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Trial record 40 of 47 for:    cord blood | ( Map: Canada )

A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor (NEWBORN-1)

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ClinicalTrials.gov Identifier: NCT02377466
Recruitment Status : Terminated (Asset terminated by PIB)
First Posted : March 3, 2015
Results First Posted : July 19, 2018
Last Update Posted : August 17, 2018
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 IV infusion
Drug: Placebo IV infusion
Enrollment 25
Recruitment Details NEWBORN-1 was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to investigate efficacy and safety of retosiban 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. The study was conducted in 3 countries.
Pre-assignment Details Twenty-five participants were randomly assigned to study treatments: 12 participants to retosiban intravenous (IV) infusion and 13 participants to matched placebo IV infusion. Two participants randomized to retosiban arm did not receive study treatment. The study was terminated early due to feasibility of recruiting the study in a timely manner.
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment. 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.
Period Title: Overall Study
Started 13 12
Treated 13 10
Completed 13 10
Not Completed 0 2
Reason Not Completed
Other: Randomized and not treated             0             2
Arm/Group Title Placebo Retosiban Total
Hide Arm/Group Description Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment. 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. Total of all reporting groups
Overall Number of Baseline Participants 13 10 23
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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 10 participants 23 participants
26.5  (6.78) 27.7  (6.73) 27.0  (6.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
Female
13
 100.0%
10
 100.0%
23
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
African American/African Heritage
2
  15.4%
2
  20.0%
4
  17.4%
Asian-Central/South Asian Heritage
0
   0.0%
1
  10.0%
1
   4.3%
Asian-East Asian Heritage
1
   7.7%
0
   0.0%
1
   4.3%
Asian-Japanese Heritage
4
  30.8%
2
  20.0%
6
  26.1%
Asian-South East Asian Heritage
1
   7.7%
0
   0.0%
1
   4.3%
White-White/Caucasian/European Heritage
5
  38.5%
5
  50.0%
10
  43.5%
1.Primary Outcome
Title Time to Delivery or Treatment Failure, Whichever Occurs First
Hide Description Time to delivery or treatment failure is the number of days from the first dose of study treatment until delivery or treatment failure whichever occurs first. Treatment failure is defined as the administration of any putative tocolytic medication for treatment of preterm labor or as prophylaxis of preterm labor. 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. The mean number of days to delivery or treatment failure along with standard deviation has been presented. Statistical analysis was not performed due to early termination of the study and resultant small sample size.
Time Frame Up to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: Days
11.10  (14.987) 18.91  (22.993)
2.Primary Outcome
Title Number of Neonates With Any Diagnosis From the Neonatal Morbidity and Mortality Composite Component
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, necrotizing enterocolitis 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, intraventricular hemorrhage (IVH), white matter injury and cerebellar hemorrhage. Neonates with any of the composite component has been presented. Statistical analysis was not performed due to early termination of study and resultant small sample size. 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 after the estimated date of delivery (EDD) of 40 0/7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Neonatal ITT Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
4 2
3.Secondary Outcome
Title Time to Delivery
Hide Description 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 mean number of days to delivery along with standard deviation has been presented.
Time Frame Up to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: Days
16.32  (18.595) 19.18  (22.770)
4.Secondary Outcome
Title Number of Participants With Births Prior to 37 0/7 Weeks Gestation
Hide Description Gestational age at birth (weeks) is defined as the gestational age when the baby is born. Participants were considered to have delivered prior to 37 0/7 weeks, that is preterm, if the gestational age 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.
Time Frame Up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
9 8
5.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.
Time Frame Up to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
4 2
6.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.
Time Frame Up to 28 days post EDD of 40 0/7 weeks gestation
Hide Outcome Measure Data
Hide Analysis Population Description
Neonatal ITT Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: Days
37.50  (34.537) 26.05  (32.689)
7.Secondary Outcome
Title Number of Participants With Births Prior to 35 0/7 Weeks Gestation
Hide Description The number of participants who delivered prior to 35 0/7 weeks gestation has been presented.
