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    Clinical Trial Results:
    A Comparative Evaluation of the Safety and Efficacy of Daptomycin Versus Standard of Care in Pediatric Subjects One - Seventeen Years of Age with Bacteremia Caused by Staphylococcus Aureus

    Summary
    EudraCT number
    		 2012-003447-29
    Trial protocol
    		 IT   ES   HU   GR   Outside EU/EEA  
    Global end of trial date
    20 Jan 2016

    Results information
    Results version number
    		 v1
    This version publication date
    29 Jun 2016
    First version publication date
    29 Jun 2016
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    3009-005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01728376
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the safety of intravenous (i.v.) daptomycin versus standard of care antibiotics in pediatric participants aged 1-17 years with S. aureus bacteremia.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. The following additional measures defined for this individual study were in place for the protection of trial participants: A stepwise approach was implemented to gate enrollment as follows: enrollment began with children aged 4-17 years; after an external Data Monitoring Committee (DMC) review, enrollment was broadened to 1-17 years. A longer daptomycin infusion time (60 minutes) was proposed for children below the age of 6 years to blunt the maximum serum concentration (Cmax), a parameter associated with potential adverse nerve effects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 3
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    Malaysia: 1
    Country: Number of subjects enrolled
    Panama: 7
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Thailand: 3
    Country: Number of subjects enrolled
    Ukraine: 25
    Country: Number of subjects enrolled
    United States: 36
    Worldwide total number of subjects
    82
    EEA total number of subjects
    2
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    61
    Adolescents (12-17 years)
    21
    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
    		 Participants aged 1-17 with bacteremia caused by S. aureus were enrolled in this study. Additional inclusion and exclusion criteria applied.

    Pre-assignment
    Screening details
    		 Participants were screened and their eligibility determined within 72 hours prior to study medication administration.

    Period 1
    Period 1 title
    Intravenous (i.v.) Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Daptomycin (1-6 year olds)
    Arm description
    		 Participants aged 1-6 years were administered daptomycin 12 mg/kg, infused once daily, intravenously, over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daptomycin
    Investigational medicinal product code
    Other name
    Cubicin®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    12 mg/kg once daily infused over 60 ± 6 minutes

    Arm title
    		 Comparator (1-6 year olds)
    Arm description
    		 Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    vancomycin (i.v.), clindamycin (i.v.), semi-synthetic penicillins (i.v.) (nafcillin, oxacillin, or cloxacillin), or first-generation cephalosporins (i.v.)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered per standard of care

    Arm title
    		 Daptomycin (7-11 year olds)
    Arm description
    		 Participants aged 7-11 years were administered daptomycin 9 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daptomycin
    Investigational medicinal product code
    Other name
    Cubicin®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    9 mg/kg once daily infused over 30 ± 3 minutes

    Arm title
    		 Comparator (7-11 year olds)
    Arm description
    		 Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    vancomycin (i.v.), clindamycin (i.v.), semi-synthetic penicillins (i.v.) (nafcillin, oxacillin, or cloxacillin), or first-generation cephalosporins (i.v.)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered per standard of care

    Arm title
    		 Daptomycin (12-17 year olds)
    Arm description
    		 Participants aged 12-17 were administered daptomycin 7 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daptomycin
    Investigational medicinal product code
    Other name
    Cubicin®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    7 mg/kg once daily infused over 30 ± 3 minutes

    Arm title
    		 Comparator (12-17 year olds)
    Arm description
    		 Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    vancomycin (i.v.), clindamycin (i.v.), semi-synthetic penicillins (i.v.) (nafcillin, oxacillin, or cloxacillin), or first-generation cephalosporins (i.v.)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered per standard of care

    Number of subjects in period 1
    		Daptomycin (1-6 year olds) Comparator (1-6 year olds) Daptomycin (7-11 year olds) Comparator (7-11 year olds) Daptomycin (12-17 year olds) Comparator (12-17 year olds)
    Started
    22
    11
    19
    9
    14
    7
    Treated
    22
    10
    19
    9
    14
    7
    Completed
    18
    10
    17
    8
    12
    5
    Not completed
    4
    1
    2
    1
    2
    2
         Persistent Positive Blood Cultures
    1
    -
    1
    -
    -
    -
         Adverse event, non-fatal
    1
    -
    1
    -
    1
    -
         No relevant bacteria, participant discharged, etc.
    2
    -
    -
    -
    1
    1
         Subject/Parent/Legal Guardian Decision
    -
    -
    -
    1
    -
    1
         Did not receive treatment
    -
    1
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Daptomycin (1-6 year olds)
    Reporting group description
    		 Participants aged 1-6 years were administered daptomycin 12 mg/kg, infused once daily, intravenously, over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days.

