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    Clinical Trial Results:
    Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical Trial (FACT) A randomized, double-blind, placebo-controlled, Phase III, international multi-centre study of 4.0 mg of Folic Acid supplementation in pregnancy for the prevention of preeclampsia

    Summary
    EudraCT number
    		 2012-001918-42
    Trial protocol
    		 GB  
    Global end of trial date
    31 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2022
    First version publication date
    26 Jun 2022
    Other versions
    Summary report(s)
    		 Effect of high dose folic acid supplementation in pregnancy on pre-eclampsia (FACT): double blind, phase III, randomised controlled, international, multicentre trial

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2009-107(Canadian)
    Additional study identifiers
    ISRCTN number
    		 ISRCTN23781770
    US NCT number
    		 NCT01355159
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ottawa Hospital Research Institute
    Sponsor organisation address
    Civic Campus, 725 Parkdale Ave, Civic Box 675 Loeb Building, Ottawa, Canada, K1Y 4E9
    Public contact
    Marissa Akow, Ottawa Hospital Research Institute, 1 613-737-8899, makow@ohri.ca
    Scientific contact
    Marissa Akow, Ottawa Hospital Research Institute, 1 613-737-8899, makow@ohri.ca
    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
    11 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To ascertain if a 4mg supplementation of Folic acid taken from early pregnancy until delivery prevents preeclampsia when compared with a placebo.
    Protection of trial subjects
    4.0mg is standard recommended dose of folic acid in pregnancy complicated by hypertensive disorders.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Apr 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 122
    Country: Number of subjects enrolled
    Australia: 310
    Country: Number of subjects enrolled
    Canada: 1207
    Country: Number of subjects enrolled
    Jamaica: 61
    Country: Number of subjects enrolled
    United Kingdom: 764
    Worldwide total number of subjects
    2464
    EEA total number of subjects
    0
    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)
    2464
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 1. Capability of subject to comprehend and comply with study requirements. 2. >=18 years of age, 3. taking <=1.1mg folic acid daily, 4. live fetus, 5. gestational age between 8 and 16 weeks, 6. plan to deliver at participating hospital, 7. Experiencing a risk factor for preeclampsia (see Protocol).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    The data coordinating centre managed treatment allocation, and all participants, site investigators, coordinators and other research staff, and members of the trial coordinating centre were blinded to treatment allocation after randomisation. No unmasking occurred during the trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Group
    Arm description
    		 Participant randomized into placebo group
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 x 1.0mg tablets once daily

    Arm title
    		 Experimental Group
    Arm description
    		 Subjects were randomized into the intervention/experimental group to receive 4.0mg of folic acid daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Folic acid
    Investigational medicinal product code
    Other name
    Vitamin B9
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 x 1.0mg tablets once daily

    Number of subjects in period 1 [1]
    		Placebo Group Experimental Group
    Started
    1236
    1227
    Completed
    1157
    1144
    Not completed
    79
    83
         No primary outcome data
    11
    -
         Consent withdrawn by subject
    47
    38
         Adverse event, non-fatal
    21
    28
         No primary data outcome
    -
    17
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Of the participants allocated to the treatment group (n = 1228), one participant withdrew consent after randomization and were not included in the baseline characteristics analysis, therefore the final treatment sample size was n = 1227.

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Placebo Group
    Reporting group description
    		 Participant randomized into placebo group

    Reporting group title
    Experimental Group
    Reporting group description
    		 Subjects were randomized into the intervention/experimental group to receive 4.0mg of folic acid daily.

    Primary: Diagnosis of preeclampsia in current pregnancy

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    End point title
    		 Diagnosis of preeclampsia in current pregnancy
    End point description
    End point type
    Primary
    End point timeframe
    During current pregnancy
    End point values
    		 Placebo Group Experimental Group
    Number of subjects analysed
    1236
    1127
    Units: Diagnosis
    21
    30
    Statistical analysis title
    		 Chi Squared
    Statistical analysis description
    Between the intervention and placebo group, chi squared, t-tests, and multiple log binomial regression was conducted on the primary outcome, and adjusting for confounders by parity, age, cigarette smoking, and other important prognostic factors identified a priori.
    Comparison groups
    Experimental Group v Placebo Group
    Number of subjects included in analysis
    2363
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Multiple log binomial regression
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 2.5
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First administration of study treatment to last completed study visit
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    active_mother
    Reporting group description
    		 -

    Reporting group title
    active_infant
    Reporting group description
    		 Infants born to mothers in the active treatment group

    Reporting group title
    placebo_infant
    Reporting group description
    		 Infants born to mothers in the placebo group

    Reporting group title
    placebo_mother
    Reporting group description
    		 -

    Serious adverse events
    		 active_mother active_infant placebo_infant placebo_mother
    Total subjects affected by serious adverse events
         subjects affected / exposed
    227 / 1227 (18.50%)
    116 / 1364 (8.50%)
    109 / 1374 (7.93%)
    195 / 1236 (15.78%)
         number of deaths (all causes)
    1
    19
    24
    8
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
    Additional description: Breast cancer
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Squamous cell carcinoma
    Additional description: Squamous cell carcinoma
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Uterine leiomyoma
    Additional description: Uterine leiomyoma
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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 disorders
    Blood pressure increased, Metabolic control
    Additional description: Blood pressure increased, Metabolic control
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Deep vein thrombosis
    Additional description: Deep vein thrombosis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Gestational hypertension
    Additional description: Gestational hypertension
         subjects affected / exposed
    7 / 1227 (0.57%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
    Additional description: Haemorrhage
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    20 / 1227 (1.63%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    16 / 1236 (1.29%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 0
    0 / 0
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
    Additional description: Hypertensive crisis
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
    Additional description: Varicose vein
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Surgical and medical procedures
    Cervix cerclage procedure
    Additional description: Cervix cerclage procedure
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Diabetes mellitus management
    Additional description: Diabetes mellitus management
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         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
    Evacuation of retained products of conception
    Additional description: Evacuation of retained products of conception
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Hospitalisation
    Additional description: Hospitalisation
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Steroid therapy
    Additional description: Steroid therapy
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Pregnancy, puerperium and perinatal conditions
    Abdominal pain, Vaginal haemorrhage
    Additional description: Abdominal pain, Vaginal haemorrhage
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Abortion induced due to congenital anomaly
    Additional description: Abortion induced due to congenital anomaly
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Abortion spontaneous
    Additional description: Abortion spontaneous
         subjects affected / exposed
    3 / 1227 (0.24%)
    4 / 1364 (0.29%)
    2 / 1374 (0.15%)
    2 / 1236 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
    0 / 2
    Death neonatal
    Additional description: Death neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    2 / 1364 (0.15%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    Discordant twin
    Additional description: Discordant twin
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failed induction of labour
    Additional description: Failed induction of labour
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    False labour
    Additional description: False labour
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Foetal death
    Additional description: Foetal death
         subjects affected / exposed
    4 / 1227 (0.33%)
    6 / 1364 (0.44%)
    10 / 1374 (0.73%)
    11 / 1236 (0.89%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 10
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 6
    0 / 8
    0 / 4
    Foetal growth restriction
    Additional description: Foetal growth restriction
         subjects affected / exposed
    1 / 1227 (0.08%)
    2 / 1364 (0.15%)
    0 / 1374 (0.00%)
    5 / 1236 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal hypokinesia
    Additional description: Foetal hypokinesia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Gestational Diabetes
    Additional description: Gestational diabetes
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage in pregnancy
    Additional description: Haemorrhage in pregnancy
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    7 / 1236 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HELLP syndrome
    Additional description: HELLP syndrome
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperemesis gravidarum
    Additional description: Hyperemesis gravidarum
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Jaundice neonatal
    Additional description: Jaundice neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    8 / 1364 (0.59%)
    7 / 1374 (0.51%)
    0 / 1236 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 8
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oligohydramnios
    Additional description: Oligohydramnios
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Placenta praevia haemorrhage
    Additional description: Placenta praevia haemorrhage
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Polyhydramnios
    Additional description: Polyhydramnios
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postpartum haemorrhage
    Additional description: Postpartum haemorrhage
         subjects affected / exposed
    15 / 1227 (1.22%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    9 / 1236 (0.73%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pre-eclampsia
    Additional description: Pre-eclampsia
         subjects affected / exposed
    16 / 1227 (1.30%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    11 / 1236 (0.89%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 0
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature baby
    Additional description: Premature baby
         subjects affected / exposed
    5 / 1227 (0.41%)
    47 / 1364 (3.45%)
    42 / 1374 (3.06%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 47
    0 / 42
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 7
    0 / 1
    Premature labour
    Additional description: Premature labour
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    6 / 1236 (0.49%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature rupture of membranes
    Additional description: Premature rupture of membranes
         subjects affected / exposed
    11 / 1227 (0.90%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    5 / 1236 (0.40%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 1
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature rupture of membranes, Placental transfusion syndrome
    Additional description: Premature rupture of membranes, Placental transfusion syndrome
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Premature separation of placenta
    Additional description: Premature separation of placenta
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         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
    Preterm premature rupture of membranes
    Additional description: Preterm premature rupture of membranes
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Pulmonary congestion, Pre-eclampsia
    Additional description: Pulmonary congestion, Pre-eclampsia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Retained products of conception
    Additional description: Retained products of conception
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shortened cervix, Polyhydraminos
    Additional description: Shortened cervix, Polyhydraminos
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Shoulder dystocia
    Additional description: Shoulder dystocia
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    2 / 1374 (0.15%)
    0 / 1236 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Small for dates baby
    Additional description: Small for dates baby
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Stillbirth
    Additional description: Stillbirth
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    2 / 1374 (0.15%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    Threatened labour
    Additional description: Threatened labour
         subjects affected / exposed
    20 / 1227 (1.63%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    18 / 1236 (1.46%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 0
    0 / 0
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical cord abnormality
    Additional description: Umbilical cord abnormality
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Uterine contractions abnormal
    Additional description: Uterine contractions abnormal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Uterine contractions during pregnancy
