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    Clinical Trial Results:
    A phase 3, double-blind, randomized, placebo-controlled study to assess the safety and efficacy of a single oral administration of nolasiban to increase ongoing pregnancy rate following fresh single blastocyst transfer resulting from IVF

    Summary
    EudraCT number
    		 2018-002910-11
    Trial protocol
    		 HU   DK   ES   BE   PL  
    Global end of trial date
    19 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jul 2022
    First version publication date
    21 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    18-OBE001-010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ObsEva SA
    Sponsor organisation address
    12, Chemin des Aulx, Geneva, Switzerland, 1228
    Public contact
    Clinical Trial Director, ObsEva SA, 41 0225523847, clinicaltrials@obseva.ch
    Scientific contact
    Clinical Trial Director, ObsEva SA, 41 0225523847, clinicaltrials@obseva.ch
    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
    24 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.
    Protection of trial subjects
    This study was to be performed in accordance with the protocol, with the ethical principles that have their origin in the Declaration of Helsinki, with the International Council for Harmonization (ICH) Harmonized Tripartite Guideline for Good Clinical Practice (GCP), with the European Union Clinical Trial Directive, and with all applicable local laws and regulations. Before initiation of the study at a given site, written approval of the protocol, the Informed Consent Form (ICF), and any information presented to potential subjects had to be obtained from the appropriate Independent Ethics Committee (IEC).
    Background therapy
    		 Subjects in this study were undergoing controlled ovarian hyperstimulation (COH) in preparation for IVF/ICSI according to the clinical center’s practice, following a gonadotropin releasing hormone (GnRH) antagonist protocol with or without pre-treatment with an oral contraceptive pill or E2. Final follicular maturation was to be performed with one administration of human chorionic gonadotropin (hCG) and luteal support was to be provided using vaginal micronized natural progesterone at 600 mg daily starting from the morning after oocyte pick-up (OPU) until at least the Week 6 visit (for subjects with positive pregnancy test at the Week 2 visit).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Nov 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 245
    Country: Number of subjects enrolled
    Spain: 30
    Country: Number of subjects enrolled
    Belgium: 16
    Country: Number of subjects enrolled
    Czechia: 172
    Country: Number of subjects enrolled
    Denmark: 78
    Country: Number of subjects enrolled
    Estonia: 44
    Country: Number of subjects enrolled
    Germany: 45
    Country: Number of subjects enrolled
    Hungary: 164
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    Russian Federation: 9
    Worldwide total number of subjects
    810
    EEA total number of subjects
    794
    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)
    810
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient screened: 29Nov2018 Last patient completed: 30Sep2019 Last neonatal follow-up data: 26May2020 Last infant follow-up data: 24Oct2020 Study conducted at 47 study sites in 10 countries [Belgium (3 sites), Canada (3), Czech Republic (10), Denmark (4), Estonia (3), Germany (6), Hungary (3), Poland (6), Russia (3), and Spain (6).

    Pre-assignment
    Screening details
    		 A total of 1264 potential subjects were screened, of whom 810 subjects were randomised. Three subjects who were all randomized to placebo were not treated, thus 807 subjects were included in the full analysis set (FAS). One subject was randomised to placebo but received nolasiban.

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    As soon as the last subject completed Week 10 and the database was locked, the treatment groups were unblinded to the Sponsor; subjects and investigators remained blinded until the end of the 6-month infant follow-up.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nolasiban 900 mg
    Arm description
    		 A single oral dose of 900 mg nolasiban was to be administered to the subject at the investigational site about 4 hours prior to the embryo transfer (ET).
    Arm type
    		 Experimental

    Investigational medicinal product name
    nolasiban
    Investigational medicinal product code
    OBE001
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    On the day of ET, subjects received a single oral dose of 900 mg nolasiban dispersed in water, approximately 4 hours prior to the transfer procedure,

    Arm title
    		 Placebo
    Arm description
    		 A single oral dose of placebo was to be administered to the subject at the investigational site about 4 hours prior to the embryo transfer (ET).
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    On the day of ET, subjects received a single oral dose of placebo dispersed in water, approximately 4 hours prior to the transfer procedure.

