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    Clinical Trial Results:
    A Prospective, Open-Label Study To Assess The Pharmacokinetics, Safety & Efficacy Of Anidulafungin When Used To Treat Children With Invasive Candidiasis, Including Candidemia

    Summary
    EudraCT number
    2008-004150-32
    Trial protocol
    ES   DE   FR   PT   IT   GR   Outside EU/EEA   GB  
    Global end of trial date
    14 Feb 2018

    Results information
    Results version number
    v2(current)
    This version publication date
    19 May 2019
    First version publication date
    30 Aug 2018
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    A8851008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00761267
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000469-PIP01-08
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 May 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of anidulafungin in children 1 month to less than (<) 18 years of age with invasive candidiasis, including candidemia (ICC).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Feb 2009
    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
    Spain: 1
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 18
    Country: Number of subjects enrolled
    Brazil: 17
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Greece: 13
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    Russian Federation: 7
    Worldwide total number of subjects
    68
    EEA total number of subjects
    19
    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)
    19
    Children (2-11 years)
    39
    Adolescents (12-17 years)
    10
    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
    The study was conducted in 10 countries between 27 Feb 2009 and 14 Feb 2018.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years
    Arm description
    Subjects received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for maximum 35 days.After >=10 days treatment, subjects with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria [1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, subjects without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days.First 6 subjects received second antifungal agent, if required at Investigator’s discretion.
    Arm type
    Experimental

    Investigational medicinal product name
    Anidulafungin
    Investigational medicinal product code
    PF-03910960
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Anidulafungin at loading dose of 3mg/kg, IV on Day 1, then maintenance dose of 1.5 mg/kg, every 24 hours for maximum of 35 days.

    Arm title
    Anidulafungin: Subjects Aged 2 to <5 Years
    Arm description
    Subjects received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, subjects with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, subjects without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Anidulafungin
    Investigational medicinal product code
    PF-03910960
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Anidulafungin at loading dose of 3 mg/kg, IV on Day 1, then maintenance dose of 1.5 mg/kg, every 24 hours for a minimum of 10 days and maximum of 35 days.

    Arm title
    Anidulafungin: Subjects Aged 5 to <18 Years
    Arm description
    Subjects received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, subjects with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, subjects without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Anidulafungin
    Investigational medicinal product code
    PF-03910960
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Anidulafungin at loading dose of 3 mg/kg, IV on Day 1, then maintenance dose of 1.5 mg/kg, every 24 hours for a minimum of 10 days and maximum of 35 days.

    Number of subjects in period 1
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years Anidulafungin: Subjects Aged 2 to <5 Years Anidulafungin: Subjects Aged 5 to <18 Years
    Started
    19
    19
    30
    Completed
    18
    16
    24
    Not completed
    1
    3
    6
         Consent withdrawn by subject
    -
    1
    -
         Lost to follow-up
    -
    -
    1
         Subject Died
    1
    2
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years
    Reporting group description
    Subjects received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for maximum 35 days.After >=10 days treatment, subjects with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria [1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, subjects without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days.First 6 subjects received second antifungal agent, if required at Investigator’s discretion.

    Reporting group title
    Anidulafungin: Subjects Aged 2 to <5 Years
    Reporting group description
    Subjects received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, subjects with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, subjects without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.

    Reporting group title
    Anidulafungin: Subjects Aged 5 to <18 Years
    Reporting group description
    Subjects received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, subjects with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, subjects without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.

    Reporting group values
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years Anidulafungin: Subjects Aged 2 to <5 Years Anidulafungin: Subjects Aged 5 to <18 Years Total
    Number of subjects
    19 19 30 68
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    19 0 0 19
        Children (2-11 years)
    0 19 20 39
        Adolescents (12-17 years)
    0 0 10 10
        Adults (18-64 years)
    0 0 0 0
        From 65-84 years
    0 0 0 0
        85 years and over
    0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    0.93 ± 0.52 3.09 ± 0.68 10.67 ± 3.68 -
    Sex: Female, Male
    Units: Subjects
        Female
    9 8 13 30
        Male
    10 11 17 38
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0
        Asian
    0 2 4 6
        Native Hawaiian or Other Pacific Islander
    0 0 0 0
        Black or African American
    0 1 0 1
        White
    19 15 20 54
        More than one race
    0 0 0 0
        Unknown or Not Reported
    0 1 6 7

    End points

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    End points reporting groups
    Reporting group title
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years
    Reporting group description
    Subjects received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for maximum 35 days.After >=10 days treatment, subjects with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria [1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, subjects without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days.First 6 subjects received second antifungal agent, if required at Investigator’s discretion.