    Additional description: Uterine contractions during pregnancy
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vasa praevia
    Additional description: Vasa praevia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Weight decrease neonatal
    Additional description: Weight decrease neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    2 / 1374 (0.15%)
    0 / 1236 (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
    General disorders and administration site conditions
    Abdominal pain, Pyrexia
    Additional description: Abdominal pain, Pyrexia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Blood pressure increased, Blood glucose
    Additional description: Blood pressure increased, Blood glucose
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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 pressure increased, Headache
    Additional description: Blood pressure increased, Headache
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Blood pressure increased, Pulmonary edema
    Additional description: Blood pressure increased, Pulmonary edema
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Cholecystitis, Cholelithiasis, Pancreatitis
    Additional description: Cholecystitis, Cholelithiasis, Pancreatitis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Cholestasis, HELLP
    Additional description: Cholestasis, HELLP
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Chorioamnionitis, Sepsis
    Additional description: Chorioamnionitis, Sepsis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Cyst
    Additional description: Cyst
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Dehydration, Gastritis, Urinary tract infection
    Additional description: Dehydration, Gastritis, Urinary tract infection
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Dysplasia
    Additional description: Dysplasia
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Elevated hepatic enzymes, Pre-eclampsia, Glucose intolerance, Placental transfusion syndrome
    Additional description: Elevated hepatic enzymes, Pre-eclampsia, Glucose intolerance, Placental transfusion syndrome
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Headache, Amylase increased
    Additional description: Headache, Amylase increased
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Headache, Hypertension, Vision blurred
    Additional description: Headache, Hypertension, Vision blurred
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Headache, Pain in extremity
    Additional description: Headache, Pain in extremity
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Headache, Oedema, Hypertension
    Additional description: Headache, Oedema, Hypertension
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Hypoglycaemia, Congenital cardiovascular anomaly
    Additional description: Hypoglycaemia, Congenital cardiovascular anomaly
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Hypoglycaemia, Sepsis
    Additional description: Hypoglycaemia, Sepsis
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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, Transient tachypnoea, Septal hypertrophy, Patent Ductus Arteriosus
    Additional description: Large for dates baby, Transient tachypnoea, Septal hypertrophy, Patent Ductus Arteriosus
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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 death due to Congenital cardiovascular anomaly, Pulmonary artery stenosis congenital
    Additional description: Neonatal death due to Congenital cardiovascular anomaly, Pulmonary artery stenosis congenital
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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 / 1
    0 / 0
    0 / 0
    Neonatal respiratory acidosis, Metabolic acidosis
    Additional description: Neonatal respiratory acidosis, Metabolic acidosis
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Premature baby, Death neonatal
    Additional description: Premature baby, Death neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Premature baby, Gastoschisis, Hyponatremia, Metabolic acidosis
    Additional description: Premature baby, Gastoschisis, Hyponatremia, Metabolic acidosis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Premature baby, Hypoglycemia, Desaturation
    Additional description: Premature baby, Hypoglycemia, Desaturation
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Premature cervical change, Polyhydraminos
    Additional description: Premature cervical change, Polyhydraminos
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Pulmonary embolism symptoms
    Additional description: Pulmonary embolism symptoms
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Tachycardia, Low hemoglobin, Viral infection
    Additional description: Tachycardia, Low hemoglobin, Viral infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Threatened labour, Cystitis
    Additional description: Threatened labour, Cystitis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Unstable foetal lie, Polyhydraminos
    Additional description: Unstable foetal lie, Polyhydraminos
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Weight loss, Hypernatraemia
    Additional description: Weight loss, Hypernatraemia
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Immune system disorders
    Anaphylactic reaction
    Additional description: Anaphylactic reaction
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Milk allergy
    Additional description: Milk allergy
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Reproductive system and breast disorders
    Cervical polyp
    Additional description: Cervical polyp
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Scrotal mass
    Additional description: Scrotal mass
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Shortened cervix
    Additional description: Shortened cervix
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal haemorrhage
    Additional description: Vaginal haemorrhage
         subjects affected / exposed
    7 / 1227 (0.57%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
    Additional description: Apnoea
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    2 / 1374 (0.15%)
    0 / 1236 (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
    Asthma
    Additional description: Asthma
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
    Additional description: Hypoxia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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 aspiration
    Additional description: Neonatal aspiration
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Additional description: Neonatal respiratory distress syndrome
         subjects affected / exposed
    0 / 1227 (0.00%)
    2 / 1364 (0.15%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia, Respiratory distress
    Additional description: Pneumonia, Respiratory distress
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Pneumonia aspiration
    Additional description: Pneumonia aspiration
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Pneumothorax
    Additional description: Pneumothorax
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Pulmonary embolism
    Additional description: Pulmonary embolism
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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 oedema
    Additional description: Pulmonary oedema
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental disorder
    Additional description: Mental disorder
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Investigations
    Blood bilirubin increased
    Additional description: Blood bilirubin increased
         subjects affected / exposed
    0 / 1227 (0.00%)
    2 / 1364 (0.15%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Blood creatinine increased
    Additional description: Blood creatinine increased
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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 glucose
    Additional description: Blood glucose
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Blood glucose decreased
    Additional description: Blood glucose decreased
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Blood glucose increased
    Additional description: Blood glucose increased
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Blood pressure increased
    Additional description: Blood pressure increased
         subjects affected / exposed
    7 / 1227 (0.57%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    6 / 1236 (0.49%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood pressure increased, Proteinuria
    Additional description: Blood pressure increased, Proteinuria
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Cardiac murmur
    Additional description: Cardiac murmur
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Foetal monitoring abnormal
    Additional description: Foetal monitoring abnormal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Foetal non-stress test abnormal
    Additional description: Foetal non-stress test abnormal
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Glucose tolerance test abnormal
    Additional description: Glucose tolerance test abnormal
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Ultrasound Doppler abnormal
    Additional description: Ultrasound Doppler abnormal
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Ultrasound scan abnormal
    Additional description: Ultrasound scan abnormal
         subjects affected / exposed
    1 / 1227 (0.08%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Urine output decreased
    Additional description: Urine output decreased
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Injury, poisoning and procedural complications
    Abdominal injury
    Additional description: Abdominal injury
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Alcohol poisoning
    Additional description: Alcohol poisoning
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Additional description: Brachial plexus injury
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Fracture
    Additional description: Fracture
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Postoperative wound complication
    Additional description: Postoperative wound complication
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         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
    Wound dehiscence
    Additional description: Wound dehiscence
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Wound infection
    Additional description: Wound infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         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
    Congenital, familial and genetic disorders
    Ankyloglossia congenital
    Additional description: Ankyloglossia congenital
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Cleft lip and palate
    Additional description: Cleft lip and palate
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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 cardiovascular anomaly
    Additional description: Congenital cardiovascular anomaly
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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 ectopic bladder
    Additional description: Congenital ectopic bladder
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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 inguinal hernia
    Additional description: Congenital inguinal hernia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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 laryngeal stridor
    Additional description: Congenital laryngeal stridor
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Cytogenetic abnormality
    Additional description: Cytogenetic abnormality
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Encephalocele
    Additional description: Encephalocele
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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 / 1
    0 / 0
    0 / 0
    Fallot's tetralogy
    Additional description: Fallot's tetralogy
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Glucose-6-phosphate dehydrogenase deficiency
    Additional description: Glucose-6-phosphate dehydrogenase deficiency
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Holoprosencephaly
    Additional description: Holoprosencephaly
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Renal aplasia
    Additional description: Renal aplasia
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Trisomy 13
    Additional description: Trisomy 13
         subjects affected / exposed
    0 / 1227 (0.00%)
    2 / 1364 (0.15%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Univentricular heart
    Additional description: Univentricular heart
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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 anomaly
    Additional description: Vascular anomaly
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    2 / 1374 (0.15%)
    0 / 1236 (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 / 2
    0 / 0
    Cardiac disorders
    Cardiac arrest
    Additional description: Cardiac arrest
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Cardiomyopathy
    Additional description: Cardiomyopathy
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Tachycardia foetal
    Additional description: Tachycardia foetal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Ventricular tachycardia
    Additional description: Ventricular tachycardia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Nervous system disorders
    Cerebral haemorrhage
    Additional description: Cerebral haemorrhage
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Cerebral ventricle dilatation
    Additional description: Cerebral ventricle dilatation
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Headache
    Additional description: Headache
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
    Additional description: Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Migraine
    Additional description: Migraine
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine, Syncope, Bell's palsy
    Additional description: Migraine, Syncope, Bell's palsy
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Partial seizures
    Additional description: Partial seizures
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Subarachnoid haemorrhage
    Additional description: Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Haemolytic anaemia
    Additional description: Haemolytic anaemia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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 transfusion syndrome
    Additional description: Placental transfusion syndrome
         subjects affected / exposed
    2 / 1227 (0.16%)
    2 / 1364 (0.15%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Gastrointestinal disorders
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
    Additional description: Abdominal pain lower
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Dyspepsia
    Additional description: Dyspepsia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Haematochezia
