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    Clinical Trial Results:
    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody against Respiratory Syncytial Virus (RSV), in Children with Hemodynamically Significant Congenital Heart Disease

    Summary
    EudraCT number
    2007-002070-61
    Trial protocol
    GB   AT   SE   BE   HU   DE   FR   PL   CZ   Outside EU/EEA  
    Global end of trial date
    26 Jun 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Jan 2016
    First version publication date
    30 Jan 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MI-CP124
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00538785
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    Milstein Building, Granta Park, Cambridge, United Kingdom, CB21 6GH
    Public contact
    Pamela Griffin, Senior Director, Clinical Development, MedImmune, LLC, griffinp@medimmune.com
    Scientific contact
    Pamela Griffin, Senior Director, Clinical Development, MedImmune, LLC, griffinp@medimmune.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Jun 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to describe the safety and tolerability of motavizumab when given monthly as prophylaxis against serious Respiratory Syncytial Virus (RSV) infection among children with hemodynamically significant congenital heart disease (CHD). This study also described the incidence of RSV hospitalization in children with hemodynamically significant CHD given motavizumab or palivizumab for prophylaxis against serious RSV disease and the incidence of RSV outpatient medically-attended lower respiratory.
    Protection of trial subjects
    Adverse events (AEs), serious adverse events (SAEs), and concomitant medications were collected from the period immediately following the first administration of study drug through Study Day 150. Blood was collected prior to the first and last doses of study drug for serum chemistry (aspartate aminotransferase [AST], alanine aminotransferase [ALT], blood urea nitrogen [BUN], and creatinine) as part of the safety evaluation; vital signs were measured prior to and 30 minutes after each dose of study drug. Subjects were evaluated just prior to each dose of study drug, with a final post-dosing follow-up evaluation at Study Day 150.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    21 Oct 2005
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy, Safety
    Long term follow-up duration
    5 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 14
    Country: Number of subjects enrolled
    Belgium: 54
    Country: Number of subjects enrolled
    Czech Republic: 74
    Country: Number of subjects enrolled
    France: 28
    Country: Number of subjects enrolled
    Germany: 66
    Country: Number of subjects enrolled
    Hungary: 53
    Country: Number of subjects enrolled
    Poland: 99
    Country: Number of subjects enrolled
    Spain: 57
    Country: Number of subjects enrolled
    Sweden: 21
    Country: Number of subjects enrolled
    United Kingdom: 57
    Country: Number of subjects enrolled
    Canada: 49
    Country: Number of subjects enrolled
    United States: 301
    Country: Number of subjects enrolled
    Bulgaria: 36
    Country: Number of subjects enrolled
    Israel: 132
    Country: Number of subjects enrolled
    Lebanon: 128
    Country: Number of subjects enrolled
    Russian Federation: 66
    Worldwide total number of subjects
    1235
    EEA total number of subjects
    545
    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)
    1235
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 1236 subjects were randomized, out of which one subject was not analyzed as was randomized without proper citizenship, at 162 sites in 16 countries within the northern hemisphere between 21Oct2005 and 14Dec2005 in Season 1 and 02Oct2007 and 31Dec2007 in Season 2; each subject participated in the study for a single RSV season.

    Pre-assignment
    Screening details
    Subjects were randomized 1:1 on Study Day 0 to receive either 15 mg/kg motavizumab or 15 mg/kg palivizumab. A permuted-block randomization method was used and a separate randomization schedule was generated for each site and cyanotic CHD strata combination.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Motavizumab (MEDI-524)
    Arm description
    Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Arm type
    Experimental

    Investigational medicinal product name
    Motavizumab
    Investigational medicinal product code
    MEDI-524
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    100 mg/mL

    Arm title
    Palivizumab
    Arm description
    Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Arm type
    Experimental

    Investigational medicinal product name
    Palivizumab
    Investigational medicinal product code
    MEDI-493
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    100 mg/mL

    Number of subjects in period 1
    Motavizumab (MEDI-524) Palivizumab
    Started
    623
    612
    Completed
    604
    595
    Not completed
    19
    17
         Withdrawal of consent
    9
    7
         Adverse event, serious fatal
    9
    10
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    -

    Reporting group values
    Overall Study Total
    Number of subjects
    1235 1235
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    1235 1235
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    0 0
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age Continuous |
    Units: months
        arithmetic mean (standard deviation)
    8.33 ± 6.45 -
    Gender, Male/Female
    Units: participants
        Female
    580 580
        Male
    655 655
    Race/Ethnicity, Customized
    Units: Subjects
        White/Non-hispanic
    1069 1069
        Black
    43 43
        Hispanic
    44 44
        Asian
    18 18
        Other
    61 61
    Region of Enrollment
    Units: Subjects
        United States
    301 301
        Spain
    57 57
        Lebanon
    128 128
        Austria
    14 14
        Israel
    132 132
        Russian Federation
    66 66
        United Kingdom
    57 57
        France
    28 28
        Czech Republic
    74 74
        Hungary
    53 53
        Canada
    49 49
        Belgium
    54 54
        Poland
    99 99
        Bulgaria
    36 36
        Germany
    66 66
        Sweden
    21 21

    End points

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    End points reporting groups
    Reporting group title
    Motavizumab (MEDI-524)
    Reporting group description
    Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

