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    Clinical Trial Results:
    A Pivotal Phase 3 Study of MEDI-524 (Numax; Motavizumab), an Enhanced Potency Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children

    Summary
    EudraCT number
    2004-000039-27
    Trial protocol
    SE   HU   CZ   DK   IS   AT   IT   GB  
    Global end of trial date
    08 May 2006

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Feb 2016
    First version publication date
    10 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MI-CP110
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00129766
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune, Inc.
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, United States, MD 20878
    Public contact
    M. Pamela Griffin, Sr. Director, Clinical Development, MedImmune, Inc., clinicaltrialenquiries@medimmune.com
    Scientific contact
    M. Pamela Griffin, Sr. Director, Clinical Development, MedImmune. Inc., clinicaltrialenquiries@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
    08 May 2006
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of respiratory syncytial virus (RSV) hospitalization among children at high risk for serious RSV disease.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Participating participant signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Nov 2004
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    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
    United States: 2297
    Country: Number of subjects enrolled
    Greece: 66
    Country: Number of subjects enrolled
    Spain: 372
    Country: Number of subjects enrolled
    Turkey: 78
    Country: Number of subjects enrolled
    Austria: 69
    Country: Number of subjects enrolled
    Russian Federation: 87
    Country: Number of subjects enrolled
    Israel: 606
    Country: Number of subjects enrolled
    Chile: 180
    Country: Number of subjects enrolled
    United Kingdom: 179
    Country: Number of subjects enrolled
    Italy: 189
    Country: Number of subjects enrolled
    France: 218
    Country: Number of subjects enrolled
    Hungary: 390
    Country: Number of subjects enrolled
    Czech Republic: 348
    Country: Number of subjects enrolled
    Canada: 266
    Country: Number of subjects enrolled
    Argentina: 72
    Country: Number of subjects enrolled
    Poland: 211
    Country: Number of subjects enrolled
    Brazil: 135
    Country: Number of subjects enrolled
    Australia: 166
    Country: Number of subjects enrolled
    Denmark: 57
    Country: Number of subjects enrolled
    Bulgaria: 196
    Country: Number of subjects enrolled
    Iceland: 39
    Country: Number of subjects enrolled
    Germany: 253
    Country: Number of subjects enrolled
    New Zealand: 52
    Country: Number of subjects enrolled
    Sweden: 109
    Worldwide total number of subjects
    6635
    EEA total number of subjects
    2696
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    779
    Infants and toddlers (28 days-23 months)
    5838
    Children (2-11 years)
    18
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 6,635 children were randomized in a 1:1 ratio at 347 centers in 24 countries within the Northern and Southern hemispheres between 01/Nov/2004 and 09/Dec/2005; each child participated in the study for a single respiratory syncytial virus (RSV) season.

    Pre-assignment
    Screening details
    Randomization was blocked by study site and stratified according to presence/absence of chronic lung disease (CLD) of prematurity requiring medical intervention/management.

    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
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Palivizumab
    Arm description
    Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Arm type
    Active comparator

    Investigational medicinal product name
    Palivizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

    Arm title
    Motavizumab
    Arm description
    Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Arm type
    Experimental

    Investigational medicinal product name
    Motavizumab
    Investigational medicinal product code
    MEDI-524
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

    Number of subjects in period 1
    Palivizumab Motavizumab
    Started
    3306
    3329
    Completed
    3246
    3270
    Not completed
    60
    59
         Withdrawal of consent
    31
    30
         Adverse event, serious fatal
    3
    8
         Lost to follow-up
    26
    21

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Palivizumab
    Reporting group description
    Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

    Reporting group title
    Motavizumab
    Reporting group description
    Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

    Reporting group values
    Palivizumab Motavizumab Total
    Number of subjects
    3306 3329 6635
    Age categorical
    Units: Subjects
    Age Continuous |
    Units: months
        arithmetic mean (standard deviation)
    3.98 ± 3.78 3.99 ± 3.75 -
    Gender, Male/Female
    Units: participants
        Female
    1495 1513 3008
        Male
    1811 1816 3627
    Region of Enrollment
    Units: Subjects
        United States
    1130 1167 2297
        Greece
    32 34 66
        Spain
    191 181 372
        Turkey
    36 42 78
        Austria
    35 34 69
        Russian Federation
    42 45 87
        Israel
    301 305 606
        Chile
    93 87 180
        United Kingdom
    89 90 179
        Italy
    93 96 189
        France
    107 111 218
        Hungary
    198 192 390
        Czech Republic
    171 177 348
        Canada
    134 132 266
        Argentina
    38 34 72
        Poland
    106 105 211
        Brazil
    69 66 135
        Australia
    85 81 166
        Denmark
    30 27 57
        Bulgaria
    95 101 196
        Iceland
    20 19 39
        Germany
    131 122 253
        New Zealand
    26 26 52
        Sweden
    54 55 109

    End points

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    End points reporting groups
    Reporting group title
    Palivizumab
    Reporting group description
    Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

    Reporting group title
    Motavizumab
    Reporting group description
    Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

    Primary: Incidence of Respiratory Syncytial Virus (RSV) Hospitalization (Includes Deaths by RSV)

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    End point title
    Incidence of Respiratory Syncytial Virus (RSV) Hospitalization (Includes Deaths by RSV)
    End point description
    RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence). The Intent-to-Treat (ITT) Population included all patients randomized into the study.
    End point type
    Primary
    End point timeframe
    Days 0 - 150
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3306
    3329
    Units: Participants
    62
    46
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    ITT population. Relative risk was calculated as (Pn/Ps) where Pn is the proportion of patients with RSV hospitalization in the motavizumab group and Ps is the proportion of patients with RSV hospitalization in the palivizumab group.
    Comparison groups
    Palivizumab v Motavizumab
    Number of subjects included in analysis
    6635
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    Method
    t-test, 2-sided
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.74
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.503
         upper limit
    1.083
    Notes
    [1] - Confidence interval and relative risk adjusted for the stratification factor of presence or absence of CLD of prematurity as specified on the CRF.