Time Frame Up to 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
9 7
8.Secondary Outcome
Title Number of Participants With Births Prior to 32 0/7 Weeks Gestation
Hide Description The 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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 9 6
Measure Type: Number
Unit of Measure: Participants
6 2
9.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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 2 2
Measure Type: Number
Unit of Measure: Participants
2 1
10.Secondary Outcome
Title Number of Participants With Births <=7 Days From the First Study Treatment
Hide Description The 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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
5 5
11.Secondary Outcome
Title Number of Participants With Births at <=48 Hours From the First Study Treatment
Hide Description The 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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
3 3
12.Secondary Outcome
Title Number of Participants With Births at <=24 Hours From the First Study Treatment
Hide Description The 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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
3 1
13.Secondary Outcome
Title Number of Neonates With Any of the Co-primary 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, bronchopulmonary dysplasia, necrotizing enterocolitis 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, IVH, white matter injury and cerebellar hemorrhage. The number of neonates with any co-primary 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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
3 0
14.Secondary Outcome
Title Number of Neonates With Each Individual Component of the 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, bronchopulmonary dysplasia, necrotizing enterocolitis 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, IVH, white matter injury and cerebellar hemorrhage. The number of neonates with each individual component of the composite component has been presented.
Time Frame Up to 28 days after the EDD of 40 0/7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Neonatal ITT Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
Fetal Death 0 0
Neonatal Death 0 0
RDS 3 2
Bronchopulmonary dysplasia 3 0
Necrotizing enterocolitis or Isolated Perforation 0 0
Sepsis 0 0
Meningitis 0 0
Retinopathy of prematurity 0 0
IVH 0 0
White Matter Injury 0 0
Cerebellar Hemorrhage 0 0
15.Secondary Outcome
Title Number of Neonatal Participants With Admission to a Particular Hospital Unit
Hide Description Neonatal healthcare resource utilization was collected from review of medical records. The number of neonatal participants who were admitted to a particular hospital unit that is, level III (or higher) intensive neonatal care (NICU), Intensive care unit (ICU), general ward, Level I - Basic Neonatal care, Well born nursery (SCBU) and Level II-Special Care Newborn nursery high dependency (NHDU) has been summarized. Neonatal Safety Population consisted of neonates whose mothers received study treatment.
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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
Level III (or higher) NICU 5 6
Intensive care unit 0 1
General Ward 2 2
Level II-Special Care NHDU 0 1
Missing 1 0
Multiple ward type 5 0
16.Secondary Outcome
Title Length of Stay in Specialized Care Unit
Hide Description Neonatal healthcare resource utilization was collected from review of medical records. The length of stay in a specialized care unit (NICU or ICU) has been presented for neonatal participants with admission to ICU or NICU.
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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 10 7
Mean (Standard Deviation)
Unit of Measure: Days
40.34  (35.475) 35.60  (35.308)
17.Secondary Outcome
Title Number of Newborn Participants With Hospital Readmission
Hide Description Newborn hospital readmission following hospitalization for birth was collected from the newborn's medical records. The number of newborn participants who had readmission to hospital is presented.
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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
0 0
18.Secondary Outcome
Title Length of Stay Following Readmission to Hospital
Hide Description Newborn hospital readmission following hospitalization for birth was collected from the newborn's medical records. Length of stay in hospital following readmission is presented for neonates.
Time Frame Up to 28 days after EDD (40 0/7 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Neonatal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Median (Full Range)
Unit of Measure: Days
0
(0 to 0)
0
(0 to 0)
19.Secondary Outcome
Title Number of Participants With Ambulatory Surgery
Hide Description Information regarding participants who had ambulatory surgery was collected from the newborn medical records. The number of neonatal participants with ambulatory surgery is presented.
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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
0 0
20.Secondary Outcome
Title Time to Treatment Failure
Hide Description Treatment failure is defined as the administration of any putative tocolytic medication for treatment of preterm labor or as prophylaxis of preterm labor. Time to treatment failure is the number of days from the first dose of study treatment until treatment failure. The mean number of days to delivery or treatment failure along with standard deviation has been presented. Only those maternal participants with treatment failure were included in the analysis. NA indicates standard deviation could not be calculated as only one participant was analyzed.
Time Frame Up to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal ITT Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 4 1
Mean (Standard Deviation)
Unit of Measure: Days
1.141  (1.4307) 0.899 [1]   (NA)
[1]
Standard deviation could not be calculated as only one participant was analyzed.
21.Secondary Outcome
Title Number of Participants Who Received Any Putative Tocolytic
Hide Description A putative tocolytic medication was the medication administered for active preterm labor or as prevention of preterm labor and included calcium channel blockers, nonsteroidal anti-inflammatory drugs, or beta agonists, or magnesium sulfate doses that exceeded prespecified IV loading doses, infusion rates, or total duration of administration.