    Number of subjects in period 1 [1]
    		Nolasiban 900 mg Placebo
    Started
    398
    409
    Completed
    161
    160
    Not completed
    237
    249
         Not pregnant
    205
    212
         Adverse event, non-fatal
    31
    34
         No embryo transfer
    -
    1
         Other
    -
    1
         Subject's request
    1
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Three subjects who were all randomised to placebo were not treated (2 due to a lack of good quality embryos, and 1 due to mistaken treatment with atosiban), thus 807 subjects were included in the FAS and SAS.
    Period 2
    Period 2 title
    Follow-up period 1
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    As soon as the last subject completed Week 10 and all data were locked, the treatment groups were unblinded to the Sponsor. Subjects and investigators remained blinded until the end of the 6-month infant follow-up period 2.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nolasiban 900 mg treated
    Arm description
    		 All Women Follow-up (AWFU) Set: All subjects, treated with nolasiban, who took part in the pregnancy outcome follow-up. This was the analysis set for the analysis of pregnancy outcome data.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nolasiban
    Investigational medicinal product code
    OBE001
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    On the day of ET, subjects received a single oral dose of 900 mg nolasiban dispersed in water, approximately 4 hours prior to the transfer procedure,

    Arm title
    		 Placebo treated
    Arm description
    		 All Women Follow-up (AWFU) Set: All subjects, treated with placebo, who took part in the pregnancy outcome follow-up. This was the analysis set for the analysis of pregnancy outcome data.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    On the day of ET, subjects received a single oral dose of placebo dispersed in water, approximately 4 hours prior to the transfer procedure.

    Number of subjects in period 2
    		Nolasiban 900 mg treated Placebo treated
    Started
    161
    160
    Completed
    155
    158
    Not completed
    6
    2
         pregnancy loss
    6
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nolasiban 900 mg
    Reporting group description
    		 A single oral dose of 900 mg nolasiban was to be administered to the subject at the investigational site about 4 hours prior to the embryo transfer (ET).

    Reporting group title
    Placebo
    Reporting group description
    		 A single oral dose of placebo was to be administered to the subject at the investigational site about 4 hours prior to the embryo transfer (ET).

    Reporting group values
    		 Nolasiban 900 mg Placebo Total
    Number of subjects
    		 398 409 807
    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)
    		 398 409 807
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 32.0 (29.0 to 34.0) 32.0 (29.0 to 34.0) -
    Gender categorical
    Units: Subjects
        Female
    		 398 409 807
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    All infant set - nolasiban
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The All Infants (AI) Set consists of all infants born alive (whose mothers were treated with nolasiban) assessed at birth and/or at least 28 days post-delivery and/or who had adverse events recorded.

    Subject analysis set title
    All infant set - placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The All Infants (AI) Set consists of all infants born alive (whose mothers were treated with placebo) assessed at birth and/or at least 28 days post-delivery and/or who had adverse events recorded.

    Subject analysis sets values
    		 All infant set - nolasiban All infant set - placebo
    Number of subjects
    158
    161
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    158
    161
        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)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    Gender categorical
    Units: Subjects
        Female
    78
    67
        Male
    80
    94

    End points

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    End points reporting groups
    Reporting group title
    Nolasiban 900 mg
    Reporting group description
    		 A single oral dose of 900 mg nolasiban was to be administered to the subject at the investigational site about 4 hours prior to the embryo transfer (ET).

    Reporting group title
    Placebo
    Reporting group description
    		 A single oral dose of placebo was to be administered to the subject at the investigational site about 4 hours prior to the embryo transfer (ET).
    Reporting group title
    Nolasiban 900 mg treated
    Reporting group description
    		 All Women Follow-up (AWFU) Set: All subjects, treated with nolasiban, who took part in the pregnancy outcome follow-up. This was the analysis set for the analysis of pregnancy outcome data.