    Reporting group title
    Palivizumab
    Reporting group description
    Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

    Primary: Number of Subjects Reporting Adverse Events Through Study Day 150

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    End point title
    Number of Subjects Reporting Adverse Events Through Study Day 150 [1]
    End point description
    Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.
    End point type
    Primary
    End point timeframe
    Days 0-150
    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: Statistical data was not planned to be reported for this endpoint
    End point values
    Motavizumab (MEDI-524) Palivizumab
    Number of subjects analysed
    618
    612
    Units: participants
    575
    566
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Laboratory Adverse Events

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    End point title
    Number of Subjects Reporting Laboratory Adverse Events [2]
    End point description
    End point type
    Primary
    End point timeframe
    Days 0-150
    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: Statistical data was not planned to be reported for this endpoint
    End point values
    Motavizumab (MEDI-524) Palivizumab
    Number of subjects analysed
    618
    612
    Units: participants
        Adrenal insufficiency
    3
    3
        Alanine aminotranferase increased
    13
    26
        Anemia
    17
    14
        Aspartate aminotransferase increased
    3
    9
        Bacteria sputum indentified
    1
    1
        Blood alkaline phosphatase increased
    1
    0
        Blood calcium decreased
    0
    1
        Blood calcium increased
    2
    0
        Blood creatinine increased
    0
    1
        Blood potassium decreased
    1
    1
        Blood potassium increased
    1
    1
        Blood sodium abnormal
    0
    1
        Blood sodium decreased
    1
    1
        Blood thyroid stimulating hormone increased
    1
    0
        Blood urea increased
    39
    34
        Brain natriuretic peptide increased
    1
    0
        C-reactive protein increased
    0
    5
        Clostridium difficiline toxin test positive
    1
    0
        Coagulation test abnormal
    1
    1
        Haematocrit drecreased
    0
    1
        Haemaglobin decreased
    0
    1
        Hepatic enzyme increased
    3
    3
        Hyperbilirubinemia
    1
    0
        Hypertransaminasemia
    0
    1
        Hypothyroidism
    3
    2
        International normalised ratio decreased
    0
    1
        International normalised ratio increased
    0
    2
        Iron deficiency anaemia
    1
    0
        Liver function test abnormal
    3
    2
        Mean cell volume decreased
    1
    0
        Neutropenia
    1
    0
        Occult blood positive
    1
    0
        Oxygen saturation decreased
    9
    4
        Platelet count decreased
    0
    1
        Renal function test abnormal
    1
    0
        Thrombocythemia
    1
    0
        Thrombocytopenia
    1
    5
        Thyroid function test abnormal
    0
    1
        Transaminases increased
    0
    2
        Urine output decreased
    1
    1
        White blood cell count increased
    1
    0
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Serious Adverse Events Through Study Day 150

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    End point title
    Number of Subjects Reporting Serious Adverse Events Through Study Day 150 [3]
    End point description
    Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
    End point type
    Primary
    End point timeframe
    Days 0-150
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical data was not planned to be reported for this endpoint
    End point values
    Motavizumab (MEDI-524) Palivizumab
    Number of subjects analysed
    618
    612
    Units: participants
    292
    304
    No statistical analyses for this end point

    Secondary: Incidence of Respiratory Syncytial Virus (RSV) hospitaliztion

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    End point title
    Incidence of Respiratory Syncytial Virus (RSV) hospitaliztion
    End point description
    An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy).
    End point type
    Secondary
    End point timeframe
    Days 0-150
    End point values
    Motavizumab (MEDI-524) Palivizumab
    Number of subjects analysed
    623
    612
    Units: participants
    12
    16
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF
    Comparison groups
    Motavizumab (MEDI-524) v Palivizumab
    Number of subjects included in analysis
    1235
    Analysis specification
    Pre-specified
    Analysis type
    other [4]
    Method
    Guess method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.746
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.344
         upper limit
    1.586
    Notes
    [4] - Analysis type - Descriptive: Study was not powered to show statistical superiority or non-inferiority in the efficacy endpoints.

    Secondary: Incidence of respiratory syncytial virus (RSV) Medically-attended Lower Respiratory Illness (MA-LRI) for Season 2 only

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    End point title
    Incidence of respiratory syncytial virus (RSV) Medically-attended Lower Respiratory Illness (MA-LRI) for Season 2 only
    End point description
    An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory.
    End point type
    Secondary
    End point timeframe
    Days 0-150
    End point values
    Motavizumab (MEDI-524) Palivizumab
    Number of subjects analysed
    304
    310
    Units: participant
    3
    6
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF
    Comparison groups
    Motavizumab (MEDI-524) v Palivizumab
    Number of subjects included in analysis
    614
    Analysis specification
    Pre-specified
    Analysis type
    other [5]
    Method
    Guess method
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.495
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.101
         upper limit
    1.989
    Notes
    [5] - Analysis type - Descriptive: Study was not powered to show statistical superiority or non-inferiority in the efficacy endpoints.

