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Trial record 4 of 9 for:    retosiban

A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour

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ClinicalTrials.gov Identifier: NCT02292771
Recruitment Status : Terminated (The study was stopped due to the feasibility of recruiting the study in a timely manner)
First Posted : November 17, 2014
Results First Posted : September 10, 2018
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Obstetric Labour, Premature
Interventions Drug: Retosiban
Drug: Atosiban
Drug: Placebo matching retosiban
Drug: Placebo matching atosiban
Enrollment 97
Recruitment Details ZINN was a randomized, double-blind, double-dummy multicenter study to compare efficacy and safety of retosiban versus atosiban in female participants aged 12 to 45 years with an uncomplicated singleton pregnancy in preterm labor with intact membranes between 24 0/7 and 33 6/7 weeks gestation.
Pre-assignment Details From 330 planned participants 97 were randomized to receive either retosiban or atosiban intravenous (IV) infusion in a ratio of 1:1. The study was terminated early due to feasibility.
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period. Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Period Title: Overall Study
Started 47 50
Completed 43 48
Not Completed 4 2
Reason Not Completed
Withdrawal by Subject             2             1
Lost to Follow-up             2             1
Arm/Group Title Retosiban Atosiban Total
Hide Arm/Group Description Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period. Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution. Total of all reporting groups
Overall Number of Baseline Participants 47 50 97
Hide Baseline Analysis Population Description
Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 50 participants 97 participants
27.7  (6.15) 27.1  (5.66) 27.4  (5.88)
[1]
Measure Analysis Population Description: Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 50 participants 97 participants
Female
47
 100.0%
50
 100.0%
97
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Maternal ITT Population
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Count of Participants
Number Analyzed 47 participants 50 participants 97 participants
White/Caucasian/European Heritage 21 31 52
American Indian or Alaskan Native 7 4 11
East Asian Heritage 9 4 13
Arabic/North African Heritage 11 10 21
African American/African Heritage 0 3 3
[1]
Measure Analysis Population Description: Maternal ITT Population
1.Primary Outcome
Title Time to Delivery From the Start of Investigational Product (IP) Administration
Hide Description Time to delivery is the number of days from the first dose of study treatment until delivery. The time to delivery was calculated as the days between the delivery and start time of the study treatment infusion using the formula: Time to delivery (days) = (date and time of delivery minus date and time of start of infusion) divided by (24 multiplied by 60). The adjusted mean number of days to delivery along with standard error has been presented. Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.
Time Frame Up to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Error)
Unit of Measure: Days
32.51  (2.990) 33.71  (2.531)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retosiban, Atosiban
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3797
Comments [Not Specified]
Method Finite mixture model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.20
Confidence Interval (2-Sided) 95%
-8.879 to 6.479
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Births Prior to 37 0/7 Weeks Gestation
Hide Description Gestational age (GA) at birth (weeks) is defined as the GA when the baby is born. Participants were considered to have delivered prior to 37 0/7 weeks, that is preterm , if the GA at birth is less than 37 0/7 weeks. The number of participants who delivered prior to 37 0/7 weeks gestation has been presented. Logistic regression model was used to calculate p-values.
Time Frame Up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
25 28
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retosiban, Atosiban
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9520
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.44 to 2.18
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Births at Term
Hide Description Participants were considered to have delivered at term if the gestational age was >=37 0/7. The number of participants who delivered at term, that is, 37 0/7 to 41 6/7 weeks gestation has been presented. Logistic regression model was used to calculate p-values.
Time Frame Up to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
21 22
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retosiban, Atosiban
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9520
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.46 to 2.29
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Length of Neonatal Hospital Stay
Hide Description The length of stay was collected from medical records and was calculated as the days between the delivery date and time and discharge date and time. Log of length of stay was calculated as treatment plus GA at randomization plus established progesterone use based on Analysis of covariance (ANCOVA) model. The p-value was calculated using t-test method. Neonatal ITT Population comprised of all neonates whose mothers were the randomized participants who have been exposed to study treatment, that is, mothers from the ITT Population.
Time Frame Up to 28 days post estimated date of delivery (EDD) of 40 0/7 weeks gestation
Hide Outcome Measure Data
Hide Analysis Population Description
Neonatal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Days
4.98
(3.54 to 6.99)
4.38
(3.15 to 6.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retosiban, Atosiban
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5672
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.73 to 1.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.222
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Neonates With Composite Neonatal Morbidity and Mortality
Hide Description The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, Respiratory Distress Syndrome (RDS), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity (ROP), Intraventricular Hemorrhage (IVH), white matter injury and cerebellar hemorrhage.
Time Frame Up to 28 weeks after EDD (40 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Neonatal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
3 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retosiban, Atosiban
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5066
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
0.30 to 11.71
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Neonates With Any Composite Neonatal Morbidity and Mortality, Excluding RDS
Hide Description The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, RDS, BPD, NEC or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, ROP, IVH, white matter injury and cerebellar hemorrhage. Number of neonates with any composite neonatal morbidity and mortality component, excluding RDS has been presented.
Time Frame Up to 28 weeks after EDD (40 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Neonatal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
0 1
7.Secondary Outcome
Title Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality
Hide Description The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, RDS, BPD, NEC or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, ROP, IVH, cerebellar hemorrhage and white matter injury included Periventricular Leukomalacia PVL), porencephalic cyst, and persistent ventriculomegaly. Number of neonates with with each individual component of the composite neonatal morbidity and mortality has been presented.
