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    Clinical Trial Results:
    Pharmacokinetics of a Single Dose of Ceftaroline fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection

    Summary
    EudraCT number
    2011-002198-44
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    04 Feb 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Aug 2018
    First version publication date
    09 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P903-21
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01298843
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Cerexa, Inc (a subsidiary of Allergan, plc)
    Sponsor organisation address
    185 Hudson Street, Plaza 5, Jersey City, United States, NJ 07302-3908
    Public contact
    Clinical Trial Registry Team, Cerexa, Inc (a subsidiary of Allergan, plc), +1 877-277-8566, IR-CTRegistration@allergan.com
    Scientific contact
    Clinical Trial Registry Team, Cerexa, Inc (a subsidiary of Allergan, plc), +1 877-277-8566, IR-CTRegistration@allergan.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000769-PIP01-09
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Feb 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Feb 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evalutate the single-dose pharmacokinetic profile, safety and tolerability of ceftaroline fosamil administered by intravenous infusion in children with ages from birth to younger than 12 years
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practices and applicable regulatory requirements. Written informed consent from parent or legally acceptable representative and verbal informed assent from subject (if age appropriate and according to local requirements) were obtained before initiating study-related assessments or procedures.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Apr 2011
    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: 53
    Worldwide total number of subjects
    53
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    11
    Newborns (0-27 days)
    12
    Infants and toddlers (28 days-23 months)
    12
    Children (2-11 years)
    18
    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
    A total of 53 (male and female) subjects between the chronological ages of 0 and 11 years with confirmed or suspected infections were enrolled in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cohort 1 (≥ 6 years to < 12 years)
    Arm description
    10 subjects from age group ≥ 6 years to < 12 years were randomised to receive 10 mg/kg (up to 600 mg for subjects ≥ 60 kg) ceftaroline fosamil as a 1-hour infusion on Study Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Ceftaroline fosamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/kg (up to 600 mg for subjects ≥ 60 kg) of ceftaroline fosamil was administered as a single 1-hour infusion.

    Arm title
    Cohort 2 (≥ 24 months to < 6 years)
    Arm description
    8 subjects from age group ≥ 24 months to < 6 years were randomised to receive 15 mg/kg ceftaroline fosamil as a 1.5-hour infusion on Study Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Ceftaroline fosamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15 mg/kg of ceftaroline fosamil was administered as a 1.5-hour infusion.

    Arm title
    Cohort 3 (≥ 28 days to < 24 months)
    Arm description
    12 subjects [young infants and toddlers ages ≥ 28 days to < 24 months (with equal representation of subjects aged 28 days to < 12 months and 12 months to < 24 months)] were randomised to receive 12 mg/kg ceftaroline fosamil as a single 1-hour infusion (age ≥ 5 months) and 8 mg/kg ceftaroline fosamil as a single 1-hour infusion (age 28 days to 5 months) on Study Day 1, respectively.
    Arm type
    Experimental

    Investigational medicinal product name
    Ceftaroline fosamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Age ≥ 5 months: 12 mg/kg of ceftaroline fosamil was administered as a single 1-hour infusion. Age 28 days to 5 months: 8 mg/kg of ceftaroline fosamil was administered as a single 1-hour infusion.

    Arm title
    Cohort 4 (≥ 38 weeks to < 28 days)
    Arm description
    12 subjects [term (gestational age ≥ 38 weeks) neonates ages < 28 days (stratified within the group as 0 to 14 days and > 14 days to < 28 days)] were randomised to receive 8 mg/kg ceftaroline fosamil as a 1-hour infusion on Study Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Ceftaroline fosamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    8 mg/kg of ceftaroline fosamil was administered as a single 1-hour infusion.

    Arm title
    Cohort 5 (32 - 37 weeks to < 28 days)
    Arm description
    11 subjects [preterm (gestational age 32 to 37 weeks) neonates ages < 28 days (stratified within the group as 0 to 14 days and > 14 days to < 28 days)] were randomised to receive 8 mg/kg ceftaroline fosamil as a 1-hour infusion on Study Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Ceftaroline fosamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    8 mg/kg of ceftaroline fosamil was administered as a single 1-hour infusion.

    Number of subjects in period 1
    Cohort 1 (≥ 6 years to < 12 years) Cohort 2 (≥ 24 months to < 6 years) Cohort 3 (≥ 28 days to < 24 months) Cohort 4 (≥ 38 weeks to < 28 days) Cohort 5 (32 - 37 weeks to < 28 days)
    Started
    10
    8
    12
    12
    11
    Completed
    10
    8
    12
    11
    11
    Not completed
    0
    0
    0
    1
    0
         Lost to follow-up
    -
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1 (≥ 6 years to < 12 years)
    Reporting group description
    10 subjects from age group ≥ 6 years to < 12 years were randomised to receive 10 mg/kg (up to 600 mg for subjects ≥ 60 kg) ceftaroline fosamil as a 1-hour infusion on Study Day 1.