    Reporting group title
    Comparator (1-6 year olds)
    Reporting group description
    		 Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days.

    Reporting group title
    Daptomycin (7-11 year olds)
    Reporting group description
    		 Participants aged 7-11 years were administered daptomycin 9 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days.

    Reporting group title
    Comparator (7-11 year olds)
    Reporting group description
    		 Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days.

    Reporting group title
    Daptomycin (12-17 year olds)
    Reporting group description
    		 Participants aged 12-17 were administered daptomycin 7 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days.

    Reporting group title
    Comparator (12-17 year olds)
    Reporting group description
    		 Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days.

    Reporting group values
    		 Daptomycin (1-6 year olds) Comparator (1-6 year olds) Daptomycin (7-11 year olds) Comparator (7-11 year olds) Daptomycin (12-17 year olds) Comparator (12-17 year olds) Total
    Number of subjects
    		 22 11 19 9 14 7 82
    Age Categorical
    Units: Subjects
        Children (2-11 years)
    		 22 11 19 9 0 0 61
        Adolescents (12-17 years)
    		 0 0 0 0 14 7 21
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 3.8 ± 1.2 4.1 ± 1.7 10.3 ± 1.2 9.5 ± 1.3 14.1 ± 1.7 14.6 ± 1.9 -
    Gender Categorical
    Units: Subjects
        Female
    		 10 9 7 1 0 1 28
        Male
    		 12 2 12 8 14 6 54

    End points

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    End points reporting groups
    Reporting group title
    Daptomycin (1-6 year olds)
    Reporting group description
    		 Participants aged 1-6 years were administered daptomycin 12 mg/kg, infused once daily, intravenously, over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days.

    Reporting group title
    Comparator (1-6 year olds)
    Reporting group description
    		 Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days.

    Reporting group title
    Daptomycin (7-11 year olds)
    Reporting group description
    		 Participants aged 7-11 years were administered daptomycin 9 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days.

    Reporting group title
    Comparator (7-11 year olds)
    Reporting group description
    		 Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days.

    Reporting group title
    Daptomycin (12-17 year olds)
    Reporting group description
    		 Participants aged 12-17 were administered daptomycin 7 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days.

    Reporting group title
    Comparator (12-17 year olds)
    Reporting group description
    		 Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days.

    Subject analysis set title
    Daptomycin (1-6 years) - mMITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants aged 1-6 years were administered daptomycin 12 mg/kg, infused once daily, intravenously, over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. The Microbiological Modified Intent-to-Treat (mMITT) population is composed of all randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.

    Subject analysis set title
    Daptomycin (7-11 years) - mMITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants aged 7-11 years were administered daptomycin 9 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. The mMITT population is composed of all randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.

    Subject analysis set title
    Daptomycin (12-17 years) - mMITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Participants aged 12-17 were administered daptomycin 7 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. The mMITT population is composed of all randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.

    Subject analysis set title
    Comparator (1-6 years) - mMITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. The mMITT population is composed of all randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.

    Subject analysis set title
    Comparator (7-11 years) - mMITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. The mMITT population is composed of all randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.

    Subject analysis set title
    Comparator (12-17 years) - mMITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. The mMITT population is composed of all randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.

    Subject analysis set title
    Daptomycin (1-6 years) - ER
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants aged 1-6 years were administered daptomycin 12 mg/kg, infused once daily, intravenously, over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. The Exposure Response (ER) population consists of any participant with at least one peak or trough plasma sample.

    Subject analysis set title
    Daptomycin (7-11 years) - ER
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants aged 7-11 years were administered daptomycin 9 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. The ER population consists of any participant with at least one peak or trough plasma sample.

    Subject analysis set title
    Daptomycin (12-17 years) - ER
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants aged 12-17 were administered daptomycin 7 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. The ER population consists of any participant with at least one peak or trough plasma sample.

    Subject analysis set title
    Daptomycin (1-6 years) - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged 1-6 years were administered daptomycin 12 mg/kg, infused once daily, intravenously, over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. The Safety population includes all participants who receive any dose of i.v. study medication (daptomycin or standard of care [SOC]); participants are categorized by actual treatment received, irrespective of the randomization assignment.

