2012
    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
    United States: 113
    Worldwide total number of subjects
    113
    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)
    33
    Children (2-11 years)
    73
    Adolescents (12-17 years)
    6
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was conducted in United States. A total of 113 subjects were treated between 9 March 2012 and 4 June 2014.

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

    Arms
    Arm title
    Alglucosidase Alfa
    Arm description
    Alglucosidase alfa produced at 4000 L scale for 52 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Alglucosidase Alfa
    Investigational medicinal product code
    Other name
    Lumizyme®
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    4000 L alglucosidase alfa as per subject's routine practice.

    Number of subjects in period 1
    Alglucosidase Alfa
    Started
    113
    Completed
    100
    Not completed
    13
         Study Terminated by Sponsor
    8
         Death
    2
         Physician decision
    1
         Consent withdrawn by subject
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Alglucosidase Alfa
    Reporting group description
    Alglucosidase alfa produced at 4000 L scale for 52 weeks.

    Reporting group values
    Alglucosidase Alfa Total
    Number of subjects
    113 113
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    4.8 ± 3.73 -
    Gender categorical
    Units: Subjects
        Female
    53 53
        Male
    60 60

    End points

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    End points reporting groups
    Reporting group title
    Alglucosidase Alfa
    Reporting group description
    Alglucosidase alfa produced at 4000 L scale for 52 weeks.

    Primary: Percentage of Subjects Who were Clinically Stable or Improved at Week 52

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    End point title
    Percentage of Subjects Who were Clinically Stable or Improved at Week 52 [1]
    End point description
    Clinical stability defined as absence of death due to disease progression or new dependency on invasive ventilation and; decline in cardiac status, motor function, and pulmonary function from baseline. Analysis was carried out on full analysis population defined as all subjects who receive at least 1 infusion of 4000 L alglucosidase alfa during the study.
    End point type
    Primary
    End point timeframe
    Week 52
    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: No statistical analyses for this endpoint
    End point values
    Alglucosidase Alfa
    Number of subjects analysed
    104
    Units: percentage of subjects
        number (confidence interval 95%)
    83.7 (75.1 to 90.2)
    No statistical analyses for this end point

    Secondary: Survival Rate at Week 52

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    End point title
    Survival Rate at Week 52
    End point description
    Percentage of subjects who were alive at Week 52, were reported. Survival rate was calculated by Kaplan-Meier estimate. Analysis was carried out on full analysis population.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Alglucosidase Alfa
    Number of subjects analysed
    113
    Units: percentage of subjects
        number (confidence interval 95%)
    98.1 (92.73 to 99.53)
    No statistical analyses for this end point

    Secondary: Invasive Ventilator-Free Survival Rate at Week 52

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    End point title
    Invasive Ventilator-Free Survival Rate at Week 52
    End point description
    Percentage of subjects who were invasive ventilator-free at week 52, were reported. Invasive ventilation was defined as mechanical ventilatory support applied with the use of an endotracheal tube or tracheostomy. Invasive ventilator-free survival rate was calculated by Kaplan-Meier estimate. Analysis was carried out on full analysis population.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Alglucosidase Alfa
    Number of subjects analysed
    81
    Units: percentage of subjects
        number (confidence interval 95%)
    92.4 (83.89 to 96.53)
    No statistical analyses for this end point

    Secondary: Change From Baseline on Left Ventricular Mass Z-Score (LVM-Z) at Week 52

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    End point title
    Change From Baseline on Left Ventricular Mass Z-Score (LVM-Z) at Week 52
    End point description
    Z-­Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates a decrease and positive change from baseline indicates an increase in LVM-Z score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy. Analysis was carried out on full analysis population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    Alglucosidase Alfa
    Number of subjects analysed
    67
    Units: Z score
        arithmetic mean (standard deviation)
    -0.5 ± 1.71
    No statistical analyses for this end point

    Secondary: Change From Baseline on Gross Motor Function Measure-88 (GMFM-88) at Week 52

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    End point title
    Change From Baseline on Gross Motor Function Measure-88 (GMFM-88) at Week 52
    End point description
    GMFM-88 (88-item measure to detect gross motor function) consists of 5 components, each measured on a 4-point Likert scale. The score for each dimension was expressed as a percentage of the maximum score for that dimension. Total score ranges from 0% to 100%, where higher scores indicate better motor functions. Analysis was carried out on full analysis population. Number of subjects analysed = subjects with baseline and Week 52 GMFM-88 data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    Alglucosidase Alfa
    Number of subjects analysed
    90
    Units: percentage of total score
        arithmetic mean (standard deviation)
    3.7 ± 17.46
    No statistical analyses for this end point