Time Frame Up to 28 weeks after EDD (40 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Neonatal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
Fetal death 0 0
Neonatal death 0 1
RDS 3 1
BPD 0 0
NEC or isolated perforation 0 0
Sepsis 0 0
Meningitis 0 0
ROP 0 0
IVH 0 0
PVL 0 0
Porencephalic Cyst 0 0
Persistent Ventriculomegaly 0 0
Cerebellar Hemorrhage 0 0
8.Secondary Outcome
Title Length of Stay in Specialized Care Unit
Hide Description Length of neonatal stay in specialized care unit like Intensive Care Unit (ICU) or Neonatal Intensive Care Unit (NICU) are reported.
Time Frame Up to 28 days post EDD (40 0/7 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Neonatal Safety Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Median (Full Range)
Unit of Measure: Days
13.65
(3.5 to 57.5)
12.49
(7.6 to 21.8)
9.Secondary Outcome
Title Number of Newborn Participants With Hospital Readmission
Hide Description Newborn hospital readmission following hospitalization for birth was obtained from the newborn's medical records. Only those participants with data available at the specified data points were analyzed.
Time Frame Up to 28 days of EDD (40 0/7 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Neonatal Safety Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 46 50
Measure Type: Number
Unit of Measure: Participants
2 3
10.Secondary Outcome
Title Number of Participants With Births Prior to 28 0/7 Weeks Gestation
Hide Description The number of participants who delivered prior to 28 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 28 0/7 week's gestation and delivered were included.
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
0 0
11.Secondary Outcome
Title Number of Participants With Births Prior to 32 0/7 Weeks Gestation
Hide Description Number of participants who delivered prior to 32 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 32 0/7 week's gestation and delivered were included.
Time Frame Up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
3 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retosiban, Atosiban
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7790
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.12 to 4.84
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants With Births Prior to 35 0/7 Weeks Gestation
Hide Description Number of participants who delivered prior to 35 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 35 0/7 week's gestation and delivered were included.
Time Frame Up to 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
14 14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retosiban, Atosiban
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6646
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.51 to 2.90
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants With Births <=7 Days From the First Study Treatment
Hide Description Number of participants who delivered in less than or equal to 7 days from first dose of study treatment has been presented.
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
10 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retosiban, Atosiban
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1432
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
0.75 to 7.24
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Number of Participants With Births <=48 Hours From the First Study Treatment
Hide Description Number of participants who delivered in less than or equal to 48 hours from first dose of study treatment has been presented.
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
6 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retosiban, Atosiban
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5250
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.43 to 5.15
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Number of Participants With Births <=24 Hours From the First Study Treatment
Hide Description Number of participants who delivered in less than or equal to 24 hours from first dose of study treatment has been presented.
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
3 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retosiban, Atosiban
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4682
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.13 to 2.58
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Number of Maternal Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. Maternal Safety Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment. The number of maternal participants who experienced at least one non-serious AE and one SAE has been presented.
Time Frame Up to 6 weeks after delivery
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
Non-serious AE 34 25
SAE 7 9
17.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants
Hide Description SBP and DBP were measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: Millimeter of mercury (mmHg)
DBP; Day 1: 15 to 30 minutes, n=42,45 Number Analyzed 42 participants 45 participants
-3.6  (10.96) -0.7  (8.95)
DBP; Day 1: 4 to 8 hours, n=42,43 Number Analyzed 42 participants 43 participants
-4.3  (11.07) -3.7  (10.28)
DBP; Day 1: 20 to 24 hours, n=38,41 Number Analyzed 38 participants 41 participants
-5.7  (9.31) -4.1  (9.90)
DBP; Day 2, n=40,42 Number Analyzed 40 participants 42 participants
-4.4  (9.57) -2.6  (9.93)
DBP; Post-infusion assessment, n=35,41 Number Analyzed 35 participants 41 participants
-1.6  (8.63) 1.3  (10.12)
SBP; Day 1: 15 to 30 minutes, n=42,45 Number Analyzed 42 participants 45 participants
-2.5  (9.53) -0.4  (11.02)
SBP; Day 1: 4 to 8 hours, n=42,43 Number Analyzed 42 participants 43 participants
-4.3  (9.05) -3.3  (12.21)
SBP; Day 1: 20 to 24 hours, n=38,41 Number Analyzed 38 participants 41 participants
