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    Clinical Trial Results:
    A Phase 1, Open-Label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

    Summary
    EudraCT number
    2019-004930-41
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    05 Jul 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Mar 2020
    First version publication date
    27 Mar 2020
    Other versions
    Summary report(s)
    Results Summary 9766-CL-0046 Part 1 and Part 2 combined in a row

    Trial information

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    Trial identification
    Sponsor protocol code
    9766-CL-0046
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03241550
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Global Development, Inc.
    Sponsor organisation address
    1 Astellas Way, Northbrook, IL, United States, 60062
    Public contact
    Study Physician, Astellas Pharma Global Development, Inc., 1 2242055223,
    Scientific contact
    Study Physician, Astellas Pharma Global Development, Inc., 1 2242055223,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001301-PIP02-12
    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
    26 Jul 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of IV and oral isavuconazonium sulfate administered daily in pediatric patients. The PK data will be utilized to establish a pediatric population PK model of isavuconazole, the active moiety of isavuconazonium sulfate.
    Protection of trial subjects
    The study is performed under carefully controlled conditions. All subjects taking part in the study will be examined thoroughly and regularly for any side effects.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Oct 2017
    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: 49
    Worldwide total number of subjects
    49
    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)
    2
    Children (2-11 years)
    27
    Adolescents (12-17 years)
    20
    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
    A total of 54 subjects were screened, out of whom 5 subjects failed screening. Forty-nine subjects were enrolled and 46 subjects received at least one dose.

    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
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate
    Arm description
    Age group 1 to < 6 years in the Part 1-study: intravenous infusion
    Arm type
    Experimental

    Investigational medicinal product name
    Isavuconazonium sulfate for injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose: 10 mg/kg (maximum 372.5 mg) isavuconazonium sulfate as 1-hour intravenous infusion. A dose was given every 8 hours on day 1 and day 2, followed by once-daily dosing for up to 26 additional days.

    Arm title
    Age group 6 to < 12 years, intravenous isavuconazonium sulfate
    Arm description
    Age group 6 to < 12 years in the Part 1-study: intravenous infusion
    Arm type
    Experimental

    Investigational medicinal product name
    Isavuconazonium sulfate for injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose: 10 mg/kg (maximum 372.5 mg) isavuconazonium sulfate as 1-hour intravenous infusion. A dose was given every 8 hours on day 1 and day 2, followed by once-daily dosing for up to 26 additional days.

    Arm title
    Age group 12 to < 18 years, intraven. isavuconazonium sulfate
    Arm description
    Age group 12 to < 18 years in the Part 1-study: intravenous infusion
    Arm type
    Experimental

    Investigational medicinal product name
    Isavuconazonium sulfate for injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose: 10 mg/kg (maximum 372.5 mg) isavuconazonium sulfate as 1-hour intravenous infusion. A dose was given every 8 hours on day 1 and day 2, followed by once-daily dosing for up to 26 additional days.

    Arm title
    Age group 6 to < 12 years, oral isavuconazonium sulfate
    Arm description
    Age group 6 to < 12 years in the Part 2-study: oral capsule
    Arm type
    Experimental

    Investigational medicinal product name
    Isavuconazonium sulfate capsule
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Dose (body weight): 149 mg (16-17 kg), 223.5 mg (18-24 kg), 298 mg (25-31 kg), 372.5 mg (≥ 32 kg) isavuconazonium sulfate as oral capsules. A dose was given every 8 hours on day 1 and day 2, followed by once-daily dosing for up to 26 additional days.

    Arm title
    Age group 12 to < 18 years, oral isavuconazonium sulfate
    Arm description
    Age group 12 to < 18 years in the Part 2-study: oral capsule
    Arm type
    Experimental

    Investigational medicinal product name
    Isavuconazonium sulfate capsule
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Dose (body weight): 149 mg (16-17 kg), 223.5 mg (18-24 kg), 298 mg (25-31 kg), 372.5 mg (≥ 32 kg) isavuconazonium sulfate as oral capsules. A dose was given every 8 hours on day 1 and day 2, followed by once-daily dosing for up to 26 additional days.