    Primary: Number of Participants Reporting any Adverse Events (AEs)

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    End point title
    Number of Participants Reporting any Adverse Events (AEs) [2]
    End point description
    Number of participants reporting one or more AEs. The Safety Population included all patients who received any study drug and had any safety follow-up.
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3298
    3315
    Units: Participants
    2837
    2839
    No statistical analyses for this end point

    Primary: Number of Participants Reporting Any Related AEs

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    End point title
    Number of Participants Reporting Any Related AEs [3]
    End point description
    Number of participants reporting one or more AEs considered related to study drug by the investigator. The Safety Population included all patients who received any study drug and had any safety follow-up.
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3298
    3315
    Units: Participants
    258
    298
    No statistical analyses for this end point

    Primary: Number of Participants Reporting any Serious Adverse Events (SAEs)

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    End point title
    Number of Participants Reporting any Serious Adverse Events (SAEs) [4]
    End point description
    Number of participants reporting one or more SAEs. The Safety Population included all patients who received any study drug and had any safety follow-up.
    End point type
    Primary
    End point timeframe
    Days 0 - 150
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3298
    3315
    Units: Participants
    506
    485
    No statistical analyses for this end point

    Primary: Number of Participants Reporting any Related SAEs

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    End point title
    Number of Participants Reporting any Related SAEs [5]
    End point description
    Number of participants reporting one or more SAEs considered related to study drug by the investigator. The Safety Population included all patients who received any study drug and had any safety follow-up.
    End point type
    Primary
    End point timeframe
    Days 0 - 150
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3298
    3315
    Units: Participants
    8
    9
    No statistical analyses for this end point

    Primary: Number of Participants Reporting AEs by Highest Severity Grade

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    End point title
    Number of Participants Reporting AEs by Highest Severity Grade [6]
    End point description
    Adverse events events were graded by severity; Level 1, 2, 3, or 4. The Safety Population included all patients who received any study drug and had any safety follow-up.
    End point type
    Primary
    End point timeframe
    Days 0 - 150
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3298
    3315
    Units: Participants
        Level 1
    1478
    1538
        Level 2
    1006
    976
        Level 3
    292
    271
        Level 4
    61
    54
    No statistical analyses for this end point

    Primary: Number of Participants who Discontinued Study Drug due to AEs

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    End point title
    Number of Participants who Discontinued Study Drug due to AEs [7]
    End point description
    The Safety Population included all patients who received any study drug and had any safety follow-up.
    End point type
    Primary
    End point timeframe
    Days 0 - 150
    Notes
    [7] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3298
    3315
    Units: Participants
    10
    13
    No statistical analyses for this end point

    Primary: Number of Participants who Died

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    End point title
    Number of Participants who Died [8]
    End point description
    The Safety Population included all patients who received any study drug and had any safety follow-up.
    End point type
    Primary
    End point timeframe
    Days 0 - 150
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3298
    3315
    Units: Participants
    4
    8
    No statistical analyses for this end point

    Primary: Number of Participants Reporting Changes in Vital Signs From Baseline

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    End point title
    Number of Participants Reporting Changes in Vital Signs From Baseline [9]
    End point description
    Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs. The Safety Population included all patients who received any study drug and had any safety follow-up.
    End point type
    Primary
    End point timeframe
    Days 0 - 150
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3298
    3315
    Units: Participants
        Fever neonatal
    0
    2
        Hyperpyrexia
    0
    1
        Hyperthermia
    3
    3
        Hypothermia
    2
    2
        Pyrexia
    559
    544
        Hypertension
    4
    4
        Hypotension
    2
    2
        Arrhythmia
    1
    0
        Bradycardia
    10
    4
        Tachycardia
    4
    6
    No statistical analyses for this end point

    Secondary: The Incidence of Outpatient Medically-Attended Lower Respiratory Illness (LRI)

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    End point title
    The Incidence of Outpatient Medically-Attended Lower Respiratory Illness (LRI)
    End point description
    LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms. The Intent-to-Treat (ITT) Population included all patients randomized into the study.
    End point type
    Secondary
    End point timeframe
    Day 0 - 150
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3306
    3329
    Units: Participant
    696
    648
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Palivizumab v Motavizumab
    Number of subjects included in analysis
    6635
    Analysis specification
    Pre-specified
    Analysis type
    superiority [10]
    P-value
    = 0.11 [11]
    Method
    Van Elteren test
    Confidence interval
    Notes
    [10] - A Van Elteren test stratified for presence or absence of CLD of prematurity requiring medical intervention was used.
    [11] - Test stratified by presence or absence of CLD of prematurity specified on the CRF

    Secondary: The Incidence of RSV-Specific Medically-Attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups

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    End point title
    The Incidence of RSV-Specific Medically-Attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups
    End point description
    The RSV-specific LRI was defined as an outpatient medically-attended LRI associated with a positive RSV test and was not inclusive of events that required hospitalization. Participants were from a pre-specified subsets of sites participating in the nasal secretion sample collection for this endpoint.
    End point type
    Secondary
    End point timeframe
    Days 0 - 150
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    1183
    1227
    Units: Participants
    46
    24
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Palivizumab v Motavizumab
    Number of subjects included in analysis
    2410
    Analysis specification
    Pre-specified
    Analysis type
    superiority [12]
    P-value
    = 0.005 [13]
    Method
    Van Elteren test
    Confidence interval
    Notes
    [12] - A Van Elteren test stratified for presence or absence of CLD of prematurity requiring medical intervention was used.
    [13] - No adjustment for multiple comparisons.

