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    Clinical Trial Results:
    A Phase III, randomized, controlled, single-blind, multicentre, parallel arm trial to assess the efficacy and safety of Pergoveris® (follitropin alfa and lutropin alfa) and GONAL-f® (follitropin alfa) for multifollicular development as part of an assisted reproductive technology treatment cycle in poor ovarian responders, as defined by the European Society of Human Reproduction and Embryology criteria

    Summary
    EudraCT number
    2013-003817-16
    Trial protocol
    CZ   SE   EE   HU   BE   GB   NL   DK   LV   ES   PL  
    Global end of trial date
    05 Aug 2015

    Results information
    Results version number
    v2(current)
    This version publication date
    12 Aug 2017
    First version publication date
    13 Aug 2016
    Other versions
    v1
    Version creation reason
    • Changes to summary attachments
    Result publication to be added
    Summary report(s)
    Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    EMR200061-005
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02047227
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck KGaA
    Sponsor organisation address
    Frankfurter Strasse 250 , Darmstadt, Germany, 64293
    Public contact
    Communication Center Merck KGaA , Merck KGaA, +49 6151725200, service@merckgroup.com
    Scientific contact
    Communication Center Merck KGaA , Merck KGaA, +49 6151725200, service@merckgroup.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate superiority of Pergoveris versus GONAL-f in poor ovarian response (POR) subjects as aligned with the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE)
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Jan 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 20
    Country: Number of subjects enrolled
    Czech Republic: 54
    Country: Number of subjects enrolled
    Denmark: 12
    Country: Number of subjects enrolled
    Estonia: 30
    Country: Number of subjects enrolled
    France: 21
    Country: Number of subjects enrolled
    Germany: 48
    Country: Number of subjects enrolled
    Hungary: 69
    Country: Number of subjects enrolled
    Italy: 111
    Country: Number of subjects enrolled
    Latvia: 57
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 107
    Country: Number of subjects enrolled
    Spain: 267
    Country: Number of subjects enrolled
    Sweden: 8
    Country: Number of subjects enrolled
    Turkey: 101
    Country: Number of subjects enrolled
    United Kingdom: 31
    Worldwide total number of subjects
    939
    EEA total number of subjects
    838
    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)
    939
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was conducted at 101 sites in 15 countries.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Pergoveris
    Arm description
    Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of r-hCG (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
    Arm type
    Experimental

    Investigational medicinal product name
    Pergoveris
    Investigational medicinal product code
    Other name
    r-hFSH/r-hLH, Follitropin alfa/Lutropin alfa
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pergoveris was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH.

    Investigational medicinal product name
    Recombinant human chorionic gonadotrophin (r-hCG)
    Investigational medicinal product code
    Other name
    Ovidrel, Ovitrelle, choriogonadotropin alfa
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    250 mcg of r-hCG was administered once subcutaneously

    Arm title
    GONAL-f
    Arm description
    GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
    Arm type
    Active comparator

    Investigational medicinal product name
    GONAL-f
    Investigational medicinal product code
    Other name
    r-hFSH, Follitropin alfa
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU.

    Investigational medicinal product name
    Recombinant human chorionic gonadotrophin (r-hCG)
    Investigational medicinal product code
    Other name
    Ovidrel, Ovitrelle, choriogonadotropin alfa
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    250 mcg of r-hCG was administered once subcutaneously.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The trial was single-blinded where the Investigator and all site personnel (with the exception of the trial Nurse/Coordinator and/or Pharmacist/Pharmacy Assistant) remained blinded, throughout the course of the trial as to which treatment each subject received. The subject, however, was informed by the trial nurse or pharmacist of which treatment they were receiving.
    Number of subjects in period 1
    Pergoveris GONAL-f
    Started
    462
    477
    Completed ovarian stimulation phase
    424
    440
    Completed
    318
    347
    Not completed
    144
    130
         Protocol deviation
             1
             -
         All embryos discarded
             12
             11
         Intention to freeze all embryos
             1
             -
         Lack of ovarian response to stimulation
             35
             32
         Adverse event, non-fatal
             2
             4
         Spontaneous pregnancy
             1
             -
         Unspecified
             10
             9
         No fertilization
             61
             51
         Lost to follow-up
             -
             3
         No oocytes retrieved
             21
             20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pergoveris
    Reporting group description
    Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of r-hCG (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.