    Additional description: Haematochezia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Intestinal obstruction
    Additional description: Intestinal obstruction
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Necrotising colitis
    Additional description: Necrotising colitis
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Pancreatitis
    Additional description: Pancreatitis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Upper gastrointestinal haemorrhage
    Additional description: Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Volvulus
    Additional description: Volvulus
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute fatty liver of pregnancy
    Additional description: Acute fatty liver of pregnancy
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Biliary colic
    Additional description: Biliary colic
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
    Additional description: Cholelithiasis
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholestasis
    Additional description: Cholestasis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         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
    Cholestasis of pregnancy
    Additional description: Cholestasis of pregnancy
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
    Additional description: Hyperbilirubinaemia
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Hyperbilirubinaemia neonatal
    Additional description: Hyperbilirubinaemia neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    2 / 1364 (0.15%)
    2 / 1374 (0.15%)
    0 / 1236 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-alcoholic steatohepatitis
    Additional description: Non-alcoholic steatohepatitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Skin and subcutaneous tissue disorders
    Eczema
    Additional description: Eczema
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Renal and urinary disorders
    Nephrolithiasis
    Additional description: Nephrolithiasis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         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
    Renal colic
    Additional description: Renal colic
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
    Additional description: Renal impairment
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Ureteric obstruction
    Additional description: Ureteric obstruction
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Urinary incontinence
    Additional description: Urinary incontinence
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Urinary retention
    Additional description: Urinary retention
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Musculoskeletal and connective tissue disorders
    Foot deformity
    Additional description: Foot deformity
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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
    Intervertebral disc protrusion
    Additional description: Intervertebral disc protrusion
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Pubic pain
    Additional description: Pubic pain
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Infections and infestations
    Appendicitis
    Additional description: Appendicitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
    Additional description: Arthritis bacterial
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Bronchiolitis
    Additional description: Bronchiolitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    2 / 1364 (0.15%)
    2 / 1374 (0.15%)
    0 / 1236 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chorioamnionitis
    Additional description: Chorioamnionitis
         subjects affected / exposed
    0 / 1227 (0.00%)
    2 / 1364 (0.15%)
    0 / 1374 (0.00%)
    0 / 1236 (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 / 2
    0 / 0
    0 / 0
    Congenital pneumonia
    Additional description: Congenital pneumonia
         subjects affected / exposed
    0 / 1227 (0.00%)
    2 / 1364 (0.15%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Endometritis
    Additional description: Endometritis
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometritis, Urinary tract infection
    Additional description: Endometritis, Urinary tract infection
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Gastroenteritis viral
    Additional description: Gastroenteritis viral
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
    Additional description: Impaired gastric emptying
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Infection, Endometritis, Left Mastitis, Urinary tract infection
    Additional description: Infection, Endometritis, Left Mastitis, Urinary tract infection
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Additional description: Influenza
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Meningitis viral
    Additional description: Meningitis viral
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    2 / 1374 (0.15%)
    0 / 1236 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastitis
    Additional description: Mastitis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Moraxella infection
    Additional description: Moraxella infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
    Additional description: Postoperative wound infection
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
    Additional description: Pyelonephritis
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    6 / 1236 (0.49%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
    Additional description: Sepsis
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis neonatal
    Additional description: Sepsis neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    3 / 1374 (0.22%)
    0 / 1236 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Streptococcal urinary tract infection
    Additional description: Streptococcal urinary tract infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (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 respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         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
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    4 / 1227 (0.33%)
    2 / 1364 (0.15%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    1 / 1236 (0.08%)
         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
    Metabolism and nutrition disorders
    Cow's milk intolerance, Gastrooesophageal reflux disease
    Additional description: Cow's milk intolerance, Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    1 / 1227 (0.08%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
    Additional description: Diabetes mellitus
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Diabetes mellitus inadequate control
    Additional description: Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         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
    Diabetic ketoacidosis
    Additional description: Diabetic ketoacidosis
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fluid overload
    Additional description: Fluid overload
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Food intolerance
    Additional description: Food intolerance
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    5 / 1227 (0.41%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
    Additional description: Hypoglycaemia
         subjects affected / exposed
    2 / 1227 (0.16%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ketosis
    Additional description: Ketosis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Metabolic syndrome
    Additional description: Metabolic syndrome
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Type 2 diabetes mellitus
    Additional description: Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 active_mother active_infant placebo_infant placebo_mother
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    910 / 1227 (74.16%)
    197 / 1364 (14.44%)
    238 / 1374 (17.32%)
    930 / 1236 (75.24%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acrochordon
    Additional description: Acrochordon
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    4 / 1374 (0.29%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    4
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vascular disorders
    Gestational hypertension
    Additional description: Gestational hypertension
         subjects affected / exposed
    20 / 1227 (1.63%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    12 / 1236 (0.97%)
         occurrences all number
    20
    0
    0
    12
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    49 / 1227 (3.99%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    42 / 1236 (3.40%)
         occurrences all number
    49
    0
    0
    42
    Subgaleal haematoma
    Additional description: Subgaleal haematoma
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hot flush
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    3
    0
    0
    3
    Labile hypertension
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    1
    0
    0
    2
    Thrombosis
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    1
    0
    1
    Thrombophlebitis superficial
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    4
    0
    0
    1
    Thrombophlebitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Phlebitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Labile blood pressure
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypotension
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    3
    0
    0
    3
    Haematoma
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Surgical and medical procedures
    Abortion induced
    Additional description: Abortion induced
         subjects affected / exposed
    1 / 1227 (0.08%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Bartholin's cyst removal
    Additional description: Bartholin's cyst removal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    External cephalic version
    Additional description: Failed external cephalic version
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory support
    Additional description: Respiratory support
         subjects affected / exposed
    0 / 1227 (0.00%)
    2 / 1364 (0.15%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Transfusion
    Additional description: Transfusion
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Wound treatment
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Tooth extraction
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    0
    0
    0
    3
    Office visit
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Ureteral stent insertion
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Surgery
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Tooth repair
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Physiotherapy
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General anaesthesia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Forceps delivery
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Episiotomy
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Foetal growth restriction
    Additional description: Foetal growth restriction
         subjects affected / exposed
    0 / 1227 (0.00%)
    9 / 1364 (0.66%)
    14 / 1374 (1.02%)
    5 / 1236 (0.40%)
         occurrences all number
    0
    9
    14
    5
    Foetal hypokinesia
    Additional description: Foetal hypokinesia
         subjects affected / exposed
    93 / 1227 (7.58%)
    18 / 1364 (1.32%)
    27 / 1374 (1.97%)
    92 / 1236 (7.44%)
         occurrences all number
    93
    18
    27
    92
    Gestational diabetes
    Additional description: Gestational diabetes
         subjects affected / exposed
    89 / 1227 (7.25%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    90 / 1236 (7.28%)
         occurrences all number
    89
    0
    1
    90
    Jaundice neonatal
    Additional description: Jaundice neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    14 / 1364 (1.03%)
    17 / 1374 (1.24%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    14
    17
    0
    Polyhydramnios
    Additional description: Polyhydramnios
         subjects affected / exposed
    8 / 1227 (0.65%)
    2 / 1364 (0.15%)
    1 / 1374 (0.07%)
    13 / 1236 (1.05%)
         occurrences all number
    8
    2
    1
    13
    Postpartum haemorrhage
    Additional description: Postpartum haemorrhage
         subjects affected / exposed
    25 / 1227 (2.04%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    32 / 1236 (2.59%)
         occurrences all number
    25
    0
    0
    32
    Pre-eclampsia
    Additional description: Pre-eclampsia
         subjects affected / exposed
    26 / 1227 (2.12%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    18 / 1236 (1.46%)
         occurrences all number
    26
    0
    0
    18
    Premature baby
    Additional description: Premature baby
         subjects affected / exposed
    3 / 1227 (0.24%)
    39 / 1364 (2.86%)
    26 / 1374 (1.89%)
    1 / 1236 (0.08%)
         occurrences all number
    3
    39
    26
    1
    Premature rupture of membranes
    Additional description: Premature rupture of membranes
         subjects affected / exposed
    18 / 1227 (1.47%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    23 / 1236 (1.86%)
         occurrences all number
    18
    1
    1
    23
    Uterine contractions during pregnancy
    Additional description: Uterine contractions during pregnancy
         subjects affected / exposed
    37 / 1227 (3.02%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    37 / 1236 (2.99%)
         occurrences all number
    37
    0
    1
    37
    Born before arrival
    Additional description: Born before arrival
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Contractions, Premature rupture of membranes
    Additional description: Contractions, Premature rupture of membranes
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Contractions, Vaginal haemorrhage
    Additional description: Contractions, Vaginal haemorrhage
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Contractions, Vaginal haemorrhage, Premature rupture of membranes
    Additional description: Contractions, Vaginal haemorrhage, Premature rupture of membranes
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Low birth weight baby, Oligohydramnios
    Additional description: Low birth weight baby, Oligohydramnios
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Placental transfusion syndrome, Oligohydramnios
    Additional description: Placental transfusion syndrome, Oligohydramnios
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain lower, Contractions
    Additional description: Abdominal pain lower, Contractions
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abortion threatened
    Additional description: Abortion threatened
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Caesarean section
    Additional description: Caesarean section
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    1
    0
    2
    Cephalhaematoma
    Additional description: Cephalhaematoma