    Secondary: Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Supine Position

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    End point title
    Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Supine Position
    End point description
    Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age, and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Analysis was carried out on full analysis population. Number of subjects analysed = subjects with baseline and Week 52 FVC data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    Alglucosidase Alfa
    Number of subjects analysed
    13
    Units: percent predicted FVC
        arithmetic mean (standard deviation)
    3.2 ± 11.07
    No statistical analyses for this end point

    Secondary: Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Sitting Position

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    End point title
    Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Sitting Position
    End point description
    Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age, and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Analysis was carried out on full analysis population. Number of subjects analysed = subjects with baseline and Week 52 FVC data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    Alglucosidase Alfa
    Number of subjects analysed
    22
    Units: percent predicted FVC
        arithmetic mean (standard deviation)
    2.3 ± 11.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported adverse events are treatment­ emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (from the first infusion of study drug up to 30 days after last infusion of study drug). Analysis was performed on safety population which included all treated subjects.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Alglucosidase Alfa 4000 L
    Reporting group description
    Alglucosidase alfa produced at 4000 L scale for 52 weeks.

    Serious adverse events
    Alglucosidase Alfa 4000 L
    Total subjects affected by serious adverse events
         subjects affected / exposed
    73 / 113 (64.60%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Jugular Vein Thrombosis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Central Venous Catheterisation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Therapeutic Procedure
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Chills
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Device Malfunction
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device Breakage
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypothermia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oedema Peripheral
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    10 / 113 (8.85%)
         occurrences causally related to treatment / all
    4 / 16
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Mental Status Changes
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Self-Injurious Ideation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Feeding Tube Complication
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Foreign Body
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femur Fracture
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Foreign Body Aspiration
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Traumatic Haemothorax
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tracheal Obstruction
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood Albumin Decreased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oxygen Saturation Decreased
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac Failure Congestive
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardio-Respiratory Arrest
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Cardiopulmonary Failure
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cyanosis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Left Ventricular Hypertrophy
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Mitral Valve Incompetence
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulseless Electrical Activity
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Sinus Tachycardia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Acute Respiratory Failure
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Apnoea
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atelectasis
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Bronchial Secretion Retention
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Chronic Respiratory Failure
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Cough
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypoxia
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary Granuloma
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory Disorder
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory Distress
         subjects affected / exposed
    16 / 113 (14.16%)
         occurrences causally related to treatment / all
    0 / 23
         deaths causally related to treatment / all
    0 / 2
    Respiratory Failure
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    Rhonchi
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory Tract Congestion
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Brain Injury
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral Ischaemia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Convulsion
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gross Motor Delay
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Loss Of Consciousness
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Eyelid Ptosis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Motion Sickness
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Dental Caries
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal Disorder
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intussusception
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Urinary Retention
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis Acute
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Purpura
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular Weakness
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Muscle Contracture
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Failure To Thrive
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fluid Overload
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Adenovirus Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bacteraemia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bacterial Tracheitis
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Device Related Infection
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Haemophilus Bacteraemia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Klebsiella Bacteraemia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lung Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metapneumovirus Infection
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Otitis Media Acute
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Parainfluenzae Virus Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Periumbilical Abscess
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    25 / 113 (22.12%)
         occurrences causally related to treatment / all
    0 / 33
         deaths causally related to treatment / all
    0 / 1
    Pneumonia Parainfluenzae Viral
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia Respiratory Syncytial Viral
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia Pseudomonal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia Viral
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Respiratory Syncytial Virus Bronchiolitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Rhinovirus Infection
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Respiratory Tract Infection Viral
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tracheitis
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Tracheostomy Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Infection Bacterial
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Infection Staphylococcal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral Infection
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Alglucosidase Alfa 4000 L
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    113 / 113 (100.00%)
    Vascular disorders
    Aortic Dilatation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Flushing
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    13
    Hypertension
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    Haematoma
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Pallor
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Hypotension
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Peripheral Coldness
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Surgical and medical procedures
    Central Venous Catheterisation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Ear Tube Removal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Gastrostomy Tube Removal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cholesteatoma
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Immune system disorders
    Food Allergy
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Drug Hypersensitivity
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Hypersensitivity
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    Multiple Allergies
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Seasonal Allergy
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    General disorders and administration site conditions
    Abasia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Asthenia