    Reporting group title
    GONAL-f
    Reporting group description
    GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.

    Reporting group values
    Pergoveris GONAL-f Total
    Number of subjects
    462 477 939
    Age categorical
    Units: Subjects
    Age Continuous
    All Randomized Subjects Set included all subjects who were randomized.
    Units: years
        arithmetic mean (standard deviation)
    38.3 ± 2.9 38.3 ± 3 -
    Gender, Male/Female
    Units: subjects
        Female
    462 477 939
        Male
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Pergoveris
    Reporting group description
    Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of r-hCG (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.

    Reporting group title
    GONAL-f
    Reporting group description
    GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.

    Primary: Number of oocytes retrieved

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    End point title
    Number of oocytes retrieved
    End point description
    Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. Intent-to-treat (ITT) analysis set included all subjects randomized who received at least 1 dose of GONAL-f or Pergoveris.
    End point type
    Primary
    End point timeframe
    At approximately 34 to 38 hours after r-hCG administration
    End point values
    Pergoveris GONAL-f
    Number of subjects analysed
    462
    477
    Units: oocytes
        arithmetic mean (standard deviation)
    3.3 ± 2.71
    3.6 ± 2.82
    Statistical analysis title
    Comparison between Pergoveris and Gonal f groups
    Comparison groups
    GONAL-f v Pergoveris
    Number of subjects included in analysis
    939
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.054
    Method
    Poisson Regression Model
    Parameter type
    Mean difference (net)
    Point estimate
    -0.235
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.4741
         upper limit
    0.003

    Secondary: Ongoing pregnancy rate

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    End point title
    Ongoing pregnancy rate
    End point description
    Ongoing pregnancy rate was defined as the percentage of subjects with a ultrasound confirmation of at least one viable fetus (positive fetal heart beat). Modified intent-to-treat (MITT) analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.
    End point type
    Secondary
    End point timeframe
    70 days after embryo transfer
    End point values
    Pergoveris GONAL-f
    Number of subjects analysed
    462
    477
    Units: percentage of subjects
        number (not applicable)
    11
    12.4
    No statistical analyses for this end point

    Secondary: Live birth rate

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    End point title
    Live birth rate
    End point description
    Live birth rate was defined as the percentage of subjects with at least one live-born neonate. MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.
    End point type
    Secondary
    End point timeframe
    Approximately 180 days following ongoing pregnancy determination
    End point values
    Pergoveris GONAL-f
    Number of subjects analysed
    462
    477
    Units: percentage of subjects
        number (not applicable)
    10.6
    11.7
    No statistical analyses for this end point

    Secondary: Embryo implantation rate

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    End point title
    Embryo implantation rate
    End point description
    Embryo implantation rate was defined as the number of gestational sacs divided by the number of embryos transferred per subject. MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration. Number of subjects analysed signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    2 to 3 days following oocyte retrieval
    End point values
    Pergoveris GONAL-f
    Number of subjects analysed
    319
    349
    Units: sacs/embryos/subject
        number (not applicable)
    14.7
    15.6
    No statistical analyses for this end point

    Secondary: Clinical pregnancy rate

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    End point title
    Clinical pregnancy rate
    End point description
    Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity. MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.
    End point type
    Secondary
    End point timeframe
    35-42 days post r-hCG administration
    End point values
    Pergoveris GONAL-f
    Number of subjects analysed
    462
    477
    Units: percentage of subjects
        number (not applicable)
    14.1
    16.8
    No statistical analyses for this end point

    Secondary: Biochemical pregnancy rate

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    End point title
    Biochemical pregnancy rate
    End point description
    Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test. MITT Analysis Set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.
    End point type
    Secondary
    End point timeframe
    15 to 20 days post r-hCG administration.
    End point values
    Pergoveris GONAL-f
    Number of subjects analysed
    462
    477
    Units: percentage of subjects
        number (not applicable)
    17.3
    23.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 180 days after ongoing pregnancy (maximum up to 365 days)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Pergoveris
    Reporting group description
    Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.