Time Frame Up to 17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
4 1
22.Secondary Outcome
Title Number of Participants With Subsequent Preterm Labor
Hide Description The participants who had not delivered after 48 hours post-infusion were contacted to determine if they had delivered or experienced any subsequent episodes of preterm labor. A subsequent episode of preterm labor was only recorded if the participant reported it to the Principal Investigator during one of the telephone follow-up calls but did not then go on to immediately deliver. However, if labor started and led to immediate delivery, then the only data collected would be the pre-specified delivery data and thus would not be counted as a subsequent episode of preterm labor. The number of participants who had a subsequent episode of preterm labor after administration of the study treatment has been presented. Maternal Safety Population comprised of all maternal participants randomly assigned to treatment who have been exposed to study treatment.
Time Frame Up to 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
1 1
23.Secondary Outcome
Title Number of Maternal Participants With 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 mey 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 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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
AEs 6 6
SAEs 0 0
24.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Hide Description SBP and DBP were measured with participants in a semirecumbent or seated position. 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 9 days
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Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
DBP; Day 1: 15 to 30 minutes; n=13, 10 Number Analyzed 13 participants 10 participants
-3.2  (10.64) -6.8  (8.22)
DBP; Day 1: 4 to 8 hours; n=11, 10 Number Analyzed 11 participants 10 participants
-9.0  (11.31) -7.0  (10.14)
DBP; Day 1: 20 to 24 hours; n=10, 8 Number Analyzed 10 participants 8 participants
-13.1  (11.05) -6.5  (8.65)
DBP; Day 2; n=11, 7 Number Analyzed 11 participants 7 participants
-10.2  (11.07) -4.0  (6.66)
DBP; Post infusion assessment; n=9, 5 Number Analyzed 9 participants 5 participants
-6.6  (12.69) -2.8  (4.76)
SBP; Day 1: 15 to 30 minutes; n=13, 10 Number Analyzed 13 participants 10 participants
-0.8  (7.50) -3.1  (10.40)
SBP; Day 1: 4 to 8 hours; n=11, 10 Number Analyzed 11 participants 10 participants
-7.1  (13.09) -1.3  (9.06)
SBP; Day 1: 20 to 24 hours; n=10, 8 Number Analyzed 10 participants 8 participants
-5.2  (12.47) 2.6  (14.56)
SBP; Day 2; n=11, 7 Number Analyzed 11 participants 7 participants
-4.5  (11.86) 0.7  (10.21)
SBP; Post infusion assessment; n=9, 5 Number Analyzed 9 participants 5 participants
-9.6  (8.69) -7.0  (8.22)
25.Secondary Outcome
Title Change From Baseline in Heart Rate
Hide Description Heart rate was measured with the participants in a semirecumbent or seated position. 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 9 days
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Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: beats per minute
Day 1: 15 to 30 minutes; n=13, 10 Number Analyzed 13 participants 10 participants
-5.1  (12.37) 1.4  (8.13)
Day 1: 4 to 8 hours; n=11, 10 Number Analyzed 11 participants 10 participants
-2.6  (10.82) -0.3  (8.12)
Day 1: 20 to 24 hours; n=9, 8 Number Analyzed 9 participants 8 participants
-4.1  (10.61) 6.5  (21.64)
Day 2; n=11, 7 Number Analyzed 11 participants 7 participants
-5.6  (15.73) -3.6  (13.91)
Post infusion assessment; n=9, 5 Number Analyzed 9 participants 5 participants
-6.1  (17.80) -3.8  (16.24)
26.Secondary Outcome
Title Change From Baseline in Temperature
Hide Description Temperature was measured with the participants in a semirecumbent or seated position. 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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: degree Celsius
Day 1: 15 to 30 minutes; n=12, 9 Number Analyzed 12 participants 9 participants
-0.028  (0.4123) -0.111  (0.1900)
Day 1: 4 to 8 hours; n=11, 10 Number Analyzed 11 participants 10 participants
0.087  (0.3947) -0.144  (0.3594)
Day 1: 20 to 24 hours; n=10, 8 Number Analyzed 10 participants 8 participants
0.104  (0.5413) -0.043  (0.3174)
Day 2; n=11, 7 Number Analyzed 11 participants 7 participants
0.105  (0.5067) 0.051  (0.2062)
Post-infusion assessment; n=9, 5 Number Analyzed 9 participants 5 participants
-0.136  (0.4668) 0.072  (0.2234)
27.Secondary Outcome
Title Change From Baseline in Respiratory Rate