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    Catheter Site Erythema
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Catheter Site Haemorrhage
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Catheter Site Extravasation
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    5
    Catheter Site Inflammation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Catheter Site Oedema
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Catheter Site Pain
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Catheter Site Rash
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Catheter Site Related Reaction
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Catheter Site Swelling
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Chest Discomfort
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Chills
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Chest Pain
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    8
    Crepitations
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Device Breakage
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Device Dislocation
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    6
    Device Issue
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Device Malfunction
         subjects affected / exposed
    9 / 113 (7.96%)
         occurrences all number
    21
    Device Occlusion
         subjects affected / exposed
    13 / 113 (11.50%)
         occurrences all number
    15
    Discomfort
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Disease Progression
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Energy Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Extravasation
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    Feeling Hot
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Gait Disturbance
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Granuloma
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    5
    Gravitational Oedema
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Influenza Like Illness
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Infusion Site Extravasation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Infusion Site Swelling
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Injection Site Extravasation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Injection Site Swelling
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Oedema
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Malaise
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Oedema Peripheral
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Pain
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Peripheral Swelling
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    5
    Pyrexia
         subjects affected / exposed
    61 / 113 (53.98%)
         occurrences all number
    218
    Secretion Discharge
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    9
    Thirst
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Thrombosis In Device
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Agitation
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    7
    Anxiety
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    Bruxism
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Attention Deficit/Hyperactivity Disorder
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    5
    Irritability
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Mental Disorder
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Mood Swings
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Oppositional Defiant Disorder
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Sleep Disorder
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Genital Discomfort
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Vaginal Prolapse
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Vulvovaginal Disorder
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Vulvovaginal Erythema
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Vulvovaginal Pruritus
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Agitation Postoperative
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Animal Bite
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Ankle Fracture
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Animal Scratch
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Arthropod Bite
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    8
    Arthropod Sting
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Concussion
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    7
    Exposure To Communicable Disease
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Eye Contusion
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Eye Injury
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Face Injury
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Fall
         subjects affected / exposed
    11 / 113 (9.73%)
         occurrences all number
    13
    Feeding Tube Complication
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Femur Fracture
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Gastrointestinal Anastomotic Leak
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    3
    Foreign Body
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Gastrointestinal Stoma Complication
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Hand Fracture
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Head Injury
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Joint Dislocation
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Humerus Fracture
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Laryngeal Injury
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Laceration
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    6
    Ligament Sprain
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    Limb Injury
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Lower Limb Fracture
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Overdose
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Periorbital Haemorrhage
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Post Procedural Haemorrhage
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Postoperative Respiratory Distress
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Postoperative Fever
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Procedural Nausea
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Procedural Pain
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    10
    Procedural Vomiting
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Scratch
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Skin Wound
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Skin Abrasion
         subjects affected / exposed
    9 / 113 (7.96%)
         occurrences all number
    14
    Soft Tissue Injury
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Splinter
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Stoma Site Erythema
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Stoma Site Irritation
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Stoma Site Haemorrhage
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Stoma Site Reaction
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Stoma Site Rash
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Thermal Burn
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Sunburn
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Tooth Avulsion
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Tibia Fracture
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Tooth Fracture
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Tooth Injury
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Tracheostomy Malfunction
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Vaccination Complication
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Wound
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Wound Dehiscence
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Investigations
    Alanine Aminotransferase Abnormal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Alanine Aminotransferase Increased
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    4
    Aspartate Aminotransferase Abnormal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    5
    Atrial Pressure Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Blood Creatine Phosphokinase Abnormal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Blood Creatine Phosphokinase Mb Increased
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    7
    Blood Culture Positive
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    7
    Blood Lactate Dehydrogenase Abnormal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Blood Lactate Dehydrogenase Increased
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Blood Potassium Decreased
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Blood Pressure Decreased
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Blood Pressure Increased
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    8
    Blood Pressure Systolic Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Blood Uric Acid Decreased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Blood Uric Acid Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Blood Zinc Decreased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Body Temperature Increased
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    Brain Natriuretic Peptide Increased
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    Breath Sounds Abnormal