    Number of subjects in period 1 [1]
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate Age group 6 to < 12 years, intravenous isavuconazonium sulfate Age group 12 to < 18 years, intraven. isavuconazonium sulfate Age group 6 to < 12 years, oral isavuconazonium sulfate Age group 12 to < 18 years, oral isavuconazonium sulfate
    Started
    9
    8
    10
    9
    10
    Completed
    9
    7
    8
    6
    8
    Not completed
    0
    1
    2
    3
    2
         Concomitant medication use
    -
    -
    -
    -
    1
         Adverse event, non-fatal
    -
    1
    1
    3
    1
         Consent withdrawn by subject
    -
    -
    1
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Reported are subjects who received at least one dose (safety population).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate
    Reporting group description
    Age group 1 to < 6 years in the Part 1-study: intravenous infusion

    Reporting group title
    Age group 6 to < 12 years, intravenous isavuconazonium sulfate
    Reporting group description
    Age group 6 to < 12 years in the Part 1-study: intravenous infusion

    Reporting group title
    Age group 12 to < 18 years, intraven. isavuconazonium sulfate
    Reporting group description
    Age group 12 to < 18 years in the Part 1-study: intravenous infusion

    Reporting group title
    Age group 6 to < 12 years, oral isavuconazonium sulfate
    Reporting group description
    Age group 6 to < 12 years in the Part 2-study: oral capsule

    Reporting group title
    Age group 12 to < 18 years, oral isavuconazonium sulfate
    Reporting group description
    Age group 12 to < 18 years in the Part 2-study: oral capsule

    Reporting group values
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate Age group 6 to < 12 years, intravenous isavuconazonium sulfate Age group 12 to < 18 years, intraven. isavuconazonium sulfate Age group 6 to < 12 years, oral isavuconazonium sulfate Age group 12 to < 18 years, oral isavuconazonium sulfate Total
    Number of subjects
    9 8 10 9 10 46
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    1 0 0 0 0 1
        Children (2-11 years)
    8 8 0 9 0 25
        Adolescents (12-17 years)
    0 0 10 0 10 20
        Adults (18-64 years)
    0 0 0 0 0 0
        From 65-84 years
    0 0 0 0 0 0
        85 years and over
    0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    3.3 ± 1.1 9.0 ± 1.7 14.6 ± 1.8 9.0 ± 1.9 14.5 ± 1.4 -
    Gender categorical
    Units: Subjects
        Female
    3 2 2 4 6 17
        Male
    6 6 8 5 4 29
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    6 6 5 2 8 27
        Hispanic or Latino
    3 2 4 7 2 18
        Missing
    0 0 1 0 0 1
    Race
    Units: Subjects
        White
    5 7 6 8 7 33
        Black or African American
    2 1 1 0 1 5
        Asian
    1 0 1 0 1 3
        American Indian or Alaska Native
    0 0 0 1 0 1
        Native Hawaiian or Other Pacific Islander
    1 0 0 0 0 1
        Other
    0 0 2 0 1 3

    End points

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    End points reporting groups
    Reporting group title
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate
    Reporting group description
    Age group 1 to < 6 years in the Part 1-study: intravenous infusion

    Reporting group title
    Age group 6 to < 12 years, intravenous isavuconazonium sulfate
    Reporting group description
    Age group 6 to < 12 years in the Part 1-study: intravenous infusion

    Reporting group title
    Age group 12 to < 18 years, intraven. isavuconazonium sulfate
    Reporting group description
    Age group 12 to < 18 years in the Part 1-study: intravenous infusion

    Reporting group title
    Age group 6 to < 12 years, oral isavuconazonium sulfate
    Reporting group description
    Age group 6 to < 12 years in the Part 2-study: oral capsule

    Reporting group title
    Age group 12 to < 18 years, oral isavuconazonium sulfate
    Reporting group description
    Age group 12 to < 18 years in the Part 2-study: oral capsule

    Primary: Cmax D3 iv (Part 1 only)