    Reporting group title
    GONAL-f
    Reporting group description
    GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.

    Serious adverse events
    Pergoveris GONAL-f
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 462 (1.73%)
    17 / 477 (3.56%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Fallot's tetralogy
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trisomy 21
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         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
    Abortion missed
         subjects affected / exposed
    1 / 462 (0.22%)
    3 / 477 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 477 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion spontaneous
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature labour
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foetal death
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperemesis gravidarum
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Imminent abortion
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature baby
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Threatened labour
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature delivery
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst ruptured
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian haemorrhage
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian rupture
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (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
    Urticaria
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         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
    Pergoveris GONAL-f
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    111 / 462 (24.03%)
    151 / 477 (31.66%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    19 / 462 (4.11%)
    10 / 477 (2.10%)
         occurrences all number
    23
    13
    Flushing
         subjects affected / exposed
    3 / 462 (0.65%)
    0 / 477 (0.00%)
         occurrences all number
    3
    0
    Circulatory collapse
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    2
    0
    Hypertension
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    3
    0
    Venous thrombosis
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Immune system disorders
    Crying
         subjects affected / exposed
    2 / 462 (0.43%)
    3 / 477 (0.63%)
         occurrences all number
    2
    3
    Food allergy
         subjects affected / exposed
    2 / 462 (0.43%)
    0 / 477 (0.00%)
         occurrences all number
    2
    0
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Hypersensitivity
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    2
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    6 / 462 (1.30%)
    12 / 477 (2.52%)
         occurrences all number
    16
    12
    Abortion missed
         subjects affected / exposed
    5 / 462 (1.08%)
    5 / 477 (1.05%)
         occurrences all number
    5
    5
    Abortion
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences all number
    1
    1
    Foetal death
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 477 (0.42%)
         occurrences all number
    0
    2
    Placenta praevia
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Vomiting in pregnancy
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 462 (1.08%)
    4 / 477 (0.84%)
         occurrences all number
    5
    7
    Injection site erythema
         subjects affected / exposed
    4 / 462 (0.87%)
    4 / 477 (0.84%)
         occurrences all number
    6
    8
    Asthenia
         subjects affected / exposed
    2 / 462 (0.43%)
    1 / 477 (0.21%)
         occurrences all number
    2
    1
    Chest discomfort
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Gait disturbance
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Hyperthermia
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Injection site haematoma
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Injection site pain
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 462 (0.43%)
    3 / 477 (0.63%)
         occurrences all number
    2
    3
    Insomnia
         subjects affected / exposed
    2 / 462 (0.43%)
    3 / 477 (0.63%)
         occurrences all number
    5
    3
    Mood swings
         subjects affected / exposed
    3 / 462 (0.65%)
    1 / 477 (0.21%)
         occurrences all number
    3
    1
    Nervousness
         subjects affected / exposed
    2 / 462 (0.43%)
    2 / 477 (0.42%)
         occurrences all number
    2
    2
    Agitation
         subjects affected / exposed
    2 / 462 (0.43%)
    0 / 477 (0.00%)
         occurrences all number
    2
    0
    Depressive symptom
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences all number
    1
    1
    Depressed mood
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Affective disorder
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Irritability
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Libido increased
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Tearfulness
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    6 / 462 (1.30%)
    6 / 477 (1.26%)
         occurrences all number
    7
    6
    Breast tenderness