    Subject analysis set title
    Daptomycin (7-11 years) - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged 7-11 years were administered daptomycin 9 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. The Safety population includes all participants who receive any dose of i.v. study medication (daptomycin or SOC); participants are categorized by actual treatment received, irrespective of the randomization assignment.

    Subject analysis set title
    Daptomycin (12-17 years) - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants aged 12-17 were administered daptomycin 7 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. The Safety population includes all participants who receive any dose of i.v. study medication (daptomycin or SOC); participants are categorized by actual treatment received, irrespective of the randomization assignment.

    Subject analysis set title
    Comparator (1-6 years) - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. The Safety population includes all participants who receive any dose of i.v. study medication (daptomycin or SOC); participants are categorized by actual treatment received, irrespective of the randomization assignment.

    Subject analysis set title
    Comparator (7-11 years) - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. The Safety population includes all participants who receive any dose of i.v. study medication (daptomycin or SOC); participants are categorized by actual treatment received, irrespective of the randomization assignment.

    Subject analysis set title
    Comparator (12-17 years) - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. The Safety population includes all participants who receive any dose of i.v. study medication (daptomycin or SOC); participants are categorized by actual treatment received, irrespective of the randomization assignment.

    Primary: Number of Participants with One or More Treatment-Emergent Adverse Events (AEs) During I.V. Treatment Phase

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    End point title
    		 Number of Participants with One or More Treatment-Emergent Adverse Events (AEs) During I.V. Treatment Phase [1]
    End point description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The Safety population includes all participants who received any dose of i.v. study medication (daptomycin or SOC); participants are categorized by actual treatment received, irrespective of the randomization assignment. AEs were collected from first dose of study medication through last follow-up visit for all randomized and treated participants.
    End point type
    Primary
    End point timeframe
    Administration of first dose through the last follow-up visit (up to 77 days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Since the study was not powered for making inferential statistical analyses for safety, only descriptive statistics were provided for the endpoint.
    End point values
    		 Daptomycin (1-6 years) - Safety Daptomycin (7-11 years) - Safety Daptomycin (12-17 years) - Safety Comparator (1-6 years) - Safety Comparator (7-11 years) - Safety Comparator (12-17 years) - Safety
    Number of subjects analysed
    22
    19
    14
    10
    9
    7
    Units: Participants
    12
    11
    6
    5
    8
    5
    No statistical analyses for this end point

    Primary: Number of Participants with One or More Treatment-Emergent Serious Adverse Events (SAEs) During I.V. Treatment Phase

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    End point title
    		 Number of Participants with One or More Treatment-Emergent Serious Adverse Events (SAEs) During I.V. Treatment Phase [2]
    End point description
    An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life-threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event. The Safety population includes all participants who received any dose of i.v. study medication (daptomycin or SOC); participants are categorized by actual treatment received, irrespective of the randomization assignment. SAEs were collected from first dose of study medication through last follow-up visit for all randomized and treated participants.
    End point type
    Primary
    End point timeframe
    Administration of first dose through the last follow-up visit (up to 77 days)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Since the study was not powered for making inferential statistical analyses for safety, only descriptive statistics were provided for the endpoint.
    End point values
    		 Daptomycin (1-6 years) - Safety Daptomycin (7-11 years) - Safety Daptomycin (12-17 years) - Safety Comparator (1-6 years) - Safety Comparator (7-11 years) - Safety Comparator (12-17 years) - Safety
    Number of subjects analysed
    22
    19
    14
    10
    9
    7
    Units: Participants
    2
    2
    1
    0
    2
    1
    No statistical analyses for this end point

    Primary: Percentage of Participants with Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal

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    End point title
    		 Percentage of Participants with Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal [3]
    End point description
    The percentage of participants with maximum post-baseline CPK elevations >500 Units Per Liter (U/L) is presented. The Safety population includes all participants who received any dose of i.v. study medication (daptomycin or SOC); participants are categorized by actual treatment received, irrespective of the randomization assignment.
    End point type
    Primary
    End point timeframe
    Baseline up to end of therapy visit (up to 44 days)
    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: Since the study was not powered for efficacy, inferential statistical analyses were neither planned or performed for this endpoint.
    End point values
    		 Daptomycin (1-6 years) - Safety Daptomycin (7-11 years) - Safety Daptomycin (12-17 years) - Safety Comparator (1-6 years) - Safety Comparator (7-11 years) - Safety Comparator (12-17 years) - Safety
    Number of subjects analysed
    22
    19
    14
    10
    9
    7
    Units: Percentage of Participants
        number (not applicable)
    40.9
    10.5
    28.6
    40
    0
    14.3
    No statistical analyses for this end point