    Reporting group title
    Placebo treated
    Reporting group description
    		 All Women Follow-up (AWFU) Set: All subjects, treated with placebo, who took part in the pregnancy outcome follow-up. This was the analysis set for the analysis of pregnancy outcome data.

    Subject analysis set title
    All infant set - nolasiban
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The All Infants (AI) Set consists of all infants born alive (whose mothers were treated with nolasiban) assessed at birth and/or at least 28 days post-delivery and/or who had adverse events recorded.

    Subject analysis set title
    All infant set - placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The All Infants (AI) Set consists of all infants born alive (whose mothers were treated with placebo) assessed at birth and/or at least 28 days post-delivery and/or who had adverse events recorded.

    Primary: Number of women pregnant at week 10 week post-ET

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    End point title
    		 Number of women pregnant at week 10 week post-ET
    End point description
    End point type
    Primary
    End point timeframe
    10 weeks after embryo transfer (ET)
    End point values
    		 Nolasiban 900 mg Placebo
    Number of subjects analysed
    398
    409
    Units: number of pregnant women
        pregnant at week 10
    161
    160
        not pregnant at week 10
    237
    249
    Statistical analysis title
    		 OPR 10 weeks post-ET
    Comparison groups
    Nolasiban 900 mg v Placebo
    Number of subjects included in analysis
    807
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.745 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.4
    Notes
    [1] - Odds ratio and 95% CI estimated using a stratified logistic regression model with fixed effect for treatment group, age and weight categories as covariates and site as a stratification factor.
    [2] - p-value calculated based on Wald chi-square statistic.

    Primary: Percentage of women pregnant at week 10 post-ET

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    End point title
    		 Percentage of women pregnant at week 10 post-ET
    End point description
    Intra-uterine pregnancy with fetal heartbeat at 10 weeks post-ET day.
    End point type
    Primary
    End point timeframe
    Pregnant 10 weeks after embryo transfer (ET)
    End point values
    		 Nolasiban 900 mg Placebo
    Number of subjects analysed
    398
    409
    Units: percent
        number (not applicable)
    40.5
    39.1
    Statistical analysis title
    		 Percentage OPR 10 weeks post-ET
    Statistical analysis description
    Ongoing Pregnancy Rate (OPR) 10 weeks post-ET using the main model (FAS)
    Comparison groups
    Placebo v Nolasiban 900 mg
    Number of subjects included in analysis
    807
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.745 [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.4
    Notes
    [3] - Odds ratio and 95% CI estimated using a stratified logistic regression model with fixed effect for treatment group, age and weight categories as covariates and site as a stratification factor.
    [4] - p-value calculated based on Wald chi-square statistic.

    Secondary: Number of live births after 24 weeks of gestation

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    End point title
    		 Number of live births after 24 weeks of gestation
    End point description
    All subjects who took part in the pregnancy outcome follow-up, analyzed according to treatment received (used for the analysis of pregnancy outcome data for the subjects).
    End point type
    Secondary
    End point timeframe
    After 24 weeks of gestation.
    End point values
    		 Nolasiban 900 mg Placebo
    Number of subjects analysed
    398
    409
    Units: number of live births
        Live birth - yes
    155
    158
        Live birth - no
    243
    251
    Statistical analysis title
    		 Number of live births
    Comparison groups
    Nolasiban 900 mg v Placebo
    Number of subjects included in analysis
    807
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.98 [6]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.34
    Notes
    [5] - In this logistic regression model, subjects who were lost to follow-up were assigned as having a positive response for confirmed pregnancy at Week 10 or later. Odds ratio and 95% CI estimated using a stratified logistic regression model with fixed effect for treatment group, age and weight categories as covariates and site as a stratification factor.
    [6] - p-value calculated based on Wald chi-square statistic.