    Secondary: The Overall Incidence of Medically-Attended Otitis Media (OM) Infections

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    End point title
    The Overall Incidence of Medically-Attended Otitis Media (OM) Infections
    End point description
    Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event. The ITT population included all patients randomized into the study.
    End point type
    Secondary
    End point timeframe
    Days 0 - 150
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3306
    3329
    Units: Participants
    461
    484
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    P-value is for overall incidence
    Comparison groups
    Palivizumab v Motavizumab
    Number of subjects included in analysis
    6635
    Analysis specification
    Pre-specified
    Analysis type
    superiority [14]
    P-value
    = 0.476 [15]
    Method
    Van Elteren test
    Confidence interval
    Notes
    [14] - A Van Elteren test stratified for presence or absence of CLD of prematurity requiring medical intervention was used.
    [15] - Test stratified by presence or absence of CLD of prematurity specified on the CRF

    Secondary: The Frequency of Prescribed Antibiotics for Medically-Attended LRI

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    End point title
    The Frequency of Prescribed Antibiotics for Medically-Attended LRI
    End point description
    The average number of presciptions per event per subject was summarized for each treatment group. The ITT population included all patients randomized into the study.
    End point type
    Secondary
    End point timeframe
    Days 0 - 150
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3306
    3329
    Units: Number of prescriptions
        arithmetic mean (standard error)
    0.32 ± 0.02
    0.3 ± 0.02
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Palivizumab v Motavizumab
    Number of subjects included in analysis
    6635
    Analysis specification
    Pre-specified
    Analysis type
    superiority [16]
    P-value
    = 0.493 [17]
    Method
    Van Elteren test
    Confidence interval
    Notes
    [16] - A Van Elteren test stratified for presence or absence of CLD of prematurity requiring medical intervention was used.
    [17] - Test stratified by presence or absence of CLD of prematurity specified on the CRF

    Secondary: The Frequency of Prescribed Antibiotics for Medically-Attended OM Infections

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    End point title
    The Frequency of Prescribed Antibiotics for Medically-Attended OM Infections
    End point description
    The average number of presciptions per event per subject was summarized for each treatment group. The ITT population included all patients randomized into the study.
    End point type
    Secondary
    End point timeframe
    Days 0 - 150
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3306
    3329
    Units: Number of prescriptions
        arithmetic mean (standard error)
    1.08 ± 0.003
    1.1 ± 0.003
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Palivizumab v Motavizumab
    Number of subjects included in analysis
    6635
    Analysis specification
    Pre-specified
    Analysis type
    superiority [18]
    P-value
    = 0.652 [19]
    Method
    Van Elteren test
    Confidence interval
    Notes
    [18] - A Van Elteren test stratified for presence or absence of CLD of prematurity requiring medical intervention was used.
    [19] - Test stratified by presence or absence of CLD of prematurity specified on the CRF

    Secondary: The Number of Participants With Anti-Motavizumab Antibodies

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    End point title
    The Number of Participants With Anti-Motavizumab Antibodies [20]
    End point description
    Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10. N varied at different timepoints: at pre-dose 1 N=3193; at 30 days post-dose 1 N=998; at 30 days post-dose 2 N=1049; at 30 days post-dose 3 N=1049; at 30 days post-dose 4, N=3013; at any time post baseline, N=3217
    End point type
    Secondary
    End point timeframe
    Day 0 - 120
    Notes
    [20] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Motavizumab
    Number of subjects analysed
    3217
    Units: Participants
        Pre-dose 1
    7
        30 Days Post-Dose 1
    1
        30 Days Post-Dose 2
    1
        30 Days Post-Dose 3
    7
        30 Days Post-Dose 4
    18
        At any time post baseline
    22
    No statistical analyses for this end point

    Secondary: The Serum Concentrations of Motavizumab at Day 0

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    End point title
    The Serum Concentrations of Motavizumab at Day 0 [21]
    End point description
    Mean serum concentrations of motavizumab at Day 0. The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug.
    End point type
    Secondary
    End point timeframe
    Day 0
    Notes
    [21] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Motavizumab
    Number of subjects analysed
    3147
    Units: microgram per milliliter (mcg/mL)
        arithmetic mean (standard deviation)
    0.01193 ± 0.2072
    No statistical analyses for this end point

    Secondary: The Trough Serum Concentrations of Motavizumab at 30 days Post Dose 1

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    End point title
    The Trough Serum Concentrations of Motavizumab at 30 days Post Dose 1 [22]
    End point description
    Mean serum concentrations of motavizumab at 30 days post Dose 1. The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 1 measurements
    End point type
    Secondary
    End point timeframe
    30 days post Dose 1
    Notes
    [22] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Motavizumab
    Number of subjects analysed
    974
    Units: mcg/mL
        arithmetic mean (standard deviation)
    45.95 ± 15.17
    No statistical analyses for this end point