    Reporting group title
    Anidulafungin: Subjects Aged 2 to <5 Years
    Reporting group description
    Subjects received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, subjects with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, subjects without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.

    Reporting group title
    Anidulafungin: Subjects Aged 5 to <18 Years
    Reporting group description
    Subjects received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, subjects with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, subjects without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.

    Subject analysis set title
    Anidulafungin: First 6 subjects aged 1 month to <2 years
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    First 6 subjects received Anidulafungin at loading dose of 3 mg/kg, IV on Day 1, then maintenance dose of 1.5 mg/kg, every 24 hours for maximum of 35 days.

    Subject analysis set title
    Anidulafungin PK subgroup of last eight: 1 month to <2 Years
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Last eight subjects received Anidulafungin loading dose of 3 mg/kg, IV on Day 1, then maintenance dose of 1.5 mg/kg, every 24 hours for minimum of 10 days and maximum of 35 days. After >=10 days of IV treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criterion [1) afebrile for >=24 hours, 2) tolerate oral medication, 3)documentation of 2 blood cultures (24 hours apart) negative for Candida species,4) Eradication/presumed eradication of Candida species from any other sites of infection if identified at enrollment, 5) Specific Candida isolate was susceptible/presumed susceptible to fluconazole, 6) switched to oral fluconazole if improvement in signs, symptoms of Candida infection] received oral fluconazole (6 to 12 mg/kg/day, maximum 800 mg/day) up to 49 days. Subjects received a second systemic antifungal agent, if required at the Investigator’s discretion.

    Subject analysis set title
    Exposure response: Hepatic adverse events
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Exposure (AUC0-24ss) response quantile analysis for subjects with evaluable PK and hepatic adverse events whilst on receiving Anidulafungin therapy.

    Subject analysis set title
    Exposure response: Gastrointestinal (GI) adverse events
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Exposure (AUC0-24ss) response quantile analysis for subjects with evaluable PK and gastrointestinal adverse events whilst on receiving Anidulafungin therapy.

    Subject analysis set title
    Exposure response: Efficacy
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Exposure (AUC0-24ss) response quantile analysis for subjects with success or failure outcome in Global Response at End of IV treatment (EOIVT) and End of treatment (EOT). Subjects with indeterminate outcome were excluded.

    Primary: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after end of treatment (EOT) (up to 91 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. EOT visit defined as last day of study treatment (IV or oral). The safety population included all randomized subjects who received at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Baseline up to 6 weeks after EOT (up to 91 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: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years Anidulafungin: Subjects Aged 2 to <5 Years Anidulafungin: Subjects Aged 5 to <18 Years
    Number of subjects analysed
    19
    19
    30
    Units: subjects
        AEs|
    17
    19
    30
        SAEs|
    7
    10
    13
    No statistical analyses for this end point

    Primary: Number of Subjects with Laboratory Abnormalities

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    End point title
    Number of Subjects with Laboratory Abnormalities [2]
    End point description
    Criteria for laboratory abnormalities: Hematology parameters:red blood cell count:<0.8*lower limit of normal (LLN); reticulocytes count(absolute or percent):<0.5*LLN or greater than (>) 1.5*upper limit of normal (ULN); Platelets: <0.5*LLN or >1.75*ULN; white blood cell count:<0.6*LLN or >1.5*ULN; neutrophils (absolute or percent):<0.8*LLN or >1.2*ULN; basophils (absolute or percent):>1.2*ULN; lymphocytes (absolute or percent):<0.8*LLN or >1.2*ULN; monocytes (absolute or percent):>1.2*ULN. Serum Chemistry parameters: sodium:<0.95*LLN or >1.05*ULN, potassium, chloride, bicarbonate, calcium:<0.9*LLN or >1.1*ULN; magnesium:>1.1*ULN or <0.9*LLN; BUN (blood urea nitrogen):>1.3* ULN, creatinine:>1.3*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase:>3.0*ULN ; total bilirubin: >1.5*ULN; albumin:<0.8*LLN or >1.2*ULN and glucose: <0.6*LLN or >1.5*ULN.Safety population:all randomized subjects who received at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Baseline up to 6 weeks after EOT (up to 91 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: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years Anidulafungin: Subjects Aged 2 to <5 Years Anidulafungin: Subjects Aged 5 to <18 Years
    Number of subjects analysed
    19
    19
    30
    Units: subjects
    19
    18
    30
    No statistical analyses for this end point