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    End point title
    Cmax D3 iv (Part 1 only) [1] [2]
    End point description
    Maximum observed drug concentration (Cmax) in plasma of intravenous isavuconazole
    End point type
    Primary
    End point timeframe
    Day 3
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports the Cmax on D3 of isavuconazole for the IV dose only.
    End point values
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate Age group 6 to < 12 years, intravenous isavuconazonium sulfate Age group 12 to < 18 years, intraven. isavuconazonium sulfate
    Number of subjects analysed
    8
    6
    8
    Units: ng/ml
        arithmetic mean (standard deviation)
    7810 ± 830
    7800 ± 1640
    5530 ± 2320
    No statistical analyses for this end point

    Primary: Ctrough D3 iv and oral (Part 1 and Part 2)

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    End point title
    Ctrough D3 iv and oral (Part 1 and Part 2) [3]
    End point description
    Lowest concentration in plasma (Ctrough) of intravenous and oral isavuconazole reached before administration of the next dose, measured on Day3
    End point type
    Primary
    End point timeframe
    D3
    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: No statistical analyses were planned for this endpoint.
    End point values
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate Age group 6 to < 12 years, intravenous isavuconazonium sulfate Age group 12 to < 18 years, intraven. isavuconazonium sulfate Age group 6 to < 12 years, oral isavuconazonium sulfate Age group 12 to < 18 years, oral isavuconazonium sulfate
    Number of subjects analysed
    9
    8
    9
    9
    10
    Units: ng/ml
        arithmetic mean (standard deviation)
    4200 ± 1440
    4310 ± 2120
    2520 ± 1120
    4660 ± 2420
    3690 ± 1900
    No statistical analyses for this end point

    Primary: AUCtau D3 iv (Part 1 only)

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    End point title
    AUCtau D3 iv (Part 1 only) [4] [5]
    End point description
    Area under the plasma concentration time curve over dosing interval (AUCtau) of intravenous isavuconazole, measured on Day3
    End point type
    Primary
    End point timeframe
    D3
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports the AUCtau on D3 of isavuconazole for the IV dose only.
    End point values
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate Age group 6 to < 12 years, intravenous isavuconazonium sulfate Age group 12 to < 18 years, intraven. isavuconazonium sulfate
    Number of subjects analysed
    8
    6
    8
    Units: h*ng/ml
        arithmetic mean (standard deviation)
    112000 ± 25000
    102000 ± 35000
    70100 ± 29600
    No statistical analyses for this end point

    Primary: tmax D3 iv (Part 1 only)

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    End point title
    tmax D3 iv (Part 1 only) [6] [7]
    End point description
    Time to reach peak plasma concentration (tmax) of intravenous isavuconazole, measured on D3
    End point type
    Primary
    End point timeframe
    D3
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports the tmax on Day 3 of isavuconazole for the IV dose only
    End point values
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate Age group 6 to < 12 years, intravenous isavuconazonium sulfate Age group 12 to < 18 years, intraven. isavuconazonium sulfate
    Number of subjects analysed
    8
    6
    8
    Units: hours
        median (full range (min-max))
    1.11 (0.883 to 1.17)
    1.08 (1.02 to 4.37)
    1.11 (0.900 to 1.17)
    No statistical analyses for this end point

    Primary: Cmax D7 iv and oral (Part 1 and Part 2)

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    End point title
    Cmax D7 iv and oral (Part 1 and Part 2) [8]
    End point description
    Maximum observed drug concentration (Cmax) in plasma of intravenous and oral isavuconazole
    End point type
    Primary
    End point timeframe
    D7
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate Age group 6 to < 12 years, intravenous isavuconazonium sulfate Age group 12 to < 18 years, intraven. isavuconazonium sulfate Age group 6 to < 12 years, oral isavuconazonium sulfate Age group 12 to < 18 years, oral isavuconazonium sulfate
    Number of subjects analysed
    9
    8
    7
    9
    8
    Units: ng/ml
        arithmetic mean (standard deviation)
    7310 ± 1210
    6780 ± 2110
    5020 ± 1200
    6040 ± 2240
    5030 ± 2170
    No statistical analyses for this end point