    Secondary: The Trough Serum Concentrations of Motavizumab at 30 days Post Dose 2

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    End point title
    The Trough Serum Concentrations of Motavizumab at 30 days Post Dose 2 [23]
    End point description
    Mean serum concentrations of motavizumab at 30 days post Dose 2. The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 2 measurements
    End point type
    Secondary
    End point timeframe
    30 days post Dose 2
    Notes
    [23] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Motavizumab
    Number of subjects analysed
    915
    Units: mcg/mL
        arithmetic mean (standard deviation)
    64.59 ± 25.6
    No statistical analyses for this end point

    Secondary: The Trough Serum Concentrations of Motavizumab at 30 days Post Dose 3

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    End point title
    The Trough Serum Concentrations of Motavizumab at 30 days Post Dose 3 [24]
    End point description
    Mean serum concentrations of motavizumab at 30 days post Dose 3. The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 3 measurements
    End point type
    Secondary
    End point timeframe
    30 days post Dose 3
    Notes
    [24] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Motavizumab
    Number of subjects analysed
    918
    Units: mcg/mL
        arithmetic mean (standard deviation)
    80.24 ± 31.22
    No statistical analyses for this end point

    Secondary: The Trough Serum Concentrations of Motavizumab at 30 days Post Dose 4

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    End point title
    The Trough Serum Concentrations of Motavizumab at 30 days Post Dose 4 [25]
    End point description
    Mean serum concentrations of motavizumab at 30 days post Dose 4. The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 4 measurements
    End point type
    Secondary
    End point timeframe
    30 days post Dose 4
    Notes
    [25] - 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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Motavizumab
    Number of subjects analysed
    2669
    Units: mcg/mL
        arithmetic mean (standard deviation)
    88.52 ± 35.43
    No statistical analyses for this end point

    Secondary: The Frequency of Medically-Attended Otitis Media (OM) Infections

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    End point title
    The Frequency of Medically-Attended Otitis Media (OM) Infections
    End point description
    Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event. The ITT population included all patients randomized into the study.
    End point type
    Secondary
    End point timeframe
    Days 0 – 150
    End point values
    Palivizumab Motavizumab
    Number of subjects analysed
    3306
    3329
    Units: participants
        0 infections
    2845
    2845
        1 infection
    329
    360
        2 infections
    100
    91
        3 or more infections
    32
    33
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Palivizumab v Motavizumab
    Number of subjects included in analysis
    6635
    Analysis specification
    Pre-specified
    Analysis type
    superiority [26]
    P-value
    = 0.5 [27]
    Method
    Van Elteren test
    Confidence interval
    Notes
    [26] - A Van Elteren test stratified for presence or absence of CLD of prematurity requiring medical intervention was used.
    [27] - Test stratified by presence or absence of CLD of prematurity specified on the CRF

    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
    Motavizumab
    Reporting group description
    Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

    Reporting group title
    Palivizumab
    Reporting group description
    Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