    Secondary: Number of Subjects With Global Response

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    End point title
    Number of Subjects With Global Response
    End point description
    Global response categorized:success,failure,indeterminate.Success:clinical response(CR)of cure(resolution of sign, symptoms attributed to Candida infection[CI];no additional systemic/oral antifungal) or improvement(significant but incomplete resolution of signs,symptoms of CI;no additional systemic antifungal) and microbiological eradication/presumed eradication(Baseline pathogen not isolated from original site culture/ culture data not available for subject with successful outcome).Failure:CR of failure(no significant improvement in signs,symptoms/death due to CI)and/or microbiological failure(persistence/new infection/relapse at follow-up).Indeterminate:CR of indeterminate(evaluation not made due to withdrawal from study prior to cure or failure assessment)and/or microbiological response of indeterminate(Culture data not available for subject with clinical outcome of indeterminate)and neither response was failure.mITT population:atleast 1 dose of study drug with confirmation of CI.
    End point type
    Secondary
    End point timeframe
    End of intravenous treatment (EOIVT) (maximum of 35 days), EOT (maximum of 49 days), during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)
    End point values
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years Anidulafungin: Subjects Aged 2 to <5 Years Anidulafungin: Subjects Aged 5 to <18 Years
    Number of subjects analysed
    16
    18
    30
    Units: subjects
        EOIVT:Success
    11
    14
    20
        EOIVT:Failure
    2
    1
    3
        EOIVT:Indeterminate
    3
    3
    7
        EOIVT:Missing
    0
    0
    0
        EOT:Success
    11
    14
    21
        EOT:Failure
    2
    1
    3
        EOT:Indeterminate
    3
    3
    6
        EOT:Missing
    0
    0
    0
        2 week follow-up:Success
    11
    13
    22
        2 week follow-up:Failure
    2
    1
    4
        2 week follow-up:Indeterminate
    3
    1
    0
        2 week follow-up:Missing
    0
    3
    4
        6 week follow-up:Success
    11
    12
    20
        6 week follow-up:Failure
    2
    2
    6
        6 week follow-up:Indeterminate
    3
    2
    0
        6 week follow-up:Missing
    0
    2
    4
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup

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    End point title
    Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup
    End point description
    Non-compartmental PK analysis was performed on individual plasma anidulafungin concentration-time data collected by serial sampling from subjects in the PK sub-study. AUC24 was calculated based on the trapezoidal rule. PK subgroup population included the first 6 subjects aged between 1 month to <2 years.
    End point type
    Secondary
    End point timeframe
    Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12 and 24 hours after the start of infusion
    End point values
    Anidulafungin: First 6 subjects aged 1 month to <2 years
    Number of subjects analysed
    6
    Units: nanogram*hour per milliliter (ng*hr/mL)
        geometric mean (geometric coefficient of variation)
    66449.1 ± 28
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup

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    End point title
    Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup
    End point description
    Cmax was obtained directly from the observed concentration data on Day 2. PK subgroup population included the first 6 subjects aged between 1 month to <2 years.
    End point type
    Secondary
    End point timeframe
    Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12, and 24 hours after the start of infusion
    End point values
    Anidulafungin: First 6 subjects aged 1 month to <2 years
    Number of subjects analysed
    6
    Units: nanogram per milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    5963.53 ± 29
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup

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    End point title
    Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup [3]
    End point description
    Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 microgram per milliliter (mcg/mL). The geometric mean and coefficient of variation was not reported since only one value was above LLOQ, hence, AUC24 of polysorbate 80 could not be calculated and has been denoted by 99999. The PK subgroup population for PS80 included all subjects aged between 1 month to <2 years who had 1 or more PK sample available. PK time points were assessed on at Day 1, Day 2, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported.
    End point type
    Secondary
    End point timeframe
    Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours delayed post-dose
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years
    Number of subjects analysed
    8
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    99999 ± 99999
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup

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    End point title
    Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup [4]
    End point description
    Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The LLOQ for all the observations of PS 80 was 5.0 mcg/ml. The geometric mean and coefficient of variation was not reported since only one value was above LLOQ, hence, Cmax of polysorbate 80 could not be calculated and has been denoted by 99999. The PK subgroup population for PS80 included all subjects aged between 1 month to <2 years who had 1 or more PK sample available. PK time points were assessed on at Day 1, Day 2, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported.
    End point type
    Secondary
    End point timeframe
    Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours delayed post-dose
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years
    Number of subjects analysed
    8
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    99999 ± 99999
    No statistical analyses for this end point

    Secondary: Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin

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    End point title
    Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin
    End point description
    AUC24 values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model. PK population included all those subjects who had 1 or more PK samples available.
    End point type
    Secondary
    End point timeframe
    Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion
    End point values
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years Anidulafungin: Subjects Aged 2 to <5 Years Anidulafungin: Subjects Aged 5 to <18 Years
    Number of subjects analysed
    17
    19
    30
    Units: microgram*hour per milliliter(mcg*hr/ml)
        arithmetic mean (standard deviation)
    69.87 ± 17.65
    82.81 ± 31.9
    86.77 ± 31.12
    No statistical analyses for this end point

    Secondary: Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin

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    End point title
    Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin
    End point description
    Cmin values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model.PK population included all those subjects who had 1 or more PK samples available.
    End point type
    Secondary
    End point timeframe
    Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion
    End point values
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years Anidulafungin: Subjects Aged 2 to <5 Years Anidulafungin: Subjects Aged 5 to <18 Years
    Number of subjects analysed
    17
    19
    30
    Units: mcg/ml
        arithmetic mean (standard deviation)
    1.98 ± 0.58
    2.51 ± 1.11
    2.52 ± 0.96
    No statistical analyses for this end point

    Secondary: Number of Subjects with Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)

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    End point title
    Number of Subjects with Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)
    End point description
    In an analysis of subjects reporting one or more all-causality hepatic adverse event(s) versus AUC0-24ss (ug*hr/mL) in 5 quantiles, no exposure-response was observed, and has been denoted by '99999'. Analysis performed on all subjects who received at least one dose of the study treatment (Anidulafungin) and had paired PK and safety data available.
    End point type
    Secondary
    End point timeframe
    Baseline to End of intravenous treatment (EOIVT) (maximum of 35 days)
    End point values
    Exposure response: Hepatic adverse events
    Number of subjects analysed
    66
    Units: subjects
    99999
    No statistical analyses for this end point

    Secondary: Number of Subjects with Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)

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    End point title
    Number of Subjects with Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)
    End point description
    In an analysis of subjects reporting one or more all-causality gastrointestinal adverse event(s) versus AUC0-24ss (ug*hr/mL) in 5 quantiles, no exposure-response was observed, and has been denoted by '99999'. Analysis performed on all subjects who received at least one dose of the study treatment (Anidulafungin) and had paired PK and safety data available.
    End point type
    Secondary
    End point timeframe
    Baseline to EOIVT (maximum of 35 days)
    End point values
    Exposure response: Gastrointestinal (GI) adverse events
    Number of subjects analysed
    66
    Units: subjects
    99999
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)

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    End point title
    Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)
    End point description
    In an analysis of success/failure versus AUC0-24ss (ug*hr/mL) in 5 quantiles, no exposure-response was observed, and has been denoted by '99999'. Success was defined as clinical response (CR) of cure (resolution of signs, symptoms attributed to Candida infection) whilst failure was defined as no CR (no significant improvement in signs symptoms or death due to Candida infection) and or microbiological failure (persistence). The mITT population was defined as all subjects who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection and those with paired PK and response of success or failure available (indeterminate response subjects were excluded). Here, ‘n' = Subjects evaluable for this endpoint at specified categories.
    End point type
    Secondary
    End point timeframe
    EOIVT (maximum of 35 days) and EOT (maximum of 49 days)
    End point values
    Exposure response: Efficacy
    Number of subjects analysed
    50
    Units: percentage of subjects
    number (not applicable)
        EOIVT (n=49)
    99999
        EOT (n=50)
    99999
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Relapsed Response

