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    Clinical Trial Results:
    A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine with Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in their Infants

    Summary
    EudraCT number
    2016-002302-39
    Trial protocol
    GB   ES  
    Global end of trial date
    12 Jul 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Apr 2020
    First version publication date
    10 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RSV-M-301
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02624947
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novavax, Inc.
    Sponsor organisation address
    21 Firstfield Road, Gaithersburg, United States, 20878
    Public contact
    Erika Trahan, Novavax, Inc. , +1 2402682000, etrahan@novavax.com
    Scientific contact
    Greg Glenn, Novavax, Inc. , +1 2402682000, gglenn@novavax.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
    12 Jul 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of maternal immunization with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI) with EITHER hypoxemia (peripheral oxygen saturation [SpO2] < 95% at sea level or < 92% at altitudes > 1800 meters) OR tachypnea (≥ 70 bpm for infants 0 to 59 days of age or ≥ 60 bpm for infants ≥ 60 days of age) through the first 90 days of life in infants of maternal RSV F vaccinees as compared to placebo recipients. In the event that efficacy is shown through the first 90 days of life, a hierarchical sequence of hypothesis tests will be carried out to examine efficacy at 120, 150, and 180 days of life.
    Protection of trial subjects
    The protocol (and amendments) were reviewed and approved by regulatory authorities in all countries; the protocol (and amendments) and consent were reviewed and approved by the ethical review committees with jurisdiction for all clinical sites. All maternal subjects gave written informed consent, and consent was obtained for infant subjects in accordance with applicable local regulatory requirements and laws. The study was conducted in accordance with the protocol, the Declaration of Helsinki (and amendments) and the International Conference on Harmonisation (ICH) Guidelines on Good Clinical Practice (GCP). An independent Data and Safety Monitoring Board monitored subject safety in a regularly scheduled and completely unblinded manner throughout active enrollment.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Dec 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1080
    Country: Number of subjects enrolled
    South Africa: 2419
    Country: Number of subjects enrolled
    New Zealand: 236
    Country: Number of subjects enrolled
    Australia: 113
    Country: Number of subjects enrolled
    Chile: 39
    Country: Number of subjects enrolled
    Argentina: 247
    Country: Number of subjects enrolled
    Mexico: 11
    Country: Number of subjects enrolled
    Philippines: 264
    Country: Number of subjects enrolled
    Bangladesh: 147
    Country: Number of subjects enrolled
    Spain: 38
    Country: Number of subjects enrolled
    United Kingdom: 32
    Worldwide total number of subjects
    4626
    EEA total number of subjects
    70
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    4626
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were recruited and enrolled in 11 countries in both the Northern and Southern hemispheres from December 2015 to July 2018. Enrollment included 4636 women, of whom 10 were found to have defects in source documents and/or consent documentation and were thus not included in any summary or analysis.

    Pre-assignment
    Screening details
    Healthy women 18 to 40 years of age with low-risk singleton pregnancies were enrolled and treated between 28 and 36 weeks gestational age based on first or second trimester dating ultrasonography. Randomization was 1:1, active to placebo in year 1 (175 subjects) then 2:1 active to placebo thereafter, and was stratified on age on site.

    Period 1
    Period 1 title
    Main study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Maternal participants - placebo
    Arm description
    Pregnant women who received one injection of placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in administration system
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of placebo (22 mM sodium phosphate, pH 6.2, with 150 mM NaCl, 1.0% histidine, and 0.03% PS-80) administered intramuscularly

    Arm title
    Maternal participants - RSV F Vaccine
    Arm description
    Pregnant women who received one dose of RSV F Vaccine
    Arm type
    Experimental

    Investigational medicinal product name
    Adjuvanted RSV F Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0ne 0.5 mL dose of adjuvanted RSV F Vaccine (120 μg RSV F protein with 0.4 mg aluminum as the phosphate salt) administered intramuscularly

    Number of subjects in period 1
    Maternal participants - placebo Maternal participants - RSV F Vaccine
    Started
    1581
    3045
    Completed
    1510
    2908
    Not completed
    71
    137
         Other
    11
    17
         Voluntary Withdrawal Unrelated to AE
    27
    48
         Investigator Decision
    3
    5
         Non-Compliance
    5
    8
         Adverse Event
    -
    5
         Sponsor Request
    1
    1
         Lost to follow-up
    24
    53

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Maternal participants - placebo
    Reporting group description
    Pregnant women who received one injection of placebo