    Serious adverse events
    Motavizumab Palivizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    485 / 3315 (14.63%)
    506 / 3298 (15.34%)
         number of deaths (all causes)
    8
    4
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    HAEMORRHAGE
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERTENSION
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    CENTRAL VENOUS CATHETERISATION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLOSTOMY CLOSURE
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EAR TUBE INSERTION
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROSTOMY CLOSURE
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROSTOMY TUBE INSERTION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ILEOSTOMY CLOSURE
         subjects affected / exposed
    0 / 3315 (0.00%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NUTRITIONAL SUPPORT
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENTRICULO-PERITONEAL SHUNT
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    HAEMANGIOMA
         subjects affected / exposed
    4 / 3315 (0.12%)
    4 / 3298 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    DRUG HYPERSENSITIVITY
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERSENSITIVITY
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMMUNISATION REACTION
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    SOCIAL STAY HOSPITALISATION
         subjects affected / exposed
    4 / 3315 (0.12%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VICTIM OF CHILD ABUSE
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    FEVER NEONATAL
         subjects affected / exposed
    2 / 3315 (0.06%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HERNIA OBSTRUCTIVE
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HERNIA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOTHERMIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OEDEMA PERIPHERAL
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALAISE
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUDDEN DEATH
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    PYREXIA
         subjects affected / exposed
    10 / 3315 (0.30%)
    9 / 3298 (0.27%)
         occurrences causally related to treatment / all
    2 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUDDEN INFANT DEATH SYNDROME
         subjects affected / exposed
    3 / 3315 (0.09%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Psychiatric disorders
    BREATH HOLDING
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESTLESSNESS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    BALANITIS
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OVARIAN CYST
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SCROTAL OEDEMA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         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
    CHILD MALTREATMENT SYNDROME
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVICE MALFUNCTION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FACE INJURY
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEEDING TUBE COMPLICATION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOREIGN BODY TRAUMA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAIR-THREAD TOURNIQUET SYNDROME
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEAD INJURY
         subjects affected / exposed
    1 / 3315 (0.03%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INJURY
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEDICAL DEVICE COMPLICATION
         subjects affected / exposed
    2 / 3315 (0.06%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL DISCHARGE
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (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 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SKULL FRACTURE
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBDURAL HAEMATOMA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRAUMATIC BRAIN INJURY
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENTRICULOPERITONEAL SHUNT MALFUNCTION
         subjects affected / exposed
    2 / 3315 (0.06%)
    4 / 3298 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIIITH NERVE INJURY
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    BIOPSY RECTUM
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYSTOGRAM
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FALSE POSITIVE LABORATORY RESULT
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (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
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INVESTIGATION
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIVER FUNCTION TEST ABNORMAL
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEDICAL OBSERVATION
         subjects affected / exposed
    2 / 3315 (0.06%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUROLOGICAL EXAMINATION
         subjects affected / exposed
    1 / 3315 (0.03%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OESOPHAGEAL PH
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OXYGEN SATURATION DECREASED
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PHYSICAL EXAMINATION
         subjects affected / exposed
    3 / 3315 (0.09%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WEIGHT DECREASED
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ATRIAL THROMBOSIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRADYCARDIA
         subjects affected / exposed
    2 / 3315 (0.06%)
    4 / 3298 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC ARREST
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE HIGH OUTPUT
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIO-RESPIRATORY ARREST
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIOGENIC SHOCK
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    CYANOSIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUPRAVENTRICULAR TACHYCARDIA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         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 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    ACRODERMATITIS ENTEROPATHICA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAL ATRESIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANKYLOGLOSSIA CONGENITAL
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRANCHIAL CLEFT CYST
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBRAL PALSY
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLEFT LIP
         subjects affected / exposed
    2 / 3315 (0.06%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLEFT LIP AND PALATE
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLEFT PALATE
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DACRYOSTENOSIS CONGENITAL
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DERMOID CYST
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAMARTOMA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIP DYSPLASIA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIMB REDUCTION DEFECT
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PHIMOSIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PILONIDAL CYST CONGENITAL
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYLORIC STENOSIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY TRACT MALFORMATION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYNDACTYLY
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TALIPES
         subjects affected / exposed
    2 / 3315 (0.06%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRACHEO-OESOPHAGEAL FISTULA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENTRICULAR SEPTAL DEFECT
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    APNOEA
         subjects affected / exposed
    14 / 3315 (0.42%)
    17 / 3298 (0.52%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    APPARENT LIFE THREATENING EVENT
         subjects affected / exposed
    2 / 3315 (0.06%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASTHMA
         subjects affected / exposed
    7 / 3315 (0.21%)
    5 / 3298 (0.15%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASPIRATION
         subjects affected / exposed
    2 / 3315 (0.06%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    ATELECTASIS
         subjects affected / exposed
    2 / 3315 (0.06%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHIAL HYPERREACTIVITY
         subjects affected / exposed
    7 / 3315 (0.21%)
    7 / 3298 (0.21%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHOPNEUMOPATHY
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHOPULMONARY DYSPLASIA
         subjects affected / exposed
    9 / 3315 (0.27%)
    10 / 3298 (0.30%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHOSPASM
         subjects affected / exposed
    3 / 3315 (0.09%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOKING
         subjects affected / exposed
    1 / 3315 (0.03%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COUGH
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOREIGN BODY ASPIRATION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOVENTILATION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOXIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTERSTITIAL LUNG DISEASE
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARYNGEAL STENOSIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARYNGEAL OEDEMA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARYNGOSPASM
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG CONSOLIDATION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NASAL CONGESTION
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OBSTRUCTIVE AIRWAYS DISORDER
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    PHARYNGEAL INFLAMMATION
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA ASPIRATION
         subjects affected / exposed
    3 / 3315 (0.09%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMOTHORAX
         subjects affected / exposed
    2 / 3315 (0.06%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY CONGESTION
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY HAEMORRHAGE
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (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 / 3315 (0.06%)
    4 / 3298 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    PULMONARY HYPERTENSIVE CRISIS
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         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 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY DISORDER
         subjects affected / exposed
    2 / 3315 (0.06%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY DISTRESS
         subjects affected / exposed
    2 / 3315 (0.06%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY FAILURE
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SLEEP APNOEA SYNDROME
         subjects affected / exposed
    1 / 3315 (0.03%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STATUS ASTHMATICUS
         subjects affected / exposed
    2 / 3315 (0.06%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STRIDOR
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TACHYPNOEA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TONSILLAR HYPERTROPHY
