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    Clinical Trial Results:
    A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (Agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms

    Summary
    EudraCT number
    2007-005668-28
    Trial protocol
    GB   NL   PT   DE   CZ   FR  
    Global end of trial date
    22 Jun 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    29 May 2016
    First version publication date
    29 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AGAL06207/EFC12821
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00701415
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Study Name: FIELD (Fabrazyme:Intervening Early at Lower Dose)
    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
    19 Aug 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy (globotriaosylceramide [GL-3] clearance), Pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks and 1.0 mg/kg every 4 weeks) in treatment-naive male pediatric subjects (≥5 years to ≤18 years of age) with Fabry disease without severe symptoms.
    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
    17 Jun 2008
    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 Kingdom: 2
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    United States: 5
    Country: Number of subjects enrolled
    Brazil: 1
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Argentina: 6
    Worldwide total number of subjects
    31
    EEA total number of subjects
    15
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    15
    Adolescents (12-17 years)
    15
    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
    The study was conducted at 12 sites in 9 countries. A total of 44 subjects were screened between 17 June 2008 and 12 April 2010.

    Pre-assignment
    Screening details
    Of 44 screened subjects, 31 subjects were randomized in 1:1 ratio to fabrazyme 0.5 mg/kg and fabrazyme 1.0 mg/kg within each age stratum (5 to ≤11 years [children] and 12 to ≤18 years [adolescents]). 13 subjects were screen failure due to failure to meet inclusion criteria or withdrawal of consent prior to all screening assessments being completed.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Fabrazyme 0.5 mg/kg
    Arm description
    Fabrazyme 0.5 mg/kg every 2 weeks up to 260 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Fabrazyme
    Investigational medicinal product code
    Other name
    Agalsidase beta, Recombinant human α-galactosidase A (r-hαGAL )
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions), the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.

    Arm title
    Fabrazyme 1.0 mg/kg
    Arm description
    Fabrazyme 1.0 mg/kg every 4 weeks up to 260 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Fabrazyme
    Investigational medicinal product code
    Other name
    Agalsidase beta, r-hαGAL
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions), the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.

    Number of subjects in period 1
    Fabrazyme 0.5 mg/kg Fabrazyme 1.0 mg/kg
    Started
    16
    15
    Completed
    15
    14
    Not completed
    1
    1
         Adverse event
    -
    1
         Social/family issues and needle phobia
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fabrazyme 0.5 mg/kg
    Reporting group description
    Fabrazyme 0.5 mg/kg every 2 weeks up to 260 weeks

    Reporting group title
    Fabrazyme 1.0 mg/kg
    Reporting group description
    Fabrazyme 1.0 mg/kg every 4 weeks up to 260 weeks

    Reporting group values
    Fabrazyme 0.5 mg/kg Fabrazyme 1.0 mg/kg Total
    Number of subjects
    16 15 31
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    11.2 ± 4 11.9 ± 4.5 -
    Gender categorical
    Units: Subjects
        Female
    0 0 0
        Male
    16 15 31

    End points

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    End points reporting groups
    Reporting group title
    Fabrazyme 0.5 mg/kg
    Reporting group description
    Fabrazyme 0.5 mg/kg every 2 weeks up to 260 weeks

    Reporting group title
    Fabrazyme 1.0 mg/kg
    Reporting group description
    Fabrazyme 1.0 mg/kg every 4 weeks up to 260 weeks