    Reporting group title
    Maternal participants - RSV F Vaccine
    Reporting group description
    Pregnant women who received one dose of RSV F Vaccine

    Reporting group values
    Maternal participants - placebo Maternal participants - RSV F Vaccine Total
    Number of subjects
    1581 3045 4626
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    1581 3045 4626
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    26 ± 5.2 26 ± 5.3 -
    Gender categorical
    Units: Subjects
        Female
    1581 3045 4626
        Male
    0 0 0
    Subject analysis sets

    Subject analysis set title
    Per-protocol efficacy infant participants
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All infant subjects who: a) are ≥ 37 weeks gestational age at birth, b) are born to maternal subjects who received a study injection as randomized and ≥ 2 weeks prior to delivery, c) have not received prophylactic treatment with palivizumab between birth and Day 180 after delivery, d) have at least one documented post-partum contact during which active and/or passive surveillance activities for RSV-suspect illness can occur, and e) have no major protocol deviations affecting the primary efficacy outcomes as determined and documented by Novavax prior to database lock and unblinding.

    Subject analysis set title
    Infant safety population - placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All infants born live to maternal subjects who received placebo

    Subject analysis set title
    Infant safety population - RSV F Vaccine
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All infants born live to maternal subjects who received RSV F Vaccine

    Subject analysis sets values
    Per-protocol efficacy infant participants Infant safety population - placebo Infant safety population - RSV F Vaccine
    Number of subjects
    4195
    1561
    3008
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    0 ± 0
    0 ± 0
    0 ± 0
    Gender categorical
    Units: Subjects
        Female
    762
    1451
        Male
    799
    1557

    End points

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    End points reporting groups
    Reporting group title
    Maternal participants - placebo
    Reporting group description
    Pregnant women who received one injection of placebo

    Reporting group title
    Maternal participants - RSV F Vaccine
    Reporting group description
    Pregnant women who received one dose of RSV F Vaccine

    Subject analysis set title
    Per-protocol efficacy infant participants
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All infant subjects who: a) are ≥ 37 weeks gestational age at birth, b) are born to maternal subjects who received a study injection as randomized and ≥ 2 weeks prior to delivery, c) have not received prophylactic treatment with palivizumab between birth and Day 180 after delivery, d) have at least one documented post-partum contact during which active and/or passive surveillance activities for RSV-suspect illness can occur, and e) have no major protocol deviations affecting the primary efficacy outcomes as determined and documented by Novavax prior to database lock and unblinding.

    Subject analysis set title
    Infant safety population - placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All infants born live to maternal subjects who received placebo

    Subject analysis set title
    Infant safety population - RSV F Vaccine
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All infants born live to maternal subjects who received RSV F Vaccine

    Primary: Medically-significant RSV lower respiratory tract infection

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    End point title
    Medically-significant RSV lower respiratory tract infection [1]
    End point description
    Percentages of infants with medically-significant RSV LRTI from delivery through 90, 120, 150, and 180 days of life, defined by: -The presence of RSV infection confirmed by detection of RSV genome by RT PCR on respiratory secretions; AND -At least one of the following: cough, nasal flaring, lower chest wall indrawing, subcostal retractions, stridor, rales, rhonchi, wheezing, crackles/crepitations, or observed apnea; AND -Evidence of medical significance as defined by the presence of: EITHER hypoxemia (peripheral oxygen saturation [SpO2] < 95% at sea level or < 92% at altitudes > 1800 meters) OR Tachypnea (≥ 70 breaths per minute [bpm] in infants 0 to 59 days of age and ≥ 60 bpm in infants ≥ 60 days of age) Data supporting the primary endpoint were obtained exclusively from observations of history and physical examination by trained study site staff, pulse oximetry with the sponsor-supplied device, and RSV detection by molecular diagnostics in the study central laboratory
    End point type
    Primary
    End point timeframe
    From delivery through 90, 120, 150, and 180 days of life
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The specified analysis of the primary endpoint was based on a 97.52% confidence interval (which was conditioned on the original group-sequential design), and exclusion of a specific target value (30%) at the lower bound. The 97.52% confidence interval about the point estimate of efficacy at 90 days was -1.0 to 63.7% and hence did not exclude values <30%. All subsequent analyses were descriptive
    End point values
    Per-protocol efficacy infant participants
    Number of subjects analysed
    4195
    Units: Efficacy (%)
    number (confidence interval 95%)
        0 - 90 Days
    39.4 (5.3 to 61.2)
        0 - 120 Days
    34.4 (1.7 to 56.2)
        0 - 150 Days
    31.4 (-1.3 to 53.6)
        0 - 180 Days
    26.6 (-7.8 to 50.1)
    No statistical analyses for this end point