    Primary: AUCtau D7 iv and oral (Part 1 and Part 2)

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    End point title
    AUCtau D7 iv and oral (Part 1 and Part 2) [9]
    End point description
    Area under the plasma concentration time curve over dosing interval (AUCtau) of intravenous and oral isavuconazole, measured on Day7
    End point type
    Primary
    End point timeframe
    D7
    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: No statistical analyses were planned for this endpoint.
    End point values
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate Age group 6 to < 12 years, intravenous isavuconazonium sulfate Age group 12 to < 18 years, intraven. isavuconazonium sulfate Age group 6 to < 12 years, oral isavuconazonium sulfate Age group 12 to < 18 years, oral isavuconazonium sulfate
    Number of subjects analysed
    8
    8
    6
    7
    5
    Units: h*ng/ml
        arithmetic mean (standard deviation)
    96800 ± 47300
    87200 ± 33200
    76800 ± 20500
    111000 ± 50200
    83300 ± 33400
    No statistical analyses for this end point

    Primary: tmax D7 iv and oral (Part 1 and Part 2)

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    End point title
    tmax D7 iv and oral (Part 1 and Part 2) [10]
    End point description
    Time to reach peak plasma concentration (tmax) of intravenous and oral isavuconazole, measured on D3
    End point type
    Primary
    End point timeframe
    D7
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate Age group 6 to < 12 years, intravenous isavuconazonium sulfate Age group 12 to < 18 years, intraven. isavuconazonium sulfate Age group 6 to < 12 years, oral isavuconazonium sulfate Age group 12 to < 18 years, oral isavuconazonium sulfate
    Number of subjects analysed
    9
    8
    7
    9
    8
    Units: hours
        median (full range (min-max))
    1.08 (1.03 to 1.35)
    1.08 (1.02 to 1.22)
    1.07 (1.02 to 1.20)
    4.00 (1.98 to 6.08)
    3.98 (3.05 to 8.03)
    No statistical analyses for this end point

    Primary: Ctrough D7 iv and oral (Part 1 and Part 2)

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    End point title
    Ctrough D7 iv and oral (Part 1 and Part 2) [11]
    End point description
    Lowest concentration in plasma (Ctrough) of intravenous and oral isavuconazole reached before administration of the next dose, measured on Day7
    End point type
    Primary
    End point timeframe
    D7
    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: No statistical analyses were planned for this endpoint.
    End point values
    Age group 1 to < 6 years, intravenous isavuconazonium sulfate Age group 6 to < 12 years, intravenous isavuconazonium sulfate Age group 12 to < 18 years, intraven. isavuconazonium sulfate Age group 6 to < 12 years, oral isavuconazonium sulfate Age group 12 to < 18 years, oral isavuconazonium sulfate
    Number of subjects analysed
    9
    8
    8
    9
    8
    Units: ng/ml
        arithmetic mean (standard deviation)
    3320 ± 1710
    2970 ± 1680
    2730 ± 1140
    3970 ± 1840
    3100 ± 1620
    No statistical analyses for this end point

    Primary: Ctrough D2 oral (Part 2 only)

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    End point title
    Ctrough D2 oral (Part 2 only) [12] [13]
    End point description
    Lowest concentration in plasma (Ctrough) of oral isavuconazole reached before administration of the next dose, measured on Day2
    End point type
    Primary
    End point timeframe
    D2
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports the Ctrough on Day2 of isavuconazole for the oral dose only.
    End point values
    Age group 6 to < 12 years, oral isavuconazonium sulfate Age group 12 to < 18 years, oral isavuconazonium sulfate
    Number of subjects analysed
    9
    10
    Units: ng/ml
        arithmetic mean (standard deviation)
    3690 ± 2070
    2550 ± 1420
    No statistical analyses for this end point

    Primary: Ctrough D5 oral (Part 2 only)