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Creatine Urine Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Creatinine Urine Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Electrocardiogram Pr Shortened
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Electrocardiogram St Segment Elevation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Electrocardiogram Qt Prolonged
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Eosinophil Count Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Electrocardiogram Abnormal
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Haematocrit Decreased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Haemoglobin Decreased
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    4
    Heart Rate Increased
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    Liver Function Test Abnormal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Neutrophil Count Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Neutrophil Count Abnormal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Occult Blood Positive
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Neutrophil Percentage Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Oxygen Saturation Decreased
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    6
    Platelet Count Increased
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Protein Urine
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Protein Urine Present
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Pulmonary Function Test Decreased
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Pulse Pressure Abnormal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Respiratory Rate Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Specific Gravity Urine
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Serum Ferritin Decreased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Sputum Culture Positive
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Staphylococcus Test Positive
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Urine Ketone Body Present
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Tuberculin Test Positive
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Urine Output Decreased
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Weight Decreased
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Weight Increased
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    White Blood Cell Count Abnormal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    White Blood Cell Count Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Bundle Branch Block Right
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Bradycardia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    4
    Cardiac Failure
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Cardiomyopathy
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Diastolic Dysfunction
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Defect Conduction Intraventricular
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    Heart Valve Incompetence
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Left Ventricular Dysfunction
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Pericardial Effusion
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    6
    Right Atrial Dilatation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Right Ventricular Hypertrophy
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Sinus Tachycardia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Sinus Bradycardia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Tachycardia
         subjects affected / exposed
    13 / 113 (11.50%)
         occurrences all number
    21
    Supraventricular Tachycardia
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    13
    Wolff-Parkinson-White Syndrome
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Tricuspid Valve Incompetence
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Cryptorchism
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Adenoidal Hypertrophy
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Aspiration
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Atelectasis
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    6
    Bronchial Hyperreactivity
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    4
    Bronchial Secretion Retention
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    6
    Bronchial Wall Thickening
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Bronchomalacia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Bronchospasm
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Choking
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    5
    Cough
         subjects affected / exposed
    36 / 113 (31.86%)
         occurrences all number
    105
    Dysphonia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    11
    Epistaxis
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    Haemoptysis
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    5
    Hypercapnia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Hypoventilation
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Hypoxia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Increased Bronchial Secretion
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    Increased Upper Airway Secretion
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    11
    Increased Viscosity Of Bronchial Secretion
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Nasal Congestion
         subjects affected / exposed
    16 / 113 (14.16%)
         occurrences all number
    23
    Nasal Discharge Discolouration
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Nasal Dryness
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Oropharyngeal Pain
         subjects affected / exposed
    13 / 113 (11.50%)
         occurrences all number
    14
    Pleural Effusion
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Pneumonia Aspiration
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    4
    Productive Cough
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Pulmonary Artery Dilatation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Pulmonary Congestion
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Respiratory Disorder
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Pulmonary Hypertension
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Respiratory Distress
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    10
    Respiratory Failure
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Respiratory Muscle Weakness
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Respiratory Tract Congestion
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    8
    Respiratory Tract Haemorrhage
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    4
    Rhinitis Allergic
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Rhinorrhoea
         subjects affected / exposed
    24 / 113 (21.24%)
         occurrences all number
    42
    Rhonchi
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Sleep Apnoea Syndrome
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    Sinus Congestion
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Sneezing
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Snoring
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Sputum Discoloured
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Sputum Increased
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Tachypnoea
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Throat Irritation
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Throat Tightness
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    3
    Tonsillar Hypertrophy
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Tracheal Ulcer
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Upper Respiratory Tract Congestion
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    14
    Upper-Airway Cough Syndrome
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Use Of Accessory Respiratory Muscles
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Wheezing
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    6
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    8
    Coagulopathy
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Eosinophilia
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    7
    Iron Deficiency Anaemia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Lymphadenitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Nervous system disorders
    Allodynia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Areflexia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Burning Sensation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Clumsiness
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Convulsion
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Dizziness
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Facial Paresis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Formication
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Gross Motor Delay
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    14 / 113 (12.39%)
         occurrences all number
    36
    Hypoaesthesia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Hyporeflexia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Hypotonia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Lethargy
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    8
    Motor Developmental Delay
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Motor Dysfunction
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Muscle Contractions Involuntary
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Nystagmus
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Paralysis Flaccid