    Secondary: RSV lower respiratory tract infection with hospitalization

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    End point title
    RSV lower respiratory tract infection with hospitalization
    End point description
    Percentages of infants with RSV LRTI with hospitalization from delivery through 90, 120, 150, and 180 days of life. An event is considered RSV LRTI hospitalization if all parameters outlined below are present during a continuous symptomatic illness episode: - RSV infection as confirmed by detection of the RSV genome by RT-PCR, AND - At least one manifestation of lower respiratory tract infection (LRTI) from among the following: cough, nasal flaring, lower chest wall indrawing, subcostal retractions, stridor, rales, rhonchi, wheezing, crackles/crepitations, or observed apnea, AND - Documented hospitalization Data supporting the secondary endpoints were obtained exclusively from observations of history and physical examination by trained study site staff, pulse oximetry with the sponsor-supplied device, and RSV detection by molecular diagnostics in the study central laboratory
    End point type
    Secondary
    End point timeframe
    Delivery through 90, 120, 150, and 180 days of life
    End point values
    Per-protocol efficacy infant participants
    Number of subjects analysed
    4195
    Units: Efficacy (%)
    number (confidence interval 95%)
        0 - 90 Days
    44.4 (19.6 to 61.5)
        0 - 120 Days
    40.9 (15.9 to 58.5)
        0 - 150 Days
    39.2 (14.0 to 57.0)
        0 - 180 Days
    40.4 (16.0 to 57.7)
    No statistical analyses for this end point

    Secondary: RSV lower respiratory tract infection with sever hypoxemia

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    End point title
    RSV lower respiratory tract infection with sever hypoxemia
    End point description
    Percentages of infants with RSV LRTI with EITHER severe hypoxemia (SpO2 < 92% at sea level or < 87% at altitudes > 1800 meters) OR the documented use of oxygen by high flow nasal cannula OR a requirement for continuous positive airway pressure OR bilevel positive airway pressure OR Bubble CPAP OR bag-mask ventilation OR intubation with subsequent mechanical ventilation OR extracorporeal membrane oxygenation. An event was considered RSV LRTI with severe hypoxemia if specific parameters were present during a continuous symptomatic illness episode. Data supporting the secondary endpoints were obtained exclusively from observations of history and physical examination by trained study site staff, pulse oximetry with the sponsor-supplied device, and RSV detection by molecular diagnostics in the study central laboratory
    End point type
    Secondary
    End point timeframe
    Delivery through 90, 120, 150, and 180 days of life
    End point values
    Per-protocol efficacy infant participants
    Number of subjects analysed
    4195
    Units: Efficacy (%)
    number (confidence interval 95%)
        0 - 90 Days
    48.3 (-8.2 to 75.3)
        0 - 120 Days
    48.3 (-3.1 to 74.1)
        0 - 150 Days
    48.3 (-1.0 to 73.5)
        0 - 180 Days
    42.2 (-10.9 to 69.9)
    No statistical analyses for this end point

    Other pre-specified: Medically-significant RSV lower respiratory tract infection (expanded data)

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    End point title
    Medically-significant RSV lower respiratory tract infection (expanded data)
    End point description
    Percentages of infants with medically-significant RSV LRTI from delivery through 90, 120, 150, and 180 days of life as defined for the primary endpoint, with the exception that evidence of RSV infection, LRTI, hypoxemia, and/or tachypnea may be based on either or both of the observations of the clinical site staff using sponsor-supplied devices and diagnostic tests OR review and abstraction of medical records for infants undergoing hospitalization for a respiratory serious adverse event.
    End point type
    Other pre-specified
    End point timeframe
    Delivery through 90, 120, 150 and 180 days of life
    End point values
    Per-protocol efficacy infant participants
    Number of subjects analysed
    4195
    Units: Efficacy (%)
    number (confidence interval 95%)
        0 - 90 Days
    40.9 (15.9 to 58.5)
        0 - 120 Days
    34.9 (9.7 to 53.1)
        0 - 150 Days
    30.5 (4.6 to 49.4)
        0 - 180 Days
    26.5 (-0.6 to 46.2)
    No statistical analyses for this end point

    Other pre-specified: RSV lower respiratory tract infection with Hospitalization (expanded data)