Hide Description Respiratory rate was measured with the participants in a semirecumbent or seated position. 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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: breaths per minute
Day 1: 15 to 30 minutes; n=11, 8 Number Analyzed 11 participants 8 participants
0.5  (3.45) -1.1  (2.90)
Day 1: 4 to 8 hours; n=8, 9 Number Analyzed 8 participants 9 participants
1.1  (3.83) -1.1  (2.15)
Day 1: 20 to 24 hours; n=9, 7 Number Analyzed 9 participants 7 participants
0.3  (2.35) -1.0  (2.77)
Day 2; n=10, 6 Number Analyzed 10 participants 6 participants
0.9  (4.01) 0.0  (1.79)
Post infusion assessment; n=8, 4 Number Analyzed 8 participants 4 participants
0.4  (4.27) 0.5  (2.52)
28.Secondary Outcome
Title Change From Baseline in Hematocrit Levels
Hide Description Blood samples were collected for the evaluation of change in hematocrit levels from Baseline. 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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Day 2; n=9, 3 Number Analyzed 9 participants 3 participants
-0.0343  (0.04324) -0.0470  (0.02773)
Post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
-0.0090  (0.02900) -0.0078  (0.02928)
29.Secondary Outcome
Title Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC)
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 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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Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: grams per liter (g/L)
Hemoglobin; Day 2; n=9, 3 Number Analyzed 9 participants 3 participants
-11.2  (11.20) -15.7  (6.66)
Hemoglobin; Post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
-1.0  (9.76) -1.6  (8.79)
MCHC; Day 2; n=9, 3 Number Analyzed 9 participants 3 participants
-0.3  (17.27) -2.7  (10.97)
MCHC; Post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
5.0  (8.52) 2.6  (5.41)
30.Secondary Outcome
Title Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count
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).
Time Frame Baseline and up to 1 week
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Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: Billion cells per liter (L)
Basophils; Day 2; n=9, 3 Number Analyzed 9 participants 3 participants
-0.003  (0.0132) 0.000  (0.0458)
Basophils; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
0.003  (0.0160) 0.058  (0.1103)
Eosinophils; Day 2; n=9, 3 Number Analyzed 9 participants 3 participants
0.004  (0.0938) -0.063  (0.0513)
Eosinophils; post-infusion assessment; 7, 5 Number Analyzed 7 participants 5 participants
0.064  (0.1321) -0.044  (0.1328)
Lymphocytes; Day 2; n=9, 3 Number Analyzed 9 participants 3 participants
0.323  (0.6117) 0.877  (0.1914)
Lymphocytes; post-infusion assessment; 7, 5 Number Analyzed 7 participants 5 participants
0.253  (1.0579) 1.006  (1.4223)
Monocytes; Day 2; n=9, 3 Number Analyzed 9 participants 3 participants
0.008  (0.3389) 0.147  (0.5773)
Monocytes; post-infusion assessment; 7, 5 Number Analyzed 7 participants 5 participants
0.141  (0.2535) -0.082  (0.4135)
Neutrophils; Day 2; n=9, 3 Number Analyzed 9 participants 3 participants
2.744  (6.9362) -1.813  (3.3001)
Neutrophils; post-infusion assessment; 7, 5 Number Analyzed 7 participants 5 participants
-2.246  (6.0323) -1.910  (2.8497)
Platelets; Day 2; n=8, 3 Number Analyzed 8 participants 3 participants
-6.4  (47.42) -24.7  (32.58)
Platelets; post-infusion assessment; 6, 5 Number Analyzed 6 participants 5 participants
-15.7  (60.48) -5.4  (33.34)
Leukocytes; Day 2; n=9, 3 Number Analyzed 9 participants 3 participants
3.10  (6.720) -0.87  (2.914)
Leukocytes; post-infusion assessment; 7, 5 Number Analyzed 7 participants 5 participants
-1.76  (5.358) -0.98  (2.645)
31.Secondary Outcome
Title Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV)
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).
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Placebo Retosiban
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Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: femtoliter (fL)
MCV; Day 2; n=9, 3 Number Analyzed 9 participants 3 participants
0.4  (2.79) 1.7  (4.73)
MCV; Post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
-1.9  (1.77) -0.8  (1.30)
MPV; Day 2; n=8, 3 Number Analyzed 8 participants 3 participants
-0.11  (0.455) -0.20  (0.436)
MPV; Post-infusion assessment; n=6, 5 Number Analyzed 6 participants 5 participants
0.02  (0.833) 0.48  (1.026)
32.Secondary Outcome
Title Change From Baseline in Erythrocyte Level
Hide Description Blood samples were collected for the evaluation of change in erythrocyte level 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).
