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    Clinical Trial Results:
    An Open Label, Intravenous to Oral Switch, Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Immunocompromised Children Aged 2 to Below 12 Years who are at High Risk for Systemic Fungal Infection

    Summary
    EudraCT number
    		 2012-001133-14
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Oct 2009

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

    Trial information

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    Trial identification
    Sponsor protocol code
    A1501088
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00739934
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 East 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center , Pfizer, Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center , Pfizer, Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000191-PIP01-08
    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
    23 Mar 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize the pharmacokinetics of voriconazole following an intravenous (IV) to oral switch regimen in immunocompromised children aged 2 to below 12 years who were at high risk for systemic fungal infection.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Dec 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    40
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were recruited from 11 centers in United States. Study was started from 09 Dec 2008 and completed on 26 Oct 2009.

    Period 1
    Period 1 title
    Baseline period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All Subjects
    Arm description
    		 Voriconazole intravenous (IV) dosing regimen was administered on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Voriconazole
    Investigational medicinal product code
    Other name
    Vfend
    Pharmaceutical forms
    Infusion, Oral suspension
    Routes of administration
    Oral use, Intravenous use
    Dosage and administration details
    Voriconazole IV dosing regimen (7 mg/kg every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated) with a maximum infusion rate of 3 mg/kg/hr. The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).

    Number of subjects in period 1
    		All Subjects
    Started
    40
    Completed
    40
    Period 2
    Period 2 title
    Voriconazole IV
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Voriconazole IV
    Arm description
    		 Voriconazole IV doses were administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Voriconazole
    Investigational medicinal product code
    Other name
    Vfend
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Voriconazole IV dosing regimen (7 mg/kg every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated) with a maximum infusion rate of 3 mg/kg/hr.

    Number of subjects in period 2
    		Voriconazole IV
    Started
    40
    Completed
    34
    Not completed
    6
         Adverse Event
    6
    Period 3
    Period 3 title
    Voriconazole Oral
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Voriconazole Oral
    Arm description
    		 Voriconazole oral doses were administered following voriconazole IV.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Voriconazole
    Investigational medicinal product code
    Other name
    Vfend
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).

    Number of subjects in period 3
    		Voriconazole Oral
    Started
    34
    Completed
    31
    Not completed
    3
         Unspecified
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline period
    Reporting group description
    		 -

    Reporting group values
    		 Baseline period Total
    Number of subjects
    		 40 40
    Age categorical
    Units: Subjects
        2 to less than (<) 6 years
    		 24 24
        6 to <12 years
    		 16 16
    Gender categorical
    Units: Subjects
        Female
    		 17 17
        Male
    		 23 23

    End points

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    End points reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 Voriconazole intravenous (IV) dosing regimen was administered on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
    Reporting group title
    Voriconazole IV
    Reporting group description
    		 Voriconazole IV doses were administered.
    Reporting group title
    Voriconazole Oral
    Reporting group description
    		 Voriconazole oral doses were administered following voriconazole IV.

    Primary: Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration

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    End point title
    		 Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration [1]
    End point description
    AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear or Log trapezoidal method. This analysis included the intent-to-treat (ITT) population– subjects who had completed PK blood sampling for at least one day.
    End point type
    Primary
    End point timeframe
    Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint. 
    End point values
    		 Voriconazole IV
    Number of subjects analysed
    36 [2]
    Units: microgram*hour per milliliter (μg*h/mL)
        geometric mean (standard deviation)
    21.42 ( 35.05 )
    Notes
    [2] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Primary: Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration

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    End point title
    		 Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration [3]
    End point description
    This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Primary
    End point timeframe
    Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint. 
    End point values
    		 Voriconazole IV
    Number of subjects analysed
    36 [4]
    Units: μg/mL
        geometric mean (standard deviation)
    4.26 ( 3.73 )
    Notes
    [4] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Primary: Time to Reach Cmax (Tmax) Following IV Administration