    Primary: Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium

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    End point title
    Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium [1]
    End point description
    Skin biopsies were taken at Baseline, Week 52, Week 156 and Week 260 or early withdrawal and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was scored for GL-3 accumulation on a severity score-scale of none, mild, moderate, severe (0-1-2-3). Scores are categorized as normal (score = 0) or abnormal (score = 1, 2 or 3). Data was summarized in terms of number of subjects with none/trace, mild, moderate and severe biopsy scores. Analysis was performed on Full analysis set (FAS) , which included all randomized subjects who received at least 1 infusion of study treatment.
    End point type
    Primary
    End point timeframe
    Baseline, Week 52, Week 156 and Week 260
    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: Since analysis is descriptive in nature, statistical data could not be provided.
    End point values
    Fabrazyme 0.5 mg/kg Fabrazyme 1.0 mg/kg
    Number of subjects analysed
    16
    15
    Units: Percentage of subjects
    number (not applicable)
        Zero (0) Skin GL-3 Score at Baseline
    18.8
    33.3
        Zero (0) Skin GL-3 Score at Week 52
    75
    80
        Zero (0) Skin GL-3 Score at Week 156
    56.3
    80
        Zero (0) Skin GL-3 Score at Week 260
    68.8
    66.7
        Mild (1) Skin GL-3 Score at Baseline
    6.3
    0
        Mild (1) Skin GL-3 Score at Week 52
    6.3
    13.3
        Mild (1) Skin GL-3 Score at Week 156
    18.8
    0
        Mild (1) Skin GL-3 Score at Week 260
    12.5
    20
        Moderate (2) Skin GL-3 Score at Baseline
    75
    66.7
        Moderate (2) Skin GL-3 Score at Week 52
    0
    0
        Moderate (2) Skin GL-3 Score at Week 156
    6.3
    13.3
        Moderate (2) Skin GL-3 Score at Week 260
    0
    6.7
        Severe (3) Skin GL-3 Score at Baseline
    0
    0
        Severe (3) Skin GL-3 Score at Week 52
    0
    0
        Severe (3) Skin GL-3 Score at Week 156
    0
    0
        Severe (3) Skin GL-3 Score at Week 260
    0
    0
        Missing Skin GL-3 Score at Baseline
    0
    0
        Missing Skin GL-3 Score at Week 52
    18.8
    6.7
        Missing Skin GL-3 Score at Week 156
    18.8
    6.7
        Missing Skin GL-3 Score at Week 260
    18.8
    6.7
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in GL-3 Clearance From Plasma

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    End point title
    Percent Change from Baseline in GL-3 Clearance From Plasma
    End point description
    Plasma samples were assayed for GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal plasma GL-3 level of 7.0 mg/mmol. Analysis was performed on FAS. Number of subjects analyzed=subjects with both baseline and post-baseline GL-3 plasma clearance assessment. Here 'n' signifies number of subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260
    End point values
    Fabrazyme 0.5 mg/kg Fabrazyme 1.0 mg/kg
    Number of subjects analysed
    14
    14
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n=14, 11)
    -52.37 ± 10.12
    -52.74 ± 6.79
        Week 28 (n=14, 14)
    -49.06 ± 15.43
    -47.55 ± 16.75
        Week 40 (n=13, 14)
    -52.01 ± 11.29
    -50.82 ± 12.87
        Week 52 (n=14, 14)
    -52.29 ± 10.48
    -45.87 ± 16.01
        Week 80 (n=13, 14)
    -52.91 ± 13.93
    -48.93 ± 14.75
        Week 104 (n=13, 14)
    -51.08 ± 20.45
    -39.92 ± 18.69
        Week 132 (n=11, 14)
    -61.39 ± 10.71
    -52.97 ± 17.1
        Week 156 (n=11, 14)
    -48.72 ± 18.48
    -44.83 ± 14.14
        Week 184 (n=12, 14)
    -53.62 ± 19.38
    -49.08 ± 17.93
        Week 208 (n=12, 14)
    -48.83 ± 16.8
    -46.09 ± 16.84
        Week 236 (n=12, 14)
    -56.44 ± 12.08
    -47.25 ± 13.04
        Week 260 (n=11, 14)
    -59.95 ± 12.39
    -46.34 ± 14.01
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in GL-3 Clearance From Urine