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    2 / 1374 (0.15%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Cervical incompetence
    Additional description: Cervical incompetence
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Prenatal screening test abnormal
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Low birth weight baby
    Additional description: Low birth weight baby
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    2 / 1374 (0.15%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Amniorrhoea
    Additional description: Amniorrhoea
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    2
    0
    0
    2
    Placenta accreta
    Additional description: Placenta accreta
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Labour pain
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Meconium stain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Foetal macrosomia
         subjects affected / exposed
    0 / 1227 (0.00%)
    2 / 1364 (0.15%)
    6 / 1374 (0.44%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    2
    6
    1
    Labour induction
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    2
    0
    0
    1
    Imminent abortion
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Meconium abnormal
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Vomiting in pregnancy
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         occurrences all number
    2
    0
    0
    4
    Umbilical cord prolapse
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Retained placenta or membranes
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    2
    0
    0
    2
    Placental disorder
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    1
    0
    0
    2
    Placenta praevia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Labour
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    2
    0
    0
    3
    Large for dates baby
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    1
    1
    Foetal distress syndrome
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Placental insufficiency
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    General disorders and administration site conditions
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    20 / 1227 (1.63%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    22 / 1236 (1.78%)
         occurrences all number
    20
    0
    0
    22
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    35 / 1227 (2.85%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    37 / 1236 (2.99%)
         occurrences all number
    35
    0
    0
    37
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    21 / 1227 (1.71%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    18 / 1236 (1.46%)
         occurrences all number
    21
    0
    0
    18
    Oedema
    Additional description: Oedema
         subjects affected / exposed
    33 / 1227 (2.69%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    38 / 1236 (3.07%)
         occurrences all number
    33
    0
    0
    38
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    93 / 1227 (7.58%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    102 / 1236 (8.25%)
         occurrences all number
    93
    0
    0
    102
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    13 / 1227 (1.06%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    7 / 1236 (0.57%)
         occurrences all number
    13
    0
    0
    7
    Abdominal cramping, Vaginal discharge
    Additional description: Abdominal cramping, Vaginal discharge
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal discomfort, Pelvic pain
    Additional description: Abdominal discomfort, Pelvic pain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain, Amniotic fluid leak
    Additional description: Abdominal pain, Amniotic fluid leak
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain, Back pain
    Additional description: Abdominal pain, Back pain
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Abdominal pain, Contractions
    Additional description: Abdominal pain, Contractions
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain, Pyrexia
    Additional description: Abdominal pain, Pyrexia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal pain, Vaginal discharge
    Additional description: Abdominal pain, Vaginal discharge
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain, Vaginal haemorrhage
    Additional description: Abdominal pain, Vaginal haemorrhage
         subjects affected / exposed
    6 / 1227 (0.49%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         occurrences all number
    6
    0
    0
    4
    Abdominal pain lower, Back pain
    Additional description: Abdominal pain lower, Back pain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain lower, Vaginal haemorrhage, Back pain
    Additional description: Abdominal pain lower, Vaginal haemorrhage, Back pain
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal pain upper, Dyspnoea
    Additional description: Abdominal pain upper, Dyspnoea
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal pain upper, Headache
    Additional description: Abdominal pain upper, Headache
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    3
    0
    0
    2
    Abdominal pain upper, Nausea
    Additional description: Abdominal pain upper, Nausea
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal pain upper, Headache, Oedema peripheral
    Additional description: Abdominal pain upper, Headache, Oedema peripheral
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    1
    0
    0
    2
    Abdominal pain, Diarrhoea, Back pain, Vaginal discharge
    Additional description: Abdominal pain, Diarrhoea, Back pain, Vaginal discharge
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal pain, Back pain, Visual impairment
    Additional description: Abdominal pain, Back pain, Visual impairment
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal pain, Headache, Oedema peripheral
    Additional description: Abdominal pain, Headache, Oedema peripheral
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain, Malaise, Heart rate increased, Dehydration
    Additional description: Abdominal pain, Malaise, Heart rate increased, Dehydration
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain, Vaginal haemorrhage, Cholestasis of pregnancy
    Additional description: Abdominal pain, Vaginal haemorrhage, Cholestasis of pregnancy
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal pain, Vomiting, Tachypnoea
    Additional description: Abdominal pain, Vomiting, Tachypnoea
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Back pain, Constipation
    Additional description: Back pain, Constipation
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Back pain, Contractions
    Additional description: Back pain, Contractions
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Back pain, Pollakiuria
    Additional description: Back pain, Pollakiuria
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Back pain, Right sided pain, Vomiting
    Additional description: Back pain, Right sided pain, Vomiting
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Back pain, Oropharyngeal pain, Diarrhoea, Pollakiuria
    Additional description: Back pain, Oropharyngeal pain, Diarrhoea, Pollakiuria
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Blood glucose, Urine ketone body present
    Additional description: Blood glucose and Urine ketone body present
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood glucose increased, Nausea
    Additional description: Blood glucose increased, Nausea
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood pressure increased, Dyspnoea
    Additional description: Blood pressure increased, Dyspnoea
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood pressure increased, Anogenital warts
    Additional description: Blood pressure increased, Anogenital warts
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Blood pressure increased, Headache
    Additional description: Blood pressure increased, Headache
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    3
    0
    0
    3
    Blood pressure increased, Oedema peripheral
    Additional description: Blood pressure increased, Oedema peripheral
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    2
    0
    0
    3
    Blood pressure increased, Visual impairment
    Additional description: Blood pressure increased, Visual impairment
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood pressure increased, Headache, Blurred vision
    Additional description: Blood pressure increased, Headache, Blurred vision
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Blood pressure increased, Oedema
    Additional description: Blood pressure increased, Oedema
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Vision blurred, Dizziness, Protein urine
    Additional description: Vision blurred, Dizziness, Protein urine
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Chest discomfort, Cough
    Additional description: Chest discomfort, Cough
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Chorioamniotis, Creatine urine increased
    Additional description: Chorioamniotis, Creatine urine increased
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Constipation, Urinary tract infection, Vaginal discharge
    Additional description: Constipation, Urinary tract infection, Vaginal discharge
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Contractions, Pelvic pain
    Additional description: Contractions, Pelvic pain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Contractions, Candida infection
    Additional description: Contractions, Candida infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Contractions, Vomiting
    Additional description: Contractions, Vomiting
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Diarrhoea, Nausea, Sensation of pressure, Vaginal discharge
    Additional description: Diarrhoea, Nausea, Sensation of pressure, Vaginal discharge
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Dry eye, Dry mouth
    Additional description: Dry eye, Dry mouth
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspnoea, Asthenia, Vision blurred
    Additional description: Dyspnoea, Asthenia, Vision blurred
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspnoea, Diarrhoea, Myalgia, Abdominal pain, Back pain
    Additional description: Dyspnoea, Diarrhoea, Myalgia, Abdominal pain, Back pain
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspnoea, Headache, Oedema, Protein urine, Blood urine
    Additional description: Dyspnoea, Headache, Oedema, Protein urine, Blood urine
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspnoea, Chest pain
    Additional description: Dyspnoea, Chest pain
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Fatigue, Abdominal pain, Nausea
    Additional description: Fatigue, Abdominal pain, Nausea
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Fatigue, Oropharyngeal pain, Abdominal pain upper
    Additional description: Fatigue, Oropharyngeal pain, Abdominal pain upper
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Headache, Amylase increased
    Additional description: Headache, Amylase increased
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache, Arthralgia
    Additional description: Headache, Arthralgia
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Headache, Back pain
    Additional description: Headache, Back pain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    Headache, Diarrhoea
    Additional description: Headache, Diarrhoea
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Headache, Oedema
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Headache, Oedema peripheral
    Additional description: Headache, Oedema peripheral
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Headache, Pain in extremity
    Additional description: Headache, Pain in extremity
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Headache, Protein urine
    Additional description: Headache, Protein urine
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Headache, Proteinuria
    Additional description: Headache, Proteinuria
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache, Urine protein/creatinine ratio
    Additional description: Headache, Urine protein/creatinine ratio
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache, Dizziness, Night sweats
    Additional description: Headache, Dizziness, Night sweats
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Headache, Ear pain, Nausea, Dyspepsia
    Additional description: Headache, Ear pain, Nausea, Dyspepsia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache, Pain in extremity, Diarrhoea
    Additional description: Headache, Pain in extremity, Diarrhoea
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache, Nausea, Back pain
    Additional description: Headache, Nausea, Back pain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Headache, Oedema, Visual impairment
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache, Oedema peripheral, Visual impairment, Abdominal pain upper, Dyspepsia
    Additional description: Headache, Oedema peripheral, Visual impairment, Abdominal pain upper, Dyspepsia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache, Oedema, Abdominal pain, Hypertension
    Additional description: Headache, Oedema, Abdominal pain, Hypertension
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache, Oedema, Abdominal pain upper, Malaise
    Additional description: Headache, Oedema, Abdominal pain upper, Malaise
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache, Oedema, Blood pressure increased, Protein urine
    Additional description: Headache, Oedema, Blood pressure increased, Protein urine
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache, Dysuria, Candida infection
    Additional description: Headache, Dysuria, Candida infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Headache, Visual impairment, Nausea, Diarrhoea
    Additional description: Headache, Visual impairment, Nausea, Diarrhoea
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Headache, Vomiting, Hypertension
    Additional description: Headache, Vomiting, Hypertension
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Hypertension, Oedema peripheral
    Additional description: Hypertension, Oedema peripheral
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Hypertension, Proteinuria
    Additional description: Hypertension, Proteinuria
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Hypertension, Heart rate increased, Palpitations
    Additional description: Hypertension, Heart rate increased, Palpitations
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Pain in extremity, Oedema peripheral, Haemoptysis
    Additional description: Pain in extremity, Oedema peripheral, Haemoptysis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lethargy, Dizziness, Dyspepsia
    Additional description: Lethargy, Dizziness, Dyspepsia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Loss of consciousness, Foetal hypokinesia