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    End point title
    RSV lower respiratory tract infection with Hospitalization (expanded data)
    End point description
    Percentages of infants with RSV LRTI with hospitalization from delivery through 90, 120, 150, and 180 days of life, defined as for the secondary endpoint, with the exception that evidence of RSV infection and LRTI may be based on either or both of the observations of the clinical site staff using sponsor-supplied devices and diagnostic tests OR review and abstraction of medical records for infants undergoing hospitalization for a respiratory serious adverse event.
    End point type
    Other pre-specified
    End point timeframe
    Delivery through 90, 120, 150 and 180 days of life
    End point values
    Per-protocol efficacy infant participants
    Number of subjects analysed
    4195
    Units: Efficacy (%)
    number (confidence interval 95%)
        0 - 90 Days
    41.7 (16.7 to 59.2)
        0 - 120 Days
    37.6 (12.1 to 55.7)
        0 - 150 Days
    35.1 (9.2 to 53.6)
        0 - 180 Days
    35.6 (10.3 to 53.7)
    No statistical analyses for this end point

    Other pre-specified: RSV lower respiratory tract infection with Severe Hypoxemia (expanded data)

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    End point title
    RSV lower respiratory tract infection with Severe Hypoxemia (expanded data)
    End point description
    Percentages of infants with RSV LRTI with EITHER severe hypoxemia OR the documented use of oxygen by high flow nasal cannula OR a requirement for continuous positive airway pressure (CPAP) OR bilevel positive airway pressure (BiPAP) OR Bubble CPAP OR bag-mask ventilation OR intubation with subsequent mechanical (or manual) ventilation OR extracorporeal membrane oxygenation (ECMO) from delivery through 90, 120, 150, and 180 days of life, as defined for the corresponding secondary endpoint with the exception that evidence of RSV infection, LRTI, severe hypoxemia, and/or respiratory support may be based on either or both of the observations of the clinical site staff using sponsor-supplied devices and diagnostic tests OR review and abstraction of medical records for infants undergoing hospitalization for a respiratory serious adverse event.
    End point type
    Other pre-specified
    End point timeframe
    Delivery through 90, 120, 150 and 180 days of life
    End point values
    Per-protocol efficacy infant participants
    Number of subjects analysed
    4195
    Units: Efficacy (%)
    number (confidence interval 95%)
        0 - 90 Days
    59.6 (32.1 to 76.0)
        0 - 120 Days
    57.4 (30.1 to 74.1)
        0 - 150 Days
    54.2 (26.0 to 71.6)
        0 - 180 Days
    51.2 (21.9 to 69.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    In maternal subjects, solicited AEs were collected for 7 days post-dosing and unsolicited AEs were collected through delivery and 180 days thereafter. In infant subjects, AEs were collected through 364 days of life.
    Adverse event reporting additional description
    Adverse event collection included solicited adverse events typical of IM vaccine reactogenicity in mothers, all adverse events, medically-attended adverse events, adverse events of special interest concerning pregnancy and the puerperium (which were treated as serious adverse events regardless of fulfillment of the ICH criteria for seriousness), an
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Maternal participants - placebo
    Reporting group description
    Pregnant women who received one injection of placebo

    Reporting group title
    Maternal participants - RSV F Vaccine
    Reporting group description
    Pregnant women who received one dose of RSV F Vaccine

    Reporting group title
    Infant Safety Population - placebo
    Reporting group description
    All infants born live to maternal subjects who received placebo

    Reporting group title
    Infant Safety Population - RSV F Vaccine
    Reporting group description
    All infants born live to maternal subjects who received RSV F Vaccine