    Secondary: Number of Subjects Who Had Anti-motavizumab Antibodies Detected

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    End point title
    Number of Subjects Who Had Anti-motavizumab Antibodies Detected [6]
    End point description
    ECLA-based method
    End point type
    Secondary
    End point timeframe
    Days 0-150
    Notes
    [6] - 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: Statistical data was not planned to be reported for this endpoint
    End point values
    Motavizumab (MEDI-524)
    Number of subjects analysed
    605
    Units: participants
    9
    No statistical analyses for this end point

    Secondary: Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1

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    End point title
    Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1 [7]
    End point description
    Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1
    End point type
    Secondary
    End point timeframe
    30 days post-dose 1
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical data was not planned to be reported for this endpoint
    End point values
    Motavizumab (MEDI-524)
    Number of subjects analysed
    521
    Units: ug/mL
        arithmetic mean (standard deviation)
    46.9 ± 15.2
    No statistical analyses for this end point

    Secondary: Mean Trough Serum Concentration of Motavizumab at Pre-dose 1

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    End point title
    Mean Trough Serum Concentration of Motavizumab at Pre-dose 1 [8]
    End point description
    Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1
    End point type
    Secondary
    End point timeframe
    Pre-dose 1
    Notes
    [8] - 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: Statistical data was not planned to be reported for this endpoint
    End point values
    Motavizumab (MEDI-524)
    Number of subjects analysed
    543
    Units: ug/mL
        arithmetic mean (standard deviation)
    0 ± 0
    No statistical analyses for this end point

    Secondary: Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2

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    End point title
    Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2 [9]
    End point description
    Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2
    End point type
    Secondary
    End point timeframe
    30 days post-dose 2
    Notes
    [9] - 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: Statistical data was not planned to be reported for this endpoint
    End point values
    Motavizumab (MEDI-524)
    Number of subjects analysed
    228
    Units: ug/mL
        arithmetic mean (standard deviation)
    60.94 ± 25.41
    No statistical analyses for this end point

    Secondary: Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3

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    End point title
    Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3 [10]
    End point description
    Trough serum concentrations (mcg/mL) of motavizumab at 30 days post-dose 3
    End point type
    Secondary
    End point timeframe
    30 days post-dose 3
    Notes
    [10] - 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: Statistical data was not planned to be reported for this endpoint
    End point values
    Motavizumab (MEDI-524)
    Number of subjects analysed
    203
    Units: ug/mL
        arithmetic mean (standard deviation)
    66.59 ± 34.51
    No statistical analyses for this end point

    Secondary: Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4

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    End point title
    Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4 [11]
    End point description
    Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4
    End point type
    Secondary
    End point timeframe
    30 days post-dose 4
    Notes
    [11] - 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: Statistical data was not planned to be reported for this endpoint
    End point values
    Motavizumab (MEDI-524)
    Number of subjects analysed
    203
    Units: ug/mL
        arithmetic mean (standard deviation)
    77.87 ± 32.75
    No statistical analyses for this end point

    Secondary: Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery with Cardiopulmonary Bypass

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    End point title
    Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery with Cardiopulmonary Bypass [12]
    End point description
    Subjects who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to have a blood sample taken for determination of study drug concentrations prior to receipt of another dose of study drug immediately following surgery.
    End point type
    Secondary
    End point timeframe
    Days 0-150
    Notes
    [12] - 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: Statistical data was not planned to be reported for this endpoint
    End point values
    Motavizumab (MEDI-524)
    Number of subjects analysed
    127
    Units: ug/mL
        arithmetic mean (standard deviation)
    48.51 ± 27.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 - Day 150
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Palivizumab
    Reporting group description
    Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

    Reporting group title
    Motavizumab (MEDI-524)
    Reporting group description
    Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