    Additional description: Loss of consciousness, Foetal hypokinesia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Malaise, Oedema peripheral
    Additional description: Malaise, Oedema peripheral
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Maternal exposure during pregnancy to Varicella
    Additional description: Maternal exposure during pregnancy to Varicella
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Migraine, Syncope, Bell's palsy
    Additional description: Migraine, Syncope, Bell's palsy
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal pain, Urinary tract infection, Dyspepsia
    Additional description: Musculoskeletal pain, Urinary tract infection, Dyspepsia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Myalgia, Vaginal discharge
    Additional description: Myalgia, Vaginal discharge
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Nausea, Palpitations, Insomnia
    Additional description: Nausea, Palpitations, Insomnia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Jaundice neonatal, Hypoglycaemia neonatal, Sepsis neonatal
    Additional description: Jaundice neonatal, Hypoglycaemia neonatal, Sepsis neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oedema peripheral, Dizziness
    Additional description: Oedema peripheral, Dizziness
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Oedema peripheral, Candida infection
    Additional description: Oedema peripheral, Candida infection
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oedema peripheral, Vulvovaginal swelling
    Additional description: Oedema peripheral, Vulvovaginal swelling
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain in extremity, Vaginal haemorrhage, Abdominal pain
    Additional description: Pain in extremity, Vaginal haemorrhage, Abdominal pain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Premature rupture of membranes, Chorioamniotis
    Additional description: Premature rupture of membranes, Chorioamniotis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Premature rupture of membranes, Vaginal haemorrhage
    Additional description: Premature rupture of membranes, Vaginal haemorrhage
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Protein urine, Oedema peripheral
    Additional description: Protein urine, Oedema peripheral
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Proteinuria, Oedema peripheral
    Additional description: Proteinuria, Oedema peripheral
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritus, Back pain, Oedema
    Additional description: Pruritus, Back pain, Oedema
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rash, Foetal hypokinesia
    Additional description: Rash, Foetal hypokinesia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rash, Pyrexia
    Additional description: Rash, Pyrexia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Reflux gastritis, Ketone body in urine
    Additional description: Reflux gastritis, Ketone body in urine
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Sciatica, Skin infection
    Additional description: Sciatica, Skin infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Shoulder dystocia, Erb's palsy
    Additional description: Shoulder dystocia, Erb's palsy
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    2 / 1374 (0.15%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Musculoskeletal pain, Rash
    Additional description: Shoulder pain, Rash
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Thirst, Hyperhidrosis
    Additional description: Thirst, Hyperhidrosis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Vaginal discomfort, Back pain, Dysuria
    Additional description: Vaginal discomfort, Back pain, Dysuria
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vaginal haemorrhage, Pain
    Additional description: Vaginal haemorrhage, Pain
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vaginal haemorrhage, Pelvic pain
    Additional description: Vaginal haemorrhage, Pelvic pain
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vaginal haemorrhage, Vaginal discharge
    Additional description: Vaginal haemorrhage, Vaginal discharge
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vaginal haemorrhage, Diarrhoea, Incontinence
    Additional description: Vaginal haemorrhage, Diarrhoea, Incontinence
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Visual impairment, Dyspnoea, Polyhydramnios
    Additional description: Visual impairment, Dyspnoea, Polyhydramnios
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vomiting, Dizziness, Migraine
    Additional description: Vomiting, Dizziness, Migraine
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain, Back pain, Vaginal discharge
    Additional description: Abdominal pain, Back pain, Vaginal discharge
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    7 / 1227 (0.57%)
    0 / 1364 (0.00%)
    7 / 1374 (0.51%)
    0 / 1236 (0.00%)
         occurrences all number
    7
    0
    7
    0
    Chest discomfort
    Additional description: Chest discomfort
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Drug level changed
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Fat necrosis
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General symptom
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Injection site nodule
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Thirst
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    1
    0
    0
    2
    Swelling
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    5 / 1236 (0.40%)
         occurrences all number
    3
    0
    0
    5
    Sensation of pressure
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         occurrences all number
    0
    0
    0
    4
    Pre-existing condition improved
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Pain
         subjects affected / exposed
    11 / 1227 (0.90%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    6 / 1236 (0.49%)
         occurrences all number
    11
    0
    0
    6
    Irritability
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    0
    0
    0
    3
    Impaired healing
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Hypothermia neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Feeling abnormal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Face oedema
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    1
    0
    0
    3
    Feeling hot
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    1
    0
    0
    2
    Immune system disorders
    ABO incompatibility
    Additional description: ABO incompatibility
         subjects affected / exposed
    0 / 1227 (0.00%)
    3 / 1364 (0.22%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Drug hypersensitivity
    Additional description: Drug hypersensitivity
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    1
    0
    0
    3
    House dust allergy
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Seasonal allergy
         subjects affected / exposed
    8 / 1227 (0.65%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         occurrences all number
    8
    0
    0
    4
    Food allergy
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Reproductive system and breast disorders
    Pelvic pain
    Additional description: Pelvic pain
         subjects affected / exposed
    32 / 1227 (2.61%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    31 / 1236 (2.51%)
         occurrences all number
    32
    0
    0
    31
    Vaginal discharge
    Additional description: Vaginal discharge
         subjects affected / exposed
    14 / 1227 (1.14%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    18 / 1236 (1.46%)
         occurrences all number
    14
    0
    0
    18
    Vaginal haemorrhage
    Additional description: Vaginal haemorrhage
         subjects affected / exposed
    56 / 1227 (4.56%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    61 / 1236 (4.94%)
         occurrences all number
    56
    1
    0
    61
    Bartholinitis
    Additional description: Bartholinitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Breast cyst
    Additional description: Breast cyst
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Breast pain
    Additional description: Breast pain
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    4
    0
    0
    1
    Breast tenderness
    Additional description: Breast tenderness
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    2
    0
    0
    3
    Cervix disorder
    Additional description: Cervix disorder
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Vulvovaginal pain
    Additional description: Vulovaginal pain
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    2
    0
    0
    3
    Vulvovaginal burning sensation
    Additional description: Vulvovaginal burning sensation
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Coital bleeding
    Additional description: Coital bleeding
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    Pelvic discomfort
    Additional description: Pelvic discomfort
         subjects affected / exposed
    7 / 1227 (0.57%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    7 / 1236 (0.57%)
         occurrences all number
    7
    0
    0
    7
    Uterine cervical pain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Cervical friability
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cervix haematoma uterine
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Vaginal lesion
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Vulvovaginal discomfort
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    3
    0
    0
    2
    Varicose veins vulval
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vaginal odour
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Vaginal laceration
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Uterine spasm
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    4
    0
    0
    3
    Uterine atony
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Uterine haemorrhage
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: Cough
         subjects affected / exposed
    16 / 1227 (1.30%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    26 / 1236 (2.10%)
         occurrences all number
    16
    0
    0
    26
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    86 / 1227 (7.01%)
    1 / 1364 (0.07%)
    2 / 1374 (0.15%)
    86 / 1236 (6.96%)
         occurrences all number
    86
    1
    2
    86
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    14 / 1227 (1.14%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    22 / 1236 (1.78%)
         occurrences all number
    14
    0
    0
    22
    Oropharyngeal pain
    Additional description: Oropharyngeal pain
         subjects affected / exposed
    19 / 1227 (1.55%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    13 / 1236 (1.05%)
         occurrences all number
    19
    0
    0
    13
    Atelectasis, Pneumothorax
    Additional description: Atelectasis, Pneumothorax
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Bronchospasm
    Additional description: Bronchospasm
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Chronic obstructive pulmonary disease
    Additional description: Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Dyspnoea exertional
    Additional description: Dyspnoea exertional
         subjects affected / exposed
    5 / 1227 (0.41%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         occurrences all number
    5
    0
    0
    4
    Wheezing
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Transient tachypnoea of the newborn
         subjects affected / exposed
    0 / 1227 (0.00%)
    5 / 1364 (0.37%)
    2 / 1374 (0.15%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    5
    2
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    Sinus congestion
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    3
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    1
    0
    0
    3
    Productive cough
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Pleural effusion
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    8 / 1227 (0.65%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    12 / 1236 (0.97%)
         occurrences all number
    8
    0
    1
    12
    Pulmonary haemorrhage neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    16 / 1227 (1.30%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    17 / 1236 (1.38%)
         occurrences all number
    16
    0
    0
    17
    Anxiety
    Additional description: Anxiety
         subjects affected / exposed
    7 / 1227 (0.57%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    5 / 1236 (0.40%)
         occurrences all number
    7
    0
    0
    5
    Anxiety attack
    Additional description: Anxiety attack
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Breath holding
    Additional description: Breath holding
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Depressed mood
    Additional description: Depressed mood
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Depression
    Additional description: Depression
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    4
    0
    0
    2
    Disturbance in attention
    Additional description: Disturbance in attention
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Postpartum depression
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         occurrences all number
    2
    0
    0
    4
    Sleep disorder
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    2
    0
    0
    2
    Panic attack
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    1
    0
    0
    2
    Nervousness
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Mood swings
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    1
    0
    0
    2
    Hepatobiliary disorders
    Hyperbilirubinaemia neonatal
    Additional description: Hyperbilirubinaemia neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    14 / 1364 (1.03%)
    18 / 1374 (1.31%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    14
    18
    0
    Cholecystitis
    Additional description: Cholecystitis
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    2
    0
    0
    2
    Hepatomegaly
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hepatic pain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Blood pressure increased
    Additional description: Blood pressure increased
         subjects affected / exposed
    52 / 1227 (4.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    40 / 1236 (3.24%)
         occurrences all number
    52
    0
    0
    40
    Protein urine present
    Additional description: Protein urine present
         subjects affected / exposed
    13 / 1227 (1.06%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    13 / 1236 (1.05%)
         occurrences all number
    13
    0
    0
    13
    Serum ferritin
    Additional description: Serum ferritin
         subjects affected / exposed
    14 / 1227 (1.14%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    7 / 1236 (0.57%)
         occurrences all number
    14
    1
    0
    7
    Blood pressure increased, Protein in urine