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    End point title
    Percent Change From Baseline in GL-3 Clearance From Urine
    End point description
    Plasma samples were assayed for total urine GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal of <0.030 mg/mmoL of creatinine. Analysis was performed on FAS. Number of subjects analyzed=subjects with both baseline and post-baseline GL-3 urine clearance assessment. Here 'n' signifies number of subjects with available data for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260
    End point values
    Fabrazyme 0.5 mg/kg Fabrazyme 1.0 mg/kg
    Number of subjects analysed
    15
    15
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n=15, 14)
    -50.77 ± 64.59
    -63.39 ± 38.81
        Week 28 (n=15, 15)
    -50.84 ± 100.61
    -52.55 ± 58.59
        Week 40 (n=15, 14)
    -44.22 ± 105.03
    -63.87 ± 24.41
        Week 52 (n=15, 14)
    -70.1 ± 41.4
    -20.72 ± 156.1
        Week 80 (n=14, 14)
    -35.84 ± 102.31
    35.22 ± 238.61
        Week 104 (n=14, 14)
    -21.92 ± 138.78
    -56.39 ± 42.39
        Week 132 (n=13, 14)
    -48.79 ± 100.1
    -45.61 ± 48.84
        Week 156 (n=13, 14)
    -65.57 ± 52.11
    -28.92 ± 84.32
        Week 184 (n=13, 14)
    -76.54 ± 38.93
    -10.5 ± 146.86
        Week 208 (n=13, 14)
    -60.94 ± 67.99
    -50.93 ± 46.52
        Week 236 (n=13, 14)
    -69.08 ± 51.72
    -40.09 ± 77.04
        Week 260 (n=13, 14)
    -57.59 ± 93.74
    -28.27 ± 56.79
    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 264) 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’ (the time from the first infusion of the study drug up to 28 days after the last infusion of study drug). Safety population included all randomized subjects who received at least one infusion of Fabrazyme.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Fabrazyme 0.5 mg/kg
    Reporting group description
    Fabrazyme 0.5 mg/kg every 2 weeks up to 260 weeks

    Reporting group title
    Fabrazyme 1.0 mg/kg
    Reporting group description
    Fabrazyme 1.0 mg/kg every 4 weeks up to 260 weeks