Time Frame Baseline and up to 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: Trillion cells per liter
Day 2; n=9, 3 Number Analyzed 9 participants 3 participants
-0.39  (0.423) -0.53  (0.153)
Post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
-0.03  (0.330) -0.02  (0.303)
33.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
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).
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: International Units per liter (IU/L)
ALP; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
-17.3  (17.56) -11.8  (6.46)
ALP; post-infusion assessment; n=8, 6 Number Analyzed 8 participants 6 participants
6.6  (31.14) -2.8  (14.08)
ALT; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
3.9  (19.60) 4.4  (10.64)
ALT; post-infusion assessment; n=8, 6 Number Analyzed 8 participants 6 participants
-8.8  (20.04) 2.5  (5.50)
AST; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
4.4  (15.69) 2.0  (10.20)
AST; post-infusion assessment; n=8, 6 Number Analyzed 8 participants 6 participants
-9.1  (13.05) -0.5  (7.45)
GGT; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
-0.9  (1.69) -0.8  (1.30)
GGT; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
4.4  (2.57) 0.4  (2.07)
LDH; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
-6.7  (33.51) -26.4  (31.86)
LDH; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
-8.1  (21.93) -7.6  (31.76)
34.Secondary Outcome
Title Change From Baseline in Albumin and Protein Levels
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).
Time Frame Baseline and up to 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: grams per liter (g/L)
Albumin; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
-3.4  (3.68) -2.6  (1.67)
Albumin; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
-1.3  (2.21) -1.0  (2.35)
Protein; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
-5.8  (6.26) -5.4  (3.58)
Protein; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
-2.4  (3.41) -1.8  (5.02)
35.Secondary Outcome
Title Change From Baseline in Anion Gap, Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level
Hide Description Blood samples were collected for the evaluation of change from Baseline in levels of anion gap, 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).
Time Frame Baseline and up to 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: millimoles per liter (mmol/L)
Anion Gap; Day 2; n=8, 4 Number Analyzed 8 participants 4 participants
0.0  (4.72) 0.0  (1.83)
Anion Gap; post-infusion assessment; n=7, 4 Number Analyzed 7 participants 4 participants
-1.6  (5.26) 0.3  (2.22)
Calcium; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
-0.042  (0.2833) -0.040  (0.1208)
Calcium; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
0.091  (0.2052) -0.048  (0.1016)
Chloride; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
1.0  (5.17) 1.8  (2.17)
Chloride; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
-0.7  (3.35) -0.6  (2.30)
Carbon Dioxide; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
-0.2  (3.63) 0.0  (2.35)
Carbon Dioxide; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
2.3  (3.64) -0.2  (2.77)
Glucose; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
1.47  (1.639) 1.98  (1.064)
Glucose; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
0.11  (2.497) 0.28  (2.109)
Potassium; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
-0.16  (0.394) 0.10  (0.515)
Potassium; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
-0.16  (0.237) 0.10  (0.283)
Magnesium; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
-0.411  (0.9476) -0.236  (0.5428)
Magnesium; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
-0.449  (0.6473) -0.056  (0.6199)
Phosphate; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
-0.133  (0.1768) 0.030  (0.2928)
Phosphate; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
0.021  (0.2018) 0.110  (0.1557)
Sodium; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
1.4  (2.96) 0.4  (1.67)
Sodium; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
0.1  (2.12) -0.8  (1.64)
36.Secondary Outcome
Title Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels
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).
Time Frame Baseline and up to 1 week
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Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: micromoles per liter (µmol/L)
Direct Bilirubin; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
0.0  (1.00) -0.4  (0.89)
Direct Bilirubin; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
0.3  (0.76) -0.4  (0.89)
Bilirubin; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
-0.7  (1.41) -0.8  (1.10)
Bilirubin; post-infusion assessment; n=8, 6 Number Analyzed 8 participants 6 participants
-0.3  (1.28) -2.0  (3.10)
Indirect Bilirubin; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
-0.7  (1.41) -0.4  (1.67)
Indirect Bilirubin; post-infusion assessment;n=7,5 Number Analyzed 7 participants 5 participants
-0.6  (1.51) -1.6  (3.85)
Creatinine; Day 2; n=6, 3 Number Analyzed 6 participants 3 participants
-0.33  (6.812) 2.37  (1.429)
Creatinine; post-infusion assessment; n=6, 3 Number Analyzed 6 participants 3 participants
1.92  (5.075) -0.33  (2.695)
Urate; Day 2; n=9, 5 Number Analyzed 9 participants 5 participants
1.1  (24.72) -22.0  (13.04)
Urate; post-infusion assessment; n=7, 5 Number Analyzed 7 participants 5 participants
12.9  (24.30) -2.0  (40.25)
37.Secondary Outcome
Title Number of Participants Who Discontinued Study Treatment Due to Clinical and Laboratory Toxicities
Hide Description Number of maternal participants who discontinued study treatment due to clinical and laboratory toxicities is presented.