    Primary: Percentage of Participants with Sustained CPK Elevations

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    End point title
    		 Percentage of Participants with Sustained CPK Elevations [4]
    End point description
    The percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the ULN, is presented. The Safety population includes all participants who received any dose of i.v. study medication (daptomycin or SOC); participants are categorized by actual treatment received, irrespective of the randomization assignment.
    End point type
    Primary
    End point timeframe
    Baseline up to end of therapy visit (up to 44 days)
    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: Since the study was not powered for efficacy, inferential statistical analyses were neither planned or performed for this endpoint.
    End point values
    		 Daptomycin (1-6 years) - Safety Daptomycin (7-11 years) - Safety Daptomycin (12-17 years) - Safety Comparator (1-6 years) - Safety Comparator (7-11 years) - Safety Comparator (12-17 years) - Safety
    Number of subjects analysed
    22
    19
    14
    10
    9
    7
    Units: Percentage of Participants
        number (not applicable)
    18.2
    0
    28.6
    20
    0
    14.3
    No statistical analyses for this end point

    Primary: Number of Participants with Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)

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    End point title
    		 Number of Participants with Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) [5]
    End point description
    Focused neurological examinations were done at baseline, twice weekly during i.v. study drug, at the End of Therapy (i.v.) visit and at the TOC/Safety Visit. The focused neurological examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers. Safety Population: includes all participants who receive any dose of i.v. study medication (daptomycin or SOC); participants are categorized by actual treatment received, irrespective of the randomization assignment.
    End point type
    Primary
    End point timeframe
    TOC Safety Visit (up to 56 days)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Since the study was not powered for efficacy, inferential statistical analyses were neither planned or performed for this endpoint.
    End point values
    		 Daptomycin (1-6 years) - Safety Daptomycin (7-11 years) - Safety Daptomycin (12-17 years) - Safety Comparator (1-6 years) - Safety Comparator (7-11 years) - Safety Comparator (12-17 years) - Safety
    Number of subjects analysed
    22
    19
    14
    10
    9
    7
    Units: Participants
        Alertness
    0
    0
    0
    0
    0
    0
        Pupillary Reflex and Tracking
    0
    1
    0
    0
    0
    0
        Peripheral Reflex - Biceps
    0
    0
    0
    0
    0
    0
        Peripheral Reflex - Patellar Tendon
    0
    1
    0
    0
    0
    0
        Peripheral Reflex - Ankle Jerk
    0
    1
    0
    0
    0
    0
        Peripheral Reflex - Plantar Response
    0
    0
    0
    0
    0
    0
        Muscle Tone - Lower/Upper Limbs
    0
    0
    2
    0
    0
    0
        Muscle Strength - Lower/Upper Limbs
    0
    0
    2
    0
    0
    0
        Coordination - (Finger to Nose)
    0
    0
    0
    0
    0
    0
        Tremor of the hands/fingers
    0
    1
    0
    0
    0
    0
        Sensation
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Trough Plasma Concentration of Daptomycin

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    End point title
    		 Trough Plasma Concentration of Daptomycin
    End point description
    Plasma concentrations summarized were measured on Days 3 through 5 of i.v. dosing. Trough concentrations were those collected 22 to 26 hours following the end of the previous day’s end of infusion and before the next infusion. Concentration values below the limit of quantification were excluded. The Exposure Response Population consists of any participant with at least one trough sample.
    End point type
    Secondary
    End point timeframe
    Days 3, 4 or 5 of treatment at pre-dose
    End point values
    		 Daptomycin (1-6 years) - ER Daptomycin (7-11 years) - ER Daptomycin (12-17 years) - ER
    Number of subjects analysed
    3
    10
    7
    Units: µg/mL
        arithmetic mean (standard deviation)
    4.72 ± 1.643
    6.39 ± 3.035
    14.69 ± 19.109
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentration (Cmax) of Daptomycin

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    End point title
    		 Maximum Plasma Concentration (Cmax) of Daptomycin
    End point description
    Plasma concentrations summarized were measured on Days 3 through 7 of i.v. dosing. Peak concentrations were those collected up to 15 minutes following the end of infusion. Concentration values below the limit of quantification were excluded. The Exposure Response Population consists of any participant with at least one peak sample.
    End point type
    Secondary
    End point timeframe
    Days 3, 4 or 5 of treatment at end of infusion
    End point values
    		 Daptomycin (1-6 years) - ER Daptomycin (7-11 years) - ER Daptomycin (12-17 years) - ER
    Number of subjects analysed
    15
    18
    8
    Units: µg/mL
        arithmetic mean (standard deviation)
    96.69 ± 32.946
    87.66 ± 34.992
    74.7 ± 34.909
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Clinical Success at TOC Visit