    Serious adverse events
    Maternal participants - placebo Maternal participants - RSV F Vaccine Infant Safety Population - placebo Infant Safety Population - RSV F Vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    455 / 1581 (28.78%)
    906 / 3045 (29.75%)
    724 / 1561 (46.38%)
    1337 / 3008 (44.45%)
         number of deaths (all causes)
    0
    2
    12
    17
         number of deaths resulting from adverse events
    0
    2
    12
    17
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 1581 (0.38%)
    11 / 3045 (0.36%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 11
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Essential hypertension
         subjects affected / exposed
    1 / 1581 (0.06%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subgaleal haematoma
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix warts
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infantile haemangioma
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of skin
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of spinal cord
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibromatosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemangioma of liver
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Lipoma
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Foetal distress syndrome
         subjects affected / exposed
    97 / 1581 (6.14%)
    200 / 3045 (6.57%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 97
    0 / 200
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Premature delivery
         subjects affected / exposed
    90 / 1581 (5.69%)
    174 / 3045 (5.71%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 90
    5 / 174
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gestational hypertension
         subjects affected / exposed
    66 / 1581 (4.17%)
    141 / 3045 (4.63%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 66
    0 / 142
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prolonged labour
         subjects affected / exposed
    47 / 1581 (2.97%)
    81 / 3045 (2.66%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 47
    0 / 81
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pre-eclampsia
         subjects affected / exposed
    43 / 1581 (2.72%)
    72 / 3045 (2.36%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 43
    0 / 73
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cephalo-pelvic disproportion
         subjects affected / exposed
    20 / 1581 (1.27%)
    47 / 3045 (1.54%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 47
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postpartum haemorrhage
         subjects affected / exposed
    17 / 1581 (1.08%)
    35 / 3045 (1.15%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 35
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature rupture of membranes
         subjects affected / exposed
    19 / 1581 (1.20%)
    24 / 3045 (0.79%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 19
    1 / 24
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failed induction of labour
         subjects affected / exposed
    11 / 1581 (0.70%)
    28 / 3045 (0.92%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 28
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prolonged pregnancy
         subjects affected / exposed
    15 / 1581 (0.95%)
    23 / 3045 (0.76%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 23
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prolonged rupture of membranes
         subjects affected / exposed
    14 / 1581 (0.89%)
    17 / 3045 (0.56%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 17
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrested labour
         subjects affected / exposed
    6 / 1581 (0.38%)
    23 / 3045 (0.76%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 23
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breech presentation
         subjects affected / exposed
    8 / 1581 (0.51%)
    14 / 3045 (0.46%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 14
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meconium stain
         subjects affected / exposed
    6 / 1581 (0.38%)
    16 / 3045 (0.53%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 16
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stillbirth
         subjects affected / exposed
    8 / 1581 (0.51%)
    14 / 3045 (0.46%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 14
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage in pregnancy
         subjects affected / exposed
    7 / 1581 (0.44%)
    13 / 3045 (0.43%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 13
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature labour
         subjects affected / exposed
    7 / 1581 (0.44%)
    12 / 3045 (0.39%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 9
    2 / 13
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature separation of placenta
         subjects affected / exposed
    7 / 1581 (0.44%)
    12 / 3045 (0.39%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 12
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Preterm premature rupture of membranes
         subjects affected / exposed
    2 / 1581 (0.13%)
    11 / 3045 (0.36%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 11
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eclampsia
         subjects affected / exposed
    6 / 1581 (0.38%)
    6 / 3045 (0.20%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal macrosomia
         subjects affected / exposed
    1 / 1581 (0.06%)
    9 / 3045 (0.30%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 9
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal hypokinesia
         subjects affected / exposed
    4 / 1581 (0.25%)
    5 / 3045 (0.16%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oligohydramnios
         subjects affected / exposed
    4 / 1581 (0.25%)
    5 / 3045 (0.16%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructed labour
         subjects affected / exposed
    2 / 1581 (0.13%)
    6 / 3045 (0.20%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gestational diabetes
         subjects affected / exposed
    4 / 1581 (0.25%)
    2 / 3045 (0.07%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine hyperstimulation
         subjects affected / exposed
    3 / 1581 (0.19%)
    3 / 3045 (0.10%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retained placenta or membranes
         subjects affected / exposed
    1 / 1581 (0.06%)
    4 / 3045 (0.13%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failed trial of labour
         subjects affected / exposed
    1 / 1581 (0.06%)
    4 / 3045 (0.13%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Threatened labour
         subjects affected / exposed
    3 / 1581 (0.19%)
    2 / 3045 (0.07%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HELLP syndrome
         subjects affected / exposed
    1 / 1581 (0.06%)
    3 / 3045 (0.10%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meconium in amniotic fluid
         subjects affected / exposed
    1 / 1581 (0.06%)
    3 / 3045 (0.10%)
    0 / 1561 (0.00%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripartum cardiomyopathy
         subjects affected / exposed
    0 / 1581 (0.00%)
    4 / 3045 (0.13%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Maternal distress during labour
         subjects affected / exposed
    0 / 1581 (0.00%)
    3 / 3045 (0.10%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Placenta praevia
         subjects affected / exposed
    0 / 1581 (0.00%)
    3 / 3045 (0.10%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical cord prolapse
         subjects affected / exposed
    2 / 1581 (0.13%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Face presentation
         subjects affected / exposed
    1 / 1581 (0.06%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal death
         subjects affected / exposed
    1 / 1581 (0.06%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Previous caesarean section
         subjects affected / exposed
    1 / 1581 (0.06%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retained products of conception
         subjects affected / exposed
    2 / 1581 (0.13%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transverse presentation
         subjects affected / exposed
    0 / 1581 (0.00%)
    2 / 3045 (0.07%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complication of pregnancy
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal growth abnormality
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal growth restriction
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    8 / 1561 (0.51%)
    16 / 3008 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 8
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    High risk pregnancy
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperemesis gravidarum
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Induced labour
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labour pain
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large for dates baby
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    3 / 1561 (0.19%)