    Secondary: Percentage of live births after 24 weeks of gestation

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    End point title
    		 Percentage of live births after 24 weeks of gestation
    End point description
    All subjects who took part in the pregnancy outcome follow-up, analyzed according to treatment received (used for the analysis of pregnancy outcome data for the subjects).
    End point type
    Secondary
    End point timeframe
    After 24 weeks of gestation.
    End point values
    		 Nolasiban 900 mg Placebo
    Number of subjects analysed
    398
    409
    Units: percent
        number (not applicable)
    38.9
    38.6
    Statistical analysis title
    		 Live birth rate
    Comparison groups
    Nolasiban 900 mg v Placebo
    Number of subjects included in analysis
    807
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.98 [8]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.34
    Notes
    [7] - In this logistic regression model, subjects who were lost to follow-up were assigned as having a positive response for confirmed pregnancy at Week 10 or later. Odds ratio and 95% CI estimated using a stratified logistic regression model with fixed effect for treatment group, age and weight categories as covariates and site as a stratification factor.
    [8] - p-value calculated based on Wald chi-square statistic.

    Secondary: Pregnancy loss rate between Week 10 and Week 24 gestation

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    End point title
    		 Pregnancy loss rate between Week 10 and Week 24 gestation
    End point description
    Pregnancy loss rate (PLR) reported after Week 10 with lost to follow-up assigned as positive response for confirmed pregnancy at Week 2 or later (FAS). EoP = end of pregnancy
    End point type
    Secondary
    End point timeframe
    Pregnancy losses reported in this table are those occurring post-Week 10 database lock.
    End point values
    		 Nolasiban 900 mg Placebo
    Number of subjects analysed
    398
    409
    Units: number
        PLR between Week 10 and EoP - yes
    6
    2
        PLR between Week 10 and EoP - no
    155
    158
        PLR between Week 2 and EoP - yes
    49
    49
        PLR between Week 2 and EoP - no
    155
    158
    No statistical analyses for this end point

    Secondary: Neonatal outcomes - AI Set

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    End point title
    		 Neonatal outcomes - AI Set
    End point description
    Analysis of neonatal health data - condition at birth: In the All Infants (AI) set, 54.5% were male and 45.5% were female (placebo [P]: 58.4% and 41.6%; nolasiban [N]: 50.6% and 49.4%, respectively). Median weight at birth was similar in both groups (P: 3214.0 g; N: 3230.0 g). The minimum weight was 900 g in the placebo group and 1080 g in the nolasiban group. Median height was the same in both groups (51.0 cm) with mean height similar in both groups (P: 50.87 cm; N: 51.20 cm). Median head circumference was also the same in both groups (34.0 cm) with similar mean values (P: 33.81 cm; N: 33.88 cm). The median Apgar scores at 1 min and 5 min were identical in both groups (P: 9.0; N: 10.0). Congenital malformations or birth defects were reported in 6 infants in each treatment group (approx. 3.8%). Neonatal illness was reported with similar frequency in both groups (P: 6.8%; N 7.6%), as was abnormal examination of infant by a paediatrician (P: 5.0%; N: 5.7%).
    End point type
    Secondary
    End point timeframe
    All Infants (AI) Set: all infants assessed at birth and/or at least 28 days post-delivery and/or who had AEs recorded.
    End point values
    		 All infant set - nolasiban All infant set - placebo
    Number of subjects analysed
    158
    161
    Units: Number of infants
        Sex - male
    80
    94
        Sex - female
    78
    67
        Congenital anomaly (at delivery)
    6
    6
        Neonatal illness (at delivery)
    12
    11
        Breastfeeding (at least 28 days after delivery)
    121
    127
        Admission to intensive care at least 28d post del
    4
    6
        Neonatal morbidities at least 28d post del
    20
    26
        - jaundice
    13
    11
        - difficulty in feeding
    6
    11
        - respiratory distress syndrome
    4
    3
        - aneamia
    2
    2
        - asphyxia
    1
    2
        - retinopathy of prematurity
    1
    1
        - sepsis
    0
    1
        - intraventricular haemorrhage
    1
    0
        - bronchopulmonary dysplasia
    0
    1
        - cerebrellar haemorrhage (uni-/bilateral)
    1
    0
    No statistical analyses for this end point

    Other pre-specified: Ages and Stages Questionnaires (ASQ-3) Abnormal Scores at Month 6

