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    Clinical Trial Results:
    TRAnexamic Acid for Preventing postpartum hemorrhage following a Cesarean Delivery : a multicenter randomised, double blind placebo controlled trial (TRAAP2)

    Summary
    EudraCT number
    		 2017-001144-36
    Trial protocol
    		 FR  
    Global end of trial date
    08 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jan 2022
    First version publication date
    15 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHUBX2015/41
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Bordeaux
    Sponsor organisation address
    12 rue Dubernat , Talence cedex, France, 33404
    Public contact
    Pr Loïc Sentilhes, Pôle obstétrique, reproduction et gynécologie, Service de Gynécologie, +33 556 79 55 79, lois.sentilhes@chu-boreaux.fr
    Scientific contact
    Pr Loïc Sentilhes, Pôle obstétrique, reproduction et gynécologie, Service de Gynécologie, +33 556 79 55 79, lois.sentilhes@chu-boreaux.fr
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test the efficacy of a low dose of tranéxamic acid (1g) delivered within two minutes of the birth of a child by caesarean section versus placebo for the prevention of postpartum hemorrhage (PPH), defined by a Calculated blood loss of more than 1000mL (calculated blood loss = estimated blood volume x (preoperative Ht - preoperative Ht) / Ht preoperative (with estimated blood volume (in mL) = weight (in kg) x 85) A transfusion into globular concentrates before the second postpartum day (D2)
    Protection of trial subjects
    The benefit/risk ratio was investigated in the study. TXA is a promising candidate as a preventive and morbidity-reducing treatment for PPH. In addition, it can be easily added to the delivery management protocol in all maternity hospitals worldwide.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jun 2017
    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
    France: 4551
    Worldwide total number of subjects
    4551
    EEA total number of subjects
    4551
    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)
    4551
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The total duration of the trial is 27 months, 24 months of inclusion and 3 months of post-partum follow-up (looking for thromboembolic complications or other remote side effects of the treatment). The total duration of the research project is 38 months 30 centres in France participated in the study.

    Pre-assignment
    Screening details
    		 Inclusion criteria: - Patient ≥ 18 years - Delivery by caesarean section - Gestational age ≥ 34 weeks + 0 days - Blood cell count within 3 days prior to caesarean delivery - Haemoglobin level at last blood sample > 9g/dl - Signed informed consent

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TXA Group
    Arm description
    		 Experimental drug 1 is tranexamic acid injection (EXACYL® 1g-10mL I.V., injectable solution)
    Arm type
    		 Experimental

    Investigational medicinal product name
    exacyl 1g-10mL
    Investigational medicinal product code
    SUB11214MIG
    Other name
    TRANEXAMIC ACID
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Il se présente sous forme de solution injectable conditionnée, pour une mise en aveugle, en flacon en verre de type 1 de 10 mL, à la concentration de 100mg /mL La voie d'administration est la Voie intraveineuse lente stricte, durant la troisième phase du travail, dans les 3 minutes suivant la naissance d’un enfant par césarienne

    Arm title
    		 Placebo Group
    Arm description
    		 Experimental drug 2 (placebo) is a 0.9%-10mL sodium chloride injection
    Arm type
    		 Placebo

    Investigational medicinal product name
    NaCL
    Investigational medicinal product code
    Other name
    Chlorure de sodium
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Il se présente sous forme de solution injectable conditionnée, pour une mise en aveugle, en flacon en verre de type 1 de 10mL. La voie d'administration est la Voie intraveineuse lente stricte

    Number of subjects in period 1
    		TXA Group Placebo Group
    Started
    2276
    2275
    Completed
    2222
    2209
    Not completed
    54
    66
         Consent withdrawn by subject
    6
    8
         exclusion criteria
    44
    54
         vaginal delivery
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TXA Group
    Reporting group description
    		 Experimental drug 1 is tranexamic acid injection (EXACYL® 1g-10mL I.V., injectable solution)

    Reporting group title
    Placebo Group
    Reporting group description
    		 Experimental drug 2 (placebo) is a 0.9%-10mL sodium chloride injection

    Reporting group values
    		 TXA Group Placebo Group Total
    Number of subjects
    		 2276 2275 4551
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 2276 2275 4551
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2276 2275 4551
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Modified ITT TXA
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Population in underwent cesarean delivery analysed modifed intention to treat in the group TXA

    Subject analysis set title
    Modified ITT Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Population in underwent cesarean delivery analysed modifed intention to treat in the placebo group

    Subject analysis sets values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects
    2222
    2209
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    2222
    2209
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    33.3 ( 5.3 )
    33.5 ( 5.3 )
    Gender categorical
    Units: Subjects
        Female
    2222
    2209
        Male
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    TXA Group
    Reporting group description
    		 Experimental drug 1 is tranexamic acid injection (EXACYL® 1g-10mL I.V., injectable solution)

    Reporting group title
    Placebo Group
    Reporting group description
    		 Experimental drug 2 (placebo) is a 0.9%-10mL sodium chloride injection

    Subject analysis set title
    Modified ITT TXA
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Population in underwent cesarean delivery analysed modifed intention to treat in the group TXA

    Subject analysis set title
    Modified ITT Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Population in underwent cesarean delivery analysed modifed intention to treat in the placebo group

    Primary: Occurrence of postpartum haemorrhage before day 2

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    End point title
    		 Occurrence of postpartum haemorrhage before day 2
    End point description
    incidence of Post Partum Haemorrhage defined as calculated blood loss >1000mL [calculated blood loss = estimated blood volume x (preoperative Ht - postoperative Ht)/preoperative Ht; where estimated blood volume (mL) = weight (kg) x 85], or the need for transfusion of at least 1 packed red blood cell before D2
    End point type
    Primary
    End point timeframe
    On the day of the cesarean delivery
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    2086
    2067
    Units: percent
    number (not applicable)
        Yes
    26.7
    31.6
        No
    73.3
    68.4
    Statistical analysis title
    		 Effect of study treatment on primary endpoints
    Statistical analysis description
    The incidence of PPH before D2 was compared between the two treatment groups using a mixed-effects Poisson regression model, with adjustment for the randomisation stratification factors of investigating centre and time of caesarean section (before or during labour).
    Comparison groups
    Modified ITT TXA v Modified ITT Placebo
    Number of subjects included in analysis
    4153
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0032
    Method
    		 Multiple imputation
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.94

    Secondary: Calculated blood loss > 500 millilitres

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    End point title
    		 Calculated blood loss > 500 millilitres
    End point description
    Incidence of calculated blood loss > 500 mL
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of caesarean birth versus placebo, on other markers of postpartum blood loss.
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    2084
    2066
    Units: percent
    number (not applicable)
        Yes
    58.2
    64.2
        No
    41.8
    35.8
    No statistical analyses for this end point

    Secondary: Calculated blood loss > 1000 millilitres

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    End point title
    		 Calculated blood loss > 1000 millilitres
    End point description
    Incidence of calculated blood loss > 1000 mL
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of a caesarean birth versus placebo, on other markers of postpartum blood
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    2084
    2066
    Units: percent
    number (not applicable)
        Yes
    26.4
    31.5
        No
    73.6
    68.5
    No statistical analyses for this end point

    Secondary: Calculated blood loss > 1500 millilitres

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    End point title
    		 Calculated blood loss > 1500 millilitres
    End point description
    Incidence of severe PPH, defined as calculated blood loss greater than 1500 mL
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of a caesarean birth versus placebo, on other markers of postpartum blood loss.
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    2084
    2066
    Units: percent
    number (not applicable)
        Yes
    10.3
    12.7
        No
    89.7
    87.3
    No statistical analyses for this end point

    Secondary: Use of an additional uterotonic

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    End point title
    		 Use of an additional uterotonic
    End point description
    Proportion of women requiring additional uterotonic treatment, including sulprostone.
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of a caesarean birth versus placebo, on other markers of postpartum blood loss.
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    2217
    2206
    Units: percent
    number (not applicable)
        Yes
    5.9
    7.2
        No
    94.1
    92.8
    Statistical analysis title
    		 Effect of study treatment on secondary endpoints
    Comparison groups
    Modified ITT TXA v Modified ITT Placebo
    Number of subjects included in analysis
    4423
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.15
    Method
    		 Regression, Linear
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.03