    Serious adverse events
    Palivizumab Motavizumab (MEDI-524)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    304 / 612 (49.67%)
    292 / 618 (47.25%)
         number of deaths (all causes)
    10
    9
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    ARTERIAL THROMBOSIS LIMB
         subjects affected / exposed
    1 / 612 (0.16%)
    3 / 618 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AORTIC STENOSIS
         subjects affected / exposed
    0 / 612 (0.00%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOTENSION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEMORAL ARTERY OCCLUSION
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOVOLAEMIC SHOCK
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOSIS
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASOSPASM
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    IMMUNISATION
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URETHRAL MEATOTOMY
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    DRUG HYPERSENSITIVITY
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    SOCIAL STAY HOSPITALISATION
         subjects affected / exposed
    0 / 612 (0.00%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    CYST
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CATHETER RELATED COMPLICATION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEATH
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    DRUG WITHDRAWAL SYNDROME
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENERAL PHYSICAL HEALTH DETERIORATION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IRRITABILITY
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYREXIA
         subjects affected / exposed
    5 / 612 (0.82%)
    5 / 618 (0.81%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MULTI-ORGAN FAILURE
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    EPIDIDYMITIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ACCIDENTAL OVERDOSE
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AORTIC INJURY
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONTUSION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEMUR FRACTURE
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEDICAL DEVICE COMPLICATION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEAD INJURY
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MULTIPLE FRACTURES
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    0 / 612 (0.00%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POSTPERICARDIOTOMY SYNDROME
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEROMA
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SHUNT MALFUNCTION
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SHUNT OCCLUSION
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SHUNT STENOSIS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBDURAL HAEMATOMA
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UPPER LIMB FRACTURE
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR PSEUDOANEURYSM
         subjects affected / exposed
    0 / 612 (0.00%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CENTRAL VENOUS PRESSURE INCREASED
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-REACTIVE PROTEIN INCREASED
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COAGULATION TEST ABNORMAL
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEDICAL OBSERVATION
         subjects affected / exposed
    1 / 612 (0.16%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIVER FUNCTION TEST ABNORMAL
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SLEEP STUDY
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    AORTIC VALVE STENOSIS
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIOVENTRICULAR BLOCK
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIOVENTRICULAR BLOCK COMPLETE
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC ANEURYSM
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC ARREST
         subjects affected / exposed
    3 / 612 (0.49%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    CARDIAC FAILURE ACUTE
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    CARDIAC FAILURE
         subjects affected / exposed
    7 / 612 (1.14%)
    5 / 618 (0.81%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    CARDIAC FAILURE CHRONIC
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE CONGESTIVE
         subjects affected / exposed
    5 / 612 (0.82%)
    4 / 618 (0.65%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC PSEUDOANEURYSM
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC TAMPONADE
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIO-RESPIRATORY ARREST
         subjects affected / exposed
    3 / 612 (0.49%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    CORONARY ARTERY OCCLUSION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYANOSIS
         subjects affected / exposed
    5 / 612 (0.82%)
    9 / 618 (1.46%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    DRESSLER'S SYNDROME
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LEFT VENTRICULAR DYSFUNCTION
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MITRAL VALVE STENOSIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERICARDIAL EFFUSION
         subjects affected / exposed
    2 / 612 (0.33%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOCARDIAL ISCHAEMIA
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY VALVE STENOSIS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUPRAVENTRICULAR TACHYCARDIA
         subjects affected / exposed
    1 / 612 (0.16%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENTRICULAR DYSFUNCTION
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TACHYCARDIA
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    AORTIC VALVE ATRESIA
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANOMALOUS PULMONARY VENOUS CONNECTION
         subjects affected / exposed
    2 / 612 (0.33%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL SEPTAL DEFECT
         subjects affected / exposed
    2 / 612 (0.33%)
    5 / 618 (0.81%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIOVENTRICULAR SEPTAL DEFECT
         subjects affected / exposed
    22 / 612 (3.59%)
    13 / 618 (2.10%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHARGE SYNDROME
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    CLEFT LIP AND PALATE
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COARCTATION OF THE AORTA
         subjects affected / exposed
    3 / 612 (0.49%)
    3 / 618 (0.49%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLEFT PALATE
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONGENITAL AORTIC DILATATION
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONGENITAL CORONARY ARTERY MALFORMATION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONGENITAL MITRAL VALVE STENOSIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONGENITAL PULMONARY VALVE ATRESIA
         subjects affected / exposed
    14 / 612 (2.29%)
    8 / 618 (1.29%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    CONGENITAL TRICUSPID VALVE ATRESIA
         subjects affected / exposed
    12 / 612 (1.96%)
    8 / 618 (1.29%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVELOPMENTAL GLAUCOMA
         subjects affected / exposed
    0 / 612 (0.00%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DOUBLE OUTLET RIGHT VENTRICLE
         subjects affected / exposed
    7 / 612 (1.14%)
    10 / 618 (1.62%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EBSTEIN'S ANOMALY
         subjects affected / exposed
    3 / 612 (0.49%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FALLOT'S TETRALOGY
         subjects affected / exposed
    49 / 612 (8.01%)
    38 / 618 (6.15%)
         occurrences causally related to treatment / all
    0 / 63
    0 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEART DISEASE CONGENITAL
         subjects affected / exposed
    9 / 612 (1.47%)
    4 / 618 (0.65%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOPLASTIC LEFT HEART SYNDROME
         subjects affected / exposed
    18 / 612 (2.94%)