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    End point title
    Ctrough D5 oral (Part 2 only) [14] [15]
    End point description
    Lowest concentration in plasma (Ctrough) of oral isavuconazole reached before administration of the next dose, measured on Day5
    End point type
    Primary
    End point timeframe
    D5
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint reports the Ctrough on Day 5 of isavuconazole for the oral dose only.
    End point values
    Age group 6 to < 12 years, oral isavuconazonium sulfate Age group 12 to < 18 years, oral isavuconazonium sulfate
    Number of subjects analysed
    8
    9
    Units: ng/ml
        arithmetic mean (standard deviation)
    4400 ± 1750
    3250 ± 1420
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first administration of study medication up to 30 days after the last administration.
    Adverse event reporting additional description
    Treatment-emergent adverse events and serious adverse events
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Age group 1 to < 6 years, intravenous isavuconazole
    Reporting group description
    Age group 1 to < 6 years in the Part 1-study: intravenous infusion

    Reporting group title
    Age group 6 to < 12 years, intravenous isavuconazole
    Reporting group description
    Age group 6 to < 12 years in the Part 1-study: intravenous infusion

    Reporting group title
    Age group 12 to < 18 years, intravenous isavuconazole
    Reporting group description
    Age group 12 to < 18 years in the Part 1-study: intravenous infusion

    Reporting group title
    Age group 6 to < 12 years, oral isavuconazole
    Reporting group description
    Age group 6 to < 12 years in the Part 2-study: oral capsule

    Reporting group title
    Age group 12 to < 18 years, oral isavuconazole
    Reporting group description
    Age group 12 to < 18 years in the Part 2-study: oral capsule