         subjects affected / exposed
    3 / 462 (0.65%)
    2 / 477 (0.42%)
         occurrences all number
    3
    2
    Vaginal haemorrhage
         subjects affected / exposed
    2 / 462 (0.43%)
    6 / 477 (1.26%)
         occurrences all number
    2
    6
    Adnexa uteri pain
         subjects affected / exposed
    2 / 462 (0.43%)
    1 / 477 (0.21%)
         occurrences all number
    2
    2
    Dyspareunia
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 477 (0.42%)
         occurrences all number
    0
    3
    Menstruation irregular
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences all number
    1
    1
    Metrorrhagia
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 477 (0.42%)
         occurrences all number
    0
    2
    Ovarian cyst
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 477 (0.42%)
         occurrences all number
    0
    2
    Uterine polyp
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences all number
    1
    1
    Vulvovaginal dryness
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 477 (0.42%)
         occurrences all number
    0
    3
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences all number
    1
    1
    Breast mass
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Nipple disorder
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Premenstrual pain
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Pelvic pain
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Vaginal inflammation
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Vulvovaginal discomfort
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal burning sensation
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Breast pain
         subjects affected / exposed
    2 / 462 (0.43%)
    2 / 477 (0.42%)
         occurrences all number
    4
    2
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 462 (0.22%)
    2 / 477 (0.42%)
         occurrences all number
    1
    2
    Overdose
         subjects affected / exposed
    1 / 462 (0.22%)
    2 / 477 (0.42%)
         occurrences all number
    1
    2
    Procedural pain
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 477 (0.42%)
         occurrences all number
    0
    2
    Animal bite
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Tooth fracture
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Body temperature increased
         subjects affected / exposed
    1 / 462 (0.22%)
    4 / 477 (0.84%)
         occurrences all number
    1
    4
    Weight increased
         subjects affected / exposed
    1 / 462 (0.22%)
    2 / 477 (0.42%)
         occurrences all number
    1
    3
    Menstruation normal
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences all number
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Blood urine present
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Urine ketone body
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Nitrite urine present
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 462 (0.43%)
    0 / 477 (0.00%)
         occurrences all number
    2
    0
    Tachycardia
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    2 / 462 (0.43%)
    1 / 477 (0.21%)
         occurrences all number
    2
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 462 (0.65%)
    0 / 477 (0.00%)
         occurrences all number
    3
    0
    Cough
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences all number
    1
    1
    Epistaxis
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 477 (0.42%)
         occurrences all number
    0
    2
    Nasal congestion
         subjects affected / exposed
    2 / 462 (0.43%)
    0 / 477 (0.00%)
         occurrences all number
    4
    0
    Nasal discomfort
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia of pregnancy
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Lymph node pain
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    46 / 462 (9.96%)
    58 / 477 (12.16%)
         occurrences all number
    60
    80
    Migraine
         subjects affected / exposed
    5 / 462 (1.08%)
    2 / 477 (0.42%)
         occurrences all number
    7
    2
    Dizziness
         subjects affected / exposed
    4 / 462 (0.87%)
    8 / 477 (1.68%)
         occurrences all number
    4
    8
    Somnolence
         subjects affected / exposed
    3 / 462 (0.65%)
    1 / 477 (0.21%)
         occurrences all number
    3
    2
    Head discomfort
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences all number
    1
    1
    Paraesthesia
         subjects affected / exposed
    1 / 462 (0.22%)
    2 / 477 (0.42%)
         occurrences all number
    1
    2
    Disturbance in attention
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Photophobia
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear swelling
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Vertigo
         subjects affected / exposed
    2 / 462 (0.43%)
    0 / 477 (0.00%)
         occurrences all number
    2
    0
    Tinnitus
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    15 / 462 (3.25%)
    12 / 477 (2.52%)
         occurrences all number
    20
    12
    Abdominal pain
         subjects affected / exposed
    12 / 462 (2.60%)