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Poor Quality Sleep
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Presyncope
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Psychomotor Hyperactivity
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Somnolence
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Speech Disorder
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Tremor
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Eye disorders
    Blepharitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Astigmatism
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Chalazion
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Conjunctival Hyperaemia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Eye Discharge
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Dry Eye
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    5
    Eye Pruritus
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Eye Irritation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Eye Swelling
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Eyelid Ptosis
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    6
    Eyelid Oedema
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Hypermetropia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Lid Sulcus Deepened
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Ocular Hyperaemia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Myopia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Photophobia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Strabismus
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Vision Blurred
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Cerumen Impaction
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    5
    Conductive Deafness
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Deafness
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Deafness Neurosensory
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Deafness Unilateral
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Ear Pain
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    8
    Eustachian Tube Dysfunction
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    Middle Ear Effusion
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    Otorrhoea
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Mixed Deafness
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Tympanic Membrane Disorder
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Tympanic Membrane Perforation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Abdominal Distension
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Abdominal Pain
         subjects affected / exposed
    10 / 113 (8.85%)
         occurrences all number
    17
    Abnormal Faeces
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Abdominal Pain Upper
         subjects affected / exposed
    11 / 113 (9.73%)
         occurrences all number
    18
    Anal Fissure
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Aphthous Stomatitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    20 / 113 (17.70%)
         occurrences all number
    23
    Dental Caries
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Dental Discomfort
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Dysphagia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    55 / 113 (48.67%)
         occurrences all number
    121
    Faecal Incontinence
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Faeces Discoloured
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Flatulence
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Gastric Ulcer
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Frequent Bowel Movements
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    3
    Gastrointestinal Disorder
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    10
    Gastritis
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    Gingival Bleeding
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Haematochezia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Haemorrhoids
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Ileus
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Lip Blister
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Infrequent Bowel Movements
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Mouth Ulceration
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Lip Ulceration
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    12 / 113 (10.62%)
         occurrences all number
    20
    Oral Disorder
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Rectal Fissure
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Regurgitation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Retained Deciduous Tooth
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Retching
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Salivary Hypersecretion
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Sensitivity Of Teeth
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Teething
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    Tongue Spasm
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Tooth Deposit
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Tooth Impacted
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    42 / 113 (37.17%)
         occurrences all number
    112
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Haematuria
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Incontinence
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Nephrolithiasis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Pollakiuria
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Proteinuria
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Urinary Hesitation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Urinary Incontinence
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    Urinary Retention
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Hepatobiliary disorders
    Hepatic Fibrosis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Cholelithiasis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Alopecia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Blister
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Cold Sweat
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Decubitus Ulcer
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Dermatitis
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Dermatitis Allergic
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Dermatitis Diaper
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    6
    Dermatitis Contact
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Dry Skin
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Ecchymosis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Erythema
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    9
    Excessive Granulation Tissue
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    5
    Granuloma Skin
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Hyperkeratosis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Ingrowing Nail
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Ingrown Hair
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Macule
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Mechanical Urticaria
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Papule
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    3
    Petechiae
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Photosensitivity Reaction
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    6
    Pruritus Generalised
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    31 / 113 (27.43%)
         occurrences all number
    42
    Rash Erythematous
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Rash Macular
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Rash Pruritic
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Red Man Syndrome
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Skin Disorder
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Seborrhoeic Dermatitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Skin Exfoliation
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Skin Hyperpigmentation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Skin Irritation
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    Skin Lesion
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Skin Ulcer
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Swelling Face
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    9 / 113 (7.96%)
         occurrences all number
    28
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    7
    Arthropathy
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Back Pain
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    6
    Axillary Mass
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Foot Deformity
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Deformity Thorax
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Fracture Pain
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Hip Deformity
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Joint Contracture
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Joint Stiffness
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Joint Swelling
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Kyphosis
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Limb Discomfort
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Muscle Contracture
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Muscle Spasms
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Muscle Tightness
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Muscular Weakness