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOCAL CORD DISORDER
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WHEEZING
         subjects affected / exposed
    5 / 3315 (0.15%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    5 / 3315 (0.15%)
    4 / 3298 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAEMIA NEONATAL
         subjects affected / exposed
    1 / 3315 (0.03%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYCLIC NEUTROPENIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMOLYTIC ANAEMIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMOLYTIC URAEMIC SYNDROME
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IRON DEFICIENCY ANAEMIA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIA
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOCYTOPENIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    ALTERED STATE OF CONSCIOUSNESS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBRAL VENTRICLE DILATATION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONVULSION
         subjects affected / exposed
    3 / 3315 (0.09%)
    4 / 3298 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONVULSION NEONATAL
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENCEPHALITIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEBRILE CONVULSION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPILEPSY
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHAGE INTRACRANIAL
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYDROCEPHALUS
         subjects affected / exposed
    5 / 3315 (0.15%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERTONIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOXIC ENCEPHALOPATHY
         subjects affected / exposed
    4 / 3315 (0.12%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTRACRANIAL PRESSURE INCREASED
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOCLONUS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LETHARGY
         subjects affected / exposed
    2 / 3315 (0.06%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SOMNOLENCE
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYNCOPE VASOVAGAL
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOCAL CORD PARESIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    PAPILLOEDEMA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RETINOPATHY OF PREMATURITY
         subjects affected / exposed
    5 / 3315 (0.15%)
    7 / 3298 (0.21%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RETINOPATHY PROLIFERATIVE
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    DEAFNESS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL DISTENSION
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN
         subjects affected / exposed
    2 / 3315 (0.06%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL STRANGULATED HERNIA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAL FISTULA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONSTIPATION
         subjects affected / exposed
    2 / 3315 (0.06%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLONIC STENOSIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    2 / 3315 (0.06%)
    5 / 3298 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPEPSIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPHAGIA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTERITIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCOLITIS
         subjects affected / exposed
    2 / 3315 (0.06%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FAECES DISCOLOURED
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCUTANEOUS FISTULA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FLATULENCE
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL DISORDER
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIATUS HERNIA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    18 / 3315 (0.54%)
    21 / 3298 (0.64%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ILEUS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (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
    56 / 3315 (1.69%)
    57 / 3298 (1.73%)
         occurrences causally related to treatment / all
    0 / 58
    0 / 58
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INGUINAL HERNIA, OBSTRUCTIVE
         subjects affected / exposed
    1 / 3315 (0.03%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTUSSUSCEPTION
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NECROTISING COLITIS
         subjects affected / exposed
    2 / 3315 (0.06%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OESOPHAGEAL MASS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (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
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    REFLUX OESOPHAGITIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    REGURGITATION
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UMBILICAL HERNIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOMITING
         subjects affected / exposed
    5 / 3315 (0.15%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    URETERIC STENOSIS
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLELITHIASIS
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLESTASIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATIC CYST
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    ANGIOEDEMA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PETECHIAE
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RASH
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (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
    2 / 3315 (0.06%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    CRANIOSYNOSTOSIS
         subjects affected / exposed
    2 / 3315 (0.06%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCLE CONTRACTURE
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OSTEOPENIA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    ANOREXIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COW'S MILK INTOLERANCE
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEHYDRATION
         subjects affected / exposed
    3 / 3315 (0.09%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FAILURE TO THRIVE
         subjects affected / exposed
    5 / 3315 (0.15%)
    6 / 3298 (0.18%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD
         subjects affected / exposed
    2 / 3315 (0.06%)
    7 / 3298 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FLUID INTAKE REDUCED
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FLUID OVERLOAD
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERCALCAEMIA
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERNATRAEMIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LACTOSE INTOLERANCE
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALNUTRITION
         subjects affected / exposed
    2 / 3315 (0.06%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WEIGHT GAIN POOR
         subjects affected / exposed
    2 / 3315 (0.06%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ZINC DEFICIENCY
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    ABSCESS NECK
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABSCESS LIMB
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (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 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERAEMIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERIAL ABSCESS CENTRAL NERVOUS SYSTEM
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (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
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERIAL TRACHEITIS
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS
         subjects affected / exposed
    35 / 3315 (1.06%)
    36 / 3298 (1.09%)
         occurrences causally related to treatment / all
    0 / 39
    0 / 46
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHIOLITIS
         subjects affected / exposed
    71 / 3315 (2.14%)
    78 / 3298 (2.37%)
         occurrences causally related to treatment / all
    1 / 87
    2 / 88
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS VIRAL
         subjects affected / exposed
    0 / 3315 (0.00%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CATHETER SEPSIS
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHOPNEUMONIA
         subjects affected / exposed
    12 / 3315 (0.36%)
    8 / 3298 (0.24%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CENTRAL LINE INFECTION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CELLULITIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLOSTRIDIAL INFECTION
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CROUP INFECTIOUS
         subjects affected / exposed
    6 / 3315 (0.18%)
    7 / 3298 (0.21%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYTOMEGALOVIRUS INFECTION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DACRYOCYSTITIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSENTERY
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROBACTER BACTERAEMIA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA SEPSIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCOLITIS VIRAL
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EXANTHEMA SUBITUM
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EXTERNAL EAR CELLULITIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS ADENOVIRUS
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS
         subjects affected / exposed
    27 / 3315 (0.81%)
    31 / 3298 (0.94%)
         occurrences causally related to treatment / all
    0 / 28
    1 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS ESCHERICHIA COLI
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS ROTAVIRUS
         subjects affected / exposed
    13 / 3315 (0.39%)
    21 / 3298 (0.64%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS SALMONELLA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    2 / 3315 (0.06%)
    6 / 3298 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HERPES ZOSTER
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMPETIGO
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFLUENZA
         subjects affected / exposed
    4 / 3315 (0.12%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    6 / 3315 (0.18%)
    8 / 3298 (0.24%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARYNGITIS
         subjects affected / exposed
    5 / 3315 (0.15%)
    5 / 3298 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOBAR PNEUMONIA
         subjects affected / exposed
    2 / 3315 (0.06%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG ABSCESS
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MENINGITIS VIRAL
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LYMPHADENITIS BACTERIAL
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NASOPHARYNGITIS
         subjects affected / exposed
    2 / 3315 (0.06%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ORAL CANDIDIASIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OSTEOMYELITIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OTITIS MEDIA
         subjects affected / exposed
    3 / 3315 (0.09%)