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    End point title
    Percentage of Subjects With Relapsed Response
    End point description
    Relapse:any baseline Candida species isolated following eradication (documented or presumed); or culture data not available for a subject with a clinical response of failure after a previous response of success. Clinical response of failure:no significant improvement in signs and symptoms, or death due to the Candida infection (CI). Subjects had received at least 3 doses of study medication to be classified as a failure. Clinical response of success: resolution of sign and symptoms attributed to Candida infection occurred with no additional systemic or oral antifungal treatment required to complete the course of therapy. Eradication or presumed eradication: baseline pathogen not isolated from original site culture(s), or culture data are not available for a subject with successful clinical outcome. End of treatment visit defined as last day of study treatment (IV or oral).mITT population:subjects who received at least 1 dose of study drug and had microbiological confirmation of CI.
    End point type
    Secondary
    End point timeframe
    During 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)
    End point values
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years Anidulafungin: Subjects Aged 2 to <5 Years Anidulafungin: Subjects Aged 5 to <18 Years
    Number of subjects analysed
    16
    18
    30
    Units: percentage of subjects
    number (not applicable)
        2 week follow-up|
    0.0
    0.0
    0.0
        6 week follow-up|
    0.0
    5.6
    6.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With New Infection

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    End point title
    Percentage of Subjects With New Infection
    End point description
    New infection was defined as a subject presenting with clinical failure with the emergence of new Candida species at the original site of infection or at a distant site of infection. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection occurred. Subjects had received at least 3 doses of study medication to be classified as a failure. End of treatment visit defined as last day of study treatment (IV or oral). The mITT population was defined as all subjects who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.
    End point type
    Secondary
    End point timeframe
    During 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)
    End point values
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years Anidulafungin: Subjects Aged 2 to <5 Years Anidulafungin: Subjects Aged 5 to <18 Years
    Number of subjects analysed
    16
    18
    30
    Units: percentage of subjects
    number (not applicable)
        2 week follow-up
    0.0
    0.0
    0.0
        6 week follow-up
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: All-Cause Mortality - Number of Subjects Who Died During Overall Study Treatment Period and Follow-Up Visits

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    End point title
    All-Cause Mortality - Number of Subjects Who Died During Overall Study Treatment Period and Follow-Up Visits
    End point description
    The safety population included all randomized subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Overall treatment period (up to 49 days); during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)
    End point values
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years Anidulafungin: Subjects Aged 2 to <5 Years Anidulafungin: Subjects Aged 5 to <18 Years
    Number of subjects analysed
    19
    19
    30
    Units: subjects
        overall study treatment period
    0
    1
    4
        2 Week FU
    0
    0
    1
        6 Week FU
    1
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 6 weeks after end of treatment (up to 91 days)
    Adverse event reporting additional description
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event. Analysis performed on safety population.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years
    Reporting group description
    Subjects received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days.After >=10 days treatment, subjects with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria [1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, subjects without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days.First 6 subjects received second antifungal agent, if required at Investigator’s discretion.

    Reporting group title
    Anidulafungin: Subjects Aged 5 to <18 Years
    Reporting group description
    Subjects received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, subjects with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, subjects without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.

    Reporting group title
    Anidulafungin: Subjects Aged 2 to <5 Years
    Reporting group description
    Subjects received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, subjects with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, subjects without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.