    Secondary: Arterial embolization

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    End point title
    		 Arterial embolization
    End point description
    Incidence of arterial embolisation and haemostasis surgery for PPH
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of a caesarean birth versus placebo, on other markers of postpartum blood loss.
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    2216
    2206
    Units: percent
    number (not applicable)
        Yes
    0.6
    0.3
        No
    99.4
    99.7
    Statistical analysis title
    		 Effect of study treatment on secondary endpoints
    Comparison groups
    Modified ITT TXA v Modified ITT Placebo
    Number of subjects included in analysis
    4422
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1933
    Method
    		 Regression, Linear
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    2.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 5.66

    Secondary: Transfusion during hospitalisation

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    End point title
    		 Transfusion during hospitalisation
    End point description
    Incidence of postpartum transfusion
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of a caesarean birth versus placebo, on other markers of postpartum blood loss.
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    2221
    2208
    Units: percent
    number (not applicable)
        Yes
    1.9
    1.8
        No
    98.1
    98.2
    Statistical analysis title
    		 Effect of study treatment on secondary endpoints
    Comparison groups
    Modified ITT Placebo v Modified ITT TXA
    Number of subjects included in analysis
    4429
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7568
    Method
    		 Mixed models analysis
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.66

    Secondary: Total number of red blood cell transfused

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    End point title
    		 Total number of red blood cell transfused
    End point description
    Number of red blood cell units transfused
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of a caesarean birth versus placebo, on other markers of postpartum blood loss.
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    42
    39
    Units: millilitre(s)
        arithmetic mean (standard deviation)
    3.1 ( 1.9 )
    3.2 ( 2.2 )
    No statistical analyses for this end point

    Secondary: Delta haemoglobin between day 2 and day 0

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    End point title
    		 Delta haemoglobin between day 2 and day 0
    End point description
    Mean change in haemoglobin levels (difference between the most recent haemoglobin measured in the 7 days prior to the caesarean section and that at day 2)
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of a caesarean birth versus placebo, on other markers of postpartum blood loss.
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    2088
    2071
    Units: g/dL
        arithmetic mean (standard deviation)
    -1.2 ( 1.2 )
    -1.4 ( 1.2 )
    Statistical analysis title
    		 Effect of study treatment on secondary endpoints
    Comparison groups
    Modified ITT TXA v Modified ITT Placebo
    Number of subjects included in analysis
    4159
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Regression, Linear
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.11
         upper limit
    		 0.25

    Secondary: Delta haematocrit between day 2 and day 0

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    End point title
    		 Delta haematocrit between day 2 and day 0
    End point description
    Mean change in haematocrit levels (difference between the most recent haematocrit measured in the 7 days prior to caesarean section and that at day 2)
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of a caesarean birth versus placebo, on other markers of postpartum blood loss.
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    2086
    2071
    Units: g/dl
        arithmetic mean (standard deviation)
    -3.5 ( 3.7 )
    -4.0 ( 3.7 )
    Statistical analysis title
    		 Effect of study treatment on secondary endpoints
    Comparison groups
    Modified ITT TXA v Modified ITT Placebo
    Number of subjects included in analysis
    4157
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Regression, Linear
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 0.75

    Secondary: Gravimetrically estimated blood loss

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    End point title
    		 Gravimetrically estimated blood loss
    End point description
    Gravimetrically estimated blood loss is described only in patients who delivered after 07 August 2018
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of caesarean birth versus placebo, on other markers of postpartum blood loss
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    1774
    1754
    Units: millilitre(s)
        arithmetic mean (standard deviation)
    688.7 ( 886.5 )
    719.3 ( 919.6 )
    Statistical analysis title
    		 Effect of study treatment on secondary endpoints
    Comparison groups
    Modified ITT TXA v Modified ITT Placebo
    Number of subjects included in analysis
    3528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.214
    Method
    		 Regression, Linear
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    -33.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -77.48
         upper limit
    		 11.37

    Secondary: Total gravimetrically estimated blood loss > 500mL

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    End point title
    		 Total gravimetrically estimated blood loss > 500mL
    End point description
    Gravimetrically estimated blood loss is described only in patients who delivered after 07 August 2018.
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of caesarean birth versus placebo, on other markers of postpartum blood loss
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    1774
    1754
    Units: percent
    number (not applicable)
        Yes
    63.9
    63.3
        No
    36.1
    36.7
    No statistical analyses for this end point

    Secondary: Total gravimetrically estimated blood loss > 1000 mL

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    End point title
    		 Total gravimetrically estimated blood loss > 1000 mL
    End point description
    Gravimetrically estimated blood loss is described only in patients who delivered after 07 August 2018.
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of caesarean birth versus placebo, on other markers of postpartum blood loss
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    1774
    1754
    Units: percent
    number (not applicable)
        Yes
    30.7
    29.7
        No
    69.3
    70.3
    No statistical analyses for this end point

    Secondary: Calculated blood loss

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    End point title
    		 Calculated blood loss
    End point description
    Mean estimated blood loss at the end of caesarean section
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of caesarean birth versus placebo, on other markers of postpartum blood loss
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    2084
    2066
    Units: millilitre(s)
        arithmetic mean (standard deviation)
    680.4 ( 748.3 )
    787.2 ( 750.0 )
    Statistical analysis title
    		 Effect of study treatment on secondary endpoints
    Comparison groups
    Modified ITT TXA v Modified ITT Placebo
    Number of subjects included in analysis
    4150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Regression, Linear
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    -107.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -151.53
         upper limit
    		 -63.11

    Secondary: Clinically significant postpartum haemorrhage

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    End point title
    		 Clinically significant postpartum haemorrhage
    End point description
    Incidence of clinically significant postpartum haemorrhage (physician's clinical judgment)
    End point type
    Secondary
    End point timeframe
    Delivered in the immediate aftermath of a caesarean birth versus placebo, on other markers of postpartum blood loss
    End point values
    		 Modified ITT TXA Modified ITT Placebo
    Number of subjects analysed
    2220
    2208
    Units: percent
    number (not applicable)
        Yes
    13.6
    14.8
        No
    86.4
    85.2
    Statistical analysis title
    		 Effect of study treatment on secondary endpoints
    Comparison groups
    Modified ITT TXA v Modified ITT Placebo
    Number of subjects included in analysis
    4428
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.372
    Method
    		 Regression, Linear
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.08

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within 12 months after the delivery
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo Group
    Reporting group description
    		 -