    Additional description: Blood pressure increased, Protein in urine
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    2
    0
    0
    1
    Blood pressure increased, Proteinuria
    Additional description: Blood pressure increased, Proteinuria
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    4
    0
    0
    2
    Alanine aminotransferase increased
    Additional description: Alanine aminotransferase increased
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    4
    0
    1
    0
    Albumin urine
    Additional description: Albumin urine test
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    2 / 1374 (0.15%)
    0 / 1236 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Aspartate aminotransferase increased
    Additional description: Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    0
    0
    0
    3
    Blood bicarbonate
    Additional description: Blood bicarbonate
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood bilirubin
    Additional description: Blood bilirubin
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood calcium
    Additional description: Blood calcium
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood chloride
    Additional description: Blood chloride
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    Blood creatine
    Additional description: Blood creatine
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood fibrinogen increased
    Additional description: Blood fibrinogen increased
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Blood gases abnormal
    Additional description: Blood gases abnormal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    3 / 1374 (0.22%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Blood iron decreased
    Additional description: Blood iron decreased
         subjects affected / exposed
    8 / 1227 (0.65%)
    0 / 1364 (0.00%)
    3 / 1374 (0.22%)
    0 / 1236 (0.00%)
         occurrences all number
    8
    0
    3
    0
    Blood lactate dehydrogenase
    Additional description: Blood lactate dehydrogenase
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Blood potassium decreased
    Additional description: Blood potassium decreased
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Blood pressure abnormal
    Additional description: Blood pressure abnormal
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    2
    0
    0
    1
    Blood pressure decreased
    Additional description: Blood pressure decreased
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    4
    0
    0
    2
    Blood sodium
    Additional description: Blood sodium
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood sodium abnormal
    Additional description: Blood sodium abnormal
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood thyroid stimulating hormone
    Additional description: Blood thyroid stimulating hormone
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    2
    0
    0
    2
    Blood urea
    Additional description: Blood urea
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood uric acid increased
    Additional description: Blood uric acid increased
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Blood urine
    Additional description: Blood urine
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    1
    0
    0
    3
    Human rhinovirus test positive
    Additional description: Human rhinovirus test positive
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Streptococcus test positive
    Additional description: Streptococcus test positive
         subjects affected / exposed
    7 / 1227 (0.57%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    8 / 1236 (0.65%)
         occurrences all number
    7
    0
    0
    8
    Respiratory syncytial virus test positive
    Additional description: Respiratory syncytial virus test positive
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Venous oxygen partial pressure decreased
    Additional description: Venous oxygen partial pressure decreased
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Total bile acids increased
    Additional description: Total bile acids increased
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    2
    0
    0
    1
    Fibronectin increased
    Additional description: Fibronectin increased
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Amniotic fluid volume increased
    Additional description: Amniotic fluid volume increased
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Amniotic fluid volume decreased
    Additional description: Amniotic fluid volume decreased
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Urine cannabinoids increased
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Urine analysis abnormal
         subjects affected / exposed
    5 / 1227 (0.41%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    9 / 1236 (0.73%)
         occurrences all number
    5
    0
    0
    9
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastric pH decreased
         subjects affected / exposed
    8 / 1227 (0.65%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    9 / 1236 (0.73%)
         occurrences all number
    8
    0
    0
    9
    Total bile acids
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Base excess
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urine ketone body present
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    Urine protein/creatinine ratio increased
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Urine albumin/creatinine ratio increased
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Foetal heart rate abnormal
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    3 / 1374 (0.22%)
    2 / 1236 (0.16%)
         occurrences all number
    3
    0
    3
    2
    Urine leukocyte esterase positive
         subjects affected / exposed
    6 / 1227 (0.49%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    5 / 1236 (0.40%)
         occurrences all number
    6
    0
    0
    5
    White blood cell count decreased
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vitamin B12
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Tri-iodothyronine
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    0
    0
    0
    3
    Serum ferritin decreased
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    2
    0
    0
    1
    Platelet count
         subjects affected / exposed
    3 / 1227 (0.24%)
    2 / 1364 (0.15%)
    1 / 1374 (0.07%)
    3 / 1236 (0.24%)
         occurrences all number
    3
    2
    1
    3
    Physical examination
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Oxygen saturation decreased
         subjects affected / exposed
    2 / 1227 (0.16%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Heart rate increased
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Heart rate abnormal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haemoglobin
         subjects affected / exposed
    12 / 1227 (0.98%)
    0 / 1364 (0.00%)
    2 / 1374 (0.15%)
    11 / 1236 (0.89%)
         occurrences all number
    12
    0
    2
    11
    Haemoglobin decreased
         subjects affected / exposed
    12 / 1227 (0.98%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    5 / 1236 (0.40%)
         occurrences all number
    12
    0
    0
    5
    Haematocrit
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    2 / 1374 (0.15%)
    2 / 1236 (0.16%)
         occurrences all number
    2
    0
    2
    2
    Glycosylated haemoglobin
         subjects affected / exposed
    6 / 1227 (0.49%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    7 / 1236 (0.57%)
         occurrences all number
    6
    0
    0
    7
    Glucose urine present
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    Glucose urine
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Glucose tolerance test
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Injury, poisoning and procedural complications
    Fall
    Additional description: Fall
         subjects affected / exposed
    9 / 1227 (0.73%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    13 / 1236 (1.05%)
         occurrences all number
    9
    0
    1
    13
    Accidental overdose
    Additional description: Accidental overdose
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Accidental poisoning
    Additional description: Accidental poisoning
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Animal bite
    Additional description: Animal bite (dog)
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ankle fracture
    Additional description: Ankle fracture
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Clavicle fracture
    Additional description: Clavicle fracture
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Maternal exposure during pregnancy to Hand-foot-and-mouth disease
    Additional description: Maternal exposure during pregnancy to Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Foreign body
    Additional description: Foreign body
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    1
    0
    0
    2
    Skeletal injury
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    Procedural complication
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Thermal burn
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Contusion
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    1
    2
    Muscle strain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         occurrences all number
    0
    0
    0
    4
    Excoriation
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Uterine rupture
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Sunburn
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Seroma
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Road traffic accident
         subjects affected / exposed
    7 / 1227 (0.57%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    5 / 1236 (0.40%)
         occurrences all number
    7
    0
    0
    5
    Perineal laceration
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    0
    0
    0
    3
    Foot fracture
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    Femoral nerve injury
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Congenital, familial and genetic disorders
    Congenital cardiovascular anomaly
    Additional description: Congenital cardiovascular anomaly
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Apert's syndrome
    Additional description: Apert's syndrome
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Atrial septal defect
    Additional description: Atrial septal defect
         subjects affected / exposed
    1 / 1227 (0.08%)
    1 / 1364 (0.07%)
    2 / 1374 (0.15%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Cataract congenital
    Additional description: Cataract congenital
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Congenital anomaly
    Additional description: Congenital anomaly
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Congenital central nervous system anomaly
    Additional description: Congenital central nervous system anomaly
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Cryptorchism
    Additional description: Cryptorchism
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Developmental hip dysplasia
    Additional description: Developmental hip dysplasia
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Congenital skin dimples
    Additional description: Congenital skin dimples
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    3 / 1374 (0.22%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Skeletal dysplasia
    Additional description: Skeletal dysplasia
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Congenital naevus
    Additional description: Congenital naevus
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Naevus flammeus
    Additional description: Naevus flammeus
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ectopic kidney
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skull malformation
    Additional description: Skull malformation
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Anomaly of external ear congenital
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Congenital Eustachian tube anomaly
    Additional description: Congenital Eustachian tube anomaly
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Congenital oral malformation
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Laryngomalacia
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Trisomy 18
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Congenital eye naevus
         subjects affected / exposed
    0 / 1227 (0.00%)
    2 / 1364 (0.15%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Congenital hydronephrosis
         subjects affected / exposed
    1 / 1227 (0.08%)
    2 / 1364 (0.15%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Macrocephaly
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Congenital adrenal gland hypoplasia
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Trisomy 21
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Talipes
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sebaceous naevus
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyloric stenosis
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pulmonary malformation
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pulmonary artery stenosis congenital
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Patent ductus arteriosus
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Limb malformation
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Kidney duplex
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypospadias
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Hydrocele
         subjects affected / exposed
    0 / 1227 (0.00%)
    3 / 1364 (0.22%)
    3 / 1374 (0.22%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Heart disease congenital
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haemangioma congenital
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    2 / 1374 (0.15%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Gastroschisis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Galactosaemia
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Exomphalos
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Congenital hypothyroidism
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    14 / 1227 (1.14%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    15 / 1236 (1.21%)
         occurrences all number
    14
    0
    0
    15
    Arrhythmia
    Additional description: Arrhythmia
         subjects affected / exposed
    1 / 1227 (0.08%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Bradycardia foetal
    Additional description: Bradycardia foetal
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    3 / 1374 (0.22%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Bradycardia
    Additional description: Bradycardia
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    2
    0
    0
    1
    Bundle branch block left
    Additional description: Bundle branch block left
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Cardiomegaly
    Additional description: Cardiomegaly