-4.1  (10.16) -5.2  (13.03)
SBP; Day 2, n=40,42 Number Analyzed 40 participants 42 participants
-3.9  (11.53) -3.0  (11.35)
SBP; Post-infusion assessment, n=35,41 Number Analyzed 35 participants 41 participants
-1.5  (11.04) -2.1  (11.37)
18.Secondary Outcome
Title Change From Baseline in Heart Rate in Maternal Participants
Hide Description Heart rate was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 1: 15 to 30 minutes, n=42,46 Number Analyzed 42 participants 46 participants
-3.0  (12.65) -0.8  (10.45)
Day 1: 4 to 8 hours, n=42, 43 Number Analyzed 42 participants 43 participants
-5.0  (13.69) -3.0  (13.65)
Day 1: 20 to 24 hours, n=38, 41 Number Analyzed 38 participants 41 participants
-1.2  (14.44) -3.1  (13.82)
Day 2, n=39, 41 Number Analyzed 39 participants 41 participants
-2.2  (11.81) -2.3  (13.44)
Post-infusion assessment, n=35, 41 Number Analyzed 35 participants 41 participants
-2.7  (12.90) -1.8  (13.83)
19.Secondary Outcome
Title Change From Baseline in Respiratory Rate in Maternal Participants
Hide Description Respiratory rate was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: breaths per minute
Day 1: 15 to 30 minutes, n=25, 28 Number Analyzed 25 participants 28 participants
0.3  (2.82) -0.6  (1.93)
Day 1: 4 to 8 hours, n=23, 24 Number Analyzed 23 participants 24 participants
0.0  (1.65) -0.8  (2.33)
Day 1: 20 to 24 hours, n=21, 21 Number Analyzed 21 participants 21 participants
0.2  (1.87) -0.6  (2.40)
Day 2, n=23, 24 Number Analyzed 23 participants 24 participants
-0.3  (1.64) 0.2  (3.45)
Post-infusion assessment, n=22, 23 Number Analyzed 22 participants 23 participants
-0.3  (2.15) -1.3  (2.70)
20.Secondary Outcome
Title Change From Baseline in Temperature in Maternal Participants
Hide Description Temperature was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: degree Celsius
Day 1: 15 to 30 minutes, n=41, 43 Number Analyzed 41 participants 43 participants
-0.02  (0.379) 0.02  (0.467)
Day 1: 4 to 8 hours, n=40, 42 Number Analyzed 40 participants 42 participants
-0.06  (0.359) 0.00  (0.507)
Day 1: 20 to 24 hours, n=37, 41 Number Analyzed 37 participants 41 participants
-0.07  (0.366) -0.03  (0.486)
Day 2, n=40, 42 Number Analyzed 40 participants 42 participants
-0.07  (0.467) -0.06  (0.353)
Post-infusion assessment, n=35, 41 Number Analyzed 35 participants 41 participants
-0.18  (0.334) -0.20  (0.422)
21.Secondary Outcome
Title Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants
Hide Description Blood samples were collected for the evaluation of change in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes count. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: Billion cells per liter (L)
Basophils;Day2,n=21,23 Number Analyzed 21 participants 23 participants
0.003  (0.0362) 0.010  (0.0304)
Basophils;Post-infusion assessment,n=24,28 Number Analyzed 24 participants 28 participants
0.001  (0.0315) 0.007  (0.0181)
Basophils;early withdrawal,n=1,1 Number Analyzed 1 participants 1 participants
-0.020 [1]   (NA) 0.030 [1]   (NA)
Eosinophils;Day2,n=21,23 Number Analyzed 21 participants 23 participants
-0.010  (0.0626) -0.037  (0.1181)
Eosinophils;Post-infusion assessment,n=24,28 Number Analyzed 24 participants 28 participants
0.023  (0.0442) 0.066  (0.1535)
Eosinophils;early withdrawal,n=1,1 Number Analyzed 1 participants 1 participants
0.030 [1]   (NA) 0.050 [1]   (NA)
Lymphocytes;Day2,n=21,23 Number Analyzed 21 participants 23 participants
0.186  (0.9115) 0.067  (0.6017)
Lymphocytes;Post-infusion assessment,n=24,28 Number Analyzed 24 participants 28 participants
0.348  (0.8611) 0.233  (0.8047)
Lymphocytes;early withdrawal,n=1,1 Number Analyzed 1 participants 1 participants
0.270 [1]   (NA) -1.770 [1]   (NA)
Monocytes;Day2,n=21,23 Number Analyzed 21 participants 23 participants
0.082  (0.2222) 0.044  (0.2702)
Monocytes;Post-infusion assessment,n=24,28 Number Analyzed 24 participants 28 participants
0.222  (0.1904) 0.133  (0.3467)
Monocytes;early withdrawal,n=1,1 Number Analyzed 1 participants 1 participants
-0.160 [1]   (NA) 0.410 [1]   (NA)
Neutrophils;Day2,n=21,23 Number Analyzed 21 participants 23 participants
0.102  (2.6712) 0.559  (3.3890)
Neutrophils;Post-infusion assessment,n=24,28 Number Analyzed 24 participants 28 participants
-1.865  (2.9246) -0.670  (2.7063)
Neutrophils;early withdrawal,n=1,1 Number Analyzed 1 participants 1 participants
-0.710 [1]   (NA) -3.550 [1]   (NA)
Platelets;Day2,n=22,25 Number Analyzed 22 participants 25 participants
0.0  (25.95) -2.4  (36.59)
Platelets;Post-infusion assessment,n=24,31 Number Analyzed 24 participants 31 participants
21.5  (63.14) 20.6  (43.74)
Platelets;early withdrawal,n=1,1 Number Analyzed 1 participants 1 participants
-33.0 [1]   (NA) -58.0 [1]   (NA)
Leukocytes;Day2,n=23,25 Number Analyzed 23 participants 25 participants
0.17  (2.785) 0.72  (2.905)
Leukocytes;Post-infusion assessment,n=25,30 Number Analyzed 25 participants 30 participants
-1.18  (2.492) -0.05  (2.756)
Leukocytes;early withdrawal,n=1,1 Number Analyzed 1 participants 1 participants
-0.60 [1]   (NA) -4.80 [1]   (NA)
[1]
NA indicates standard deviation was not calculable for a single data point.
22.Secondary Outcome
Title Change From Baseline in Erythrocytes in Maternal Participants
Hide Description Blood samples were collected for the evaluation of change in erythrocytes from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: Trillion cells per liter
Day 2, n=23, 27 Number Analyzed 23 participants 27 participants
-0.22  (0.284) -0.29  (0.261)
Post-infusion assessment, n=25, 31 Number Analyzed 25 participants 31 participants
0.06  (0.257) 0.05  (0.236)
Early withdrawal, n =1, 1 Number Analyzed 1 participants 1 participants
-0.20 [1]   (NA) -0.70 [1]   (NA)
[1]
NA indicates standard deviation was not calculable for a single data point.