Time Frame Up to 48 hours post-infusion
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Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
0 0
38.Secondary Outcome
Title Number of Maternal Participants With a Score of 12 or Higher on the Edinburgh Postnatal Depression Scale (EPDS)
Hide Description The effect of preterm birth on maternal health status was assessed using the EPDS. The EPDS is a 10-item self-reported assessment of depression, validated for administration during both the antenatal and the post-natal periods. Items are rated on a 4-point variable Likert scale, ranging from 0 to 3. The total score was calculated by adding individual scores for each item and ranged from 0 to 30. A score of less than 8 indicates depression not likely; score of 9 to 11 indicates possible depression and a score of more than 12 indicates an increased probability of depression. Maternal participants were required to complete the EPDS at the maternal follow-up assessment 6 weeks post-delivery.
Time Frame Up to 6 weeks post delivery
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Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
2 0
39.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 Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
0 1
40.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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Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
0 1
41.Secondary Outcome
Title Number of Fetal Participants With AEs and SAEs Prior to Delivery
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. Fetal AEs and SAEs included the adverse events that were experienced by the fetus prior to delivery. The number of fetal participants who experienced at least one AE and one SAE has been presented.
Time Frame Up to 17 weeks post-infusion
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Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
AE 3 5
SAE 0 1
42.Secondary Outcome
Title Number of Participants With Fetal Acidosis
Hide Description The number of participants with fetal acidosis is presented.
Time Frame Up to 16 weeks
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Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
0 0
43.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
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
3 5
44.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.
Time Frame Up to 5 minutes after birth
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Hide Analysis Population Description
Neonatal ITT Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: Score on APGAR scale
one minute at birth 7.3  (1.80) 7.5  (1.78)
five minutes at birth 8.5  (1.05) 8.7  (1.06)
45.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.
Time Frame Up to 17 weeks
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Neonatal ITT Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: grams (g)
2015.0  (805.67) 2121.2  (681.31)
46.Secondary Outcome
Title Head Circumference of Neonates
Hide Description The head circumference was determined from the neonate birth record.
Time Frame Up to 17 weeks
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Hide Analysis Population Description
Neonatal ITT Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: centimeters (cm)
29.57  (2.791) 30.13  (3.059)
47.Secondary Outcome
Title Number of Neonatal Participants With 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 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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Hide Analysis Population Description
Neonatal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
AEs 8 7
SAEs 3 5
48.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
Hide Outcome Measure Data
Hide Analysis Population Description
Neonatal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
8 5
49.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
Hide Outcome Measure Data
Hide Analysis Population Description
Neonatal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, intravenous (IV) loading dose over 5 minutes and continuous infusion rate for remainder of 48-hour treatment period.Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
4 2
50.Secondary Outcome
Title Maternal Length of Stay in Hospital
Hide Description Details on maternal health care resource use (both for hospitalizations related to preterm labor not resulting in a delivery and hospitalizations related to preterm labor/normal labor resulting in a delivery) associated with an episode of preterm labor, preterm delivery and normal term delivery (>= 37 weeks gestation) were collected from review of medical records. Length of hospital stay associated with hospital admission for preterm labor and normal term labor/term delivery is presented. One participant in the retosiban arm did not have hospitalization data; hence, was excluded from the analysis at delivery. Only participants with data available at the specified time points were analyzed (indicated by n=X) in category titles. NA indicates standard deviation could not be calculated as only one participant was analyzed.
Time Frame Up to 28 days post EDD (40 0/7 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Mean (Standard Deviation)
Unit of Measure: Days
Preterm labor; n=1, 0 Number Analyzed 1 participants 0 participants
2.642 [1]   (NA)
Preterm delivery; n=9, 7 Number Analyzed 9 participants 7 participants
10.177  (11.9312) 13.583  (20.7670)
Normal term delivery; n=4, 2 Number Analyzed 4 participants 2 participants
3.719  (2.2309) 4.635  (2.7616)
[1]
Standard deviation could not be calculated as only one participant was analyzed.