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    End point title
    		 Ages and Stages Questionnaires (ASQ-3) Abnormal Scores at Month 6
    End point description
    Subjects were invited to complete the Ages and Stages Questionnaire-3 (ASQ-3) at 6 months after birth, corrected for gestational age at birth (i.e., at 6 months after the expected term date). Abnormal scores were defined in the ASQ-3 User Guide as domain scores below the following cut-offs: 29.65 points for communication, 25.14 points for fine motor, 22.25 points for gross motor, 25.34 points for personal-social, and 27.72 points for problem-solving. Only questionnaires completed within 150 days to 211 days after expected term date are included for the 6-month assessment.
    End point type
    Other pre-specified
    End point timeframe
    To evaluate infant development outcome at 6 months after birth (adjusted for gestational age).
    End point values
    		 All infant set - nolasiban All infant set - placebo
    Number of subjects analysed
    145
    140
    Units: number of infants below the cut-off
        Communication
    6
    3
        Fine motor
    15
    11
        Gross motor
    43
    35
        Personal-social
    28
    19
        Problem solving
    9
    1
        Overall (one or more area below cut-off)
    61
    50
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    TEAEs occurring in subjects from the day of study drug administration until 28 days after delivery. Only SAEs were collected for the foetuses / neonates (from birth up to 28 days).
    Adverse event reporting additional description
    Mother: All AEs from informed consent until Week 10. From Week 10 until birth, only AEs which could affect foetal outcome or AEs that the investigator suspected were related to IMP. Foetus: only AEs resulting in SAEs (until birth). Neonate (from birth up to 28 days): only AEs resulting in SAEs (until 28 days).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Safety analysis set - nolasiban
    Reporting group description
    		 Nosaliban 900 mg up to Week 10 Safety Analysis Set (SAS). A single oral dose of 900 mg nolasiban was administered to the subject at the investigational site about 4 hours prior to the embryo transfer (ET). The Safety Analysis Set consists of all randomised subjects who received study medication (analysed according to treatment received). Note that 1 subject was randomised to placebo but was treated with nolasiban.

    Reporting group title
    Safety analysis set - placebo
    Reporting group description
    		 Placebo up to Week 10 Safety Analysis Set (SAS). A single oral dose of matching placebo was administered to the subject at the investigational site about 4 hours prior to the embryo transfer (ET). The Safety Analysis Set consists of all randomised subjects who received study medication (analysed according to treatment received). Note that 1 subject was randomised to placebo but was treated with nolasiban.

    Reporting group title
    All women follow-up set - nolasiban
    Reporting group description
    		 The All Women Follow-up (AWFU) Set consists of all subjects who have confirmed ongoing pregnancy at week 10. This is the analysis set for the analysis of Pregnancy Outcome data for the mothers (analysed according to treatment received).

    Reporting group title
    All women follow-up set - placebo
    Reporting group description
    		 The All Women Follow-up (AWFU) Set consists of all subjects who have confirmed ongoing pregnancy at week 10. This is the analysis set for the analysis of Pregnancy Outcome data for the mothers (analysed according to treatment received).

    Reporting group title
    All infants set - nolasiban
    Reporting group description
    		 The All Infants (AI) Set consists of all infants born alive. This is the analysis set for the analysis of the Neonatal Health data at birth and at 28 days, and the ASQ-3 data (analysed according to treatment received by the mothers). Only SAEs were collected for the neonates, therefore added '0' for non-serious AEs.

    Reporting group title
    All infants set - placebo
    Reporting group description
    		 The All Infants (AI) Set consists of all infants born alive. This is the analysis set for the analysis of the Neonatal Health data at birth and at 28 days, and the ASQ-3 data (analysed according to treatment received by the mothers). Only SAEs were collected for the neonates, therefore added '0' for non-serious AEs. In addition to the SAEs provided in the overview, an SAE of congenital pyelocaliectasis was reported in a neonate (placebo) after database lock.