23.Secondary Outcome
Title Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC) in Maternal Participants
Hide Description Blood samples were collected for the evaluation of change in hemoglobin levels and MCHC from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus. NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: grams per liter (g/L)
Hemoglobin; Day2, n=23, 27 Number Analyzed 23 participants 27 participants
-5.4  (7.81) -8.4  (6.86)
Hemoglobin; Post-infusion assessment, n=25, 31 Number Analyzed 25 participants 31 participants
0.8  (7.55) 0.5  (5.37)
Hemoglobin; early withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
-8.0 [1]   (NA) -19.0 [1]   (NA)
MCHC; Day 2, n=23, 27 Number Analyzed 23 participants 27 participants
1.0  (9.41) 0.9  (6.85)
MCHC; Post-infusion assessment, n=25, 31 Number Analyzed 25 participants 31 participants
1.0  (7.36) 0.4  (8.98)
MCHC; early withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
-3.0 [1]   (NA) 24.0 [1]   (NA)
[1]
NA indicates standard deviation was not calculable for a single data point.
24.Secondary Outcome
Title Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) in Maternal Participants
Hide Description Blood samples were collected for the evaluation of change in MCV and MPV from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: femtoliter (fL)
MCV; Day 2, n=23, 27 Number Analyzed 23 participants 27 participants
0.3  (2.67) -0.4  (1.82)
MCV; Post-infusion assessment, n=25, 31 Number Analyzed 25 participants 31 participants
-1.2  (2.17) -1.0  (2.22)
MCV; early withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
-1.0 [1]   (NA) -5.0 [1]   (NA)
MPV; Day 2, n=22, 25 Number Analyzed 22 participants 25 participants
0.05  (0.607) 0.06  (0.553)
MPV, Post-infusion assessment, n=24, 31 Number Analyzed 24 participants 31 participants
-0.10  (0.639) -0.03  (0.803)
MPV, early withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
0.00 [1]   (NA) -1.40 [1]   (NA)
[1]
NA indicates standard deviation was not calculable for a single data point.
25.Secondary Outcome
Title Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants
Hide Description Blood samples were collected for the evaluation of change in ALP, ALT, AST, GGT and LDH from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: International Units per liter (IU/L)
ALP; Day 2, n=35, 35 Number Analyzed 35 participants 35 participants
-10.1  (12.12) -12.6  (13.07)
ALP; Post-infusion assessment, n=30, 35 Number Analyzed 30 participants 35 participants
14.1  (39.85) 5.9  (15.87)
ALP; early withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
-6.0 [1]   (NA) -19.0 [1]   (NA)
AST; Day 2, n=34, 35 Number Analyzed 34 participants 35 participants
-0.9  (4.82) -1.7  (3.07)
AST; Post-infusion assessmet, n=29, 35 Number Analyzed 29 participants 35 participants
-1.3  (4.87) -1.3  (4.09)
AST; early withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
-3.0 [1]   (NA) 1.0 [1]   (NA)
ALT; Day 2, n= 35, 35 Number Analyzed 35 participants 35 participants
-0.2  (2.53) 0.0  (2.40)
ALT; Post-infusion assessment, n= 30, 35 Number Analyzed 30 participants 35 participants
0.0  (6.34) 0.8  (6.19)
ALT; early withdrawal, n= 1, 1 Number Analyzed 1 participants 1 participants
-2.0 [1]   (NA) 5.0 [1]   (NA)
GGT; Day 2, n= 35, 35 Number Analyzed 35 participants 35 participants
-0.4  (2.44) -0.9  (3.08)
GGT; Post-infusion assessment, n=30, 35 Number Analyzed 30 participants 35 participants
17.6  (79.05) 2.3  (4.39)
GGT; eearly withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
0.0 [1]   (NA) 0.0 [1]   (NA)
LDH; Day 2, n=34, 35 Number Analyzed 34 participants 35 participants
-9.7  (50.58) -20.0  (29.18)
LDH; Post-infusion assessment, n=29, 35 Number Analyzed 29 participants 35 participants
-2.4  (22.08) -5.4  (30.93)
LDH; early withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
-18.0 [1]   (NA) -59.0 [1]   (NA)
[1]
NA indicates standard deviation was not calculable for a single data point.
26.Secondary Outcome
Title Change From Baseline in Albumin and Protein Levels in Maternal Participants
Hide Description Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: grams per liter (g/L)
Albumin; Day 2, n=35, 35 Number Analyzed 35 participants 35 participants
-1.9  (2.28) -2.0  (1.95)
Albumin; Post-infusion assessment, n=30, 35 Number Analyzed 30 participants 35 participants
0.3  (2.39) -0.2  (2.26)
Albumin; early withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
-4.0 [1]   (NA) -8.0 [1]   (NA)
Protein; Day 2, n=35, 35 Number Analyzed 35 participants 35 participants
-3.7  (4.18) -3.3  (3.69)
Protein; Post-infusion assessment, n=30, 35 Number Analyzed 30 participants 35 participants
0.5  (4.73) 0.0  (4.05)
Protein; early withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
-5.0 [1]   (NA) -12.0 [1]   (NA)
[1]
NA indicates standard deviation was not calculable for a single data point.