    12 / 3008 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Placenta praevia haemorrhage
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Placental disorder
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Placental insufficiency
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyhydramnios
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postmature baby
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroplacental haematoma
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shoulder dystocia
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    1 / 1561 (0.06%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine contractions during pregnancy
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine hypertonus
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 1581 (0.06%)
    5 / 3045 (0.16%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 1581 (0.06%)
    5 / 3045 (0.16%)
    2 / 1561 (0.13%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Funisitis
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Low birth weight baby
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    98 / 1561 (6.28%)
    149 / 3008 (4.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 98
    0 / 149
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Small for dates baby
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    72 / 1561 (4.61%)
    151 / 3008 (5.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 72
    1 / 151
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice neonatal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    52 / 1561 (3.33%)
    97 / 3008 (3.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 52
    0 / 98
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cephalhaematoma
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    2 / 1561 (0.13%)
    4 / 3008 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decrease neonatal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    2 / 1561 (0.13%)
    4 / 3008 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Caput succedaneum
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Poor weight gain neonatal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature baby
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical cord abnormality
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical granuloma
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 1581 (0.13%)
    1 / 3045 (0.03%)
    2 / 1561 (0.13%)
    5 / 3008 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 1581 (0.00%)
    2 / 3045 (0.07%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Developmental delay
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    2 / 1561 (0.13%)
    6 / 3008 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fever neonatal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    4 / 3008 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macrosomia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    3 / 3008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden infant death syndrome
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    3 / 3008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    Oedema peripheral
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Temperature regulation disorder
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death neonatal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    3 / 1561 (0.19%)
    3 / 3008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 3
    Death
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    4 / 3008 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 4
    Psychiatric disorders
    Perinatal depression
         subjects affected / exposed
    2 / 1581 (0.13%)
    3 / 3045 (0.10%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised anxiety disorder
         subjects affected / exposed
    0 / 1581 (0.00%)
    2 / 3045 (0.07%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sleep disorder
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine atony
         subjects affected / exposed
    1 / 1581 (0.06%)
    2 / 3045 (0.07%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulval haematoma
         subjects affected / exposed
    0 / 1581 (0.00%)
    2 / 3045 (0.07%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shortened cervix
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine pain
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal discharge
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose veins vulval
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulval oedema
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal discomfort
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal swelling
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testicular retraction
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    5 / 1561 (0.32%)
    6 / 3008 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acquired phimosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enlarged clitoris
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal testicular torsion
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Penile adhesion
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Penis disorder
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Perineal injury
         subjects affected / exposed
    2 / 1581 (0.13%)
    5 / 3045 (0.16%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal laceration
         subjects affected / exposed
    1 / 1581 (0.06%)
    4 / 3045 (0.13%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine cervical laceration
         subjects affected / exposed
    3 / 1581 (0.19%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine rupture
         subjects affected / exposed
    2 / 1581 (0.13%)
    2 / 3045 (0.07%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failed forceps delivery
         subjects affected / exposed
    0 / 1581 (0.00%)
    3 / 3045 (0.10%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post lumbar puncture syndrome
         subjects affected / exposed
    2 / 1581 (0.13%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine dehiscence
         subjects affected / exposed
    1 / 1581 (0.06%)
    2 / 3045 (0.07%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 1581 (0.06%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention postoperative
         subjects affected / exposed
    1 / 1581 (0.06%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal biophysical profile score abnormal
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    3 / 1561 (0.19%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    3 / 3008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    3 / 3008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury to brachial plexus due to birth trauma
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial injury
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brachial plexus injury
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound necrosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Foetal monitoring abnormal
         subjects affected / exposed
    3 / 1581 (0.19%)
    5 / 3045 (0.16%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    2 / 1581 (0.13%)
    3 / 3045 (0.10%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amniotic fluid index decreased
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal heart rate increased
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seroconversion test positive
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ultrasound Doppler abnormal
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac murmur
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    13 / 1561 (0.83%)
    23 / 3008 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 13
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acoustic stimulation tests abnormal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Apgar score low
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Body height below normal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac murmur functional
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HIV test positive
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin abnormal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Karyotype analysis abnormal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Opiates positive
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reflex test abnormal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular resistance pulmonary increased
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Nonreassuring foetal heart rate pattern
         subjects affected / exposed
    10 / 1581 (0.63%)
    24 / 3045 (0.79%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 24
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia foetal
         subjects affected / exposed
    3 / 1581 (0.19%)
    10 / 3045 (0.33%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 10
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    4 / 1581 (0.25%)
    7 / 3045 (0.23%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia foetal
         subjects affected / exposed
    5 / 1581 (0.32%)
    6 / 3045 (0.20%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal heart rate deceleration abnormality