    Reporting group title
    Cohort 2 (≥ 24 months to < 6 years)
    Reporting group description
    8 subjects from age group ≥ 24 months to < 6 years were randomised to receive 15 mg/kg ceftaroline fosamil as a 1.5-hour infusion on Study Day 1.

    Reporting group title
    Cohort 3 (≥ 28 days to < 24 months)
    Reporting group description
    12 subjects [young infants and toddlers ages ≥ 28 days to < 24 months (with equal representation of subjects aged 28 days to < 12 months and 12 months to < 24 months)] were randomised to receive 12 mg/kg ceftaroline fosamil as a single 1-hour infusion (age ≥ 5 months) and 8 mg/kg ceftaroline fosamil as a single 1-hour infusion (age 28 days to 5 months) on Study Day 1, respectively.

    Reporting group title
    Cohort 4 (≥ 38 weeks to < 28 days)
    Reporting group description
    12 subjects [term (gestational age ≥ 38 weeks) neonates ages < 28 days (stratified within the group as 0 to 14 days and > 14 days to < 28 days)] were randomised to receive 8 mg/kg ceftaroline fosamil as a 1-hour infusion on Study Day 1.

    Reporting group title
    Cohort 5 (32 - 37 weeks to < 28 days)
    Reporting group description
    11 subjects [preterm (gestational age 32 to 37 weeks) neonates ages < 28 days (stratified within the group as 0 to 14 days and > 14 days to < 28 days)] were randomised to receive 8 mg/kg ceftaroline fosamil as a 1-hour infusion on Study Day 1.

    Reporting group values
    Cohort 1 (≥ 6 years to < 12 years) Cohort 2 (≥ 24 months to < 6 years) Cohort 3 (≥ 28 days to < 24 months) Cohort 4 (≥ 38 weeks to < 28 days) Cohort 5 (32 - 37 weeks to < 28 days) Total
    Number of subjects
    10 8 12 12 11 53
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 11 11
        Newborns (0-27 days)
    0 0 0 12 0 12
        Infants and toddlers (28 days-23 months)
    0 0 12 0 0 12
        Children (2-11 years)
    10 8 0 0 0 18
        Adolescents (12-17 years)
    0 0 0 0 0 0
        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
    Gender categorical
    Units: Subjects
        Female
    5 4 2 6 2 19
        Male
    5 4 10 6 9 34

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1 (≥ 6 years to < 12 years)
    Reporting group description
    10 subjects from age group ≥ 6 years to < 12 years were randomised to receive 10 mg/kg (up to 600 mg for subjects ≥ 60 kg) ceftaroline fosamil as a 1-hour infusion on Study Day 1.

    Reporting group title
    Cohort 2 (≥ 24 months to < 6 years)
    Reporting group description
    8 subjects from age group ≥ 24 months to < 6 years were randomised to receive 15 mg/kg ceftaroline fosamil as a 1.5-hour infusion on Study Day 1.

    Reporting group title
    Cohort 3 (≥ 28 days to < 24 months)
    Reporting group description
    12 subjects [young infants and toddlers ages ≥ 28 days to < 24 months (with equal representation of subjects aged 28 days to < 12 months and 12 months to < 24 months)] were randomised to receive 12 mg/kg ceftaroline fosamil as a single 1-hour infusion (age ≥ 5 months) and 8 mg/kg ceftaroline fosamil as a single 1-hour infusion (age 28 days to 5 months) on Study Day 1, respectively.

    Reporting group title
    Cohort 4 (≥ 38 weeks to < 28 days)
    Reporting group description
    12 subjects [term (gestational age ≥ 38 weeks) neonates ages < 28 days (stratified within the group as 0 to 14 days and > 14 days to < 28 days)] were randomised to receive 8 mg/kg ceftaroline fosamil as a 1-hour infusion on Study Day 1.

    Reporting group title
    Cohort 5 (32 - 37 weeks to < 28 days)
    Reporting group description
    11 subjects [preterm (gestational age 32 to 37 weeks) neonates ages < 28 days (stratified within the group as 0 to 14 days and > 14 days to < 28 days)] were randomised to receive 8 mg/kg ceftaroline fosamil as a 1-hour infusion on Study Day 1.