27.Secondary Outcome
Title Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants
Hide Description Blood samples were collected for the evaluation of change from Baseline in levels of calcium, chloride, carbon dioxide, glucose, potassium, magnesium, phosphate, and sodium. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: millimoles per liter (mmol/L)
Calcium; Day 2, n=34, 35 Number Analyzed 34 participants 35 participants
-0.097  (0.1125) -0.078  (0.0884)
Calcium; Post-infusion assessment, n=29, 35 Number Analyzed 29 participants 35 participants
0.018  (0.0953) 0.023  (0.0861)
Calcium; early withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
-0.120 [1]   (NA) -0.230 [1]   (NA)
Chloride; Day 2, n=35, 35 Number Analyzed 35 participants 35 participants
1.5  (2.02) 1.4  (2.03)
Chloride; Post-infusion assessment, n=30, 35 Number Analyzed 30 participants 35 participants
-1.5  (1.83) -1.3  (2.63)
Chloride; early withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
2.0 [1]   (NA) 8.0 [1]   (NA)
Carbon dioxide; Day 2, n=34, 35 Number Analyzed 34 participants 35 participants
0.7  (2.34) 0.3  (2.63)
Carbon dioxide, Post-infusion assessment, n=29,35 Number Analyzed 29 participants 35 participants
1.9  (2.06) 1.9  (2.67)
Carbon dioxide, early withdrawal, n=1, 1 Number Analyzed 1 participants 1 participants
-2.0 [1]   (NA) 6.0 [1]   (NA)
Glucose; Day 2, n=35,35 Number Analyzed 35 participants 35 participants
0.13  (2.013) 1.51  (2.156)
Glucose; Post-infusion assessment, n=30, 35 Number Analyzed 30 participants 35 participants
-0.70  (1.994) -0.35  (2.283)
Glucose; early withdrawal, n= 1, 1 Number Analyzed 1 participants 1 participants
0.70 [1]   (NA) -5.20 [1]   (NA)
Potassium; Day 2, n= 34, 35 Number Analyzed 34 participants 35 participants
0.06  (0.392) -0.06  (0.346)
Potassium; Post-infusion assessment, n= 29, 35 Number Analyzed 29 participants 35 participants
0.21  (0.362) 0.18  (0.355)
Potassium; early withdrawal, n= 1,1 Number Analyzed 1 participants 1 participants
-0.10 [1]   (NA) 0.50 [1]   (NA)
Magnesium; Day 2, n= 35,35 Number Analyzed 35 participants 35 participants
0.073  (0.2098) -0.003  (0.0657)
Magnesium, Post-infusion assessment, n= 30,35 Number Analyzed 30 participants 35 participants
0.026  (0.0760) 0.009  (0.0772)
Magnesium; early withdrawal, n= 1,1 Number Analyzed 1 participants 1 participants
-0.060 [1]   (NA) 0.030 [1]   (NA)
Phosphate; Day 2, n= 35,35 Number Analyzed 35 participants 35 participants
-0.101  (0.2684) -0.170  (0.2357)
Phosphate; Post-infusion assessment, n= 30,35 Number Analyzed 30 participants 35 participants
0.041  (0.2267) 0.094  (0.2864)
Phosphate; early withdrawal, n= 1,1 Number Analyzed 1 participants 1 participants
0.100 [1]   (NA) -0.120 [1]   (NA)
Sodium; Day 2, n= 35,35 Number Analyzed 35 participants 35 participants
0.7  (2.13) 0.1  (1.69)
Sodium; Post-infusion assessment, n= 30,35 Number Analyzed 30 participants 35 participants
-1.1  (2.05) -0.2  (2.11)
Sodium; early withdrawal, n= 1,1 Number Analyzed 1 participants 1 participants
-1.0 [1]   (NA) 3.0 [1]   (NA)
[1]
NA indicates standard deviation was not calculable for a single data point.
28.Secondary Outcome
Title Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants
Hide Description Blood samples were collected for the evaluation of change from Baseline in levels of direct bilirubin, bilirubin, indirect bilirubin, creatinine and urate. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: micromoles per liter (µmol/L)
Direct Bilirubin; Day2, n=35,35 Number Analyzed 35 participants 35 participants
-0.3  (0.85) -0.3  (0.66)
Post-infusion assessment, n=30,35 Number Analyzed 30 participants 35 participants
-0.5  (3.41) -0.1  (0.73)
Direct Bilirubin;early withdrawal, n=1,1 Number Analyzed 1 participants 1 participants
0.0 [1]   (NA) 0.0 [1]   (NA)
Bilirubin;Day2, n= 35,35 Number Analyzed 35 participants 35 participants
-0.7  (2.52) -1.3  (2.03)
Bilirubin; Post-infusion assessment, n= 30, 35 Number Analyzed 30 participants 35 participants
-1.1  (8.24) -0.5  (2.01)
Bilirubin; early withdrawal, n= 1,1 Number Analyzed 1 participants 1 participants
-2.0 [1]   (NA) -3.0 [1]   (NA)
Indirect Bilirubin; Day2, n=35,35 Number Analyzed 35 participants 35 participants
-0.4  (2.35) -1.1  (1.98)
Indirect Bilirubin;Postinfusion assessment,n=30,35 Number Analyzed 30 participants 35 participants
-0.6  (5.06) -0.4  (2.03)
Indirect Bilirubin; early withdrawal, n=1,1 Number Analyzed 1 participants 1 participants
-2.0 [1]   (NA) -3.0 [1]   (NA)
Creatinine; Day2, n=35,34 Number Analyzed 35 participants 34 participants
1.75  (6.765) 0.04  (5.336)
Creatinine; Post-infusion assessment, n=30,33 Number Analyzed 30 participants 33 participants
2.19  (4.437) 0.72  (4.680)
Creatinine; early withdrawal, n=1,1 Number Analyzed 1 participants 1 participants
-0.90 [1]   (NA) -6.10 [1]   (NA)
[1]
NA indicates standard deviation was not calculable for a single data point.
29.Secondary Outcome
Title Number of Maternal Participants With AEs of Special Interest (AESI)
Hide Description Maternal AESI included: maternal death; chorioamnionitis and its complications (clinical chorioamnionitis, preterm premature rupture of membranes, endomyometritis, wound infection, pelvic abscess, bacteremia, septic shock, disseminated intravascular coagulation, and adult RDS); placental abruption; postpartum hemorrhage - postpartum hemorrhage and/or retained placenta and pulmonary edema. The number of participants with at least one AESI has been presented.