         subjects affected / exposed
    12 / 113 (10.62%)
         occurrences all number
    15
    Musculoskeletal Pain
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    5
    Musculoskeletal Chest Pain
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Musculoskeletal Stiffness
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Myopathy
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Neck Pain
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    5
    Osteopenia
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    Pain In Jaw
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    3
    Pain In Extremity
         subjects affected / exposed
    16 / 113 (14.16%)
         occurrences all number
    23
    Scoliosis
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    6
    Tendinous Contracture
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Tendon Discomfort
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Tendon Disorder
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Endocrine disorders
    Precocious Puberty
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Abnormal Weight Gain
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Decreased Appetite
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    Dehydration
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    7
    Electrolyte Imbalance
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Failure To Thrive
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Hypochloraemia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Hypoglycaemia
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Iron Deficiency
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Vitamin D Deficiency
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    Infections and infestations
    Abscess Limb
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Acarodermatitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Adenovirus Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Atypical Pneumonia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Bacterial Tracheitis
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    7
    Beta Haemolytic Streptococcal Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Body Tinea
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Bronchiolitis
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Candida Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    8
    Chronic Sinusitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Cellulitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Clostridium Difficile Colitis
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Conjunctivitis
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    9
    Croup Infectious
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Ear Infection
         subjects affected / exposed
    12 / 113 (10.62%)
         occurrences all number
    20
    Device Related Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Enterovirus Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Ear Lobe Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Erythema Infectiosum
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Folliculitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Eye Infection
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Fungal Infection
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Fungal Skin Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Furuncle
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    11 / 113 (9.73%)
         occurrences all number
    15
    Gastroenteritis Viral
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    Gastroenteritis Norovirus
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Gastrointestinal Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Gingival Abscess
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Gingivitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Haemophilus Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Hand-Foot-And-Mouth Disease
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Herpes Zoster
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Hordeolum
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    5
    Impetigo
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    10
    Labyrinthitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Lice Infestation
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Lobar Pneumonia
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Lip Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Nail Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    12 / 113 (10.62%)
         occurrences all number
    23
    Oral Candidiasis
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    4
    Oral Herpes
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Otitis Externa Fungal
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Otitis Externa
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    5
    Otitis Media
         subjects affected / exposed
    23 / 113 (20.35%)
         occurrences all number
    35
    Otitis Media Acute
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    7
    Otitis Media Chronic
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    6
    Pharyngitis
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    14
    Pharyngitis Streptococcal
         subjects affected / exposed
    13 / 113 (11.50%)
         occurrences all number
    24
    Pneumonia
         subjects affected / exposed
    17 / 113 (15.04%)
         occurrences all number
    32
    Pneumonia Viral
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Pseudomonas Infection
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    5
    Rash Pustular
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Respiratory Tract Infection
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Rhinitis
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    8
    Rhinovirus Infection
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    4
    Rotavirus Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    6
    Skin Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Staphylococcal Infection
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    5
    Stoma Site Infection
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Streptococcal Infection
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Streptococcal Urinary Tract Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Subcutaneous Abscess
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Tinea Infection
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Tooth Abscess
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Tonsillitis
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Tracheitis
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    12
    Tooth Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Tracheobronchitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Tracheostomy Infection
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    9
    Upper Respiratory Tract Infection Bacterial
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    49 / 113 (43.36%)
         occurrences all number
    104
    Urinary Tract Infection
         subjects affected / exposed
    19 / 113 (16.81%)
         occurrences all number
    31
    Viral Infection
         subjects affected / exposed
    15 / 113 (13.27%)
         occurrences all number
    23
    Viral Rash
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    7
    Vulvovaginal Mycotic Infection
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Oct 2012
    6-month administrative analysis was added. -For the primary efficacy endpoint, in addition to the analysis using the full analysis set specified in the original protocol, the analysis was also to be conducted on the Per-Protocol Analysis Set. -The efficacy endpoint of left ventricular mass index Z- score (LVMI-Z) was revised to LVM-Z. -Shortening of the post-infusion observation period was changed from being allowed after a 6-month treatment period to being allowed after a 3-month treatment period. -Home infusions were changed from being allowed after 4 infusions in subjects with no history of moderate or severe infusion-associated reactions (IARs) or serious adverse events (SAEs) to being allowed after 2 infusions in subjects with no history of moderate or severe IARs or SAEs. -The Sponsor’s department name, Global Patient Safety and Risk Management, was updated for a recent name change to Global Pharmacovigilance and Epidemiology. -Text was added to clarify that pulmonary function tests were not required in young subjects unable to undergo testing. -The protocol was modified to ensure that subject position during measurement of vital signs was to be recorded in the electronic case report form and that vital signs and weight were to be obtained at every study visit. -The IgG antibodies, inhibitory antibodies, and urine pregnancy testing schedules were clarified. -Text referring to subjects’ previous treatment “in the commercial setting” was deleted as subjects treated with 160L scale product in other clinical trials were eligible to enroll. - Measurement of R voltage V6 and S voltage V1 were removed from the ECG. -Text was deleted to reflect that efficacy and safety results would not be summarized by baseline Pompe disease status. -The presentation of results of planned clinical laboratory assessments was clarified. -The stipulation that the Data Safety Monitoring Board (DSMB) would be comprised of 4 physicians was removed.

    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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