    4 / 3298 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OTITIS MEDIA BACTERIAL
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (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
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERTUSSIS
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PHARYNGITIS
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PHARYNGOTONSILLITIS
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    27 / 3315 (0.81%)
    31 / 3298 (0.94%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 31
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    PNEUMONIA ADENOVIRAL
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA BACTERIAL
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA BORDETELLA
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (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
    0 / 3315 (0.00%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL
         subjects affected / exposed
    2 / 3315 (0.06%)
    10 / 3298 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA PARAINFLUENZAE VIRAL
         subjects affected / exposed
    1 / 3315 (0.03%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA VIRAL
         subjects affected / exposed
    3 / 3315 (0.09%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POSTOPERATIVE WOUND INFECTION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYELONEPHRITIS
         subjects affected / exposed
    2 / 3315 (0.06%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYELONEPHRITIS ACUTE
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (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
    25 / 3315 (0.75%)
    40 / 3298 (1.21%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY SYNCYTIAL VIRUS INFECTION
         subjects affected / exposed
    3 / 3315 (0.09%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RHINITIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    3 / 3298 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ROTAVIRUS INFECTION
         subjects affected / exposed
    0 / 3315 (0.00%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    2 / 3315 (0.06%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUSITIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STAPHYLOCOCCAL INFECTION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRACHEITIS
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRACHEOBRONCHITIS
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         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
    14 / 3315 (0.42%)
    22 / 3298 (0.67%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    10 / 3315 (0.30%)
    7 / 3298 (0.21%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION BACTERIAL
         subjects affected / exposed
    1 / 3315 (0.03%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION ENTEROCOCCAL
         subjects affected / exposed
    1 / 3315 (0.03%)
    1 / 3298 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION PSEUDOMONAL
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UROSEPSIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VARICELLA
         subjects affected / exposed
    0 / 3315 (0.00%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIRAL INFECTION
         subjects affected / exposed
    4 / 3315 (0.12%)
    7 / 3298 (0.21%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIRAL RHINITIS
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    6 / 3315 (0.18%)
    2 / 3298 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND INFECTION
         subjects affected / exposed
    1 / 3315 (0.03%)
    0 / 3298 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Motavizumab Palivizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2784 / 3315 (83.98%)
    2777 / 3298 (84.20%)
    Investigations
    BLOOD UREA INCREASED
         subjects affected / exposed
    35 / 3315 (1.06%)
    25 / 3298 (0.76%)
         occurrences all number
    35
    25
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    HAEMANGIOMA
         subjects affected / exposed
    29 / 3315 (0.87%)
    38 / 3298 (1.15%)
         occurrences all number
    34
    41
    Congenital, familial and genetic disorders
    DACRYOSTENOSIS CONGENITAL
         subjects affected / exposed
    35 / 3315 (1.06%)
    33 / 3298 (1.00%)
         occurrences all number
    37
    34
    Respiratory, thoracic and mediastinal disorders
    BRONCHIAL HYPERREACTIVITY
         subjects affected / exposed
    44 / 3315 (1.33%)
    54 / 3298 (1.64%)
         occurrences all number
    48
    62
    ASTHMA
         subjects affected / exposed
    33 / 3315 (1.00%)
    37 / 3298 (1.12%)
         occurrences all number
    37
    45
    RESPIRATORY DISORDER
         subjects affected / exposed
    295 / 3315 (8.90%)
    275 / 3298 (8.34%)
         occurrences all number
    380
    374
    NASAL CONGESTION
         subjects affected / exposed
    269 / 3315 (8.11%)
    265 / 3298 (8.04%)
         occurrences all number
    318
    326
    COUGH
         subjects affected / exposed
    220 / 3315 (6.64%)
    216 / 3298 (6.55%)
         occurrences all number
    260
    262
    WHEEZING
         subjects affected / exposed
    51 / 3315 (1.54%)
    70 / 3298 (2.12%)
         occurrences all number
    61
    85
    RHINORRHOEA
         subjects affected / exposed
    99 / 3315 (2.99%)
    92 / 3298 (2.79%)
         occurrences all number
    124
    112
    Immune system disorders
    IMMUNISATION REACTION
         subjects affected / exposed
    102 / 3315 (3.08%)
    97 / 3298 (2.94%)
         occurrences all number
    138
    122
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    66 / 3315 (1.99%)
    73 / 3298 (2.21%)
         occurrences all number
    67
    75
    Eye disorders
    CONJUNCTIVITIS
         subjects affected / exposed
    246 / 3315 (7.42%)
    251 / 3298 (7.61%)
         occurrences all number
    271
    285
    General disorders and administration site conditions
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    41 / 3315 (1.24%)
    28 / 3298 (0.85%)
         occurrences all number
    52
    38
    INJECTION SITE PAIN
         subjects affected / exposed
    45 / 3315 (1.36%)
    49 / 3298 (1.49%)
         occurrences all number
    81
    94
    IRRITABILITY
         subjects affected / exposed
    193 / 3315 (5.82%)
    164 / 3298 (4.97%)
         occurrences all number
    299
    243
    PYREXIA
         subjects affected / exposed
    543 / 3315 (16.38%)
    556 / 3298 (16.86%)
         occurrences all number
    718
    729
    Psychiatric disorders
    AGITATION
         subjects affected / exposed
    35 / 3315 (1.06%)
    47 / 3298 (1.43%)
         occurrences all number
    51
    61
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    54 / 3315 (1.63%)
    70 / 3298 (2.12%)
         occurrences all number
    55
    73
    CONSTIPATION
         subjects affected / exposed
    234 / 3315 (7.06%)
    227 / 3298 (6.88%)
         occurrences all number
    265
    262
    DIARRHOEA
         subjects affected / exposed
    254 / 3315 (7.66%)
    274 / 3298 (8.31%)
         occurrences all number
    295
    306
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    190 / 3315 (5.73%)
    190 / 3298 (5.76%)
         occurrences all number
    197
    198
    FLATULENCE
         subjects affected / exposed
    126 / 3315 (3.80%)
    119 / 3298 (3.61%)
         occurrences all number
    170
    135
    UMBILICAL HERNIA
         subjects affected / exposed
    77 / 3315 (2.32%)
    63 / 3298 (1.91%)
         occurrences all number
    77
    63
    TEETHING
         subjects affected / exposed
    299 / 3315 (9.02%)
    282 / 3298 (8.55%)
         occurrences all number
    417
    408
    VOMITING
         subjects affected / exposed
    158 / 3315 (4.77%)
    164 / 3298 (4.97%)
         occurrences all number
    174
    179
    Skin and subcutaneous tissue disorders
    DERMATITIS ATOPIC
         subjects affected / exposed
    44 / 3315 (1.33%)
    53 / 3298 (1.61%)
         occurrences all number
    48
    55
    DERMATITIS DIAPER
         subjects affected / exposed
    177 / 3315 (5.34%)
    192 / 3298 (5.82%)
         occurrences all number
    199
    233
    DRY SKIN
         subjects affected / exposed
    35 / 3315 (1.06%)
    25 / 3298 (0.76%)
         occurrences all number
    37
    26
    ECZEMA
         subjects affected / exposed
    132 / 3315 (3.98%)
    95 / 3298 (2.88%)
         occurrences all number
    140
    100
    RASH
         subjects affected / exposed
    130 / 3315 (3.92%)
    103 / 3298 (3.12%)
         occurrences all number
    147
    110
    SEBORRHOEIC DERMATITIS
         subjects affected / exposed
    56 / 3315 (1.69%)
    52 / 3298 (1.58%)
         occurrences all number
    57
    53
    Infections and infestations
    BRONCHIOLITIS
         subjects affected / exposed
    193 / 3315 (5.82%)
    222 / 3298 (6.73%)
         occurrences all number
    226
    263
    BRONCHITIS
         subjects affected / exposed
    230 / 3315 (6.94%)
    260 / 3298 (7.88%)
         occurrences all number
    328
    356
    GASTROENTERITIS
         subjects affected / exposed
    199 / 3315 (6.00%)
    207 / 3298 (6.28%)
         occurrences all number
    212
    223
    CANDIDIASIS
         subjects affected / exposed
    58 / 3315 (1.75%)
    79 / 3298 (2.40%)
         occurrences all number
    65
    93
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    130 / 3315 (3.92%)
    133 / 3298 (4.03%)
         occurrences all number
    159
    165
    NASOPHARYNGITIS
         subjects affected / exposed
    240 / 3315 (7.24%)
    262 / 3298 (7.94%)
         occurrences all number
    325
    333
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    40 / 3315 (1.21%)
    32 / 3298 (0.97%)
         occurrences all number
    40
    36
    PHARYNGITIS
         subjects affected / exposed
    70 / 3315 (2.11%)
    91 / 3298 (2.76%)
         occurrences all number
    81
    101
    ORAL CANDIDIASIS
         subjects affected / exposed
    101 / 3315 (3.05%)
    107 / 3298 (3.24%)
         occurrences all number
    113
    120
    OTITIS MEDIA
         subjects affected / exposed
    432 / 3315 (13.03%)
    418 / 3298 (12.67%)
         occurrences all number
    575
    565
    OTITIS MEDIA ACUTE
         subjects affected / exposed
    65 / 3315 (1.96%)
    54 / 3298 (1.64%)
         occurrences all number
    83
    79
    PNEUMONIA
         subjects affected / exposed
    15 / 3315 (0.45%)
    35 / 3298 (1.06%)
         occurrences all number
    15
    39
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    956 / 3315 (28.84%)
    981 / 3298 (29.75%)
         occurrences all number
    1420
    1482
    RHINITIS
         subjects affected / exposed
    440 / 3315 (13.27%)
    444 / 3298 (13.46%)
         occurrences all number
    600
    593
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    56 / 3315 (1.69%)
    60 / 3298 (1.82%)
         occurrences all number
    64
    64
    VIRAL INFECTION
         subjects affected / exposed
    86 / 3315 (2.59%)
    98 / 3298 (2.97%)
         occurrences all number
    103
    112