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Cyanosis
    Additional description: Cyanosis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    3 / 1374 (0.22%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Foetal heart rate deceleration abnormality
         subjects affected / exposed
    1 / 1227 (0.08%)
    1 / 1364 (0.07%)
    3 / 1374 (0.22%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    1
    3
    0
    Bradycardia neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pericardial cyst
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Wolff-Parkinson-White syndrome
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    7 / 1227 (0.57%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    7
    0
    0
    2
    Tachycardia foetal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Pericarditis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Pericardial effusion
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Klinefelter's syndrome
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Extrasystoles
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Carpal tunnel syndrome
    Additional description: Carpal tunnel syndrome
         subjects affected / exposed
    19 / 1227 (1.55%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    17 / 1236 (1.38%)
         occurrences all number
    19
    0
    0
    17
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    64 / 1227 (5.22%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    44 / 1236 (3.56%)
         occurrences all number
    64
    0
    0
    44
    Headache
    Additional description: Headache
         subjects affected / exposed
    276 / 1227 (22.49%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    302 / 1236 (24.43%)
         occurrences all number
    276
    0
    0
    302
    Hypoaesthesia
    Additional description: Hypoaesthesia
         subjects affected / exposed
    12 / 1227 (0.98%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    13 / 1236 (1.05%)
         occurrences all number
    12
    0
    0
    13
    Migraine
    Additional description: Migraine
         subjects affected / exposed
    26 / 1227 (2.12%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    22 / 1236 (1.78%)
         occurrences all number
    26
    0
    0
    22
    Sciatica
    Additional description: Sciatica
         subjects affected / exposed
    12 / 1227 (0.98%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    18 / 1236 (1.46%)
         occurrences all number
    12
    0
    0
    18
    Aphasia
    Additional description: Aphasia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Apraxia
    Additional description: Apraxia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Burning sensation
    Additional description: Burning sensation
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Convulsion
    Additional description: Convulsion
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Depressed level of consciousness
    Additional description: Depressed level of consciousness
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyperglycaemic seizure
    Additional description: Hyperglycaemic seizure
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    6 / 1236 (0.49%)
         occurrences all number
    3
    0
    0
    6
    VIIth nerve paralysis
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    VIth nerve paralysis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tremor
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tension headache
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Syncope
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    6 / 1236 (0.49%)
         occurrences all number
    4
    0
    0
    6
    Somnolence
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    2
    0
    0
    1
    Sinus headache
         subjects affected / exposed
    5 / 1227 (0.41%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    5
    0
    0
    0
    Presyncope
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    6 / 1236 (0.49%)
         occurrences all number
    2
    0
    0
    6
    Paraesthesia
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    8 / 1236 (0.65%)
         occurrences all number
    4
    0
    0
    8
    Nerve compression
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Migraine with aura
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         occurrences all number
    2
    0
    0
    4
    Loss of consciousness
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Lethargy
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypotonic-hyporesponsive episode
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    63 / 1227 (5.13%)
    1 / 1364 (0.07%)
    3 / 1374 (0.22%)
    54 / 1236 (4.37%)
         occurrences all number
    63
    1
    3
    54
    Splenic cyst
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Thrombocytopenia neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    2 / 1374 (0.15%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Thrombocytopenia
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    1
    0
    0
    3
    Ear and labyrinth disorders
    Acoustic stimulation tests abnormal
    Additional description: Acoustic stimulation tests abnormal
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Deafness
    Additional description: Deafness
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Ear pain
    Additional description: Ear pain
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    7 / 1236 (0.57%)
         occurrences all number
    2
    0
    0
    7
    Ear discomfort
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Tinnitus
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    2
    0
    0
    2
    Eye disorders
    Conjunctivitis
    Additional description: Conjunctivitis
         subjects affected / exposed
    14 / 1227 (1.14%)
    1 / 1364 (0.07%)
    6 / 1374 (0.44%)
    13 / 1236 (1.05%)
         occurrences all number
    14
    1
    6
    13
    Vision Blurred
    Additional description: Vision Blurred
         subjects affected / exposed
    20 / 1227 (1.63%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    19 / 1236 (1.54%)
         occurrences all number
    20
    0
    0
    19
    Visual impairment
    Additional description: Visual impairment
         subjects affected / exposed
    53 / 1227 (4.32%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    61 / 1236 (4.94%)
         occurrences all number
    53
    0
    0
    61
    Diabetic retinopathy
    Additional description: Diabetic retinopathy
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Dry eye
    Additional description: Dry eye
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Sunset eyes
    Additional description: Sunset Eyes/ Setting sun phenomenon
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chorioretinopathy
    Additional description: Chorioretinopathy
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Vitreous floaters
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         occurrences all number
    3
    0
    0
    4
    Visual field defect
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    2
    0
    0
    1
    Scintillating scotoma
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Photopsia
         subjects affected / exposed
    10 / 1227 (0.81%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    7 / 1236 (0.57%)
         occurrences all number
    10
    0
    0
    7
    Photophobia
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    3
    0
    0
    2
    Periorbital oedema
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Eye pain
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    1
    0
    0
    2
    Gastrointestinal disorders
    Abdominal pain lower
    Additional description: Abdominal pain lower
         subjects affected / exposed
    8 / 1227 (0.65%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    20 / 1236 (1.62%)
         occurrences all number
    8
    0
    0
    20
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    57 / 1227 (4.65%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    58 / 1236 (4.69%)
         occurrences all number
    57
    0
    0
    58
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    82 / 1227 (6.68%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    64 / 1236 (5.18%)
         occurrences all number
    82
    0
    0
    64
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    33 / 1227 (2.69%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    34 / 1236 (2.75%)
         occurrences all number
    33
    0
    1
    34
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    46 / 1227 (3.75%)
    0 / 1364 (0.00%)
    2 / 1374 (0.15%)
    53 / 1236 (4.29%)
         occurrences all number
    46
    0
    2
    53
    Dyspepsia
    Additional description: Dyspepsia
         subjects affected / exposed
    126 / 1227 (10.27%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    136 / 1236 (11.00%)
         occurrences all number
    126
    1
    0
    136
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    61 / 1227 (4.97%)
    5 / 1364 (0.37%)
    4 / 1374 (0.29%)
    54 / 1236 (4.37%)
         occurrences all number
    61
    5
    4
    54
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    85 / 1227 (6.93%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    96 / 1236 (7.77%)
         occurrences all number
    85
    0
    0
    96
    Toothache
    Additional description: Toothache
         subjects affected / exposed
    7 / 1227 (0.57%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    14 / 1236 (1.13%)
         occurrences all number
    7
    0
    0
    14
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    90 / 1227 (7.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    85 / 1236 (6.88%)
         occurrences all number
    90
    0
    0
    85
    Abdominal pain, Nausea
    Additional description: Abdominal pain, Nausea
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Constipation, Dyspepsia
    Additional description: Constipation, Dyspepsia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal discomfort
    Additional description: Abdominal discomfort
         subjects affected / exposed
    8 / 1227 (0.65%)
    0 / 1364 (0.00%)
    6 / 1374 (0.44%)
    0 / 1236 (0.00%)
         occurrences all number
    8
    0
    6
    0
    Dry mouth
    Additional description: Dry mouth
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Gastrointestinal inflammation
    Additional description: Gastrointestinal inflammation
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tooth abscess
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         occurrences all number
    1
    0
    0
    4
    Retching
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    Proctitis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Periodontal disease
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Oesophageal spasm
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Lip swelling
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Intestinal dilatation
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infantile colic
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haemorrhoids
         subjects affected / exposed
    10 / 1227 (0.81%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    9 / 1236 (0.73%)
         occurrences all number
    10
    0
    0
    9
    Haematemesis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Gingivitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gingival swelling
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    Gingival bleeding
         subjects affected / exposed
    5 / 1227 (0.41%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    5
    0
    0
    3
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Gastritis
         subjects affected / exposed
    5 / 1227 (0.41%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    5
    0
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Food poisoning
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    1
    0
    0
    2
    Flank pain
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    2
    0
    0
    1
    Oral pain
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
    Additional description: Pruritus
         subjects affected / exposed
    48 / 1227 (3.91%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    41 / 1236 (3.32%)
         occurrences all number
    48
    0
    0
    41
    Rash
    Additional description: Rash
         subjects affected / exposed
    19 / 1227 (1.55%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    11 / 1236 (0.89%)
         occurrences all number
    19
    1
    0
    11
    Acne
    Additional description: Acne
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cafe au lait spots
    Additional description: Cafe au lait spots
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dermatitis atopic
    Additional description: Dermatitis atopic
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Dermatitis diaper
    Additional description: Dermatitis diaper
         subjects affected / exposed
    0 / 1227 (0.00%)
    2 / 1364 (0.15%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Polymorphic eruption of pregnancy
    Additional description: Polymorphic eruption of pregnancy
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    5 / 1236 (0.40%)
         occurrences all number
    0
    0
    0
    5
    Scar pain
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Swelling face
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin irritation
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rosacea
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Rash pruritic
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    5 / 1236 (0.40%)
         occurrences all number
    0
    0
    0
    5
    Petechiae
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Night sweats
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Keloid scar
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ingrowing nail
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    Hypersensitivity
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    0
    0
    0
    3
    Erythema
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Erythema nodosum
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Proteinuria
    Additional description: Proteinuria
         subjects affected / exposed
    31 / 1227 (2.53%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    28 / 1236 (2.27%)
         occurrences all number
    31
    0
    0
    28
    Bladder pain
    Additional description: Bladder pain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    0
    0
    0
    2
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    6 / 1236 (0.49%)
         occurrences all number
    1
    0
    0
    6
    Pyelocaliectasis
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal injury
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Urine odour abnormal
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Kidney enlargement
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tachypnoea