    Reporting group title
    TXA Group
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Group TXA Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    345 / 2209 (15.62%)
    342 / 2222 (15.39%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oncocytoma (10048757)
    Additional description: Oncocytoma (10048757)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian neoplasm (10061535)
    Additional description: Ovarian neoplasm (10061535)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma (10046798)
    Additional description: Uterine leiomyoma (10046798)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Bleeding varicose vein (10005144)
    Additional description: Bleeding varicose vein (10005144)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis (10051055)
    Additional description: Deep vein thrombosis (10051055)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemodynamic instability (10052076)
    Additional description: Haemodynamic instability (10052076)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage (10055798)
    Additional description: Haemorrhage (10055798)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension (10020772)
    Additional description: Hypertension (10020772)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 2209 (0.27%)
    3 / 2222 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension (10021097)
    Additional description: Hypotension (10021097)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jugular vein thrombosis (10023237)
    Additional description: Jugular vein thrombosis (10023237)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic venous thrombosis (10034272)
    Additional description: Pelvic venous thrombosis (10034272)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial (10043595)
    Additional description: Thrombophlebitis superficial (10043595)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Breast conserving surgery (10076783)
    Additional description: Breast conserving surgery (10076783)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Caecectomy (10062859)
    Additional description: Caecectomy (10062859)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy (10008611)
    Additional description: Cholecystectomy (10008611)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eventration repair (10072804)
    Additional description: Eventration repair (10072804)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hysterectomy (10021151)
    Additional description: Hysterectomy (10021151)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal anastomosis (10057146)
    Additional description: Intestinal anastomosis (10057146)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myomectomy (10028634)
    Additional description: Myomectomy (10028634)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrectomy (10029116)
    Additional description: Nephrectomy (10029116)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctectomy (10077252)
    Additional description: Proctectomy (10077252)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retained placenta operation (10078243)
    Additional description: Retained placenta operation (10078243)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    3 / 2222 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salpingo-oophorectomy (10039464)
    Additional description: Salpingo-oophorectomy (10039464)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scar excision (10039583)
    Additional description: Scar excision (10039583)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    3 / 2222 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suture insertion (10052665)
    Additional description: Suture insertion (10052665)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transfusion (10066152)
    Additional description: Transfusion (10066152)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine dilation and curettage (10057304)
    Additional description: Uterine dilation and curettage (10057304)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wedge resection toenail (10047884)
    Additional description: Wedge resection toenail (10047884)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Anaphylactoid syndrome of pregnancy (10067010)
    Additional description: Anaphylactoid syndrome of pregnancy (10067010)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eclampsia (10014129)
    Additional description: Eclampsia (10014129)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gestational hypertension (10070538)
    Additional description: Gestational hypertension (10070538)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice neonatal (10023138)
    Additional description: Jaundice neonatal (10023138)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Low birth weight baby (10067508)
    Additional description: Low birth weight baby (10067508)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripartum cardiomyopathy (10049430)
    Additional description: Peripartum cardiomyopathy (10049430)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpartum haemorrhage (10036417)
    Additional description: Postpartum haemorrhage (10036417)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    246 / 2209 (11.14%)
    233 / 2222 (10.49%)
         occurrences causally related to treatment / all
    3 / 246
    4 / 233
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retained placenta or membranes (10038758)
    Additional description: Retained placenta or membranes (10038758)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 2209 (0.27%)
    4 / 2222 (0.18%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic delivery (10044520)
    Additional description: Traumatic delivery (10044520)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine atony (10046763)
    Additional description: Uterine atony (10046763)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 2209 (0.50%)
    8 / 2222 (0.36%)
         occurrences causally related to treatment / all
    1 / 11
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decrease neonatal (10047894)
    Additional description: Weight decrease neonatal (10047894)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest discomfort (10008469)
    Additional description: Chest discomfort (10008469)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain (10008479)
    Additional description: Chest pain (10008479)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia (10020843)
    Additional description: Hyperthermia (10020843)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise (10025482)
    Additional description: Malaise (10025482)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral (10030124)
    Additional description: Oedema peripheral (10030124)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia (10037660)
    Additional description: Pyrexia (10037660)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction (10002198)
    Additional description: Anaphylactic reaction (10002198)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock (10002199)
    Additional description: Anaphylactic shock (10002199)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity (10020751)
    Additional description: Hypersensitivity (10020751)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometriosis (10014778)
    Additional description: Endometriosis (10014778)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrocystic breast disease (10016621)
    Additional description: Fibrocystic breast disease (10016621)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia (10027514)
    Additional description: Metrorrhagia (10027514)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian vein thrombosis (10072059)
    Additional description: Ovarian vein thrombosis (10072059)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    6 / 2222 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fluid collection (10065388)
    Additional description: Pelvic fluid collection (10065388)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haematoma (10063875)
    Additional description: Uterine haematoma (10063875)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haemorrhage (10046788)
    Additional description: Uterine haemorrhage (10046788)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    3 / 2222 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine pain (10046809)
    Additional description: Uterine pain (10046809)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulvovaginal discomfort (10047786)
    Additional description: Vulvovaginal discomfort (10047786)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema (10001029)
    Additional description: Acute pulmonary oedema (10001029)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea (10013968)
    Additional description: Dyspnoea (10013968)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion (10035598)
    Additional description: Pleural effusion (10035598)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration (10035669)
    Additional description: Pneumonia aspiration (10035669)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism (10037377)
    Additional description: Pulmonary embolism (10037377)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema (10037423)
    Additional description: Pulmonary oedema (10037423)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress (10038687)
    Additional description: Respiratory distress (10038687)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Brief psychotic disorder, with postpartum onset (10006362)
    Additional description: Brief psychotic disorder, with postpartum onset (10006362)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression (10012378)
    Additional description: Depression (10012378)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perinatal depression (10078366)
    Additional description: Perinatal depression (10078366)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic stress disorder (10036316)
    Additional description: Post-traumatic stress disorder (10036316)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizoaffective disorder (10039621)
    Additional description: Schizoaffective disorder (10039621)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone (10004637)
    Additional description: Bile duct stone (10004637)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic (10004663)
    Additional description: Biliary colic (10004663)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis (10008604)
    Additional description: Cholangitis (10008604)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis (10008629)
    Additional description: Cholelithiasis (10008629)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis migration (10068884)
    Additional description: Cholelithiasis migration (10068884)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular injury (10019837)
    Additional description: Hepatocellular injury (10019837)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood glucose increased (10005557)
    Additional description: Blood glucose increased (10005557)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hysteroscopy (10050125)
    Additional description: Hysteroscopy (10050125)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory marker increased (10069826)
    Additional description: Inflammatory marker increased (10069826)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Arterial injury (10003162)
    Additional description: Arterial injury (10003162)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    3 / 2222 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder injury (10061698)
    Additional description: Bladder injury (10061698)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dural tear (10063395)
    Additional description: Dural tear (10063395)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body (10070245)
    Additional description: Foreign body (10070245)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site haemorrhage (10051100)
    Additional description: Incision site haemorrhage (10051100)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 2209 (0.50%)
    5 / 2222 (0.23%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury (10061225)
    Additional description: Limb injury (10061225)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medication error (10027091)
    Additional description: Medication error (10027091)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage (10051077)
    Additional description: Post procedural haemorrhage (10051077)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound complication (10061468)
    Additional description: Postoperative wound complication (10061468)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage (10071229)
    Additional description: Procedural haemorrhage (10071229)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    27 / 2209 (1.22%)