    Primary: Mean Ceftaroline Plasma Concentrations

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    End point title
    Mean Ceftaroline Plasma Concentrations [1]
    End point description
    End point type
    Primary
    End point timeframe
    Mean Ceftaroline Plasma Concentrations were measured from the end of infusion (± 5 minutes) to 5 to 7 hours after end of infusion.
    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: The primary objective of this study is to evaluate the safety and tolerability of ceftaroline in children and it is not powered for inferential statistical analysis.
    End point values
    Cohort 1 (≥ 6 years to < 12 years) Cohort 2 (≥ 24 months to < 6 years) Cohort 3 (≥ 28 days to < 24 months) Cohort 4 (≥ 38 weeks to < 28 days) Cohort 5 (32 - 37 weeks to < 28 days)
    Number of subjects analysed
    10
    8
    12
    12 [2]
    11 [3]
    Units: ng/mL
    arithmetic mean (standard deviation)
        At end of infusion (± 5 minutes)
    18325.08 ± 3563.06
    23052.72 ± 5485.06
    16938.9 ± 3693.24
    10530.69 ± 2529.54
    11091.64 ± 1505.9
        15 to 45 minutes from end of infusion
    12114.21 ± 3157.54
    14860.3 ± 3448.84
    12549.92 ± 2861.96
    9782.58 ± 2013.87
    10348.61 ± 1064.83
        3 to 4 hours from end of infusion
    2769.49 ± 890.7
    3626.51 ± 1663.57
    3286.77 ± 1215.47
    4600.61 ± 819.13
    5061.97 ± 1668.45
        5 to 7 hours from end of infusion
    1138.3 ± 489.43
    1600.83 ± 641.75
    1573.37 ± 688.59
    2687.71 ± 623.84
    3115.87 ± 1350.72
    Notes
    [2] - Mean Ceftaroline Plasma Concentrations 15 to 45 min from end of infusion are based on 11 subjects.
    [3] - Mean Ceftaroline Plasma Concentrations at end of infusion and 15 to 45 min are based on 9 subjects.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 14 days (Study Day 15) after ceftaroline fosamil administration.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Cohort 1 (≥ 6 years to < 12 years)
    Reporting group description
    Subjects from age group ≥ 6 years to < 12 years received 10 mg/kg (up to 600 mg for subjects ≥ 60 kg) ceftaroline fosamil as a 1-hour infusion.

    Reporting group title
    Cohort 2 (≥ 24 months to < 6 years)
    Reporting group description
    Subjects from age group ≥ 24 months to < 6 years received 15 mg/kg ceftaroline fosamil as a 1.5-hour infusion.

    Reporting group title
    Cohort 3 (≥ 28 days to < 24 months)
    Reporting group description
    Young infants and toddlers ages ≥ 28 days to < 24 months (with equal representation of subjects aged 28 days to < 12 months and 12 months to < 24 months) received 12 mg/kg ceftaroline fosamil as a single 1-hour infusion (age ≥ 5 months) and 8 mg/kg ceftaroline fosamil as a single 1-hour infusion (age 28 days to 5 months), respectively.

    Reporting group title
    Cohort 4 (≥ 38 weeks to < 28 days)
    Reporting group description
    Term (gestational age ≥ 38 weeks) neonates ages < 28 days (stratified within the group as 0 to 14 days and > 14 days to < 28 days) received 8 mg/kg ceftaroline fosamil as a 1-hour infusion.

    Reporting group title
    Cohort 5 (32 - 37 weeks to < 28 days)
    Reporting group description
    Preterm (gestational age 32 to 37 weeks) neonates ages < 28 days (stratified within the group as 0 to 14 days and > 14 days to < 28 days) received 8 mg/kg ceftaroline fosamil as a 1-hour infusion.

    Serious adverse events
    Cohort 1 (≥ 6 years to < 12 years) Cohort 2 (≥ 24 months to < 6 years) Cohort 3 (≥ 28 days to < 24 months) Cohort 4 (≥ 38 weeks to < 28 days) Cohort 5 (32 - 37 weeks to < 28 days)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia neonatal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         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
    Nervous system disorders
    Tremor
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (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
    Skin and subcutaneous tissue disorders
    Rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Cohort 1 (≥ 6 years to < 12 years) Cohort 2 (≥ 24 months to < 6 years) Cohort 3 (≥ 28 days to < 24 months) Cohort 4 (≥ 38 weeks to < 28 days) Cohort 5 (32 - 37 weeks to < 28 days)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    0 / 8 (0.00%)
    7 / 12 (58.33%)
    7 / 12 (58.33%)
    6 / 11 (54.55%)
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Overdose
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Procedural pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood phosphorus increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Congenital, familial and genetic disorders
    Coarctation of the aorta
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Respiratory acidosis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Tachypnoea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Anaemia neonatal
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Coagulopathy
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nervous system disorders
    Tremor
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Device occlusion
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Infusion site pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Perianal erythema
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Alkalosis hypochloraemic
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Candidiasis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Nov 2010
    The following changes were implemented with Amendment 1: changes to trial objective(s), dosage determination, clarifications regarding sample collection, vital sign assessment, exclusion criteria and other clarifications.
    12 Jul 2011
    The following changes were implemented with Amendment 2: changes to subject disposition, enrolment, inclusion and exclusion criteria and other clarifications.
    16 Aug 2011
    The following changes were implemented with Amendment 3: corrections to 'bedside' Schwartz formula.
    14 Dec 2011
    The following changes were implemented with Amendment 4: updated study drug information to be consistent with the current version of the Investigator’s Brochure.

    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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