    Serious adverse events
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years Anidulafungin: Subjects Aged 5 to <18 Years Anidulafungin: Subjects Aged 2 to <5 Years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 19 (36.84%)
    13 / 30 (43.33%)
    10 / 19 (52.63%)
         number of deaths (all causes)
    1
    5
    2
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Unintentional medical device removal
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Brachiocephalic vein thrombosis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Aspiration bronchial
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Seizure
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic pseudocyst
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal sepsis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 30 (6.67%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Anidulafungin:Subjects Aged 1 month to less than(<)2 Years Anidulafungin: Subjects Aged 5 to <18 Years Anidulafungin: Subjects Aged 2 to <5 Years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 19 (89.47%)
    30 / 30 (100.00%)
    17 / 19 (89.47%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Hypotension
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 30 (10.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    3
    3
    Phlebitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Poor venous access
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    Shock
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Haemorrhage
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Endometrial neoplasm
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Catheter site erythema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Catheter site haematoma
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Catheter site haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Catheter site inflammation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Catheter site pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Catheter site rash
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Catheter site related reaction
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Generalised oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Hyperpyrexia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Hypothermia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Infusion site extravasation
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Malaise
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    4 / 19 (21.05%)
    6 / 30 (20.00%)
    3 / 19 (15.79%)
         occurrences all number
    6
    6
    4
    Face oedema
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    3 / 19 (15.79%)
         occurrences all number
    0
    1
    3
    Depression
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Irritability
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Genital erythema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Penile oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Scrotal oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Uterine haematoma
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Vulvovaginal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal stoma complication
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Accidental overdose
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Excoriation
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 19 (10.53%)
    3 / 30 (10.00%)
    2 / 19 (10.53%)
         occurrences all number
    3
    3
    2
    Amylase increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 19 (10.53%)
    2 / 30 (6.67%)
    1 / 19 (5.26%)
         occurrences all number
    4
    2
    1
    Bacterial test positive
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Enterobacter test positive
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Klebsiella test positive
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Liver function test abnormal
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Platelet count increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Transaminases increased
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 30 (6.67%)
    0 / 19 (0.00%)
         occurrences all number
    1
    2
    0
    Urine output decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Blood bicarbonate decreased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Candida test positive
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    Carbon dioxide decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    1
    1
    0
    Liver function test increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 30 (6.67%)
    0 / 19 (0.00%)
         occurrences all number
    0
    3
    0
    Sinus arrhythmia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 30 (6.67%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Cough
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 19 (5.26%)
    5 / 30 (16.67%)
    3 / 19 (15.79%)
         occurrences all number
    1
    6
    3
    Haemoptysis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    2
    0
    1
    Hypoxia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Lung disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Pleural effusion
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Productive cough
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    2
    Respiratory distress
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinalgia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Tachypnoea
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchospasm
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Laryngospasm
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Tonsillar erythema
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    2
    Anaemia
         subjects affected / exposed
    5 / 19 (26.32%)
    1 / 30 (3.33%)
    3 / 19 (15.79%)
         occurrences all number
    9
    1
    5
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Febrile neutropenia
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 30 (6.67%)
    1 / 19 (5.26%)
         occurrences all number
    0
    3
    1
    Leukopenia
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    2
    Neutropenia
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 30 (10.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    4
    0
    Pancytopenia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    Splenomegaly
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    2 / 19 (10.53%)
    2 / 30 (6.67%)
    1 / 19 (5.26%)
         occurrences all number
    5
    2
    2
    Thrombocytosis
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 30 (6.67%)
    0 / 19 (0.00%)
         occurrences all number
    1
    2
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Areflexia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Seizure
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    2
    Headache
         subjects affected / exposed
    0 / 19 (0.00%)
    6 / 30 (20.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    7
    2
    Loss of consciousness
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Tremor
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 30 (6.67%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Eye disorders
    Pupil fixed
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Strabismus
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Eye discharge
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    Eye irritation
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Eyelid oedema
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Periorbital oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 30 (10.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    4
    1
    Abdominal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 30 (10.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    3
    4
    Anorectal discomfort
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    3 / 19 (15.79%)
    9 / 30 (30.00%)
    2 / 19 (10.53%)
         occurrences all number
    3
    12
    4
    Dry mouth
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    2
    Dysphagia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal motility disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    3
    Ileus
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Intra-abdominal haemorrhage
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 30 (10.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    3
    1
    Pancreatic disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Pancreatic pseudocyst
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Pancreatitis acute