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    End point title
    		 Time to Reach Cmax (Tmax) Following IV Administration [5]
    End point description
    This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Primary
    End point timeframe
    Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint. 
    End point values
    		 Voriconazole IV
    Number of subjects analysed
    36 [6]
    Units: hours
        median (full range (min-max))
    2.3 (1 to 4.07)
    Notes
    [6] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Primary: AUC12,ss Following Oral Administration

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    End point title
    		 AUC12,ss Following Oral Administration [7]
    End point description
    AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear or Log trapezoidal method. This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Primary
    End point timeframe
    Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint. 
    End point values
    		 Voriconazole Oral
    Number of subjects analysed
    33 [8]
    Units: μg*h/mL
        geometric mean (standard deviation)
    18.64 ( 50.63 )
    Notes
    [8] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Primary: Cmax,ss Following Oral Administration

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    End point title
    		 Cmax,ss Following Oral Administration [9]
    End point description
    This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Primary
    End point timeframe
    Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint. 
    End point values
    		 Voriconazole Oral
    Number of subjects analysed
    33 [10]
    Units: μg/mL
        geometric mean (standard deviation)
    3.62 ( 4.66 )
    Notes
    [10] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Primary: Tmax Following Oral Administration

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    End point title
    		 Tmax Following Oral Administration [11]
    End point description
    This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Primary
    End point timeframe
    Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint. 
    End point values
    		 Voriconazole Oral
    Number of subjects analysed
    33 [12]
    Units: hours
        median (full range (min-max))
    1.07 (0.73 to 8.03)
    Notes
    [12] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Secondary: AUC12 Following an IV Loading Dose

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    End point title
    		 AUC12 Following an IV Loading Dose
    End point description
    AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear or Log trapezoidal method. This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Secondary
    End point timeframe
    Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
    End point values
    		 Voriconazole IV
    Number of subjects analysed
    33 [13]
    Units: μg*h/mL
        geometric mean (standard deviation)
    7.85 ( 6.71 )
    Notes
    [13] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Secondary: Cmax Following an IV Loading Dose

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    End point title
    		 Cmax Following an IV Loading Dose
    End point description
    This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Secondary
    End point timeframe
    Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
    End point values
    		 Voriconazole IV
    Number of subjects analysed
    33 [14]
    Units: μg/mL
        geometric mean (standard deviation)
    2.15 ( 1.1 )
    Notes
    [14] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Secondary: Tmax Following an IV Loading Dose

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    End point title
    		 Tmax Following an IV Loading Dose
    End point description
    This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Secondary
    End point timeframe
    Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
    End point values
    		 Voriconazole IV
    Number of subjects analysed
    33 [15]
    Units: hours
        median (full range (min-max))
    2.3 (1.72 to 4.08)
    Notes
    [15] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Secondary: Trough Concentrations (Cmin)

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    End point title
    		 Trough Concentrations (Cmin)
    End point description
    This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day. Here, n = number of subjects who contributed to data.
    End point type
    Secondary
    End point timeframe
    Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose
    End point values
    		 All Subjects
    Number of subjects analysed
    36 [16]
    Units: μg/mL
    geometric mean (standard deviation)
        IV Day 7 (up to Day 20) (n=36)
    0.61 ( 2.56 )
        Oral Day 7 (up to Day 30) (n=32)
    0.52 ( 3.32 )
    Notes
    [16] - N = number of subjects with analyzable data
    No statistical analyses for this end point

    Secondary: AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration

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    End point title
    		 AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
    End point description
    AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear or Log trapezoidal method. This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Secondary
    End point timeframe
    Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
    End point values
    		 Voriconazole IV
    Number of subjects analysed
    39 [17]
    Units: μg*h/mL
    geometric mean (standard deviation)
        Day 1
    20.98 ( 8.05 )
        Day 7 (up to Day 20)
    41.95 ( 14.3 )
    Notes
    [17] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Secondary: Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration

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    End point title
    		 Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
    End point description
    This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Secondary
    End point timeframe
    Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
    End point values
    		 Voriconazole IV
    Number of subjects analysed
    39 [18]
    Units: μg/mL
    geometric mean (standard deviation)
        Day 7
    2.97 ( 0.94 )
        Day 7 (up to Day 20)
    4.47 ( 1.44 )
    Notes
    [18] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Secondary: Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration

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    End point title
    		 Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
    End point description
    Zero Tmax refers to the highest concentration observed for one subject at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process. This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Secondary
    End point timeframe
    Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
    End point values
    		 Voriconazole IV
    Number of subjects analysed
    39 [19]
    Units: hours
    median (full range (min-max))
        Day 1
    4 (1.72 to 8)
        Day 7 (up to Day 20)
    4 (0 to 12.05)
    Notes
    [19] - N=number of subjects with analyzable data.
    No statistical analyses for this end point

    Secondary: AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

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    End point title
    		 AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
    End point description
    AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear or Log trapezoidal method. This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Secondary
    End point timeframe
    Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
    End point values
    		 Voriconazole Oral
    Number of subjects analysed
    33 [20]
    Units: μg*h/mL
        geometric mean (standard deviation)
    51.65 ( 27.88 )
    Notes
    [20] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Secondary: Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

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    End point title
    		 Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
    End point description
    This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Secondary
    End point timeframe
    Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
    End point values
    		 Voriconazole Oral
    Number of subjects analysed
    33 [21]
    Units: μg/mL
        geometric mean (standard deviation)
    5.62 ( 2.54 )
    Notes
    [21] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Secondary: Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

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    End point title
    		 Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
    End point description
    This analysis included the ITT population- subjects who had completed PK blood sampling for at least one day.
    End point type
    Secondary
    End point timeframe
    Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
    End point values
    		 Voriconazole Oral
    Number of subjects analysed
    33 [22]
    Units: hours
        median (full range (min-max))
    3.97 (0.92 to 8.03)
    Notes
    [22] - N = number of subjects with analyzable data.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 1 month after last dose of investigational product
    Adverse event reporting additional description
    Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as  serious in one subject and as non-­serious in another subject. EU BR specific AE tables were generated separately as per EU format using latest coding.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Voriconazole Oral
    Reporting group description
    		 Voriconazole oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning  and evening and lasted 6.5 days (up to Day 30 if clinically indicated).

    Reporting group title
    Voriconazole IV
    Reporting group description
    		 Voriconazole IV dosing regimen (7 mg/kg every 12 hours) was administered on Days 1 to 7 (up to Day 20 or more if clinically indicated).