         subjects affected / exposed
    2 / 1581 (0.13%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal heart rate disorder
         subjects affected / exposed
    1 / 1581 (0.06%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Bradycardia neonatal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cyanosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal tachycardia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Right atrial dilatation
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital naevus
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    177 / 1561 (11.34%)
    307 / 3008 (10.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 183
    0 / 314
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital umbilical hernia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    146 / 1561 (9.35%)
    259 / 3008 (8.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 146
    0 / 261
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Birth mark
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    96 / 1561 (6.15%)
    195 / 3008 (6.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 99
    0 / 199
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankyloglossia congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    19 / 1561 (1.22%)
    44 / 3008 (1.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 19
    0 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemangioma congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    23 / 1561 (1.47%)
    24 / 3008 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 25
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital skin dimples
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    14 / 1561 (0.90%)
    22 / 3008 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 14
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microcephaly
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    9 / 1561 (0.58%)
    23 / 3008 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 9
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    4 / 1561 (0.26%)
    19 / 3008 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Naevus flammeus
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    5 / 1561 (0.32%)
    17 / 3008 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital acrochordon
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    4 / 1561 (0.26%)
    13 / 3008 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cryptorchism
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    6 / 1561 (0.38%)
    10 / 3008 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial septal defect
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    7 / 1561 (0.45%)
    7 / 3008 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polydactyly
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    7 / 1561 (0.45%)
    16 / 3008 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 7
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital melanocytic naevus
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    12 / 3008 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accessory auricle
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    10 / 3008 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngomalacia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    5 / 1561 (0.32%)
    6 / 3008 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital melanosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    2 / 1561 (0.13%)
    9 / 3008 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Preauricular cyst
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    6 / 1561 (0.38%)
    5 / 3008 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital pneumonia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    3 / 1561 (0.19%)
    7 / 3008 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital torticollis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    5 / 1561 (0.32%)
    5 / 3008 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labial tie
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    5 / 1561 (0.32%)
    5 / 3008 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supernumerary nipple
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    4 / 1561 (0.26%)
    6 / 3008 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular septal defect
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    5 / 1561 (0.32%)
    5 / 3008 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abnormal palmar/plantar creases
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    3 / 1561 (0.19%)
    6 / 3008 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Developmental hip dysplasia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    4 / 1561 (0.26%)
    4 / 3008 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plagiocephaly
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    4 / 1561 (0.26%)
    4 / 3008 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Strabismus congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    7 / 3008 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clinodactyly
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    6 / 3008 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dacryostenosis congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    3 / 1561 (0.19%)
    4 / 3008 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glucose-6-phosphate dehydrogenase deficiency
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    2 / 1561 (0.13%)
    4 / 3008 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypospadias
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    5 / 3008 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Talipes
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    5 / 3008 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniosynostosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    4 / 1561 (0.26%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macrocephaly
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    4 / 1561 (0.26%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear malformation
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    3 / 3008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microtia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    3 / 3008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Penile torsion
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    4 / 3008 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Persistent foetal circulation
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    4 / 1561 (0.26%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Phimosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    3 / 3008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull malformation
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    3 / 3008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deafness congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    3 / 3008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eyelid ptosis congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Micrognathia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    3 / 3008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patent ductus arteriosus
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    2 / 1561 (0.13%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sebaceous naevus
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    2 / 1561 (0.13%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ABO haemolytic disease of newborn
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anomaly of external ear congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Branchial cyst
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Camptodactyly congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral palsy
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Chordee
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cleft lip
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cleft palate
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital hearing disorder
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital knee dislocation
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital pulmonary hypertension
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pectus excavatum
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary artery stenosis congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Single umbilical artery
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Telangiectasia congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trisomy 21
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    2 / 1561 (0.13%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accessory breast
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal atresia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anomalous pulmonary venous connection
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Beckwith-Wiedemann syndrome
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Buried penis syndrome
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac septal defect