    Serious adverse events
    Age group 1 to < 6 years, intravenous isavuconazole Age group 6 to < 12 years, intravenous isavuconazole Age group 12 to < 18 years, intravenous isavuconazole Age group 6 to < 12 years, oral isavuconazole Age group 12 to < 18 years, oral isavuconazole
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 9 (33.33%)
    4 / 8 (50.00%)
    5 / 10 (50.00%)
    5 / 9 (55.56%)
    3 / 10 (30.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Vascular disorders
    Embolism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Engraftment syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease in lung
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Mucosal inflammation
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 8 (25.00%)
    1 / 10 (10.00%)
    2 / 9 (22.22%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Oedema genital
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Penile pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal incontinence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Cytarabine syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Age group 1 to < 6 years, intravenous isavuconazole Age group 6 to < 12 years, intravenous isavuconazole Age group 12 to < 18 years, intravenous isavuconazole Age group 6 to < 12 years, oral isavuconazole Age group 12 to < 18 years, oral isavuconazole
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 9 (77.78%)
    8 / 8 (100.00%)
    10 / 10 (100.00%)
    9 / 9 (100.00%)
    9 / 10 (90.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 8 (25.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
         occurrences all number
    1
    3
    0
    1
    1
    Hypotension
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    Venoocclusive disease
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    2
    Surgical and medical procedures
    Bone marrow transplant
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Central venous catheter removal
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 8 (25.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Immune system disorders
    Engraftment syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    2 / 10 (20.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    2
    1
    0
    Graft versus host disease
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    1
    0
    1
    Graft versus host disease in gastrointestinal tract
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Graft versus host disease in liver
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Graft versus host disease in skin
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 8 (25.00%)
    3 / 10 (30.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    3
    0
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    3 / 10 (30.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    3
    0
    0
    Mucosal inflammation
         subjects affected / exposed
    4 / 9 (44.44%)
    4 / 8 (50.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    4
    5
    2
    0
    3
    Pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Puncture site pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    4 / 9 (44.44%)
    3 / 8 (37.50%)
    4 / 10 (40.00%)
    3 / 9 (33.33%)
    2 / 10 (20.00%)
         occurrences all number
    4
    3
    5
    4
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Delirium
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Depressed mood
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Depression
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Disorientation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dissociation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Irritability
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    Psychotic disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Reproductive system and breast disorders
    Acquired phimosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Metrorrhagia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Testis discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vaginal discharge
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Infusion related reaction
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Procedural nausea
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Procedural pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Procedural vomiting
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Scratch
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Blood alkaline phosphatase decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood fibrinogen decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood fibrinogen increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood urea increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Blood urine present
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood zinc decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Calcium ionised decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Carbon dioxide decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cardiac murmur
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Colonoscopy
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Crystal urine present
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cystatin C abnormal
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    7
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Roseolovirus test positive
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Transaminases increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Urine analysis abnormal
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    1
    2
    White blood cell count decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    9
    0
    0
    Cardiac disorders
    Atrial tachycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Conduction disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tachycardia
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 8 (25.00%)
    2 / 10 (20.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    1
    2
    2
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 8 (12.50%)
    3 / 10 (30.00%)
    0 / 9 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    3
    2
    11
    0
    2
    Eosinophilia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Febrile neutropenia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    1
    0
    0
    0
    2
    Neutropenia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Pancytopenia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    3 / 9 (33.33%)
    1 / 8 (12.50%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    8
    3
    9
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    2 / 9 (22.22%)
    2 / 8 (25.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    2
    2
    0
    1
    Haemoptysis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Hypoxia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    0
    0
    1
    Nasal inflammation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    3
    0
    Pleural effusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Pleuritic pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tachypnoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    0
    1
    Dyskinesia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    0
    3
    1
    Intention tremor
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tremor
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    0
    1
    Ear and labyrinth disorders
    Dysacusis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Ear discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 8 (25.00%)
    2 / 10 (20.00%)
    3 / 9 (33.33%)
    2 / 10 (20.00%)
         occurrences all number
    3
    3
    2
    3
    2
    Abdominal pain lower
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Anorectal discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    Diarrhoea
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 8 (37.50%)
    2 / 10 (20.00%)
    2 / 9 (22.22%)
    1 / 10 (10.00%)
         occurrences all number
    9
    4
    2
    2
    1
    Flatulence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gingival hypertrophy
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Lip swelling
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    2 / 10 (20.00%)
         occurrences all number
    1
    0
    1
    1
    2
    Oral pain
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Perianal erythema
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Proctalgia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    Stomatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
    4 / 10 (40.00%)
         occurrences all number
    1
    0
    0
    4
    5
    Hepatobiliary disorders
    Hepatomegaly
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 8 (37.50%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    4
    1
    0
    0
    Haematuria
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Blister
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Erythema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Papule
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    Pruritus allergic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Pruritus generalised
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    2 / 10 (20.00%)
    1 / 9 (11.11%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    2
    1
    2
    Rash erythematous
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Rash follicular
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Rash generalised
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rash macular
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Skin irritation
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin mass
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Urticaria
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    3 / 10 (30.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    3
    1
    2
    Back pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    2 / 10 (20.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    1
    1
    Flank pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    4 / 10 (40.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    4
    1
    1
    Pain in jaw
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    1
    1
    Fluid imbalance
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Fluid retention
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    1
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    3
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Hypermagnesaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Hypernatraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    1
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    3 / 10 (30.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    3
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Malnutrition
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Infections and infestations
    BK virus infection
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 8 (25.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Bacteraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    0
    1
    Cellulitis orbital
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    Cystitis viral
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    0
    1
    Device related infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Epstein-Barr viraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Human herpesvirus 6 infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    3
    0
    0
    Lower respiratory tract infection viral
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Mastoiditis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Ophthalmic herpes simplex
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Tracheitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Vascular access site infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Viral haemorrhagic cystitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Aug 2017
    Changes to the protocol included changing the lower age limit for cohort 1 from 2 years of age to 1 year of age, and adding a dose rationale for subjects 1 to 2 years of age.
    26 Apr 2018
    Changes to the protocol included the addition of oral cohorts 4 and 5 to constitute part 2 of the study, including rationale, dosing regimen, and pharmacokinetics sampling profile for subjects in the oral cohorts. All subjects in cohorts 1 through 3 were administered only intravenous drug and thus were unaffected by the changes made in this Amendment.

    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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