51.Secondary Outcome
Title Number of Participants With Hospital Admissions Related to Preterm Labor and Preterm Delivery
Hide Description Maternal healthcare resource utilization associated with an episode of preterm labor and preterm delivery were collected from the review of medical records. One participant in the retosiban arm did not have hospitalization data; hence, was excluded from the analysis at delivery. The number of participants who had hospital admission for preterm labor and preterm delivery has been presented. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Time Frame Up to 28 days after EDD (40 0/7 weeks of gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
Preterm labor; n=13, 10 Number Analyzed 13 participants 10 participants
1 0
Preterm delivery; n=13, 9 Number Analyzed 13 participants 9 participants
9 7
52.Secondary Outcome
Title Number of Participants Admitted to Particular Hospital Unit
Hide Description Maternal healthcare resource utilization associated with an episode of preterm labor, preterm delivery and normal term delivery were collected from the review of medical records. The number of participants who were admitted to a particular hospital unit has been presented.
Time Frame Up to 28 days post EDD (40 0/7 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
General ward 9 2
Private/Semi-private room 3 2
Labor and delivery 2 3
Labor and delivery to post-partum 0 1
Post-partum 0 1
Ward not specified 0 1
Labor ward 0 1
Antenatal ward 0 1
Postnatal ward 0 1
53.Secondary Outcome
Title Number of Participants With Different Modes of Transportation to Hospital
Hide Description The means by which the maternal participants were transported to the hospital i.e. ground ambulance/emergency vehicle (gr. amb/emer. veh), air ambulance, family member or other means were obtained from the review of medical records. The number of maternal participants with the corresponding mode of transportation is presented for preterm labor visit and delivery visit. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).
Time Frame Up to 28 days post EDD (40 0/7 weeks gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
Maternal Safety Population
Arm/Group Title Placebo Retosiban
Hide Arm/Group Description:
Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.
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 13 10
Measure Type: Number
Unit of Measure: Participants
Preterm labor; gr. amb/emer. veh; n=1, 0 Number Analyzed 1 participants 0 participants
0
Preterm labor; air ambulance; n=1, 0 Number Analyzed 1 participants 0 participants
0
Preterm labor; family member; n=1, 0 Number Analyzed 1 participants 0 participants
1
Preterm labor; other; n=1, 0 Number Analyzed 1 participants 0 participants
0
Delivery; gr. amb/emer. veh; n=5, 5 Number Analyzed 5 participants 5 participants
2 1
Delivery; air ambulance; n=5, 5 Number Analyzed 5 participants 5 participants
0 0
Delivery; family member; n=5, 5 Number Analyzed 5 participants 5 participants
3 3
Delivery; other; n=5, 5 Number Analyzed 5 participants 5 participants
0 1
Preterm labor;<24 hour stay;gr. amb/emer.veh;n=1,0 Number Analyzed 1 participants 0 participants
0
Preterm labor; <24 hour stay;air ambulance; n=1, 0 Number Analyzed 1 participants 0 participants
0
Preterm labor; <24 hour stay;family member; n=1, 0 Number Analyzed 1 participants 0 participants
1
Preterm labor; <24 hour stay;other; n=1, 0 Number Analyzed 1 participants 0 participants
0
54.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
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 per hour
83.4
(5.25%)
55.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 On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) will be collected from the start of study treatment and until the follow up contact (Up to 6 weeks after delivery).
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.
 
Arm/Group Title Placebo (Maternal) Retosiban (Maternal) Placebo (Fetal) Retosiban (Fetal) Placebo (Neonatal) Retosiban (Neonatal)
Hide Arm/Group Description Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment. 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. Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment. 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. Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment. 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.