    16 / 618 (2.59%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYDROCELE
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOPLASTIC RIGHT HEART SYNDROME
         subjects affected / exposed
    2 / 612 (0.33%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOSPADIAS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTERRUPTION OF AORTIC ARCH
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LEFT VENTRICLE OUTFLOW TRACT OBSTRUCTION
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEDIUM-CHAIN ACETYL-COENZYME A DEHYDROGENASE DEFICIENCY
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MITRAL VALVE ATRESIA
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PATENT DUCTUS ARTERIOSUS
         subjects affected / exposed
    2 / 612 (0.33%)
    4 / 618 (0.65%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MULTIPLE CARDIAC DEFECTS
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY ARTERY ATRESIA
         subjects affected / exposed
    1 / 612 (0.16%)
    4 / 618 (0.65%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PHIMOSIS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYLORIC STENOSIS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY SEQUESTRATION
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SCIMITAR SYNDROME
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RIGHT VENTRICLE OUTFLOW TRACT OBSTRUCTION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SHONE COMPLEX
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRANSPOSITION OF THE GREAT VESSELS
         subjects affected / exposed
    6 / 612 (0.98%)
    4 / 618 (0.65%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRUNCUS ARTERIOSUS PERSISTENT
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UNIVENTRICULAR HEART
         subjects affected / exposed
    11 / 612 (1.80%)
    9 / 618 (1.46%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEAFNESS BILATERAL
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENTRICULAR SEPTAL DEFECT
         subjects affected / exposed
    36 / 612 (5.88%)
    29 / 618 (4.69%)
         occurrences causally related to treatment / all
    0 / 38
    0 / 32
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ACUTE PULMONARY OEDEMA
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ADENOIDAL HYPERTROPHY
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    APNOEA
         subjects affected / exposed
    3 / 612 (0.49%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASPIRATION
         subjects affected / exposed
    2 / 612 (0.33%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    APNOEIC ATTACK
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATELECTASIS
         subjects affected / exposed
    2 / 612 (0.33%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHIAL HYPERREACTIVITY
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHOPULMONARY DYSPLASIA
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHOSPASM
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHYLOTHORAX
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COUGH
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOKING
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIAPHRAGMATIC HERNIA
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIAPHRAGM MUSCLE WEAKNESS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPNOEA
         subjects affected / exposed
    2 / 612 (0.33%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIAPHRAGMATIC PARALYSIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOXIA
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARYNGEAL GRANULOMA
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG CONSOLIDATION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG INFILTRATION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA ASPIRATION
         subjects affected / exposed
    3 / 612 (0.49%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    2 / 612 (0.33%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMOTHORAX
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONITIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY ARTERY STENOSIS
         subjects affected / exposed
    5 / 612 (0.82%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY CONGESTION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY HYPERTENSION
         subjects affected / exposed
    2 / 612 (0.33%)
    3 / 618 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY HYPERTENSIVE CRISIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY OEDEMA
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY VEIN OCCLUSION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY ARREST
         subjects affected / exposed
    1 / 612 (0.16%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    PULMONARY VEIN STENOSIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY FAILURE
         subjects affected / exposed
    4 / 612 (0.65%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY DISTRESS
         subjects affected / exposed
    4 / 612 (0.65%)
    4 / 618 (0.65%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STRIDOR
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TACHYPNOEA
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRACHEOMALACIA
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WHEEZING
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOCYTOPENIA
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    ANOXIC ENCEPHALOPATHY
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBRAL INFARCTION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONVULSION
         subjects affected / exposed
    1 / 612 (0.16%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEBRILE CONVULSION
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PHRENIC NERVE PARALYSIS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOCLONUS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TONIC CLONIC MOVEMENTS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    STRABISMUS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    2 / 612 (0.33%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONSTIPATION
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTERITIS
         subjects affected / exposed
    3 / 612 (0.49%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCOLITIS
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCUTANEOUS FISTULA
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRITIS
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    6 / 612 (0.98%)
    4 / 618 (0.65%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL INFLAMMATION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INGUINAL HERNIA
         subjects affected / exposed
    3 / 612 (0.49%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INGUINAL HERNIA, OBSTRUCTIVE
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTESTINAL ISCHAEMIA
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERITONEAL HAEMORRHAGE
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPIGELIAN HERNIA
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RECTAL HAEMORRHAGE
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOMITING
         subjects affected / exposed
    4 / 612 (0.65%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOLVULUS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    NEPHROLITHIASIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL FAILURE ACUTE
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYELOCALIECTASIS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL TUBULAR NECROSIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    RASH MACULO-PAPULAR
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DERMATITIS ALLERGIC
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URTICARIA
         subjects affected / exposed
    0 / 612 (0.00%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    SOFT TISSUE NECROSIS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    ADRENAL INSUFFICIENCY
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOTHYROIDISM
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
         subjects affected / exposed
    1 / 612 (0.16%)
    3 / 618 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FAILURE TO THRIVE