Time Frame Up to 6 weeks post-delivery
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
4 7
30.Secondary Outcome
Title Number of Maternal Participants With Disease Related AEs (DRE)
Hide Description Maternal DREs included: signs and symptoms of labor discomfort (example, cramping, backache, muscle aches, nausea); subsequent episodes of preterm labor and hospitalization for delivery. The number of participants with at least one DRE has been presented.
Time Frame Up to 6 weeks post-delivery
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
5 5
31.Secondary Outcome
Title Number of Participants With Fetal Non-serious AEs and SAEs
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. The number of participants who experienced at least one non-serious AE and one SAE has been presented.
Time Frame Up to 17 weeks
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
Non-serious AE 6 6
SAE 4 2
32.Secondary Outcome
Title Number of Participants With Fetal AESI
Hide Description Fetal AESI included: intrauterine fetal demise; category II or III fetal heart rate tracing; and fetal inflammatory response syndrome characterized by cord blood interleukin-6 >11 picogram per milliliter (pg/mL), funisitis, or chorionic vasculitis. The number of participants who experienced at least one AESI has been presented.
Time Frame Up to 17 weeks
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
5 5
33.Secondary Outcome
Title Neonatal APGAR Scores
Hide Description APGAR is a quick test to assess the health of new born children. The test is performed at 1 and 5 minutes after birth. APGAR scale is determined by evaluating the new born on five categories (appearance, pulse, grimace, activity and respiration) on a scale from zero to two, then summing up the five values obtained. APGAR score ranges from 0 to 10 where a score of 7 and above is normal. The mean and standard deviation of APGAR scores at one minute and at five minutes of birth has been presented.Only those participants with data available at the specified data points were analyzed.
Time Frame Up to 5 minutes after birth
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Neonatal ITT Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: Score on APGAR scale
one minute, n=46, 50 Number Analyzed 46 participants 50 participants
8.2  (1.35) 8.4  (1.14)
five minutes, n=46, 50 Number Analyzed 46 participants 50 participants
9.1  (0.96) 9.4  (0.67)
34.Secondary Outcome
Title Weight of Neonates
Hide Description The weight of neonates was obtained from the neonate birth record. The mean weight of neonates and standard deviation has been presented. Only those participants with data available at the specified data points were analyzed.
Time Frame Up to 17 weeks
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Neonatal ITT Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 46 49
Mean (Standard Deviation)
Unit of Measure: grams (g)
2761.9  (567.84) 2844.4  (664.80)
35.Secondary Outcome
Title Head Circumference of Neonates
Hide Description The head circumference was determined from the neonate birth record. Only those participants with data available at the specified data points were analyzed.
Time Frame Up to 17 weeks
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Neonatal ITT Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 43 42
Mean (Standard Deviation)
Unit of Measure: centimeters (cm)
32.95  (2.179) 33.00  (1.892)
36.Secondary Outcome
Title Number of Neonatal Participants With Non-serious AEs and SAEs
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. The number of participants who experienced at least one non-serious AE and one SAE has been presented. Neonatal Safety Population consisted of neonates whose mothers received randomized treatment.
Time Frame Up to 28 days after the EDD of 40 weeks gestation
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Neonatal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
Non-serious AEs 23 17
SAEs 10 11
37.Secondary Outcome
Title Number of Neonatal Participants With AESI
Hide Description Neonatal AESI included: Neonatal death; Asphyxia; Infections (early onset neonatal sepsis, septic shock, pneumonia, meningitis); RDS; Hypotension; IVH/periventricular leukomalacia; Bronchopulmonary dysplasia; Neonatal acidosis; Hyperbilirubinemia; Necrotizing enterocolitis; and Hypoxic ischemic encephalopathy. The number of neonatal participants who experienced at least one AESI has been presented.
Time Frame Up to 28 days after EDD of 40 weeks gestation
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Neonatal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
19 16
38.Secondary Outcome
Title Number of Neonatal Participants With DRE
Hide Description The disease related neonatal events occurring in Infants born prior to 37 completed weeks included: apnea (severe), respiratory failure due to fatigue, hypoxia, or air leak from alveolar injury, patent ductus arteriosus, bradycardia, ventriculomegaly, cerebellar hemorrhage, hydrocephalus other than congenital, gastroesophageal reflux, aspiration pneumonia, anemia, retinopathy of prematurity (all stages), hearing disorder, temperature instability and hypoglycemia. The number of participants with at least one DRE has been presented.
Time Frame Up to 28 days after EDD of 40 weeks gestation
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Neonatal Safety Population
Arm/Group Title Retosiban Atosiban
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Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
5 3
39.Secondary Outcome
Title Maternal Length of Stay in Hospital
Hide Description The length of hospital stay associated with hospital admission for preterm labor and term labor/term delivery was collected from review of medical records. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Up to 28 days post EDD (40 0/7 weeks gestation)
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Median (Full Range)
Unit of Measure: Days
Preterm labor, n=13, 10 Number Analyzed 13 participants 10 participants
5.549
(1.32 to 72.00)
7.487
(0.87 to 37.82)
Term labor, n=25, 28 Number Analyzed 25 participants 28 participants
3.146
(0.17 to 62.71)
3.398
(0.41 to 36.74)
40.Secondary Outcome
Title Number of Participants Admitted to Particular Hospital Unit
Hide Description Maternal healthcare resource utilization associated with an episode of preterm labor and normal term delivery were collected from the review of medical records. The number of participants who were admitted to a particular hospital unit like general ward, private/semi-private room, recovery, and other has been presented.