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Choledochal cyst
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondrodystrophy
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chromosomal deletion
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cleft uvula
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital aortic anomaly
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital cardiovascular anomaly
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Congenital central nervous system anomaly
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital cerebral cyst
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital choroid plexus cyst
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital claw toe
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital eye disorder
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital genital malformation female
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital hydronephrosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital hyperextension of knee
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital megacolon
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital mitral valve incompetence
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital nephrotic syndrome
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Congenital nose malformation
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital pulmonary artery anomaly
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital renal disorder
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital tracheomalacia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital tricuspid valve incompetence
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital varicella infection
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital vesicoureteric reflux
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermoid cyst
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extrarenal pelvis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Galactosaemia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart disease congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertelorism of orbit
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interruption of aortic arch
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal malrotation
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Low set ears
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macroglossia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mosaicism
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Odontogenic cyst
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Persistent pupillary membrane
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal cyst congenital
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scaphocephaly
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syndactyly
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thalassaemia alpha
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital Cleft Hand
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 1581 (0.44%)
    17 / 3045 (0.56%)
    0 / 1561 (0.00%)
    3 / 3008 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 17
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    4 / 1581 (0.25%)
    4 / 3045 (0.13%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia of pregnancy
         subjects affected / exposed
    1 / 1581 (0.06%)
    3 / 3045 (0.10%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    2 / 1581 (0.13%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bicytopenia
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia neonatal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polycythaemia neonatorum
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia neonatal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    3 / 1581 (0.19%)
    4 / 3045 (0.13%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    2 / 1581 (0.13%)
    1 / 3045 (0.03%)
    1 / 1561 (0.06%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 1581 (0.06%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    1 / 1561 (0.06%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal respiratory distress syndrome
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    36 / 1561 (2.31%)
    62 / 3008 (2.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 36
    0 / 62
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Transient tachypnoea of the newborn
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    9 / 1561 (0.58%)
    19 / 3008 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 9
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal asphyxia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    10 / 1561 (0.64%)
    15 / 3008 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 11
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Meconium aspiration syndrome
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    6 / 1561 (0.38%)
    16 / 3008 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 6
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 4
    Bronchial obstruction
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    3 / 1561 (0.19%)
    6 / 3008 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infantile apnoea
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    3 / 1561 (0.19%)
    4 / 3008 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal hypoxia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    5 / 3008 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rales
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    2 / 1561 (0.13%)
    4 / 3008 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal tachypnoea
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    5 / 3008 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    2 / 1561 (0.13%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cyanosis neonatal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    2 / 1561 (0.13%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal congestion
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal respiratory failure
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory symptom
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stridor
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachypnoea
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Apparent life threatening event
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Choking
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphonia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Grunting
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal respiratory depression
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary artery stenosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheal stenosis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper airway obstruction
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Use of accessory respiratory muscles
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    False labour
         subjects affected / exposed
    1 / 1581 (0.06%)
    2 / 3045 (0.07%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    2 / 1581 (0.13%)
    2 / 3045 (0.07%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 1581 (0.00%)
    2 / 3045 (0.07%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complex partial seizures
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 1581 (0.06%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    7 / 1561 (0.45%)
    12 / 3008 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    Encephalopathy neonatal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    7 / 3008 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Febrile convulsion
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    4 / 3008 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    2 / 3008 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Convulsion neonatal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fine motor delay
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gross motor delay
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotonia
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infantile spasms
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Poor sucking reflex
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reflexes abnormal
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tethered cord syndrome
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign intracranial hypertension
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    0 / 1581 (0.00%)
    1 / 3045 (0.03%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Opsoclonus myoclonus
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Conductive deafness
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    1 / 3008 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 1581 (0.00%)
    0 / 3045 (0.00%)
    1 / 1561 (0.06%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 1581 (0.13%)
    2 / 3045 (0.07%)
    4 / 1561 (0.26%)
    17 / 3008 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 1581 (0.00%)
    3 / 3045 (0.10%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 1581 (0.13%)
    0 / 3045 (0.00%)
    0 / 1561 (0.00%)
    0 / 3008 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to