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    End point title
    		 Percentage of Participants with Clinical Success at TOC Visit
    End point description
    This is the Investigator's assessment of clinical response at TOC/Safety Visit with regard to the determination of the resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study. The mMITT population is composed of all randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.
    End point type
    Secondary
    End point timeframe
    7-14 days after the last dose of study medication (up to 56 days)
    End point values
    		 Daptomycin (1-6 years) - mMITT Daptomycin (7-11 years) - mMITT Daptomycin (12-17 years) - mMITT Comparator (1-6 years) - mMITT Comparator (7-11 years) - mMITT Comparator (12-17 years) - mMITT
    Number of subjects analysed
    20
    17
    14
    8
    9
    5
    Units: Percentage of Participants
    number (not applicable)
        Cure
    80
    94.1
    78.6
    87.5
    77.8
    60
        Improved
    5
    0
    7.1
    0
    0
    0
    Statistical analysis title
    		 Daptomycin vs. Comparator: 1-6 years
    Statistical analysis description
    Difference in satisfactory response between treatment groups (Daptomycin - Comparator). Satisfactory response = cured + improved.
    Comparison groups
    Daptomycin (1-6 years) - mMITT v Comparator (1-6 years) - mMITT
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference (%)
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.3
         upper limit
    		 25.3
    Statistical analysis title
    		 Daptomycin vs. Comparator: 12-17 years
    Statistical analysis description
    Difference in satisfactory response between treatment groups (Daptomycin - Comparator). Satisfactory response = cured + improved.
    Comparison groups
    Daptomycin (12-17 years) - mMITT v Comparator (12-17 years) - mMITT
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference (%)
    Point estimate
    25.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21
         upper limit
    		 72.4
    Statistical analysis title
    		 Daptomycin vs. Comparator: 7-11 years
    Statistical analysis description
    Difference in satisfactory response between treatment groups (Daptomycin - Comparator). Satisfactory response = cured + improved.
    Comparison groups
    Daptomycin (7-11 years) - mMITT v Comparator (7-11 years) - mMITT
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference (%)
    Point estimate
    16.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13
         upper limit
    		 45.7

    Secondary: Percentage of Participants with Overall Success at TOC Visit

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    End point title
    		 Percentage of Participants with Overall Success at TOC Visit
    End point description
    Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed. The mMITT population is composed of all randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.
    End point type
    Secondary
    End point timeframe
    7-14 days after the last dose of study medication (up to 56 days)
    End point values
    		 Daptomycin (1-6 years) - mMITT Daptomycin (7-11 years) - mMITT Daptomycin (12-17 years) - mMITT Comparator (1-6 years) - mMITT Comparator (7-11 years) - mMITT Comparator (12-17 years) - mMITT
    Number of subjects analysed
    20
    17
    14
    8
    9
    5
    Units: Percentage of Participants
    number (not applicable)
        Overall Success
    80
    82.4
    50
    75
    44.4
    60
    Statistical analysis title
    		 Daptomycin vs. Comparator: 1-6 years
    Statistical analysis description
    Difference in success response between treatment arms (Daptomycin - Comparator).
    Comparison groups
    Daptomycin (1-6 years) - mMITT v Comparator (1-6 years) - mMITT
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference (%)
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.8
         upper limit
    		 39.8
    Statistical analysis title
    		 Daptomycin vs. Comparator: 7-11 years
    Statistical analysis description
    Difference in success response between treatment arms (Daptomycin - Comparator).
    Comparison groups
    Daptomycin (7-11 years) - mMITT v Comparator (7-11 years) - mMITT
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference (%)
    Point estimate
    37.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 75.1
    Statistical analysis title
    		 Daptomycin vs. Comparator: 12-17 years
    Statistical analysis description
    Difference in success response between treatment arms (Daptomycin - Comparator).
    Comparison groups
    Daptomycin (12-17 years) - mMITT v Comparator (12-17 years) - mMITT
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference (%)
    Point estimate
    -10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -60.3
         upper limit
    		 40.3

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Administration of first dose through the last follow-up visit (up to 77 days)
    Adverse event reporting additional description
    Safety Population - includes all participants who received any dose of i.v. study medication (daptomycin or standard of care comparator). Participants in the safety population were categorized by actual treatment received, irrespective of the randomization assignment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Daptomycin 12 mg/kg (1-6 yrs)
    Reporting group description
    		 Participants aged 1-6 years were administered daptomycin 12 mg/kg, infused once daily, intravenously, over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. AEs and SAEs were collected from first dose of study medication through last follow-up visit from participants on i.v. and/or oral medication.