    Serious adverse events
    Fabrazyme 0.5 mg/kg Fabrazyme 1.0 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 16 (37.50%)
    5 / 15 (33.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Multiple Injuries
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Central Venous Catheterisation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Elective Surgery
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Body Mass Index Decreased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical Device Complication
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal Ideation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Microalbuminuria
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Media
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinea Pedis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Fabrazyme 0.5 mg/kg Fabrazyme 1.0 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 16 (100.00%)
    15 / 15 (100.00%)
    Vascular disorders
    Angiopathy
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Flushing
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    6
    0
    Hypotension
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    Pallor
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    5
    3
    Raynaud's Phenomenon
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Sinus Operation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergy To Arthropod Bite
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 16 (18.75%)
    1 / 15 (6.67%)
         occurrences all number
    10
    1
    Catheter Site Pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Chest Discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Chills
         subjects affected / exposed
    6 / 16 (37.50%)
    2 / 15 (13.33%)
         occurrences all number
    13
    2
    Face Oedema
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    5 / 16 (31.25%)
    2 / 15 (13.33%)
         occurrences all number
    23
    2
    Feeling Cold
         subjects affected / exposed
    3 / 16 (18.75%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Feeling Hot
         subjects affected / exposed
    0 / 16 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    0
    5
    Feeling Of Body Temperature Change
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    General Physical Health Deterioration
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Influenza Like Illness
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Infusion Site Extravasation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Infusion Site Pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Injection Site Haemorrhage
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    7
    2
    Medical Device Complication
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    Oedema Peripheral
         subjects affected / exposed
    3 / 16 (18.75%)
    2 / 15 (13.33%)
         occurrences all number
    4
    2
    Pain
         subjects affected / exposed
    4 / 16 (25.00%)
    3 / 15 (20.00%)
         occurrences all number
    8
    6
    Pyrexia
         subjects affected / exposed
    12 / 16 (75.00%)
    8 / 15 (53.33%)
         occurrences all number
    36
    36
    Soft Tissue Inflammation
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Abnormal Behaviour
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Confusional State
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Depression
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Depressive Symptom
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Disorientation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Dysphoria
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Hallucination
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Listless
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Sleep Disorder
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Panic Attack
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Penile Pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Penile Discharge
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Scrotal Angiokeratoma
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    2
    2
    Injury, poisoning and procedural complications
    Animal Bite
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Arthropod Bite
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Arthropod Sting
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Contusion
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Concussion
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Ear Injury
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Excoriation
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Frostbite
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Genital Injury
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Hand Fracture
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Head Injury
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Joint Injury
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Humerus Fracture
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Laceration
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Ligament Rupture
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Ligament Sprain
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Limb Injury
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Muscle Rupture
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Muscle Strain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Overdose
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Procedural Pain
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    3
    Post-Traumatic Pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Road Traffic Accident
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Skin Abrasion
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Soft Tissue Injury
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    4
    Tendon Rupture
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Tooth Fracture
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Wound Complication
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Wound Dehiscence
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood Pressure Increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Beta 2 Microglobulin Increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Body Temperature Increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Eosinophil Count Increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Heart Rate Increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Neutrophil Count Increased
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Urine Albumin/Creatinine Ratio Abnormal
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Protein Urine Present
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Vitamin B12 Decreased
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Vitamin D Decreased
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Allergic Respiratory Symptom
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Allergic Cough
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Bronchial Obstruction
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Bronchospasm
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    Catarrh
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    8 / 16 (50.00%)
    5 / 15 (33.33%)
         occurrences all number
    48
    13
    Dry Throat
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    3 / 16 (18.75%)
    2 / 15 (13.33%)
         occurrences all number
    8
    12
    Epistaxis
         subjects affected / exposed
    3 / 16 (18.75%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Oropharyngeal Pain
         subjects affected / exposed
    3 / 16 (18.75%)
    6 / 15 (40.00%)
         occurrences all number
    7
    7
    Nasal Congestion
         subjects affected / exposed
    5 / 16 (31.25%)
    1 / 15 (6.67%)
         occurrences all number
    15
    2
    Pharyngeal Erythema
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Respiratory Tract Congestion
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Respiratory Failure
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Rhinitis Allergic
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Sinus Congestion
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Sneezing
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Throat Irritation
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Tachypnoea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Tonsillar Hypertrophy
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Upper Respiratory Tract Congestion
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Wheezing
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    4
    Leukopenia
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    4
    Eosinophilia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Monocytopenia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Nervous system disorders
    Burning Sensation
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Dizziness
         subjects affected / exposed
    4 / 16 (25.00%)
    4 / 15 (26.67%)
         occurrences all number
    8
    4
    Disturbance In Attention
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    10
    0
    Headache
         subjects affected / exposed
    8 / 16 (50.00%)
    4 / 15 (26.67%)
         occurrences all number
    49
    8
    Hypoaesthesia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    3
    Paraesthesia
         subjects affected / exposed
    6 / 16 (37.50%)
    3 / 15 (20.00%)
         occurrences all number
    59
    11
    Presyncope
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Slow Response To Stimuli
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Speech Disorder
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctival Hyperaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Corneal Deposits
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Dry Eye
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Lacrimation Increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Ocular Vascular Disorder
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Periorbital Oedema