    27 / 2222 (1.22%)
         occurrences causally related to treatment / all
    0 / 27
    1 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scar (10039580)
    Additional description: Scar (10039580)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous haematoma (10042345)
    Additional description: Subcutaneous haematoma (10042345)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical procedure repeated (10042618)
    Additional description: Surgical procedure repeated (10042618)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric injury (10046405)
    Additional description: Ureteric injury (10046405)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine perforation (10046810)
    Additional description: Uterine perforation (10046810)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine rupture (10046820)
    Additional description: Uterine rupture (10046820)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    3 / 2222 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular injury (10047080)
    Additional description: Vascular injury (10047080)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular procedure complication (10057462)
    Additional description: Vascular procedure complication (10057462)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound evisceration (10054108)
    Additional description: Wound evisceration (10054108)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Urachal abnormality (10066125)
    Additional description: Urachal abnormality (10066125)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure (10007554)
    Additional description: Cardiac failure (10007554)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest (10007617)
    Additional description: Cardio-respiratory arrest (10007617)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive cardiomyopathy (10056370)
    Additional description: Congestive cardiomyopathy (10056370)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations (10033557)
    Additional description: Palpitations (10033557)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Altered state of consciousness (10001854)
    Additional description: Altered state of consciousness (10001854)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amnesia (10001949)
    Additional description: Amnesia (10001949)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haematoma (10053942)
    Additional description: Cerebral haematoma (10053942)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy (10015037)
    Additional description: Epilepsy (10015037)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion (10016284)
    Additional description: Febrile convulsion (10016284)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure (10018100)
    Additional description: Generalised tonic-clonic seizure (10018100)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache (10019211)
    Additional description: Headache (10019211)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 2209 (0.23%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness (10024855)
    Additional description: Loss of consciousness (10024855)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine with aura (10027607)
    Additional description: Migraine with aura (10027607)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Motor dysfunction (10061296)
    Additional description: Motor dysfunction (10061296)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia (10033775)
    Additional description: Paraesthesia (10033775)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior reversible encephalopathy syndrome (10071066)
    Additional description: Posterior reversible encephalopathy syndrome (10071066)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reversible cerebral vasoconstriction syndrome (10073240)
    Additional description: Reversible cerebral vasoconstriction syndrome (10073240)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure (10039906)
    Additional description: Seizure (10039906)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia (10002034)
    Additional description: Anaemia (10002034)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia of pregnancy (10066468)
    Additional description: Anaemia of pregnancy (10066468)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Tinnitus (10043882)
    Additional description: Tinnitus (10043882)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo (10047340)
    Additional description: Vertigo (10047340)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Photopsia (10034962)
    Additional description: Photopsia (10034962)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment (10038848)
    Additional description: Retinal detachment (10038848)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual impairment (10047571)
    Additional description: Visual impairment (10047571)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain (10000081)
    Additional description: Abdominal pain (10000081)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower (10000084)
    Additional description: Abdominal pain lower (10000084)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall haematoma (10067383)
    Additional description: Abdominal wall haematoma (10067383)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    6 / 2222 (0.27%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure (10002153)
    Additional description: Anal fissure (10002153)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendiceal mucocoele (10057986)
    Additional description: Appendiceal mucocoele (10057986)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites (10003445)
    Additional description: Ascites (10003445)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative (10009900)
    Additional description: Colitis ulcerative (10009900)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea (10012735)
    Additional description: Diarrhoea (10012735)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis (10017853)
    Additional description: Gastritis (10017853)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis (10018830)
    Additional description: Haematemesis (10018830)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernial eventration (10057391)
    Additional description: Hernial eventration (10057391)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus (10021328)
    Additional description: Ileus (10021328)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction (10022687)
    Additional description: Intestinal obstruction (10022687)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    4 / 2222 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction (10062062)
    Additional description: Large intestinal obstruction (10062062)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea (10028813)
    Additional description: Nausea (10028813)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute (10033647)
    Additional description: Pancreatitis acute (10033647)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal disorder (10061343)
    Additional description: Peritoneal disorder (10061343)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal haemorrhage (10034666)
    Additional description: Peritoneal haemorrhage (10034666)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction (10041101)
    Additional description: Small intestinal obstruction (10041101)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strangulated umbilical hernia (10076931)
    Additional description: Strangulated umbilical hernia (10076931)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia (10045458)
    Additional description: Umbilical hernia (10045458)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting (10047700)
    Additional description: Vomiting (10047700)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema (10002424)
    Additional description: Angioedema (10002424)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised erythema (10051576)
    Additional description: Generalised erythema (10051576)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus (10037087)
    Additional description: Pruritus (10037087)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash (10037844)
    Additional description: Rash (10037844)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury (10069339)
    Additional description: Acute kidney injury (10069339)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anuria (10002847)
    Additional description: Anuria (10002847)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria (10018867)
    Additional description: Haematuria (10018867)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic (10038419)
    Additional description: Renal colic (10038419)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal vein thrombosis (10038548)
    Additional description: Renal vein thrombosis (10038548)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder rupture (10046530)
    Additional description: Urinary bladder rupture (10046530)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinoma (10050091)
    Additional description: Urinoma (10050091)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperparathyroidism primary (10020707)
    Additional description: Hyperparathyroidism primary (10020707)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion (10050296)
    Additional description: Intervertebral disc protrusion (10050296)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain (10028836)
    Additional description: Neck pain (10028836)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal wall abscess (10000099)
    Additional description: Abdominal wall abscess (10000099)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    4 / 2222 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall infection (10051254)
    Additional description: Abdominal wall infection (10051254)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast abscess (10006171)
    Additional description: Breast abscess (10006171)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometritis (10014791)
    Additional description: Endometritis (10014791)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    6 / 2222 (0.27%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometritis decidual (10014792)
    Additional description: Endometritis decidual (10014792)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    5 / 2222 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia infection (10061126)
    Additional description: Escherichia infection (10061126)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital infection (10048461)
    Additional description: Genital infection (10048461)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site abscess (10049660)
    Additional description: Incision site abscess (10049660)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected cyst (10058015)
    Additional description: Infected cyst (10058015)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection (10061229)
    Additional description: Lung infection (10061229)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphangitis (10025226)
    Additional description: Lymphangitis (10025226)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle abscess (10049206)
    Additional description: Muscle abscess (10049206)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia (10034016)
    Additional description: Paronychia (10034016)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess (10034236)
    Additional description: Pelvic abscess (10034236)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal abscess (10052457)
    Additional description: Perineal abscess (10052457)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis (10034674)
    Additional description: Peritonitis (10034674)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia (10035664)
    Additional description: Pneumonia (10035664)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpartum sepsis (10036422)
    Additional description: Postpartum sepsis (10036422)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Puerperal pyrexia (10037294)
    Additional description: Puerperal pyrexia (10037294)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis (10037596)
    Additional description: Pyelonephritis (10037596)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute (10037597)
    Additional description: Pyelonephritis acute (10037597)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis (10040047)
    Additional description: Sepsis (10040047)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock (10040070)
    Additional description: Septic shock (10040070)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection (10040872)
    Additional description: Skin infection (10040872)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection (10046571)