         subjects affected / exposed
    5 / 612 (0.82%)
    3 / 618 (0.49%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIET REFUSAL
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD
         subjects affected / exposed
    3 / 612 (0.49%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEEDING DISORDER
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOPHAGIA
         subjects affected / exposed
    2 / 612 (0.33%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOOD INTOLERANCE
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METABOLIC ACIDOSIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WEIGHT GAIN POOR
         subjects affected / exposed
    2 / 612 (0.33%)
    3 / 618 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    ABDOMINAL SEPSIS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ADENOVIRAL UPPER RESPIRATORY INFECTION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ADENOVIRUS INFECTION
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERAEMIA
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERIAL PYELONEPHRITIS
         subjects affected / exposed
    2 / 612 (0.33%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS
         subjects affected / exposed
    10 / 612 (1.63%)
    12 / 618 (1.94%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    BRONCHIOLITIS
         subjects affected / exposed
    16 / 612 (2.61%)
    15 / 618 (2.43%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 27
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    BRONCHITIS VIRAL
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    BRONCHOPNEUMONIA
         subjects affected / exposed
    6 / 612 (0.98%)
    4 / 618 (0.65%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    CLOSTRIDIUM DIFFICILE COLITIS
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CELLULITIS
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CROUP INFECTIOUS
         subjects affected / exposed
    1 / 612 (0.16%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EAR INFECTION
         subjects affected / exposed
    0 / 612 (0.00%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENDOCARDITIS BACTERIAL
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENDOCARDITIS
         subjects affected / exposed
    0 / 612 (0.00%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA URINARY TRACT INFECTION
         subjects affected / exposed
    3 / 612 (0.49%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROBACTER BACTERAEMIA
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS
         subjects affected / exposed
    18 / 612 (2.94%)
    17 / 618 (2.75%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS NOROVIRUS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS ROTAVIRUS
         subjects affected / exposed
    14 / 612 (2.29%)
    7 / 618 (1.13%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    6 / 612 (0.98%)
    5 / 618 (0.81%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    KLEBSIELLA SEPSIS
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    LARYNGITIS
         subjects affected / exposed
    2 / 612 (0.33%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    4 / 612 (0.65%)
    4 / 618 (0.65%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOBAR PNEUMONIA
         subjects affected / exposed
    1 / 612 (0.16%)
    3 / 618 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG INFECTION
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LYMPHANGITIS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG INFECTION PSEUDOMONAL
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MENINGITIS MENINGOCOCCAL
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEDIASTINITIS
         subjects affected / exposed
    2 / 612 (0.33%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METAPNEUMOVIRUS INFECTION
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NASOPHARYNGITIS
         subjects affected / exposed
    1 / 612 (0.16%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OTITIS MEDIA
         subjects affected / exposed
    1 / 612 (0.16%)
    5 / 618 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OTITIS MEDIA ACUTE
         subjects affected / exposed
    1 / 612 (0.16%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OTITIS MEDIA VIRAL
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PARAINFLUENZAE VIRUS INFECTION
         subjects affected / exposed
    3 / 612 (0.49%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    23 / 612 (3.76%)
    20 / 618 (3.24%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PHARYNGITIS
         subjects affected / exposed
    1 / 612 (0.16%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA ADENOVIRAL
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA INFLUENZAL
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PSEUDOMONAL SEPSIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYELONEPHRITIS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS
         subjects affected / exposed
    9 / 612 (1.47%)
    6 / 618 (0.97%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY SYNCYTIAL VIRUS INFECTION
         subjects affected / exposed
    4 / 612 (0.65%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    1 / 612 (0.16%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    4 / 612 (0.65%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RHINITIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ROTAVIRUS INFECTION
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUSITIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    STAPHYLOCOCCAL MEDIASTINITIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STAPHYLOCOCCAL INFECTION
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STREPTOCOCCAL BACTERAEMIA
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBCUTANEOUS ABSCESS
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TONSILLITIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRACHEITIS
         subjects affected / exposed
    0 / 612 (0.00%)
    2 / 618 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    11 / 612 (1.80%)
    11 / 618 (1.78%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    2 / 612 (0.33%)
    6 / 618 (0.97%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION PSEUDOMONAL
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION BACTERIAL
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VARICELLA
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIRAL INFECTION
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIRAL SINUSITIS
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 612 (0.00%)
    3 / 618 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND INFECTION
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 618 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND INFECTION STAPHYLOCOCCAL
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 618 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Palivizumab Motavizumab (MEDI-524)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    540 / 612 (88.24%)
    553 / 618 (89.48%)
    Investigations
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    9 / 612 (1.47%)
    3 / 618 (0.49%)
         occurrences all number
    9
    3
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    25 / 612 (4.08%)
    13 / 618 (2.10%)
         occurrences all number
    25
    13
    WEIGHT DECREASED
         subjects affected / exposed
    6 / 612 (0.98%)
    7 / 618 (1.13%)
         occurrences all number
    6
    7
    OXYGEN SATURATION DECREASED
         subjects affected / exposed
    4 / 612 (0.65%)
    9 / 618 (1.46%)
         occurrences all number
    5
    10
    BLOOD UREA INCREASED
         subjects affected / exposed
    34 / 612 (5.56%)
    39 / 618 (6.31%)
         occurrences all number
    35
    39
    Cardiac disorders
    CARDIAC FAILURE
         subjects affected / exposed
    10 / 612 (1.63%)
    9 / 618 (1.46%)
         occurrences all number
    10
    10
    CYANOSIS
         subjects affected / exposed
    25 / 612 (4.08%)
    25 / 618 (4.05%)
         occurrences all number
    32
    42
    Respiratory, thoracic and mediastinal disorders