         subjects affected / exposed
    1 / 1227 (0.08%)
    2 / 1364 (0.15%)
    3 / 1374 (0.22%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    2
    3
    0
    Renal tubular acidosis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Renal pain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Renal cyst
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pollakiuria
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    1
    0
    0
    2
    Nephropathy
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Micturition urgency
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Ketonuria
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Haematuria
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Glycosuria
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    2
    0
    0
    2
    Urinary hesitation
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Endocrine disorders
    Basedow's disease
    Additional description: Basedow's disease
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypothyroidism
         subjects affected / exposed
    9 / 1227 (0.73%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    9
    0
    0
    3
    Hyperthyroidism
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    19 / 1227 (1.55%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    20 / 1236 (1.62%)
         occurrences all number
    19
    0
    0
    20
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    68 / 1227 (5.54%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    74 / 1236 (5.99%)
         occurrences all number
    68
    0
    0
    74
    Muscle spasms
    Additional description: Muscle spasms
         subjects affected / exposed
    36 / 1227 (2.93%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    35 / 1236 (2.83%)
         occurrences all number
    36
    0
    0
    35
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    20 / 1227 (1.63%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    10 / 1236 (0.81%)
         occurrences all number
    20
    0
    0
    10
    Musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    16 / 1227 (1.30%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    14 / 1236 (1.13%)
         occurrences all number
    16
    0
    0
    14
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    19 / 1227 (1.55%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    19 / 1236 (1.54%)
         occurrences all number
    19
    0
    0
    19
    Symphysiolysis
    Additional description: Symphysiolysis
         subjects affected / exposed
    13 / 1227 (1.06%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    23 / 1236 (1.86%)
         occurrences all number
    13
    0
    0
    23
    Bursitis
    Additional description: Bursitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Coccydynia
    Additional description: Coccydynia
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Costochondritis
    Additional description: Costochondritis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ligament pain
    Additional description: Ligament pain
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    6 / 1236 (0.49%)
         occurrences all number
    3
    0
    0
    6
    Tenosynovitis stenosans
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    7 / 1227 (0.57%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    11 / 1236 (0.89%)
         occurrences all number
    7
    0
    0
    11
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Polyarthritis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Plantar fasciitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain in jaw
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    0
    0
    0
    3
    Joint stiffness
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Groin pain
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    7 / 1236 (0.57%)
         occurrences all number
    3
    0
    0
    7
    Infections and infestations
    Candidiasis
    Additional description: Candidiasis
         subjects affected / exposed
    9 / 1227 (0.73%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    17 / 1236 (1.38%)
         occurrences all number
    9
    1
    0
    17
    Fungal infection
    Additional description: Fungal infection
         subjects affected / exposed
    16 / 1227 (1.30%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    10 / 1236 (0.81%)
         occurrences all number
    16
    0
    0
    10
    Gastroenteritis viral
    Additional description: Gastroenteritis viral
         subjects affected / exposed
    34 / 1227 (2.77%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    35 / 1236 (2.83%)
         occurrences all number
    34
    0
    0
    35
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    16 / 1227 (1.30%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    29 / 1236 (2.35%)
         occurrences all number
    16
    0
    0
    29
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    24 / 1227 (1.96%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    16 / 1236 (1.29%)
         occurrences all number
    24
    1
    0
    16
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    80 / 1227 (6.52%)
    2 / 1364 (0.15%)
    1 / 1374 (0.07%)
    85 / 1236 (6.88%)
         occurrences all number
    80
    2
    1
    85
    Postoperative wound infection
    Additional description: Postoperative wound infection
         subjects affected / exposed
    7 / 1227 (0.57%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    14 / 1236 (1.13%)
         occurrences all number
    7
    0
    0
    14
    Sinusitis
    Additional description: Sinusitis
         subjects affected / exposed
    18 / 1227 (1.47%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    18 / 1236 (1.46%)
         occurrences all number
    18
    0
    0
    18
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    15 / 1227 (1.22%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    23 / 1236 (1.86%)
         occurrences all number
    15
    1
    1
    23
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    82 / 1227 (6.68%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    89 / 1236 (7.20%)
         occurrences all number
    82
    0
    0
    89
    Urinary tract infection, Wound infection
    Additional description: Urinary tract infection, Wound infection
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abscess
    Additional description: Abscess
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abscess oral
    Additional description: Abscess oral
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Acute sinusitis
    Additional description: Acute sinusitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Croup infectious
    Additional description: Croup infectious
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    9 / 1227 (0.73%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    9
    0
    0
    2
    Dacryocystitis
    Additional description: Dacryocystitis
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    10 / 1227 (0.81%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    6 / 1236 (0.49%)
         occurrences all number
    10
    0
    1
    6
    Ureaplasma test positive
    Additional description: Ureaplasma test positive
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Chikungunya virus infection
    Additional description: Chikungunya virus infectiom
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    2
    0
    0
    3
    Oral herpes
    Additional description: Oral herpes
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    2
    0
    0
    2
    Vulvovaginal mycotic infection
    Additional description: Vulvovaginal mycotic infection
         subjects affected / exposed
    5 / 1227 (0.41%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    5
    0
    0
    3
    Uterine infection
    Additional description: Uterine infection
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Bacterial vaginosis
    Additional description: Bacterial vaginosis
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    6 / 1236 (0.49%)
         occurrences all number
    2
    0
    0
    6
    Nail infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Lung infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Escherichia infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    1
    1
    Staphylococcal infection
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    2
    0
    0
    1
    Parvovirus infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Perineal abscess
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Febrile infection
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    2
    0
    0
    1
    Haematoma infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Abscess limb
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vaginal abscess
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    5 / 1236 (0.40%)
         occurrences all number
    4
    0
    0
    5
    Oral infection
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    6 / 1227 (0.49%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    9 / 1236 (0.73%)
         occurrences all number
    6
    0
    0
    9
    Varicella
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Vaginal infection
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    6 / 1236 (0.49%)
         occurrences all number
    4
    0
    0
    6
    Trichomoniasis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin infection
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pilonidal cyst
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    4
    0
    0
    3
    Oral candidiasis
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    2 / 1374 (0.15%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    2
    1
    Omphalitis
         subjects affected / exposed
    1 / 1227 (0.08%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Lice infestation
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    12 / 1227 (0.98%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    8 / 1236 (0.65%)
         occurrences all number
    12
    0
    0
    8
    Infected bite
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    2 / 1236 (0.16%)
         occurrences all number
    2
    0
    0
    2
    Herpes virus infection
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    3
    0
    0
    1
    Herpes simplex
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Furuncle
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Eye infection
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Impetigo
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Laryngitis
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
    Additional description: Hypoglycaemia
         subjects affected / exposed
    5 / 1227 (0.41%)
    9 / 1364 (0.66%)
    14 / 1374 (1.02%)
    4 / 1236 (0.32%)
         occurrences all number
    5
    9
    14
    4
    Cow's milk intolerance
    Additional description: Cow's milk intolerance
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Decreased appetite
         subjects affected / exposed
    4 / 1227 (0.33%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    3 / 1236 (0.24%)
         occurrences all number
    4
    0
    0
    3
    Metabolic disorder
         subjects affected / exposed
    0 / 1227 (0.00%)
    1 / 1364 (0.07%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Decreased insulin requirement
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    9 / 1227 (0.73%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    8 / 1236 (0.65%)
         occurrences all number
    9
    0
    0
    8
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    4 / 1236 (0.32%)
         occurrences all number
    1
    0
    0
    4
    Metabolic acidosis
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lactose intolerance
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    0
    1
    Hypokalaemia
         subjects affected / exposed
    3 / 1227 (0.24%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Hypoglycaemia neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    5 / 1364 (0.37%)
    6 / 1374 (0.44%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    5
    6
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 1227 (0.00%)
    0 / 1364 (0.00%)
    1 / 1374 (0.07%)
    1 / 1236 (0.08%)
         occurrences all number
    0
    0
    1
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    1 / 1236 (0.08%)
         occurrences all number
    1
    0
    0
    1
    Glucose tolerance impaired
         subjects affected / exposed
    2 / 1227 (0.16%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Feeding disorder neonatal
         subjects affected / exposed
    0 / 1227 (0.00%)
    3 / 1364 (0.22%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Increased insulin requirement
         subjects affected / exposed
    1 / 1227 (0.08%)
    0 / 1364 (0.00%)
    0 / 1374 (0.00%)
    0 / 1236 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Mar 2011
    The following Inclusion Criteria was removed: Subject’s primary obstetrical care provider agrees with subject’s participation in the study. Rational: The Qualified Investigator will decide on the Participant’s eligibility. If the Participant is agreeable, the primary obstetrical provider will be notified of the Participant’s study involvement.
    20 Jul 2011
    The subject will be provided with written instructions on how to take the Study Treatment. Rational: Current labels do not include instructions on how to take Study Treatment. Instructions are presently on the Participant Diary. The Participant Diary, which is given to the Participant at each study visit, includes detailed, written instructions on how to take the Study Treatment. Participants will also be given verbal instructions at each study visit. Furthermore, over-labelling to ensure regulatory compliance in other participating countries is required.
    15 Dec 2011
    Subject is taking ≤1 mg of folic acid daily at the time of randomization and amended protocol so allowable amount of folic acid intake to be ≤1.1 mg of folic acid daily at the time of randomization. Rationale: 1.1 mg of Folic Acid may be prescribed as standard of care in many participating hospitals. The additional 0.1 mg may inhibit Participant recruitment. It was decided to increase the folic acid amounts from ≤ 1mg to ≤1.1mg. The additional 0.1 mg poses no safety concerns and does not affect the methodology of the Trial.
    18 Mar 2013
    Amendment to include confirmation of fetal/embryonic viability* prior to subject randomization Rationale: Define the physical examination requirements for Visit 1. After confirmation of fetal/embryonic cardiac activity post 8 weeks of gestation, in the absence of significant vaginal bleeding, the risk of miscarriage is significantly reduced, and the requirement for re-confirmation of viability is not required.

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

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30209050
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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