    Additional description: Urinary tract infection (10046571)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus (10012601)
    Additional description: Diabetes mellitus (10012601)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia (10020583)
    Additional description: Hypercalcaemia (10020583)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia (10020646)
    Additional description: Hyperkalaemia (10020646)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia (10020993)
    Additional description: Hypoglycaemia (10020993)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia neonatal (10020994)
    Additional description: Hypoglycaemia neonatal (10020994)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Group TXA Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1206 / 2209 (54.59%)
    1213 / 2222 (54.59%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Borderline mucinous tumour of ovary (10073266)
    Additional description: Borderline mucinous tumour of ovary (10073266)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Haemangioma of liver (10018821)
    Additional description: Haemangioma of liver (10018821)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Uterine leiomyoma (10046798)
    Additional description: Uterine leiomyoma (10046798)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Bleeding varicose vein (10005144)
    Additional description: Bleeding varicose vein (10005144)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Flushing (10016825)
    Additional description: Flushing (10016825)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences all number
    2
    0
    Haematoma (10018852)
    Additional description: Haematoma (10018852)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 2209 (0.36%)
    2 / 2222 (0.09%)
         occurrences all number
    8
    2
    Haemodynamic instability (10052076)
    Additional description: Haemodynamic instability (10052076)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Haemorrhage (10055798)
    Additional description: Haemorrhage (10055798)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Hot flush (10060800)
    Additional description: Hot flush (10060800)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    7 / 2222 (0.32%)
         occurrences all number
    4
    7
    Hypertension (10020772)
    Additional description: Hypertension (10020772)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    44 / 2209 (1.99%)
    49 / 2222 (2.21%)
         occurrences all number
    46
    49
    Hypotension (10021097)
    Additional description: Hypotension (10021097)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    29 / 2209 (1.31%)
    22 / 2222 (0.99%)
         occurrences all number
    29
    22
    Labile blood pressure (10023533)
    Additional description: Labile blood pressure (10023533)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    1
    Labile hypertension (10049079)
    Additional description: Labile hypertension (10049079)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Orthostatic hypotension (10031127)
    Additional description: Orthostatic hypotension (10031127)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences all number
    2
    1
    Pallor (10033546)
    Additional description: Pallor (10033546)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    1
    Shock (10040560)
    Additional description: Shock (10040560)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Thrombophlebitis superficial (10043595)
    Additional description: Thrombophlebitis superficial (10043595)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    3 / 2222 (0.14%)
         occurrences all number
    0
    4
    Thrombosis (10043607)
    Additional description: Thrombosis (10043607)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences all number
    2
    1
    Varicose vein (10046996)
    Additional description: Varicose vein (10046996)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    3 / 2222 (0.14%)
         occurrences all number
    3
    3
    Surgical and medical procedures
    Caesarean section (10006924)
    Additional description: Caesarean section (10006924)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    General anaesthesia (10018060)
    Additional description: General anaesthesia (10018060)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Haemostasis (10067439)
    Additional description: Haemostasis (10067439)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Salpingectomy (10039449)
    Additional description: Salpingectomy (10039449)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Pregnancy, puerperium and perinatal conditions
    Amniorrhexis (10051641)
    Additional description: Amniorrhexis (10051641)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Foetal macrosomia (10053700)
    Additional description: Foetal macrosomia (10053700)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Gestational diabetes (10018209)
    Additional description: Gestational diabetes (10018209)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Gestational hypertension (10070538)
    Additional description: Gestational hypertension (10070538)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Postpartum haemorrhage (10036417)
    Additional description: Postpartum haemorrhage (10036417)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    40 / 2209 (1.81%)
    36 / 2222 (1.62%)
         occurrences all number
    40
    36
    Pre-eclampsia (10036485)
    Additional description: Pre-eclampsia (10036485)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 2209 (0.23%)
    6 / 2222 (0.27%)
         occurrences all number
    5
    6
    Retained placenta or membranes (10038758)
    Additional description: Retained placenta or membranes (10038758)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    2 / 2222 (0.09%)
         occurrences all number
    2
    2
    Uterine atony (10046763)
    Additional description: Uterine atony (10046763)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    2 / 2222 (0.09%)
         occurrences all number
    4
    2
    Uterine inversion (10046796)
    Additional description: Uterine inversion (10046796)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia (10003549)
    Additional description: Asthenia (10003549)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences all number
    0
    2
    Chest discomfort (10008469)
    Additional description: Chest discomfort (10008469)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    1 / 2222 (0.05%)
         occurrences all number
    3
    1
    Chest pain (10008479)
    Additional description: Chest pain (10008479)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    7 / 2222 (0.32%)
         occurrences all number
    3
    7
    Chills (10008531)
    Additional description: Chills (10008531)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    6 / 2222 (0.27%)
         occurrences all number
    1
    6
    Crepitations (10011376)
    Additional description: Crepitations (10011376)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Drug intolerance (10061822)
    Additional description: Drug intolerance (10061822)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Face oedema (10016029)
    Additional description: Face oedema (10016029)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Fatigue (10016256)
    Additional description: Fatigue (10016256)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    1
    Feeling abnormal (10016322)
    Additional description: Feeling abnormal (10016322)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Generalised oedema (10018092)
    Additional description: Generalised oedema (10018092)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Hernia (10019909)
    Additional description: Hernia (10019909)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Hyperthermia (10020843)
    Additional description: Hyperthermia (10020843)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 2209 (0.45%)
    9 / 2222 (0.41%)
         occurrences all number
    10
    9
    Hypothermia (10021113)
    Additional description: Hypothermia (10021113)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Inflammation (10061218)
    Additional description: Inflammation (10061218)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Injection site haematoma (10022066)
    Additional description: Injection site haematoma (10022066)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Injection site pain (10022086)
    Additional description: Injection site pain (10022086)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Injection site paraesthesia (10022088)
    Additional description: Injection site paraesthesia (10022088)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Localised oedema (10048961)
    Additional description: Localised oedema (10048961)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Malaise (10025482)
    Additional description: Malaise (10025482)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    21 / 2209 (0.95%)
    13 / 2222 (0.59%)
         occurrences all number
    21
    13
    Oedema (10030095)
    Additional description: Oedema (10030095)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 2209 (0.50%)
    16 / 2222 (0.72%)
         occurrences all number
    11
    16
    Oedema peripheral (10030124)
    Additional description: Oedema peripheral (10030124)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    129 / 2209 (5.84%)
    133 / 2222 (5.99%)
         occurrences all number
    131
    135
    Pain (10033371)
    Additional description: Pain (10033371)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    4 / 2222 (0.18%)
         occurrences all number
    4
    4
    Pyrexia (10037660)
    Additional description: Pyrexia (10037660)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 2209 (0.32%)
    18 / 2222 (0.81%)
         occurrences all number
    7
    19
    Sense of oppression (10040007)
    Additional description: Sense of oppression (10040007)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    1
    Swelling (10042674)
    Additional description: Swelling (10042674)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Hypersensitivity (10020751)
    Additional description: Hypersensitivity (10020751)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    2 / 2222 (0.09%)
         occurrences all number
    2
    2
    Reproductive system and breast disorders
    Breast cyst (10006220)
    Additional description: Breast cyst (10006220)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Breast engorgement (10006240)
    Additional description: Breast engorgement (10006240)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Breast mass (10006272)
    Additional description: Breast mass (10006272)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences all number
    2
    0
    Dyspareunia (10013941)
    Additional description: Dyspareunia (10013941)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Female genital tract fistula (10061149)
    Additional description: Female genital tract fistula (10061149)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Galactocele (10017590)
    Additional description: Galactocele (10017590)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Lactation disorder (10061261)
    Additional description: Lactation disorder (10061261)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    2 / 2222 (0.09%)
         occurrences all number
    2
    2
    Metrorrhagia (10027514)
    Additional description: Metrorrhagia (10027514)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    1 / 2222 (0.05%)
         occurrences all number
    4
    1
    Nipple disorder (10029417)
    Additional description: Nipple disorder (10029417)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    1
    Ovarian cyst (10033132)
    Additional description: Ovarian cyst (10033132)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Pelvic pain (10034263)
    Additional description: Pelvic pain (10034263)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences all number
    1
    2
    Threatened uterine rupture (10080427)
    Additional description: Threatened uterine rupture (10080427)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    2 / 2222 (0.09%)
         occurrences all number
    3
    2
    Uterine haemorrhage (10046788)
    Additional description: Uterine haemorrhage (10046788)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    4 / 2222 (0.18%)
         occurrences all number
    2
    4
    Uterine pain (10046809)
    Additional description: Uterine pain (10046809)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences all number
    2
    0
    Uterine spasm (10046823)
    Additional description: Uterine spasm (10046823)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Vaginal discharge (10046901)