    Serious adverse events
    		 Voriconazole Oral Voriconazole IV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 34 (38.24%)
    6 / 40 (15.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Aspartate aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus test
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Transplant failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venoocclusive disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Posterior reversible encephalopathy syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Medical device complication
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 34 (14.71%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Graft versus host disease in skin
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (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
    Hypoxia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cytomegalovirus infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter bacteraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter sepsis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Voriconazole Oral Voriconazole IV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 34 (100.00%)
    39 / 40 (97.50%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant mesenchymoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Vascular disorders
    Capillary leak syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Hypotension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 34 (32.35%)
    13 / 40 (32.50%)
         occurrences all number
    11
    13
    Venoocclusive disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Catheter site erythema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Catheter site haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Catheter site pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Chest pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Chills
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Drug withdrawal syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Face oedema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Facial pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Gravitational oedema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 34 (8.82%)
    2 / 40 (5.00%)
         occurrences all number
    3
    2
    Localised oedema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Mucosal inflammation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 34 (32.35%)
    20 / 40 (50.00%)
         occurrences all number
    11
    24
    Medical device complication
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 34 (11.76%)
    7 / 40 (17.50%)
         occurrences all number
    4
    7
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 34 (32.35%)
    15 / 40 (37.50%)
         occurrences all number
    11
    19
    Suprapubic pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Immune system disorders
    Engraftment syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    4 / 40 (10.00%)
         occurrences all number
    2
    4
    Acute graft versus host disease in skin
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Graft versus host disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 34 (11.76%)
    3 / 40 (7.50%)
         occurrences all number
    4
    3
    Multiple allergies
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Genital erythema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Pelvic pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Pruritus genital
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Apnoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Atelectasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Epistaxis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 34 (14.71%)
    3 / 40 (7.50%)
         occurrences all number
    5
    4
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    3 / 40 (7.50%)
         occurrences all number
    2
    3
    Hypoxia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Lung infiltration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Nasal disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Nasal dryness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Oropharyngeal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Paranasal sinus mucosal hypertrophy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Pharyngeal inflammation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Pulmonary oedema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Rhinorrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Sinus disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Tachypnoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    6 / 40 (15.00%)
         occurrences all number
    2
    6
    Wheezing
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Aggression
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Agitation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Anxiety
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Confusional state
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Hallucination
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Insomnia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Irritability
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 34 (8.82%)
    1 / 40 (2.50%)
         occurrences all number
    3
    1
    Staring
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 34 (23.53%)
    6 / 40 (15.00%)
         occurrences all number
    9
    8
    Aspartate aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 34 (20.59%)
    5 / 40 (12.50%)
         occurrences all number
    9
    8
    Bacterial test positive
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Blood albumin decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Blood alkaline phosphatase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Blood bicarbonate decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    3
    Blood bilirubin increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 34 (8.82%)
    2 / 40 (5.00%)
         occurrences all number
    3
    2
    Blood creatinine increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Blood immunoglobulin G decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Blood lactate dehydrogenase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Blood pressure increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Blood urea increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Chest X-ray abnormal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    CSF virus identified
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Clostridium test positive
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Cytomegalovirus test
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Cytomegalovirus test positive
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Electrocardiogram QT prolonged
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 34 (14.71%)
    3 / 40 (7.50%)
         occurrences all number
    6
    3
    Heart rate increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Hepatic enzyme decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Hepatic enzyme increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 34 (11.76%)
    3 / 40 (7.50%)
         occurrences all number
    4
    5
    Human herpes virus 6 serology positive
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Liver function test abnormal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Lipase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Oxygen saturation decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 34 (8.82%)
    4 / 40 (10.00%)
         occurrences all number
    3
    4
    Transaminases increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Urine output decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    3 / 40 (7.50%)
         occurrences all number
    2
    3
    Viral test positive
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Visual tracking test abnormal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Weight increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    White blood cell count decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Contusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Graft complication
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Laceration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Joint injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Overdose
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Scratch
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Suture related complication
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Congenital, familial and genetic disorders
    Factor VII deficiency
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Cardiac disorders
    Atrioventricular block first degree
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Bradycardia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Dilatation ventricular
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Left ventricular hypertrophy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Sinus tachycardia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Tachycardia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Ventricular extrasystoles
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Burning sensation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Lethargy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 34 (8.82%)
    4 / 40 (10.00%)
         occurrences all number
    3
    4
    Somnolence
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Tremor
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Haemolysis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Leukocytosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Neutropenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Pancytopenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Splenomegaly