    13 / 477 (2.73%)
         occurrences all number
    15
    13
    Diarrhoea
         subjects affected / exposed
    4 / 462 (0.87%)
    7 / 477 (1.47%)
         occurrences all number
    4
    8
    Abdominal pain lower
         subjects affected / exposed
    5 / 462 (1.08%)
    5 / 477 (1.05%)
         occurrences all number
    5
    5
    Vomiting
         subjects affected / exposed
    4 / 462 (0.87%)
    5 / 477 (1.05%)
         occurrences all number
    5
    5
    Abdominal discomfort
         subjects affected / exposed
    5 / 462 (1.08%)
    3 / 477 (0.63%)
         occurrences all number
    5
    3
    Abdominal distension
         subjects affected / exposed
    1 / 462 (0.22%)
    7 / 477 (1.47%)
         occurrences all number
    1
    9
    Constipation
         subjects affected / exposed
    2 / 462 (0.43%)
    1 / 477 (0.21%)
         occurrences all number
    2
    1
    Toothache
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences all number
    1
    1
    Abdominal tenderness
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Abdominal rigidity
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Anal fissure
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 462 (0.00%)
    4 / 477 (0.84%)
         occurrences all number
    0
    5
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences all number
    1
    1
    Haematuria
         subjects affected / exposed
    1 / 462 (0.22%)
    2 / 477 (0.42%)
         occurrences all number
    1
    2
    Proteinuria
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences all number
    1
    1
    Dysuria
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Cystitis noninfective
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Pollakiuria
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Urethral pain
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    2 / 462 (0.43%)
    2 / 477 (0.42%)
         occurrences all number
    2
    2
    Dermatitis allergic
         subjects affected / exposed
    1 / 462 (0.22%)
    1 / 477 (0.21%)
         occurrences all number
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 477 (0.42%)
         occurrences all number
    0
    2
    Acne
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Dermatitis atopic
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Papule
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Photosensitivity reaction
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Pityriasis rosea
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Skin burning sensation
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Solar dermatitis
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 462 (0.87%)
    6 / 477 (1.26%)
         occurrences all number
    5
    6
    Neck pain
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 477 (0.42%)
         occurrences all number
    0
    2
    Arthralgia
         subjects affected / exposed
    2 / 462 (0.43%)
    3 / 477 (0.63%)
         occurrences all number
    2
    5
    Muscle tightness
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 477 (0.42%)
         occurrences all number
    0
    2
    Fluid retention
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 462 (0.87%)
    2 / 477 (0.42%)
         occurrences all number
    4
    2
    Urinary tract infection
         subjects affected / exposed
    2 / 462 (0.43%)
    3 / 477 (0.63%)
         occurrences all number
    2
    3
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 462 (0.22%)
    3 / 477 (0.63%)
         occurrences all number
    1
    3
    Cystitis
         subjects affected / exposed
    0 / 462 (0.00%)
    3 / 477 (0.63%)
         occurrences all number
    0
    3
    Gastroenteritis
         subjects affected / exposed
    1 / 462 (0.22%)
    2 / 477 (0.42%)
         occurrences all number
    1
    3
    Oral herpes
         subjects affected / exposed
    1 / 462 (0.22%)
    2 / 477 (0.42%)
         occurrences all number
    1
    2
    Sinusitis bacterial
         subjects affected / exposed
    0 / 462 (0.00%)
    2 / 477 (0.42%)
         occurrences all number
    0
    2
    Bacterial disease carrier
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Herpes simplex
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Genital herpes
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Hordeolum
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Vaginal infection
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 462 (0.00%)
    1 / 477 (0.21%)
         occurrences all number
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 462 (0.22%)
    0 / 477 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Apr 2014
    The following changes were made in the amended protocol: - The patient population and inclusion criteria of the trial were aligned with the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE)- - Clarification was made on the emergency unblinding procedure. - Clarification was made on the pregnancy testing criteria and embryology assessments. - Clarification was made on the definitions of serious adverse event and last safety visit.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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