    Additional description: Vaginal discharge (10046901)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal pruritus (10056530)
    Additional description: Vulvovaginal pruritus (10056530)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma (10003553)
    Additional description: Asthma (10003553)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Choking sensation (10008590)
    Additional description: Choking sensation (10008590)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Cough (10011224)
    Additional description: Cough (10011224)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences all number
    1
    3
    Dyspnoea (10013968)
    Additional description: Dyspnoea (10013968)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 2209 (0.23%)
    4 / 2222 (0.18%)
         occurrences all number
    5
    4
    Emphysema (10014561)
    Additional description: Emphysema (10014561)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Oropharyngeal pain (10068319)
    Additional description: Oropharyngeal pain (10068319)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Productive cough (10036790)
    Additional description: Productive cough (10036790)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Rales (10037833)
    Additional description: Rales (10037833)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Respiratory distress (10038687)
    Additional description: Respiratory distress (10038687)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea (10039101)
    Additional description: Rhinorrhoea (10039101)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Throat irritation (10043521)
    Additional description: Throat irritation (10043521)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Wheezing (10047924)
    Additional description: Wheezing (10047924)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety (10002855)
    Additional description: Anxiety (10002855)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 2209 (0.32%)
    4 / 2222 (0.18%)
         occurrences all number
    7
    4
    Depressed mood (10012374)
    Additional description: Depressed mood (10012374)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Depression (10012378)
    Additional description: Depression (10012378)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences all number
    2
    1
    Dissociation (10013457)
    Additional description: Dissociation (10013457)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Emotional distress (10049119)
    Additional description: Emotional distress (10049119)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 2209 (0.41%)
    8 / 2222 (0.36%)
         occurrences all number
    9
    8
    Hallucination (10019063)
    Additional description: Hallucination (10019063)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Hallucination, visual (10019075)
    Additional description: Hallucination, visual (10019075)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Insomnia (10022437)
    Additional description: Insomnia (10022437)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Mental disorder (10061284)
    Additional description: Mental disorder (10061284)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Perinatal depression (10078366)
    Additional description: Perinatal depression (10078366)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    6 / 2222 (0.27%)
         occurrences all number
    4
    6
    Sleep disorder (10040984)
    Additional description: Sleep disorder (10040984)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Cholelithiasis (10008629)
    Additional description: Cholelithiasis (10008629)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    2 / 2222 (0.09%)
         occurrences all number
    2
    2
    Hepatocellular injury (10019837)
    Additional description: Hepatocellular injury (10019837)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 2209 (0.27%)
    10 / 2222 (0.45%)
         occurrences all number
    6
    10
    Investigations
    Activated partial thromboplastin time prolonged (10000636)
    Additional description: Activated partial thromboplastin time prolonged (10000636)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences all number
    2
    0
    Antinuclear antibody (10002807)
    Additional description: Antinuclear antibody (10002807)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased (10059570)
    Additional description: Blood alkaline phosphatase increased (10059570)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Blood creatinine increased (10005483)
    Additional description: Blood creatinine increased (10005483)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences all number
    2
    1
    Blood culture positive (10005488)
    Additional description: Blood culture positive (10005488)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Blood glucose fluctuation (10049803)
    Additional description: Blood glucose fluctuation (10049803)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Blood uric acid increased (10005861)
    Additional description: Blood uric acid increased (10005861)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    C-reactive protein increased (10006825)
    Additional description: C-reactive protein increased (10006825)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences all number
    2
    1
    Citrobacter test positive (10069963)
    Additional description: Citrobacter test positive (10069963)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Electrocardiogram abnormal (10014363)
    Additional description: Electrocardiogram abnormal (10014363)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin decreased (10018884)
    Additional description: Haemoglobin decreased (10018884)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 2209 (0.23%)
    2 / 2222 (0.09%)
         occurrences all number
    5
    2
    Homans' sign positive (10051031)
    Additional description: Homans' sign positive (10051031)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Liver function test abnormal (10024690)
    Additional description: Liver function test abnormal (10024690)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    2
    Oxygen saturation decreased (10033318)
    Additional description: Oxygen saturation decreased (10033318)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences all number
    1
    2
    Proteus test positive (10070134)
    Additional description: Proteus test positive (10070134)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Renal function test abnormal (10061480)
    Additional description: Renal function test abnormal (10061480)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Smear cervix abnormal (10041206)
    Additional description: Smear cervix abnormal (10041206)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Transaminases increased (10054889)
    Additional description: Transaminases increased (10054889)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Anaesthetic complication (10060938)
    Additional description: Anaesthetic complication (10060938)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Arterial injury (10003162)
    Additional description: Arterial injury (10003162)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    3 / 2222 (0.14%)
         occurrences all number
    3
    3
    Bladder injury (10061698)
    Additional description: Bladder injury (10061698)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    4 / 2222 (0.18%)
         occurrences all number
    3
    4
    Dural tear (10063395)
    Additional description: Dural tear (10063395)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences all number
    1
    2
    Fall (10016173)
    Additional description: Fall (10016173)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences all number
    2
    0
    Head injury (10019196)
    Additional description: Head injury (10019196)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Incision site discharge (10082296)
    Additional description: Incision site discharge (10082296)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 2209 (0.50%)
    6 / 2222 (0.27%)
         occurrences all number
    11
    6
    Incision site haematoma (10059241)
    Additional description: Incision site haematoma (10059241)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    24 / 2209 (1.09%)
    12 / 2222 (0.54%)
         occurrences all number
    24
    12
    Incision site haemorrhage (10051100)
    Additional description: Incision site haemorrhage (10051100)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 2209 (0.45%)
    6 / 2222 (0.27%)
         occurrences all number
    10
    6
    Incision site hypoaesthesia (10069386)
    Additional description: Incision site hypoaesthesia (10069386)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Incision site oedema (10065614)
    Additional description: Incision site oedema (10065614)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    3 / 2222 (0.14%)
         occurrences all number
    1
    3
    Incision site pain (10058043)
    Additional description: Incision site pain (10058043)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Joint dislocation (10023204)
    Additional description: Joint dislocation (10023204)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain (10024453)
    Additional description: Ligament sprain (10024453)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Meniscus injury (10072970)
    Additional description: Meniscus injury (10072970)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Post lumbar puncture syndrome (10060854)
    Additional description: Post lumbar puncture syndrome (10060854)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    4 / 2222 (0.18%)
         occurrences all number
    2
    4
    Post procedural urine leak (10057587)
    Additional description: Post procedural urine leak (10057587)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Postoperative wound complication (10061468)
    Additional description: Postoperative wound complication (10061468)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    36 / 2209 (1.63%)
    28 / 2222 (1.26%)
         occurrences all number
    36
    28
    Procedural haemorrhage (10071229)
    Additional description: Procedural haemorrhage (10071229)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 2209 (0.36%)
    7 / 2222 (0.32%)
         occurrences all number
    8
    7
    Procedural hypotension (10062300)
    Additional description: Procedural hypotension (10062300)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    2 / 2222 (0.09%)
         occurrences all number
    2
    2
    Procedural pain (10064882)
    Additional description: Procedural pain (10064882)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Reproductive tract procedural complication (10081324)
    Additional description: Reproductive tract procedural complication (10081324)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    3 / 2222 (0.14%)
         occurrences all number
    1
    3
    Scar (10039580)
    Additional description: Scar (10039580)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 2209 (0.36%)
    7 / 2222 (0.32%)
         occurrences all number
    8
    7
    Surgical procedure repeated (10042618)
    Additional description: Surgical procedure repeated (10042618)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Transfusion-associated dyspnoea (10072266)
    Additional description: Transfusion-associated dyspnoea (10072266)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Uterine rupture (10046820)
    Additional description: Uterine rupture (10046820)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    4 / 2222 (0.18%)
         occurrences all number
    1
    4
    Wound (10052428)
    Additional description: Wound (10052428)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Wound secretion (10048629)
    Additional description: Wound secretion (10048629)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Wrong technique in product usage process (10076573)
    Additional description: Wrong technique in product usage process (10076573)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Thalassaemia (10043388)
    Additional description: Thalassaemia (10043388)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrioventricular block (10003671)
    Additional description: Atrioventricular block (10003671)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Bradycardia (10006093)
    Additional description: Bradycardia (10006093)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    4 / 2222 (0.18%)
         occurrences all number
    2
    4
    Extrasystoles (10015856)
    Additional description: Extrasystoles (10015856)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Palpitations (10033557)
    Additional description: Palpitations (10033557)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    3 / 2222 (0.14%)