    ATELECTASIS
         subjects affected / exposed
    7 / 612 (1.14%)
    3 / 618 (0.49%)
         occurrences all number
    7
    3
    COUGH
         subjects affected / exposed
    71 / 612 (11.60%)
    92 / 618 (14.89%)
         occurrences all number
    95
    120
    NASAL CONGESTION
         subjects affected / exposed
    33 / 612 (5.39%)
    26 / 618 (4.21%)
         occurrences all number
    45
    31
    PLEURAL EFFUSION
         subjects affected / exposed
    6 / 612 (0.98%)
    9 / 618 (1.46%)
         occurrences all number
    7
    9
    PNEUMOTHORAX
         subjects affected / exposed
    7 / 612 (1.14%)
    2 / 618 (0.32%)
         occurrences all number
    7
    2
    RESPIRATORY DISORDER
         subjects affected / exposed
    28 / 612 (4.58%)
    23 / 618 (3.72%)
         occurrences all number
    35
    27
    WHEEZING
         subjects affected / exposed
    10 / 612 (1.63%)
    10 / 618 (1.62%)
         occurrences all number
    12
    10
    RHINORRHOEA
         subjects affected / exposed
    45 / 612 (7.35%)
    49 / 618 (7.93%)
         occurrences all number
    70
    64
    Immune system disorders
    IMMUNISATION REACTION
         subjects affected / exposed
    8 / 612 (1.31%)
    6 / 618 (0.97%)
         occurrences all number
    11
    8
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    16 / 612 (2.61%)
    14 / 618 (2.27%)
         occurrences all number
    22
    15
    Eye disorders
    CONJUNCTIVITIS
         subjects affected / exposed
    27 / 612 (4.41%)
    39 / 618 (6.31%)
         occurrences all number
    32
    42
    General disorders and administration site conditions
    IRRITABILITY
         subjects affected / exposed
    37 / 612 (6.05%)
    22 / 618 (3.56%)
         occurrences all number
    48
    33
    PYREXIA
         subjects affected / exposed
    177 / 612 (28.92%)
    180 / 618 (29.13%)
         occurrences all number
    286
    285
    Psychiatric disorders
    RESTLESSNESS
         subjects affected / exposed
    3 / 612 (0.49%)
    6 / 618 (0.97%)
         occurrences all number
    3
    7
    Gastrointestinal disorders
    FLATULENCE
         subjects affected / exposed
    6 / 612 (0.98%)
    5 / 618 (0.81%)
         occurrences all number
    7
    5
    CONSTIPATION
         subjects affected / exposed
    31 / 612 (5.07%)
    44 / 618 (7.12%)
         occurrences all number
    35
    47
    DIARRHOEA
         subjects affected / exposed
    64 / 612 (10.46%)
    69 / 618 (11.17%)
         occurrences all number
    70
    80
    ENTERITIS
         subjects affected / exposed
    4 / 612 (0.65%)
    7 / 618 (1.13%)
         occurrences all number
    4
    8
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    23 / 612 (3.76%)
    19 / 618 (3.07%)
         occurrences all number
    23
    19
    VOMITING
         subjects affected / exposed
    49 / 612 (8.01%)
    59 / 618 (9.55%)
         occurrences all number
    60
    70
    TEETHING
         subjects affected / exposed
    36 / 612 (5.88%)
    44 / 618 (7.12%)
         occurrences all number
    56
    54
    Skin and subcutaneous tissue disorders
    DERMATITIS
         subjects affected / exposed
    3 / 612 (0.49%)
    7 / 618 (1.13%)
         occurrences all number
    3
    7
    DERMATITIS CONTACT
         subjects affected / exposed
    7 / 612 (1.14%)
    5 / 618 (0.81%)
         occurrences all number
    7
    5
    DERMATITIS ATOPIC
         subjects affected / exposed
    3 / 612 (0.49%)
    6 / 618 (0.97%)
         occurrences all number
    3
    7
    ECZEMA
         subjects affected / exposed
    9 / 612 (1.47%)
    11 / 618 (1.78%)
         occurrences all number
    9
    13
    DRY SKIN
         subjects affected / exposed
    2 / 612 (0.33%)
    6 / 618 (0.97%)
         occurrences all number
    2
    6
    DERMATITIS DIAPER
         subjects affected / exposed
    31 / 612 (5.07%)
    32 / 618 (5.18%)
         occurrences all number
    38
    38
    RASH
         subjects affected / exposed
    21 / 612 (3.43%)
    27 / 618 (4.37%)
         occurrences all number
    25
    27
    RASH MACULO-PAPULAR
         subjects affected / exposed
    6 / 612 (0.98%)
    9 / 618 (1.46%)
         occurrences all number
    6
    10
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    6 / 612 (0.98%)
    4 / 618 (0.65%)
         occurrences all number
    6
    5
    HYPOKALAEMIA
         subjects affected / exposed
    5 / 612 (0.82%)
    6 / 618 (0.97%)
         occurrences all number
    6
    6
    Infections and infestations
    BRONCHIOLITIS
         subjects affected / exposed
    10 / 612 (1.63%)
    16 / 618 (2.59%)
         occurrences all number
    11
    18
    BRONCHITIS
         subjects affected / exposed
    41 / 612 (6.70%)
    40 / 618 (6.47%)
         occurrences all number
    57
    48
    CANDIDIASIS
         subjects affected / exposed
    5 / 612 (0.82%)
    6 / 618 (0.97%)
         occurrences all number
    7
    6
    CROUP INFECTIOUS
         subjects affected / exposed
    9 / 612 (1.47%)
    2 / 618 (0.32%)
         occurrences all number
    9
    2
    GASTROENTERITIS
         subjects affected / exposed
    48 / 612 (7.84%)
    56 / 618 (9.06%)
         occurrences all number
    53
    62
    EAR INFECTION
         subjects affected / exposed
    7 / 612 (1.14%)
    9 / 618 (1.46%)
         occurrences all number
    9
    11
    EXANTHEMA SUBITUM
         subjects affected / exposed
    7 / 612 (1.14%)
    6 / 618 (0.97%)
         occurrences all number
    7
    6
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    5 / 612 (0.82%)
    9 / 618 (1.46%)
         occurrences all number
    5
    9
    INFLUENZA
         subjects affected / exposed
    3 / 612 (0.49%)
    6 / 618 (0.97%)
         occurrences all number
    3
    6
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    9 / 612 (1.47%)
    9 / 618 (1.46%)
         occurrences all number
    13
    12
    NASOPHARYNGITIS
         subjects affected / exposed
    57 / 612 (9.31%)
    67 / 618 (10.84%)
         occurrences all number
    79
    83
    ORAL CANDIDIASIS
         subjects affected / exposed
    7 / 612 (1.14%)
    10 / 618 (1.62%)
         occurrences all number
    11
    10
    OTITIS MEDIA
         subjects affected / exposed
    70 / 612 (11.44%)
    73 / 618 (11.81%)
         occurrences all number
    95
    97
    OTITIS MEDIA ACUTE
         subjects affected / exposed
    19 / 612 (3.10%)
    26 / 618 (4.21%)
         occurrences all number
    25
    30
    PHARYNGITIS
         subjects affected / exposed
    24 / 612 (3.92%)
    31 / 618 (5.02%)
         occurrences all number
    28
    37
    PNEUMONIA
         subjects affected / exposed
    13 / 612 (2.12%)
    11 / 618 (1.78%)
         occurrences all number
    14
    12
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    4 / 612 (0.65%)
    11 / 618 (1.78%)
         occurrences all number
    5
    12
    RHINITIS
         subjects affected / exposed
    77 / 612 (12.58%)
    91 / 618 (14.72%)
         occurrences all number
    99
    115
    SINUSITIS
         subjects affected / exposed
    7 / 612 (1.14%)
    10 / 618 (1.62%)
         occurrences all number
    8
    11
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    164 / 612 (26.80%)
    160 / 618 (25.89%)
         occurrences all number
    254
    235
    TONSILLITIS
         subjects affected / exposed
    8 / 612 (1.31%)
    18 / 618 (2.91%)
         occurrences all number
    8
    21
    VARICELLA
         subjects affected / exposed
    5 / 612 (0.82%)
    11 / 618 (1.78%)
         occurrences all number
    5
    11
    VIRAL INFECTION
         subjects affected / exposed
    30 / 612 (4.90%)
    38 / 618 (6.15%)
         occurrences all number
    33
    47
    URINARY TRACT INFECTION
         subjects affected / exposed
    9 / 612 (1.47%)
    12 / 618 (1.94%)
         occurrences all number
    9
    13
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    15 / 612 (2.45%)
    12 / 618 (1.94%)
         occurrences all number
    16
    13