Time Frame Up to 28 days post EDD (40 0/7 weeks gestation)
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Maternal Safety Population
Arm/Group Title Retosiban Atosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: Participants
Preterm labor, general ward 9 7
Preterm labor, private/semi-private room 1 0
Preterm, Other 3 4
Normal term labor, general ward 16 12
Normal term labor, ward-not specified 2 0
Normal term labor,private/semi-private room 1 7
Normal term labor, recovery 1 2
Normal term labor, Other 5 7
41.Secondary Outcome
Title Retosiban Clearance
Hide Description Maternal blood samples were collected at the indicated time points for pharmacokinetic analysis. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).
Time Frame Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion
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Hide Analysis Population Description
Maternal Safety Population. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).
Arm/Group Title Retosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed 53
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour
83.4
(5.25%)
42.Secondary Outcome
Title Volume of Distribution of Retosiban
Hide Description Maternal blood samples were collected at the indicated time points for pharmacokinetic analysis. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).
Time Frame Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal Safety Population. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).
Arm/Group Title Retosiban
Hide Arm/Group Description:
Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed 53
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
68.6
(109%)
Time Frame Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894.
Adverse Event Reporting Description SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
 
Arm/Group Title Retosiban (Maternal) Atosiban (Maternal) Retosiban (Fetal) Atosiban (Fetal) Retosiban (Neonatal) Atosiban (Neonatal)
Hide Arm/Group Description Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period. Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution. Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period. Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution. Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period. Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
All-Cause Mortality
Retosiban (Maternal) Atosiban (Maternal) Retosiban (Fetal) Atosiban (Fetal) Retosiban (Neonatal) Atosiban (Neonatal)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)      0/50 (0.00%)      0/47 (0.00%)      0/50 (0.00%)      0/46 (0.00%)      1/50 (2.00%)    
Hide Serious Adverse Events
Retosiban (Maternal) Atosiban (Maternal) Retosiban (Fetal) Atosiban (Fetal) Retosiban (Neonatal) Atosiban (Neonatal)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/47 (14.89%)      9/50 (18.00%)      4/47 (8.51%)      2/50 (4.00%)      10/46 (21.74%)      11/50 (22.00%)    
Cardiac disorders             
Foetal heart rate disorder  1  0/47 (0.00%)  0 0/50 (0.00%)  0 1/47 (2.13%)  1 1/50 (2.00%)  1 0/46 (0.00%)  0 0/50 (0.00%)  0
Foetal heart rate deceleration abnormality  1  0/47 (0.00%)  0 0/50 (0.00%)  0 1/47 (2.13%)  1 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Congenital, familial and genetic disorders             
Congenital hydronephrosis  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 1/50 (2.00%)  1 0/46 (0.00%)  0 0/50 (0.00%)  0
Ankyloglossia congenital  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Atrial septal defect  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Cataract congenital  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Pyloric stenosis  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Ventricular septal defect  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Eye disorders             
Visual impairment  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Gastrointestinal disorders             
Abdominal pain  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Pancreatitis  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Retroperitoneal haematoma  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Gastric perforation  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
General disorders             
Sudden infant death syndrome  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Hepatobiliary disorders             
Cholelithiasis  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Hyperbilirubinaemia neonatal  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 4/46 (8.70%)  4 3/50 (6.00%)  3
Immune system disorders             
Milk allergy  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Infections and infestations             
Amniotic cavity infection  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Appendicitis  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Haematoma infection  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Postoperative wound infection  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Urinary tract infection  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Bacterial disease carrier  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Gastroenteritis  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Injury, poisoning and procedural complications             
Abdominal wound dehiscence  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Investigations             
Foetal monitoring abnormal  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Blood bilirubin increased  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Pregnancy, puerperium and perinatal conditions             
Postpartum haemorrhage  1  0/47 (0.00%)  0 3/50 (6.00%)  3 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Preterm premature rupture of membranes  1  1/47 (2.13%)  1 2/50 (4.00%)  2 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Normal labour  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Pre-eclampsia  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Premature labour  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Premature separation of placenta  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Oligohydramnios  1  0/47 (0.00%)  0 0/50 (0.00%)  0 2/47 (4.26%)  2 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Hydrops foetalis  1  0/47 (0.00%)  0 0/50 (0.00%)  0 1/47 (2.13%)  1 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Jaundice neonatal  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 2/50 (4.00%)  2
Respiratory, thoracic and mediastinal disorders             
Neonatal respiratory distress syndrome  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 1/50 (2.00%)  1
Choking  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Hypoxia  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Meconium aspiration syndrome  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Pneumothorax  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Retosiban (Maternal) Atosiban (Maternal) Retosiban (Fetal) Atosiban (Fetal) Retosiban (Neonatal) Atosiban (Neonatal)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/47 (72.34%)      25/50 (50.00%)      6/47 (12.77%)      6/50 (12.00%)      23/46 (50.00%)      17/50 (34.00%)    
Blood and lymphatic system disorders             
Polycythaemia neonatorum  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Anaemia  1  4/47 (8.51%)  4 2/50 (4.00%)  2 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Anaemia of pregnancy  1  1/47 (2.13%)  1 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Leukocytosis  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Cardiac disorders             
Foetal heart rate disorder  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 4/50 (8.00%)  4 0/46 (0.00%)  0 0/50 (0.00%)  0
Foetal heart rate deceleration abnormality  1  0/47 (0.00%)  0 0/50 (0.00%)  0 3/47 (6.38%)  15 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Bradycardia foetal  1  0/47 (0.00%)  0 0/50 (0.00%)  0 1/47 (2.13%)  1 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Tachycardia  1  1/47 (2.13%)  1 1/50 (2.00%)  1 1/47 (2.13%)  1 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Bradycardia  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Tachycardia foetal  1  0/47 (0.00%)  0 0/50 (0.00%)  0 1/47 (2.13%)  3 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Congenital, familial and genetic disorders             