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Photophobia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Vision Blurred
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Visual Acuity Reduced
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Conductive Deafness
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Deafness
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Deafness Bilateral
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Deafness Neurosensory
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Deafness Unilateral
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Middle Ear Effusion
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Otorrhoea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Tinnitus
         subjects affected / exposed
    3 / 16 (18.75%)
    4 / 15 (26.67%)
         occurrences all number
    4
    4
    Tympanic Membrane Hyperaemia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    9 / 16 (56.25%)
    6 / 15 (40.00%)
         occurrences all number
    51
    7
    Abdominal Pain Lower
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Abdominal Tenderness
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Abdominal Pain Upper
         subjects affected / exposed
    4 / 16 (25.00%)
    4 / 15 (26.67%)
         occurrences all number
    11
    10
    Constipation
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Dental Caries
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    10 / 16 (62.50%)
    8 / 15 (53.33%)
         occurrences all number
    39
    16
    Epigastric Discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Frequent Bowel Movements
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Food Poisoning
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal Disorder
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Irritable Bowel Syndrome
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    9 / 16 (56.25%)
    7 / 15 (46.67%)
         occurrences all number
    37
    14
    Oral Mucosal Erythema
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Salivary Hypersecretion
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Vomiting
         subjects affected / exposed
    9 / 16 (56.25%)
    7 / 15 (46.67%)
         occurrences all number
    43
    10
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Hydroureter
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Hydronephrosis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Microalbuminuria
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Angiokeratoma
         subjects affected / exposed
    9 / 16 (56.25%)
    5 / 15 (33.33%)
         occurrences all number
    33
    9
    Blister
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Dermatitis Contact
         subjects affected / exposed
    2 / 16 (12.50%)
    2 / 15 (13.33%)
         occurrences all number
    3
    4
    Dry Skin
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Erythema
         subjects affected / exposed
    4 / 16 (25.00%)
    1 / 15 (6.67%)
         occurrences all number
    31
    2
    Hyperhidrosis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Miliaria
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Night Sweats
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    4
    Petechiae
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    4 / 16 (25.00%)
    1 / 15 (6.67%)
         occurrences all number
    4
    1
    Pruritus
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Rash Erythematous
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Rash Macular
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Swelling Face
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Telangiectasia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Umbilical Erythema
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 16 (25.00%)
    1 / 15 (6.67%)
         occurrences all number
    17
    1
    Back Pain
         subjects affected / exposed
    2 / 16 (12.50%)
    2 / 15 (13.33%)
         occurrences all number
    10
    3
    Foot Deformity
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Haemarthrosis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Groin Pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Joint Range Of Motion Decreased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Joint Swelling
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Muscular Weakness
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Muscle Spasms
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Neck Pain
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 15 (0.00%)
         occurrences all number
    4
    0
    Pain In Extremity
         subjects affected / exposed
    8 / 16 (50.00%)
    5 / 15 (33.33%)
         occurrences all number
    40
    28
    Tendonitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hyperparathyroidism Secondary
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Failure To Thrive
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Iron Deficiency
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Obesity
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Vitamin B12 Deficiency
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Underweight
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Vitamin D Deficiency
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Infections and infestations
    Acute Sinusitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Chlamydial Infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Catheter Site Infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Coxsackie Viral Infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Ear Infection
         subjects affected / exposed
    5 / 16 (31.25%)
    1 / 15 (6.67%)
         occurrences all number
    9
    1
    Enterobiasis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Erysipelas
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 16 (12.50%)
    2 / 15 (13.33%)
         occurrences all number
    7
    3
    Gastroenteritis Viral
         subjects affected / exposed
    3 / 16 (18.75%)
    1 / 15 (6.67%)
         occurrences all number
    3
    1
    Herpes Virus Infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Herpes Simplex
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Hordeolum
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Impetigo
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Influenza
         subjects affected / exposed
    3 / 16 (18.75%)
    3 / 15 (20.00%)
         occurrences all number
    4
    4
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    7 / 16 (43.75%)
    5 / 15 (33.33%)
         occurrences all number
    24
    20
    Molluscum Contagiosum
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Oral Herpes
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    5
    0
    Otitis Media Chronic
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Parasitic Gastroenteritis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Pharyngitis Streptococcal
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    4
    0
    Pneumonia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    3
    Respiratory Tract Infection Viral
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Rhinitis
         subjects affected / exposed
    5 / 16 (31.25%)
    3 / 15 (20.00%)
         occurrences all number
    8
    6
    Sinusitis
         subjects affected / exposed
    3 / 16 (18.75%)
    1 / 15 (6.67%)
         occurrences all number
    4
    1
    Staphylococcal Infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Tinea Versicolour
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Tinea Infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Tooth Infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    6 / 16 (37.50%)
    5 / 15 (33.33%)
         occurrences all number
    11
    8
    Viral Infection
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    3
    7
    Viral Rhinitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Viral Pharyngitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Dec 2008
    It included following changes: -Total blood volume for a specific procedure or for all procedures in the protocol were removed and was detailed in the informed consent form. -Clarification and additional information given for GFRiohexol rate was added for subjects with a documented low protein intake. -The contraindications mentioned in the labeling of both Fabrazyme and Omnipaque were included in the protocol as an exclusion criteria. -The number of subjects enrolled and the number of centers were increased to increase the scientific value and robustness of the trial. Pharmacokinetic samples were not collected from all subjects. -The parameters for αGAL activity were clarified. -A window for measurement of vital signs was added.
    30 Apr 2010
    It included following changes: -The sample size of subjects was decreased (n=35) due to unforeseen difficulties including unexpectedly high screen failure rates. -Additional information/clarification was added to the protocol related to home infusions and time windows around home infusion to ensure consistency between sites in management of home infusions and the safety of subjects receiving home infusions. -Clarification related to the dose and body weight was added to allow additional flexibility due to home infusions. -Blood sampling amounts and timepoints specified to ensure enough samples were collected for PK analyses following reduction in enrollment. -Three consecutive urine samples were collected to measure kidney function. -Recording of concomitant therapies was added.
    25 Jun 2010
    It included following changes: -The infusion time window for the every 2 weeks regimen was extended from ±3 days to ±7 days to reduce the deviation rate, which was estimated to be approximately 10% and was designed to lessen the burden on subjects and was deemed acceptable from a clinical perspective provided that no 2 infusions were administered less than 7 days apart. -Infusion-associated reactions were considered related to study drug.

    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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