All-Cause Mortality
Placebo (Maternal) Retosiban (Maternal) Placebo (Fetal) Retosiban (Fetal) Placebo (Neonatal) Retosiban (Neonatal)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/10 (0.00%)   0/13 (0.00%)   0/10 (0.00%)   0/13 (0.00%)   0/10 (0.00%) 
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Placebo (Maternal) Retosiban (Maternal) Placebo (Fetal) Retosiban (Fetal) Placebo (Neonatal) Retosiban (Neonatal)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/10 (0.00%)   0/13 (0.00%)   1/10 (10.00%)   3/13 (23.08%)   5/10 (50.00%) 
Cardiac disorders             
Cardiac arrest  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Congenital, familial and genetic disorders             
Ankyloglossia congenital  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  1/10 (10.00%) 
Congenital hypothyroidism  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  1/10 (10.00%) 
Gastrointestinal disorders             
Inguinal hernia  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  2/10 (20.00%) 
Meconium plug syndrome  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Infections and infestations             
Group B streptococcus neonatal sepsis  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  1/10 (10.00%) 
Tracheitis  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  1/10 (10.00%) 
Pregnancy, puerperium and perinatal conditions             
Umbilical cord prolapse  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  1/10 (10.00%)  0/13 (0.00%)  0/10 (0.00%) 
Psychiatric disorders             
Selective eating disorder  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Neonatal respiratory distress syndrome  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  2/13 (15.38%)  1/10 (10.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
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Frequency Threshold for Reporting Other Adverse Events 0%
Placebo (Maternal) Retosiban (Maternal) Placebo (Fetal) Retosiban (Fetal) Placebo (Neonatal) Retosiban (Neonatal)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/13 (46.15%)   6/10 (60.00%)   3/13 (23.08%)   5/10 (50.00%)   8/13 (61.54%)   7/10 (70.00%) 
Blood and lymphatic system disorders             
Anaemia  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Thrombocytopenia  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  1/10 (10.00%) 
Cardiac disorders             
Foetal heart rate disorder  1  0/13 (0.00%)  0/10 (0.00%)  2/13 (15.38%)  5/10 (50.00%)  0/13 (0.00%)  0/10 (0.00%) 
Foetal heart rate deceleration abnormality  1  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Eye disorders             
Conjunctival haemorrhage  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  1/10 (10.00%) 
Gastrointestinal disorders             
Constipation  1  1/13 (7.69%)  1/10 (10.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Abdominal discomfort  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Diarrhoea  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Haemorrhoids  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Inguinal hernia  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  2/13 (15.38%)  2/10 (20.00%) 
Haematochezia  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  1/10 (10.00%) 
Necrotising colitis  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Vomiting  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
General disorders             
Oedema  1  0/13 (0.00%)  1/10 (10.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Pyrexia  1  0/13 (0.00%)  1/10 (10.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Granuloma  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Hepatobiliary disorders             
Hyperbilirubinaemia neonatal  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  6/13 (46.15%)  4/10 (40.00%) 
Jaundice  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  1/10 (10.00%) 
Cholestasis  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Infections and infestations             
Abscess limb  1  0/13 (0.00%)  1/10 (10.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Amniotic cavity infection  1  0/13 (0.00%)  1/10 (10.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Bacterial vulvovaginitis  1  0/13 (0.00%)  1/10 (10.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Kidney infection  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Viral upper respiratory tract infection  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Device related infection  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Oral candidiasis  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  1/10 (10.00%) 
Injury, poisoning and procedural complications             
Contusion  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  1/10 (10.00%) 
Vaccination complication  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Investigations             
Blood calcium decreased  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Blood glucose decreased  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Liver function test increased  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Body temperature fluctuation  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Metabolism and nutrition disorders             
Feeding intolerance  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Hypoglycaemia  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders             
Myalgia  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Pain in extremity  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Osteopenia  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Nervous system disorders             
Headache  1  1/13 (7.69%)  1/10 (10.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Intraventricular haemorrhage  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Motor dysfunction  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Pregnancy, puerperium and perinatal conditions             
Oligohydramnios  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Uterine contractions abnormal  1  0/13 (0.00%)  1/10 (10.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Reproductive system and breast disorders             
Oedema genital  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Dyspnoea  1  0/13 (0.00%)  1/10 (10.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Neonatal respiratory distress syndrome  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  2/13 (15.38%)  2/10 (20.00%) 
Bronchopulmonary dysplasia  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  3/13 (23.08%)  0/10 (0.00%) 
Pleural effusion  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Respiratory acidosis  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Tachypnoea  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders             
Pruritus  1  0/13 (0.00%)  1/10 (10.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Pruritus generalised  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Dermatitis diaper  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Dry skin  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Intertrigo  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Seborrhoea  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
Vascular disorders             
Hypertension  1  1/13 (7.69%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%) 
Hypotension  1  0/13 (0.00%)  0/10 (0.00%)  0/13 (0.00%)  0/10 (0.00%)  1/13 (7.69%)  0/10 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02377466     History of Changes
Other Study ID Numbers: 200719
First Submitted: February 26, 2015
First Posted: March 3, 2015
Results First Submitted: January 22, 2018
Results First Posted: July 19, 2018
Last Update Posted: August 17, 2018