Congenital hydronephrosis  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Hydrocele  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Ear and labyrinth disorders             
Auditory disorder  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Eye disorders             
Eyelid oedema  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Gastrointestinal disorders             
Infantile colic  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 1/50 (2.00%)  1
Constipation  1  10/47 (21.28%)  12 5/50 (10.00%)  5 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Flatulence  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Inguinal hernia  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Regurgitation  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Umbilical hernia  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Vomiting  1  1/47 (2.13%)  1 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Abdominal pain upper  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Abdominal rigidity  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Dental caries  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Gingival bleeding  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Toothache  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
General disorders             
Generalised oedema  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Pyrexia  1  1/47 (2.13%)  1 3/50 (6.00%)  3 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Asthenia  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Chest pain  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Non-cardiac chest pain  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Oedema peripheral  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Peripheral swelling  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Suprapubic pain  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Hepatobiliary disorders             
Hyperbilirubinaemia neonatal  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 10/46 (21.74%)  10 8/50 (16.00%)  8
Jaundice  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 2/46 (4.35%)  3 0/50 (0.00%)  0
Hyperbilirubinaemia  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Hepatic steatosis  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Infections and infestations             
Urinary tract infection  1  4/47 (8.51%)  4 3/50 (6.00%)  3 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Bacterial vaginosis  1  1/47 (2.13%)  1 2/50 (4.00%)  2 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Cervicitis  1  1/47 (2.13%)  1 2/50 (4.00%)  2 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Gastroenteritis  1  1/47 (2.13%)  1 2/50 (4.00%)  2 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Viral upper respiratory tract infection  1  0/47 (0.00%)  0 3/50 (6.00%)  3 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Asymptomatic bacteriuria  1  0/47 (0.00%)  0 2/50 (4.00%)  2 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Candida infection  1  1/47 (2.13%)  1 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Vaginitis gardnerella  1  1/47 (2.13%)  1 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Escherichia urinary tract infection  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Genital candidiasis  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Herpes zoster  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Influenza  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Pulpitis dental  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Pyuria  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Nasopharyngitis  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 2/50 (4.00%)  3
Skin candida  1  0/47 (0.00%)  0 1/50 (2.00%)  2 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Ureaplasma infection  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Vaginal infection  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Injury, poisoning and procedural complications             
Procedural pain  1  3/47 (6.38%)  3 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Abdominal wound dehiscence  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Investigations             
Escherichia test positive  1  2/47 (4.26%)  2 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Psychiatric evaluation abnormal  1  0/47 (0.00%)  0 2/50 (4.00%)  2 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Candida test positive  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Haemoglobin decreased  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Klebsiella test positive  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
White blood cell count increased  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Metabolism and nutrition disorders             
Hypernatraemia  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Hypoglycaemia  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Metabolic acidosis  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Hyperglycaemia  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Iron deficiency  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Back pain  1  1/47 (2.13%)  1 2/50 (4.00%)  2 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Arthralgia  1  1/47 (2.13%)  1 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Flank pain  1  2/47 (4.26%)  2 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Musculoskeletal chest pain  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Neck pain  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Pain in extremity  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Eyelid haemangioma  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 1/50 (2.00%)  1
Nervous system disorders             
Cerebral haemorrhage  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Headache  1  8/47 (17.02%)  8 3/50 (6.00%)  3 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Dizziness  1  1/47 (2.13%)  1 3/50 (6.00%)  3 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Burning sensation  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Syncope  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Pregnancy, puerperium and perinatal conditions             
Foetal hypokinesia  1  1/47 (2.13%)  1 0/50 (0.00%)  0 2/47 (4.26%)  2 1/50 (2.00%)  1 0/46 (0.00%)  0 0/50 (0.00%)  0
Oligohydramnios  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 1/50 (2.00%)  1 0/46 (0.00%)  0 0/50 (0.00%)  0
Postpartum haemorrhage  1  1/47 (2.13%)  1 2/50 (4.00%)  2 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Gestational hypertension  1  1/47 (2.13%)  1 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Polyhydramnios  1  2/47 (4.26%)  2 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Premature labour  1  2/47 (4.26%)  2 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Preterm premature rupture of membranes  1  2/47 (4.26%)  2 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Jaundice neonatal  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 2/50 (4.00%)  2
Cephalhaematoma  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Psychiatric disorders             
Insomnia  1  2/47 (4.26%)  2 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Agitation  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Depression  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Mood swings  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Renal and urinary disorders             
Renal pain  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Reproductive system and breast disorders             
Scrotal oedema  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Testicular retraction  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 0/50 (0.00%)  0
Vaginal haemorrhage  1  2/47 (4.26%)  4 1/50 (2.00%)  2 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Breast engorgement  1  0/47 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Uterine atony  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Vulval oedema  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Vulvovaginal pruritus  1  1/47 (2.13%)  1 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Neonatal respiratory distress syndrome  1  4/47 (8.51%)  4 1/50 (2.00%)  1 0/47 (0.00%)  0 0/50 (0.00%)  0 0/46 (0.00%)  0 0/50 (0.00%)  0
Transient tachypnoea of the newborn  1  0/47 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0 0/50 (0.00%)  0 1/46 (2.17%)  1 1/50 (2.00%)  1
Apnoea  1