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Thrombocytopenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 34 (11.76%)
    4 / 40 (10.00%)
         occurrences all number
    4
    5
    Ear and labyrinth disorders
    Ear pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Eye disorders
    Astigmatism
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Blindness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Conjunctival haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Colour blindness acquired
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Eye pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Eye irritation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Dry eye
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Eye pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Lacrimation decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Myopia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Periorbital oedema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Vision blurred
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Visual acuity reduced
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal discomfort
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Abdominal distension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Anorectal discomfort
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 34 (26.47%)
    9 / 40 (22.50%)
         occurrences all number
    10
    10
    Abdominal pain upper
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Ascites
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 34 (20.59%)
    5 / 40 (12.50%)
         occurrences all number
    7
    5
    Gastric haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 34 (17.65%)
    6 / 40 (15.00%)
         occurrences all number
    6
    7
    Dysphagia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Gastritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Gastrooesophageal reflux disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Gingival bleeding
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Haematemesis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Gingival hypertrophy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Lip ulceration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Lip dry
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Mouth haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 34 (17.65%)
    3 / 40 (7.50%)
         occurrences all number
    6
    4
    Oral disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Oral pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Proctalgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 34 (11.76%)
    4 / 40 (10.00%)
         occurrences all number
    5
    4
    Hepatobiliary disorders
    Hepatomegaly
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 40 (7.50%)
         occurrences all number
    1
    5
    Hepatosplenomegaly
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Hyperbilirubinaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 34 (11.76%)
    5 / 40 (12.50%)
         occurrences all number
    4
    6
    Skin and subcutaneous tissue disorders
    Alopecia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 34 (20.59%)
    6 / 40 (15.00%)
         occurrences all number
    7
    6
    Dermatitis contact
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Dry skin
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Erythema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Papule
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 34 (29.41%)
    12 / 40 (30.00%)
         occurrences all number
    10
    12
    Rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 34 (26.47%)
    8 / 40 (20.00%)
         occurrences all number
    10
    8
    Rash erythematous
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Rash macular
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Rash pruritic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Rash maculo-papular
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    3 / 40 (7.50%)
         occurrences all number
    3
    3
    Skin disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 34 (8.82%)
    3 / 40 (7.50%)
         occurrences all number
    3
    3
    Skin discolouration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Skin exfoliation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Skin lesion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Skin hyperpigmentation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Swelling face
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Urticaria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Bladder spasm
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Cystitis haemorrhagic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Dysuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 34 (17.65%)
    4 / 40 (10.00%)
         occurrences all number
    6
    4
    Glycosuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Haematuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 34 (11.76%)
    3 / 40 (7.50%)
         occurrences all number
    4
    3
    Oliguria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Pyelocaliectasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Renal impairment
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Urethral pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Cushingoid
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Bone pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Groin pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Pain in extremity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 34 (8.82%)
    2 / 40 (5.00%)
         occurrences all number
    4
    2
    Infections and infestations
    Alpha haemolytic streptococcal infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Bacteraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Bacterial infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Bacterial sepsis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Clostridium difficile infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Candida infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Conjunctivitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    Cystitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Cytomegalovirus infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 34 (8.82%)
    2 / 40 (5.00%)
         occurrences all number
    3
    2
    Cytomegalovirus viraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 34 (8.82%)
    1 / 40 (2.50%)
         occurrences all number
    3
    1
    Enterococcal infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Enterococcal bacteraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Escherichia bacteraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Herpes virus infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis adenovirus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Human herpesvirus 6 infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Oral candidiasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 34 (11.76%)
    0 / 40 (0.00%)
         occurrences all number
    4
    0
    Paronychia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Pneumonia cytomegaloviral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Rhinovirus infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Sinusitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 34 (11.76%)
    3 / 40 (7.50%)
         occurrences all number
    4
    3
    Staphylococcal bacteraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection staphylococcal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Streptococcal bacteraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Urinary tract infection viral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Viraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Viral rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Viral upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 34 (17.65%)
    5 / 40 (12.50%)
         occurrences all number
    6
    6
    Fluid overload
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Fluid retention
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 34 (14.71%)
    8 / 40 (20.00%)
         occurrences all number
    5
    8
    Hyperamylasaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    Hypercalcaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 34 (14.71%)
    7 / 40 (17.50%)
         occurrences all number
    9
    8
    Hyperkalaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    4 / 40 (10.00%)
         occurrences all number
    1
    4
    Hypermagnesaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Hypertriglyceridaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    4
    1
    Hyperuricaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Hypoalbuminaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    3 / 40 (7.50%)
         occurrences all number
    4
    3
    Hypocalcaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Hypomagnesaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 34 (11.76%)
    3 / 40 (7.50%)
         occurrences all number
    4
    3
    Hypokalaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 34 (8.82%)
    7 / 40 (17.50%)
         occurrences all number
    4
    8
    Hyponatraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Hypophagia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Hypophosphataemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Malnutrition
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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