    Serious adverse events
    		 Safety analysis set - nolasiban Safety analysis set - placebo All women follow-up set - nolasiban All women follow-up set - placebo All infants set - nolasiban All infants set - placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 399 (2.01%)
    8 / 408 (1.96%)
    10 / 161 (6.21%)
    2 / 160 (1.25%)
    6 / 158 (3.80%)
    7 / 161 (4.35%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Rhabdomyoma
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital hand malformation
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mandibulofacial dysostosis
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular septal defect
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    2 / 158 (1.27%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polydactyly
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    1 / 158 (0.63%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aorta hypoplasia
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    1 / 158 (0.63%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital hydronephrosis
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    1 / 158 (0.63%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital ureteric anomaly
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cryptorchism
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    1 / 158 (0.63%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Truncus arteriosus persistent
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract malformation
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Selective abortion
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    3 / 399 (0.75%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion missed
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion late
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    2 / 161 (1.24%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    2 / 161 (1.24%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal death
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    2 / 160 (1.25%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small for dates baby
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine atony
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian hyperstimulation syndrome
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    3 / 399 (0.75%)
    5 / 408 (1.23%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic pain
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Neonatal respiratory distress
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    1 / 158 (0.63%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cystitis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis neonatal
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety analysis set - nolasiban Safety analysis set - placebo All women follow-up set - nolasiban All women follow-up set - placebo All infants set - nolasiban All infants set - placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    95 / 399 (23.81%)
    107 / 408 (26.23%)
    12 / 161 (7.45%)
    8 / 160 (5.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Rhabdomyoma
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Surgical and medical procedures
    Selective abortion
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    27 / 399 (6.77%)
    24 / 408 (5.88%)
    2 / 161 (1.24%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    27
    24
    2
    0
    0
    0
    Biochemical pregnancy
         subjects affected / exposed
    9 / 399 (2.26%)
    16 / 408 (3.92%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    9
    16
    0
    0
    0
    0
    Abortion missed
         subjects affected / exposed
    4 / 399 (1.00%)
    6 / 408 (1.47%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    4
    6
    1
    0
    0
    0
    Haemorrhage in pregnancy
         subjects affected / exposed
    4 / 399 (1.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    4
    1
    0
    0
    0
    0
    Ectopic pregnancy
         subjects affected / exposed
    3 / 399 (0.75%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    Subchorionic haematoma
         subjects affected / exposed
    2 / 399 (0.50%)
    2 / 408 (0.49%)
    0 / 161 (0.00%)
    1 / 160 (0.63%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    2
    2
    0
    1
    0
    0
    Abortion threatened
         subjects affected / exposed
    1 / 399 (0.25%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Imminent abortion
         subjects affected / exposed
    1 / 399 (0.25%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Abortion complete
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Anembryonic gestation
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gestational diabetes
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    2 / 161 (1.24%)
    2 / 160 (1.25%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    2
    2
    0
    0
    Retained products of conception
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Small for dates baby
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    1 / 161 (0.62%)
    2 / 160 (1.25%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    Abortion late
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    2 / 161 (1.24%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Foetal death
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    2 / 160 (1.25%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Uterine atony
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 399 (0.50%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    9 / 399 (2.26%)
    12 / 408 (2.94%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    9
    12
    0
    0
    0
    0
    Pelvic pain
         subjects affected / exposed
    11 / 399 (2.76%)
    7 / 408 (1.72%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    13
    7
    0
    0
    0
    0
    Ovarian hyperstimulation syndrome
         subjects affected / exposed
    6 / 399 (1.50%)
    9 / 408 (2.21%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    6
    12
    0
    0
    0
    0
    Uterine haematoma
         subjects affected / exposed
    1 / 399 (0.25%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Adnexa uteri pain
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Breast mass