         occurrences all number
    1
    3
    Sinus tachycardia (10040752)
    Additional description: Sinus tachycardia (10040752)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Tachycardia (10043071)
    Additional description: Tachycardia (10043071)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 2209 (0.32%)
    8 / 2222 (0.36%)
         occurrences all number
    7
    8
    Nervous system disorders
    Carpal tunnel syndrome (10007697)
    Additional description: Carpal tunnel syndrome (10007697)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences all number
    2
    1
    Cervical radiculopathy (10050217)
    Additional description: Cervical radiculopathy (10050217)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Dizziness postural (10013578)
    Additional description: Dizziness postural (10013578)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Dysarthria (10013887)
    Additional description: Dysarthria (10013887)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Headache (10019211)
    Additional description: Headache (10019211)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    46 / 2209 (2.08%)
    44 / 2222 (1.98%)
         occurrences all number
    47
    45
    Loss of consciousness (10024855)
    Additional description: Loss of consciousness (10024855)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Migraine (10027599)
    Additional description: Migraine (10027599)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 2209 (0.23%)
    0 / 2222 (0.00%)
         occurrences all number
    5
    0
    Migraine with aura (10027607)
    Additional description: Migraine with aura (10027607)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Motor dysfunction (10061296)
    Additional description: Motor dysfunction (10061296)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Paraesthesia (10033775)
    Additional description: Paraesthesia (10033775)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 2209 (0.23%)
    3 / 2222 (0.14%)
         occurrences all number
    5
    3
    Presyncope (10036653)
    Additional description: Presyncope (10036653)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 2209 (0.41%)
    6 / 2222 (0.27%)
         occurrences all number
    9
    6
    Sciatica (10039674)
    Additional description: Sciatica (10039674)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Sensory disturbance (10040026)
    Additional description: Sensory disturbance (10040026)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Syncope (10042772)
    Additional description: Syncope (10042772)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Tremor (10044565)
    Additional description: Tremor (10044565)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 2209 (0.36%)
    5 / 2222 (0.23%)
         occurrences all number
    8
    5
    Blood and lymphatic system disorders
    Anaemia (10002034)
    Additional description: Anaemia (10002034)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    242 / 2209 (10.96%)
    212 / 2222 (9.54%)
         occurrences all number
    242
    212
    Anaemia of pregnancy (10066468)
    Additional description: Anaemia of pregnancy (10066468)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    69 / 2209 (3.12%)
    48 / 2222 (2.16%)
         occurrences all number
    70
    48
    Coagulopathy (10009802)
    Additional description: Coagulopathy (10009802)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Hyperfibrinogenaemia (10051124)
    Additional description: Hyperfibrinogenaemia (10051124)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Normocytic anaemia (10029784)
    Additional description: Normocytic anaemia (10029784)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Pancytopenia (10033661)
    Additional description: Pancytopenia (10033661)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia (10043554)
    Additional description: Thrombocytopenia (10043554)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    7 / 2222 (0.32%)
         occurrences all number
    3
    7
    Thrombocytosis (10043563)
    Additional description: Thrombocytosis (10043563)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Tinnitus (10043882)
    Additional description: Tinnitus (10043882)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    6 / 2222 (0.27%)
         occurrences all number
    4
    6
    Tympanic membrane perforation (10045210)
    Additional description: Tympanic membrane perforation (10045210)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Vertigo (10047340)
    Additional description: Vertigo (10047340)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    102 / 2209 (4.62%)
    112 / 2222 (5.04%)
         occurrences all number
    104
    113
    Eye disorders
    Chalazion (10008388)
    Additional description: Chalazion (10008388)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Eyelid oedema (10015993)
    Additional description: Eyelid oedema (10015993)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Photophobia (10034960)
    Additional description: Photophobia (10034960)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences all number
    0
    2
    Photopsia (10034962)
    Additional description: Photopsia (10034962)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    8 / 2222 (0.36%)
         occurrences all number
    3
    8
    Vision blurred (10047513)
    Additional description: Vision blurred (10047513)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences all number
    2
    1
    Visual impairment (10047571)
    Additional description: Visual impairment (10047571)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal distension (10000060)
    Additional description: Abdominal distension (10000060)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 2209 (0.23%)
    4 / 2222 (0.18%)
         occurrences all number
    5
    4
    Abdominal pain (10000081)
    Additional description: Abdominal pain (10000081)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 2209 (0.23%)
    8 / 2222 (0.36%)
         occurrences all number
    5
    8
    Abdominal pain lower (10000084)
    Additional description: Abdominal pain lower (10000084)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences all number
    2
    1
    Abdominal pain upper (10000087)
    Additional description: Abdominal pain upper (10000087)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    6 / 2222 (0.27%)
         occurrences all number
    0
    6
    Abdominal wall haematoma (10067383)
    Additional description: Abdominal wall haematoma (10067383)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    46 / 2209 (2.08%)
    33 / 2222 (1.49%)
         occurrences all number
    46
    33
    Constipation (10010774)
    Additional description: Constipation (10010774)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    105 / 2209 (4.75%)
    115 / 2222 (5.18%)
         occurrences all number
    106
    115
    Diarrhoea (10012735)
    Additional description: Diarrhoea (10012735)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 2209 (0.59%)
    8 / 2222 (0.36%)
         occurrences all number
    13
    8
    Dyspepsia (10013946)
    Additional description: Dyspepsia (10013946)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Flatulence (10016766)
    Additional description: Flatulence (10016766)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences all number
    2
    1
    Gastrointestinal pain (10017999)
    Additional description: Gastrointestinal pain (10017999)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease (10017885)
    Additional description: Gastrooesophageal reflux disease (10017885)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences all number
    1
    2
    Haemorrhoids (10019022)
    Additional description: Haemorrhoids (10019022)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 2209 (0.41%)
    5 / 2222 (0.23%)
         occurrences all number
    9
    5
    Haemorrhoids thrombosed (10019023)
    Additional description: Haemorrhoids thrombosed (10019023)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia oral (10057371)
    Additional description: Hypoaesthesia oral (10057371)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Intestinal mass (10059017)
    Additional description: Intestinal mass (10059017)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Nausea (10028813)
    Additional description: Nausea (10028813)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    475 / 2209 (21.50%)
    529 / 2222 (23.81%)
         occurrences all number
    502
    545
    Obstruction gastric (10029957)
    Additional description: Obstruction gastric (10029957)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Toothache (10044055)
    Additional description: Toothache (10044055)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Umbilical hernia (10045458)
    Additional description: Umbilical hernia (10045458)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences all number
    2
    0
    Vomiting (10047700)
    Additional description: Vomiting (10047700)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    254 / 2209 (11.50%)
    299 / 2222 (13.46%)
         occurrences all number
    264
    316
    Skin and subcutaneous tissue disorders
    Acne (10000496)
    Additional description: Acne (10000496)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Blister (10005191)
    Additional description: Blister (10005191)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Dermatitis (10012431)
    Additional description: Dermatitis (10012431)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences all number
    2
    0
    Dermatitis allergic (10012434)
    Additional description: Dermatitis allergic (10012434)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Dermatitis contact (10012442)
    Additional description: Dermatitis contact (10012442)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    1
    Ecchymosis (10014080)
    Additional description: Ecchymosis (10014080)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences all number
    1
    2
    Eczema (10014184)
    Additional description: Eczema (10014184)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Erythema (10015150)
    Additional description: Erythema (10015150)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    5 / 2222 (0.23%)
         occurrences all number
    4
    5
    Hyperhidrosis (10020642)
    Additional description: Hyperhidrosis (10020642)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 2209 (0.23%)
    4 / 2222 (0.18%)
         occurrences all number
    5
    4
    Pruritus (10037087)
    Additional description: Pruritus (10037087)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    17 / 2209 (0.77%)
    17 / 2222 (0.77%)
         occurrences all number
    17
    17
    Pruritus generalised (10052576)
    Additional description: Pruritus generalised (10052576)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    2 / 2222 (0.09%)
         occurrences all number
    4
    2
    Rash (10037844)
    Additional description: Rash (10037844)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    6 / 2222 (0.27%)
         occurrences all number
    3
    6
    Rash erythematous (10037855)
    Additional description: Rash erythematous (10037855)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Rash pruritic (10037884)
    Additional description: Rash pruritic (10037884)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Scar pain (10049002)
    Additional description: Scar pain (10049002)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 2209 (0.23%)
    10 / 2222 (0.45%)
         occurrences all number
    5
    10
    Skin maceration (10048625)
    Additional description: Skin maceration (10048625)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    1
    Subcutaneous emphysema (10042344)
    Additional description: Subcutaneous emphysema (10042344)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Urticaria (10046735)
    Additional description: Urticaria (10046735)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences all number
    2
    1
    Renal and urinary disorders
    Acute kidney injury (10069339)
    Additional description: Acute kidney injury (10069339)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Dysuria (10013990)
    Additional description: Dysuria (10013990)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 2209 (0.41%)
    9 / 2222 (0.41%)
         occurrences all number
    9
    10
    Haematuria (10018867)
    Additional description: Haematuria (10018867)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences all number
    2
    1
    Hypotonic urinary bladder (10058914)
    Additional description: Hypotonic urinary bladder (10058914)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Nephrolithiasis (10029148)