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 May 2005
    MI-CP124 (Season 1) amendment-1 included that children with respiratory symptoms must have a negative RSV test prior to randomizationin order to exclude children infected with RSV from the study.
    17 Apr 2006
    MI-CP124 (Season 1) amendment-2 included the following changes: section 'Clinical Experience with MEDI-524' was updated to include the results of a review of safety date from MI-CP124 and the Phase 3 study, MI-CP110; sample size was increased from 600 subjects to 1400 subjects (700 per arm), in order to collect additional safety information; inclusion criterion 2 was updated to clarify that during the first season of the study, children with aortic stenosis, pulmonic lesions, or coarctation of the aorta alone were not eligible for the study, and to specify that children with acyanotic cardiac lesions must have had pulmonary hypertension or the need for daily medication to manage their CHD to be eligible for enrollment; details of randomization were revised; window for the Study Day 150 visit was changed from “Study Day 150(±7)” to “Study Day 150-157;" descriptions of hospitalizations were modifies to ensure that specimens for RSV detection were obtained from subjects when they were hospitalized at a hospital other than the study site, and indicate that RSV testing on respiratory secretions would be performed by central RT-PCR, and not by RSV antigen testing; congenital anomaly/birth defect was deleted from the definition of an SAE and listed cardiac/respiratory deteriorations under medical events to be reported as hospitalizations and SAEs.
    20 Apr 2007
    MI-CP124 (Season 2) amendment-1 included the following changes: section 'Preclinical Experience with Motavizumab' was updated with the overall results of a chronic toxicity study of motavizumab in cynomolgus monkeys; primary objectives were updated and 'secondary objectives' were added to evaluate the effect of motavizumab on rates of RSV-specific, medically-attended outpatient lower respiratory infection (LRI ); exclusion criteria 11 was modified by removing palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody from the list of immunoglobulin products, not allowed to be taken within 3 months prior to enrollment and a new criteria was added for specifying that receipt of palivizumab within 3 months prior to enrollment was not allowed; “assessment of medically-attended LRI” was added to the schedule of events on Study Days 30, 60, 90, 120, and 150; sections 'Medically-Attended Lower Respiratory Tract Infection Episode and Definition of Serious Adverse Events' were updated; section 'Interruption or Discontinuation of Study Dosing in Individual Subjects' was revised by adding the following item to the list, “a severe or life- threatening serious systemic, allergic, or local reaction thought to be related to study drug” as a reason for interrupting or discontinuing study drug;” updated section 'Sample Size' with a discussion of the rationale for increasing the sample size and added Probability of Observing a Point Estimate of Relative Risk <1.0 to the protocol; added a fourth endpoint of “the incidence of RSV-specific, medically-attended outpatient LRI through Study Day 150;” replaced MEDI-524 by “motavizumab”, where appropriate, throughout the protocol.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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