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Breast tenderness
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Genital haemorrhage
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Genital swelling
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Uterine haemorrhage
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vulvovaginal burning sensation
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vulvovaginal discomfort
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Hyperventilation
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Psychiatric disorders
    Cardiovascular somatic symptom disorder
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Investigations
    Blood triglycerides increased
         subjects affected / exposed
    0 / 399 (0.00%)
    2 / 408 (0.49%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Haematocrit increased
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Heart rate increased
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    1 / 399 (0.25%)
    2 / 408 (0.49%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Congenital hand malformation
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Mandibulofacial dysostosis
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 399 (1.25%)
    6 / 408 (1.47%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    6
    6
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 399 (0.25%)
    3 / 408 (0.74%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Migraine
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Hypercoagulation
         subjects affected / exposed
    2 / 399 (0.50%)
    2 / 408 (0.49%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Anaemia
         subjects affected / exposed
    1 / 399 (0.25%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    1 / 160 (0.63%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 399 (0.00%)
    0 / 408 (0.00%)
    1 / 161 (0.62%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 399 (2.01%)
    5 / 408 (1.23%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    9
    5
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    2 / 399 (0.50%)
    3 / 408 (0.74%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 399 (0.50%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 399 (0.00%)
    2 / 408 (0.49%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    2 / 399 (0.50%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    1 / 399 (0.25%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Ascites
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 399 (0.50%)
    3 / 408 (0.74%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 399 (0.25%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    2 / 399 (0.50%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 399 (0.50%)
    3 / 408 (0.74%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Cystitis
         subjects affected / exposed
    2 / 399 (0.50%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Herpes virus infection
         subjects affected / exposed
    2 / 399 (0.50%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 399 (0.25%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Bacteriuria
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 399 (0.25%)
    0 / 408 (0.00%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Varicella zoster virus infection
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Iron deficiency
         subjects affected / exposed
    0 / 399 (0.00%)
    1 / 408 (0.25%)
    0 / 161 (0.00%)
    0 / 160 (0.00%)
    0 / 158 (0.00%)
    0 / 161 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Nov 2018
    - Specification that 3 PK samples were to be collected at 3.5 h, 5 h, and ≥7 h (up to a maximum of 72 h) following nolasiban/placebo administration. - Specification that nolasiban concentration was to be measured in plasma (instead of serum). - Clarification that the PK analysis set would include only those subjects who received active study medication (i.e., nolasiban). - Clarification that population PK analyses would be described and reported separately. - Specification that blood samples for measurement of P4 and E2 were to be collected on the day before/of hCG injection. - Addition of a schematic diagram to clarify the assessments and procedures to be performed at the baseline visit. - Specification that analysis of rates of live birth and pregnancy loss would be performed using a gestational age limit of 22 weeks in addition to the analyses using 20-week and 24-week limits. - Addition of ASQ-3 questionnaire completion at 12 months. - Specification that miscarriage or foetal death in utero after 10 weeks of pregnancy was to be considered an SAE, and that spontaneous abortions before 10 weeks were to be reported as AEs and as “pregnancy and obstetrical outcomes of interest.” - Introduction of the category of “pregnancy and obstetrical outcomes of interest,” with resulting change to the eCRF AE forms. - Description of the destruction of (un)used IMP.
    07 Aug 2019
    - Specification that PK would also be analysed for nolasiban metabolites and clarification that PK results were to be reported separate from the main CSR. - Removal of the analysis of live birth at 20 weeks of gestation. - Clarification of the definition of pregnancy loss. - Addition of the requirement that any congenital anomalies be confirmed by a dysmorphologist. - Addition of the collection of information from an infant physical examination at 12 months. - Introduction of separate study objectives, endpoints, and analyses for the US health authorities
    02 Dec 2019
    - Removal of the collection of the ASQ-3 and infant physical examination at 12-months. - Removal of US objectives, endpoints and analysis which were introduced in amendment 2 (protocol version 3.0). - Clarification that the verification of congenital anomalies by a dysmorphologist is managed by the Sponsor. - Correction to categories of pre-term births.

    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.
    Of 807 subjects treated, 321 had confirmed pregnancies at Week 10. Follow-up (FU) data were provided for 329 foetuses. Pregnancies resulted in live birth for 313 subjects, assuming +ve outcome in case of loss to FU. Neonatal FU data on 319 infants.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33534895
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