    Additional description: Nephrolithiasis (10029148)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Prerenal failure (10072370)
    Additional description: Prerenal failure (10072370)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Proteinuria (10037032)
    Additional description: Proteinuria (10037032)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences all number
    1
    2
    Renal colic (10038419)
    Additional description: Renal colic (10038419)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Renal failure (10038435)
    Additional description: Renal failure (10038435)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Stress urinary incontinence (10066218)
    Additional description: Stress urinary incontinence (10066218)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Tubulointerstitial nephritis (10048302)
    Additional description: Tubulointerstitial nephritis (10048302)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Urinary bladder rupture (10046530)
    Additional description: Urinary bladder rupture (10046530)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Urinary retention (10046555)
    Additional description: Urinary retention (10046555)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    170 / 2209 (7.70%)
    161 / 2222 (7.25%)
         occurrences all number
    170
    161
    Endocrine disorders
    Hyperthyroidism (10020850)
    Additional description: Hyperthyroidism (10020850)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia (10003239)
    Additional description: Arthralgia (10003239)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences all number
    1
    2
    Axillary mass (10049021)
    Additional description: Axillary mass (10049021)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Back pain (10003988)
    Additional description: Back pain (10003988)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 2209 (0.23%)
    12 / 2222 (0.54%)
         occurrences all number
    5
    12
    Coccydynia (10009829)
    Additional description: Coccydynia (10009829)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    1
    Diastasis recti abdominis (10073169)
    Additional description: Diastasis recti abdominis (10073169)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    0 / 2222 (0.00%)
         occurrences all number
    3
    0
    Fistula (10016717)
    Additional description: Fistula (10016717)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Flank pain (10016750)
    Additional description: Flank pain (10016750)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    1 / 2222 (0.05%)
         occurrences all number
    3
    1
    Intervertebral disc protrusion (10050296)
    Additional description: Intervertebral disc protrusion (10050296)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Muscle spasms (10028334)
    Additional description: Muscle spasms (10028334)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    0 / 2222 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal chest pain (10050819)
    Additional description: Musculoskeletal chest pain (10050819)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences all number
    1
    2
    Musculoskeletal pain (10028391)
    Additional description: Musculoskeletal pain (10028391)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    3 / 2222 (0.14%)
         occurrences all number
    4
    3
    Myositis (10028653)
    Additional description: Myositis (10028653)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Neck pain (10028836)
    Additional description: Neck pain (10028836)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    4 / 2222 (0.18%)
         occurrences all number
    1
    4
    Pain in extremity (10033425)
    Additional description: Pain in extremity (10033425)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 2209 (0.23%)
    5 / 2222 (0.23%)
         occurrences all number
    6
    5
    Polyarthritis (10036030)
    Additional description: Polyarthritis (10036030)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Infections and infestations
    Abdominal wall abscess (10000099)
    Additional description: Abdominal wall abscess (10000099)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences all number
    2
    0
    Acarodermatitis (10063409)
    Additional description: Acarodermatitis (10063409)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Bacterial disease carrier (10004017)
    Additional description: Bacterial disease carrier (10004017)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Bacterial vaginosis (10004055)
    Additional description: Bacterial vaginosis (10004055)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences all number
    2
    0
    Bronchitis (10006451)
    Additional description: Bronchitis (10006451)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Cystitis (10011781)
    Additional description: Cystitis (10011781)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    1 / 2222 (0.05%)
         occurrences all number
    3
    1
    Cystitis bacterial (10065198)
    Additional description: Cystitis bacterial (10065198)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    1
    Cystitis escherichia (10011790)
    Additional description: Cystitis escherichia (10011790)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences all number
    2
    0
    Dermatophytosis (10012504)
    Additional description: Dermatophytosis (10012504)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Dermatophytosis of nail (10012511)
    Additional description: Dermatophytosis of nail (10012511)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Ear infection (10014011)
    Additional description: Ear infection (10014011)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Endometritis (10014791)
    Additional description: Endometritis (10014791)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    8 / 2222 (0.36%)
         occurrences all number
    2
    8
    Endometritis decidual (10014792)
    Additional description: Endometritis decidual (10014792)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences all number
    1
    2
    Fungal infection (10017533)
    Additional description: Fungal infection (10017533)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Incision site abscess (10049660)
    Additional description: Incision site abscess (10049660)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    2 / 2222 (0.09%)
         occurrences all number
    2
    2
    Influenza (10022000)
    Additional description: Influenza (10022000)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Lung infection (10061229)
    Additional description: Lung infection (10061229)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Lymphangitis (10025226)
    Additional description: Lymphangitis (10025226)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Mastitis (10026883)
    Additional description: Mastitis (10026883)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    3 / 2222 (0.14%)
         occurrences all number
    2
    3
    Nasal herpes (10074936)
    Additional description: Nasal herpes (10074936)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences all number
    0
    2
    Nasopharyngitis (10028810)
    Additional description: Nasopharyngitis (10028810)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Oral herpes (10067152)
    Additional description: Oral herpes (10067152)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    3 / 2222 (0.14%)
         occurrences all number
    0
    3
    Pilonidal cyst (10035043)
    Additional description: Pilonidal cyst (10035043)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    0 / 2222 (0.00%)
         occurrences all number
    2
    0
    Pneumonia (10035664)
    Additional description: Pneumonia (10035664)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Puerperal pyrexia (10037294)
    Additional description: Puerperal pyrexia (10037294)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Purulent discharge (10037569)
    Additional description: Purulent discharge (10037569)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    1 / 2222 (0.05%)
         occurrences all number
    2
    1
    Pyelonephritis (10037596)
    Additional description: Pyelonephritis (10037596)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    2 / 2222 (0.09%)
         occurrences all number
    1
    2
    Sinusitis (10040753)
    Additional description: Sinusitis (10040753)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Skin infection (10040872)
    Additional description: Skin infection (10040872)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 2209 (0.14%)
    4 / 2222 (0.18%)
         occurrences all number
    3
    4
    Tonsillitis (10044008)
    Additional description: Tonsillitis (10044008)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Urinary tract infection (10046571)
    Additional description: Urinary tract infection (10046571)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 2209 (0.18%)
    10 / 2222 (0.45%)
         occurrences all number
    4
    10
    Vaginal infection (10046914)
    Additional description: Vaginal infection (10046914)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    1
    Vaginitis gardnerella (10046957)
    Additional description: Vaginitis gardnerella (10046957)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    1 / 2222 (0.05%)
         occurrences all number
    1
    1
    Vulvovaginal mycotic infection (10064899)
    Additional description: Vulvovaginal mycotic infection (10064899)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperinsulinaemic hypoglycaemia (10077216)
    Additional description: Hyperinsulinaemic hypoglycaemia (10077216)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia (10020646)
    Additional description: Hyperkalaemia (10020646)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemia (10020993)
    Additional description: Hypoglycaemia (10020993)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 2209 (0.09%)
    2 / 2222 (0.09%)
         occurrences all number
    2
    2
    Hypokalaemia (10021015)
    Additional description: Hypokalaemia (10021015)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    2 / 2222 (0.09%)
         occurrences all number
    0
    2
    Hypovitaminosis (10021135)
    Additional description: Hypovitaminosis (10021135)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 2209 (0.05%)
    0 / 2222 (0.00%)
         occurrences all number
    1
    0
    Hypovolaemia (10021137)
    Additional description: Hypovolaemia (10021137)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1
    Obesity (10029883)
    Additional description: Obesity (10029883)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 2209 (0.00%)
    1 / 2222 (0.05%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Dec 2017
    1. Additional information in participant information letter upon request of CNIL (French Data Protection Authority) 2. Modification of the circuit of centralization of the nominative data 3. Addition of a investigating site (CHU de Caen)
    15 Feb 2018
    1. The 4-hour delay after the injection before the start of breastfeeding is removed 2. Comprehensive safety of all serious adverse events is reduced to the 1st month of participation. Only serious adverse events will then be reported. 3. A secondary medico-economic objective is added: calculation of the incremental cost/effectiveness ratio of TXA versus placebo from the point of view of health insurance 4. The inclusion criterion 'CBC within 3 days prior to caesarean section' becomes '...within 7 days prior to caesarean section'. 5. Change of the principal investigator of Sites CHU de Rennes and CHU de Toulouse 6. Addition of two investigating sites : CHI de Créteil and CH de Pau
    18 Jun 2018
    1. Changing the way centralized data is transmitted 2. The addition of a TRAAP 2 presentation poster for waiting rooms. 3. Addition of two investigating sites : CHU de Poitiers et CHU de Strasbourg (second site) 4. Modification of the possibility of participating in another study for TRAPP 2 participant
    09 Jan 2019
    1. Midwife role clarification. 2. Addition of a list of adverse events not to be reported (provided that they are not serious) 3. Updating the protocol and the information note in accordance with General Data Protection Regulation (GDPR) 4. Update of the SPC of Exacyl (Annex 2 of the protocol) 5. Update of the coordinating correspondents 6. Various typo corrections
    31 May 2019
    1. Increase in the number of expected patients 2. Punctual corrections in the protocol 3. Timing of study treatment 4. Modification of principal investigator for 2 sites : CHU de Besançon and CHU de Strasbourg

    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/33913639
    http://www.ncbi.nlm.nih.gov/pubmed/32005192
    For support, Contact us.
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