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Nov 2004
    A summary of changes made to create Version 2.0 were as follows. Updated clinical experience with motavizumab. Indicated that liquid palivizumab had now been licensed in the U.S. by FDA. Clarified that blood would be collected to allow for measurement of study drug serum levels and immune reactivity for palivizumab as well as motavizumab. Exclusion criterion was revised as to add varicella zoster immune globulin (VZIG) to the list of polyclonal antibodies whose use within 3 months prior to randomization would result in exclusion. Indicated that receipt of listed concomitant medications had to result in a Medical Monitor review to determine whether or not study drug would be discontinued in the patient in question. The maximum number of days between screening and Study Day 0 was increased from 7 to 30 to allow for more flexibility during screening. Parents/guardians would be provided with study site contact information instead of a telephone calling card. Clarified the evaluation and diagnosis of medically-attended acute respiratory illnesses. Clarified the definition of LRI. Investigational Drug Safety was replaced with other Pharmacovigilance department throughout as the point of contact for serious adverse event (SAE) reporting and day-to-day safety monitoring.
    22 Jun 2005
    The changes were: Updated clinical experience with motavizumab. Revised statistical considerations with the following changes: Updated the non-inferiority margin. Redefining efficacy in terms of relative risk rather than relative efficacy. Clarifying that non-inferiority would be tested prior to superiority. Removing the requirement of a positive point estimate in order to claim non-inferiority.
    20 Dec 2005
    The one change was increasing the target enrollment by approximately 15 percent (%) (from 5750 to 6600).

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/20008423
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