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Saliva altered
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    4 / 19 (21.05%)
    5 / 30 (16.67%)
    7 / 19 (36.84%)
         occurrences all number
    6
    5
    17
    Food poisoning
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Oral pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Salivary hypersecretion
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Henoch-Schonlein purpura nephritis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Acute kidney injury
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary retention
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 30 (6.67%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Hepatobiliary disorders
    Hepatitis acute
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatomegaly
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 30 (6.67%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    1
    Cholestasis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Ocular icterus
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    Device malfunction
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Decubitus ulcer
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Ecchymosis
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 30 (6.67%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Erythema
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Livedo reticularis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Petechiae
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Pruritus generalised
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    2 / 19 (10.53%)
    2 / 30 (6.67%)
    2 / 19 (10.53%)
         occurrences all number
    3
    2
    2
    Rash generalised
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Rash macular
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Scar pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Skin discolouration
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Skin haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Dermatitis diaper
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Toxic skin eruption
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Muscular weakness
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Endocrine disorders
    Thyroiditis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Dehydration
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Electrolyte imbalance
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Hypernatraemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 30 (6.67%)
    1 / 19 (5.26%)
         occurrences all number
    1
    2
    1
    Hypoglycaemia
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 30 (3.33%)
    2 / 19 (10.53%)
         occurrences all number
    1
    1
    2
    Hypokalaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 19 (0.00%)
    4 / 30 (13.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    5
    0
    Hypoproteinaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    2 / 19 (10.53%)
         occurrences all number
    0
    1
    2
    Metabolic acidosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Enterococcal sepsis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    1
    1
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Liver abscess
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 30 (6.67%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Otitis media acute
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Pneumonia
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 30 (10.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    3
    0
    Purulent discharge
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Relapsing fever
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Splenic abscess
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Staphylococcal infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Systemic candida
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 30 (3.33%)
    2 / 19 (10.53%)
         occurrences all number
    1
    1
    2
    Uterine abscess
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Atypical pneumonia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Bacteraemia
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    2
    1
    0
    Catheter site infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Bacterial infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    catheter site cellulitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Device related infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Pseudomonas infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Pyelonephritis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Rash pustular
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Sepsis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 30 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    Skin infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 30 (3.33%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 30 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    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
    12 Mar 2008
    Exclusion criterion to exclude premature neonates born at gestation of less than 36 weeks (unless the sum of gestational age plus chronological age was at least 44 weeks) was added, as well as a new section on central venous catheter management.
    19 Aug 2010
    (1)Enrollment of subjects with Candida endocarditis on the basis of at least 1 positive blood culture for Candida spp. and evidence of endocarditis on echocardiogram, and, enrollment of subjects with Candida osteomyelitis on the basis of at least 1 positive culture for Candida spp. from a bone biopsy or aspirate and evidence of osteomyelitis on Magnetic Resonance Imaging (MRI) was allowed; (2) Subjects in the PK subgroup (ie, the first 6 subjects between 1 month and <2 years of age enrolled at selected centers) could be given anidulafungin as either monotherapy or in combination with a second antifungal treatment, at the Investigator’s discretion; (3) Clarified maximum total duration of treatment in the study was 49 days, and the maximum allowed treatment duration with anidulafungin was 35 days; (4) Modified oral fluconazole switch criteria, such that in addition to other criteria currently listed in the protocol, switching to fluconazole could occur if microbiological eradication was presumed based on clinical signs and symptoms, and if susceptibility to fluconazole was presumed based on the Candida species, identified and based on local Candida resistance patterns; (5) Clarified that subjects could have at least 1 clinical criterion present either at the time of study entry or within 96 hours prior to study entry.
    08 Dec 2011
    At the request of the Korean authorities, the Sponsor removed all aspects of the protocol related to the enrollment of subjects with Candida endocarditis and Candida osteomyelitis; study centers in Korea were not permitted to enroll subjects with these conditions.
    07 Jan 2013
    The protocol was updated to include: (1) the Sponsor’s recent standard protocol template text, including language regarding females and males of childbearing potential, pregnancy testing and contraception; (2) expected SAEs and additional SAE reporting requirements; (3) medication error reporting requirements and (4) Portugal opted out of enrolling Candida endocarditis and Candida osteomyelitis subjects.
    06 Jul 2015
    Included measurement of plasma levels of the excipient polysorbate 80, a solubilizing agent contained in the intravenous (IV) formulation of anidulafungin, due to the lack of excipient exposure/response data of polysorbate 80 in very young children (eg, <2 years of age).
    16 Sep 2016
    (1) Study population was broadened to include children aged 1 month to <2 years only who were at high risk for candidiasis; (2)Amended exclusion criteria, including those related to prior systemic antifungal therapy and removal of prosthetic devices and/or vascular catheters at the suspected site of infection; (3) Added an interim analysis; (4) Reduced the volume of blood required for polysorbate 80 PK samples and added details for preferred sample collection times; (5) Provided instructions for withdrawal of subjects without microbiologically confirmed invasive candidiasis, including ICC.

    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.
    Since there was no exposure response relationship, a tabular presentation has not been displayed as in the US Basic Results/ posting because of limitations with the EU posting structure.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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