    Reporting group title
    Comparator (1-6 yrs)
    Reporting group description
    		 Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. AEs and SAEs were collected from first dose of study medication through last follow-up visit from participants on i.v. and/or oral medication.

    Reporting group title
    Daptomycin 9 mg/kg (7-11 yrs)
    Reporting group description
    		 Participants aged 7-11 years were administered daptomycin 9 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. AEs and SAEs were collected from first dose of study medication through last follow-up visit from participants on i.v. and/or oral medication.

    Reporting group title
    Comparator (7-11 yrs)
    Reporting group description
    		 Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. AEs and SAEs were collected from first dose of study medication through last follow-up visit from participants on i.v. and/or oral medication.

    Reporting group title
    Daptomycin 7 mg/kg (12-17 yrs)
    Reporting group description
    		 Participants aged 12-17 were administered daptomycin 7 mg/kg, infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. AEs and SAEs were collected from first dose of study medication through last follow-up visit from participants on i.v. and/or oral medication.

    Reporting group title
    Comparator (12-17 yrs)
    Reporting group description
    		 Recommended as i.v. vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. AEs and SAEs were collected from first dose of study medication through last follow-up visit from participants on i.v. and/or oral medication.

    Serious adverse events
    		 Daptomycin 12 mg/kg (1-6 yrs) Comparator (1-6 yrs) Daptomycin 9 mg/kg (7-11 yrs) Comparator (7-11 yrs) Daptomycin 7 mg/kg (12-17 yrs) Comparator (12-17 yrs)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 22 (27.27%)
    2 / 10 (20.00%)
    4 / 19 (21.05%)
    3 / 9 (33.33%)
    3 / 14 (21.43%)
    2 / 7 (28.57%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Venous thrombosis limb
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    General disorders and administration site conditions
    Device breakage
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Intestine transplant rejection
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone fistula
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Synovitis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    0 / 0
    Bone abscess
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Muscle abscess
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Daptomycin 12 mg/kg (1-6 yrs) Comparator (1-6 yrs) Daptomycin 9 mg/kg (7-11 yrs) Comparator (7-11 yrs) Daptomycin 7 mg/kg (12-17 yrs) Comparator (12-17 yrs)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 22 (40.91%)
    6 / 10 (60.00%)
    11 / 19 (57.89%)
    9 / 9 (100.00%)
    8 / 14 (57.14%)
    5 / 7 (71.43%)
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Thrombophlebitis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Catheter site discharge
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Catheter site oedema
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Catheter site pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Device breakage
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Infusion site pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    2 / 22 (9.09%)
    1 / 10 (10.00%)
    1 / 19 (5.26%)
    2 / 9 (22.22%)
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    3
    1
    1
    3
    2
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Reproductive system and breast disorders
    Epididymal cyst
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    Atelectasis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pharyngeal ulceration
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Hypoxia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pulmonary mass
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    0
    2
    0
    Blood potassium decreased
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Blood sodium decreased
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Body temperature increased
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Contusion
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Excoriation
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Wound
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Wound dehiscence
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Lethargy
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Abdominal lymphadenopathy
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Anaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    Thrombocytosis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    4 / 22 (18.18%)
    1 / 10 (10.00%)
    1 / 19 (5.26%)
    3 / 9 (33.33%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    4
    1
    1
    3
    1
    0
    Nausea
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 10 (20.00%)
    2 / 19 (10.53%)
    0 / 9 (0.00%)
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    4
    4
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Acne
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Erythema
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    2 / 9 (22.22%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Rash
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Rash erythematous
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Rash macular
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Renal failure acute
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Renal necrosis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Haemarthrosis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Myositis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Abscess
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Arthritis bacterial
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Candida infection
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    1 / 19 (5.26%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    Infected skin ulcer
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lung abscess
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Osteomyelitis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    Osteomyelitis acute
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Postoperative wound infection
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Rash pustular
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Rhinovirus infection
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Systemic candida
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Varicella
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 19 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Fluid overload
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 19 (5.26%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Hypernatraemia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 10 (0.00%)
    0 / 19 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0

    More information

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

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

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

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