A Phase III Efficacy and Safety Study of Intravenous Reto... | NCT02377466

ID	Type	Description	Link
2014-003326-41	EudraCT Number

Status Module

Name	Class
PPD Development, LP	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Retosiban	Experimental	Retosiban treatment will be administered as a 6 mg IV loading dose over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion over 48 hours. For subjects with an inadequate response after the first hour of treatment, another 6 mg loading dose will be administered and infusion rate will be increased to 12 mg/hour for the remainder of the 48 hour treatment period. The retosiban dosing regimen will require adjustment in subjects treated concomitantly with drugs that are strong Cytochrome 3A4 inhibitors or inducers.	Drug: Retosiban IV infusion
Placebo	Placebo Comparator	The placebo control will be a normal saline (0.9% sodium chloride [NaCl]) infusion matched for the loading dose and continuous infusion rates, including a dose increase in subjects with an inadequate response after the first hour of treatment.	Drug: Placebo IV infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Retosiban IV infusion	Drug	Retosiban for IV administration will be supplied as solution for infusion, consisting of a clear colorless solution of retosiban at a concentration of 15 milligram per milliliter (mg/mL).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Delivery or Treatment Failure, Whichever Occurs First	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.	Up to 17 weeks
Number of Neonates With Any Diagnosis From the Neonatal Morbidity and Mortality Composite Component	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.	Up to 28 days after the estimated date of delivery (EDD) of 40 0/7 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to Delivery	The time to delivery was calculated as the days between the delivery and start time of the study treatment infusion using the formula: Time to delivery (days) = (date and time of delivery minus date and time of start of infusion) divided by (24 multiplied by 60). The mean number of days to delivery along with standard deviation has been presented.	Up to 17 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed and dated written informed consent is required prior to a subject's participation in the study and the performance of any protocol specific procedures. Adolescents aged 12 to 17 years must provide written agreement to participate in the study in accordance with applicable regulatory and country or state requirements. Subjects will also be asked to sign a release for medical records at the time of consenting to allow access to both the maternal and neonatal records including information about delivery and infant care as well as information collected prior to the consent having been signed.
Females aged 12 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes in preterm.
Gestational age between 24 and 33 weeks as determined by (1) known fertilization date, either in vitro fertilization or intrauterine insemination, (2) last menstrual period confirmed by the earliest ultrasound prior to 24 weeks gestation, or (3) the earliest ultrasound alone prior to 24 weeks gestation, whichever is the most accurate method available for each subject. In situations where prenatal ultrasound records are not available at the time the subject presents, the investigator will make every effort to obtain these records (either via computer records, directly from the subject's primary care obstetrician, or via telephone). However, in cases in which these records are not readily available (e.g., off hours, holiday), it is within the investigator's discretion to use GA based on a verbal history from the subject with the intent of getting confirmation from the medical records as soon as possible.
Females must be diagnosed with preterm labor according to both of the following criteria: a) Regular uterine contractions at a rate of >=4 contractions of at least 30 seconds' duration during a 30-minute interval confirmed by tocodynamometry and at least 1 of the following, b) Cervical dilation >=2 centimeter (cm) and <=4 cm by digital cervical examination or c) If <2 cm dilation by digital cervical examination, a cervical change consisting of an increase of at least 25% effacement or 1-cm dilation.
Current or past tocolytic treatment as follows: a) Subjects in whom tocolytic treatment has not been initiated prior to consent are eligible for the study, b) Transferred or referred subjects for whom parenteral magnesium sulfate treatment has been started before Screening are eligible provided they meet all eligibility criteria, c) Subjects receiving a prohibited tocolytic in this study are eligible only if the treatment is stopped before randomization and provided they meet all eligibility criteria, d) Subjects with a historical failure of a tocolytic treatment in a previous episode of preterm labor during the current pregnancy are eligible provided they meet all eligibility criteria.

Exclusion Criteria:

Fever with a temperature >100.4 degree Fahrenheit (38 degree centigrade) for more than 1 hour or >=101 degree Fahrenheit (38.3 degree centigrade) in the 24 hours prior to the start of study treatment.
Women with maternal-fetal conditions that potentially necessitate the need for delivery, such as pre-eclampsia or fetal compromise.
A fetus with any diagnosis, condition, treatment, or other factor that in the opinion of the investigator has the potential to affect or confound assessments of efficacy or safety (for example: nonreassuring fetal status, intrauterine growth restriction, major congenital anomaly).
Preterm premature rupture of membranes.
Women with any confirmed or suspected contraindication to prolongation of pregnancy, such as placental abruption, chorioamnionitis, or placenta previa.
Evidence of polyhydramnios (AFI >25 cm) or oligohydramnios (AFI <5 cm).
Women with co-morbid medical or obstetric conditions that in the opinion of the investigator have the potential to complicate the pregnancy course and outcomes, such as uncontrolled hypertension or uncontrolled diabetes (if known, history of glycosylated hemoglobin >8% at any time during pregnancy), or compromise the safety of the subject, such as underlying cardiovascular disorder (specifically ischemic cardiac disease, congenital heart disease, pulmonary hypertension, valvular heart disease, arrhythmias, and cardiomyopathy).
Women with a history of substance abuse during the pregnancy or urine drug screen positive for cocaine, phencyclidine (PCP), methamphetamine, or amphetamine.
Women in whom the combination of history and screening test results is suggestive of abuse or dependency that may have the potential to complicate the pregnancy outcome.
Women with any diagnosis, condition, treatment, or other factor that, in the opinion of the investigator, has the potential to affect or confound assessments of efficacy or safety.
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
History of sensitivity to any of the investigational products (IPs) or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline/ Pharmaceutical Product Development (GSK/PPD) medical monitor, contraindicates the subject's participation.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35233	United States
GSK Investigational Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	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.
FG001	Retosiban

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Sep 8, 2017	Dec 12, 2017

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Delivery or Treatment Failure, Whichever Occurs First

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.

Maternal ITT Population

Posted

Mean

Standard Deviation

Days

Up to 17 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants	OG00013 OG00110

Title

Denominators

Categories

Title	Measurements
	OG00011.10± 14.987 OG00118.91± 22.993

Primary

Number of Neonates With Any Diagnosis From the Neonatal Morbidity and Mortality Composite Component

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.

Neonatal ITT Population

Posted

Number

Participants

Up to 28 days after the estimated date of delivery (EDD) of 40 0/7 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Time to Delivery

The time to delivery was calculated as the days between the delivery and start time of the study treatment infusion using the formula: Time to delivery (days) = (date and time of delivery minus date and time of start of infusion) divided by (24 multiplied by 60). The mean number of days to delivery along with standard deviation has been presented.

Maternal ITT Population

Posted

Mean

Standard Deviation

Days

Up to 17 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts

Secondary

Number of Participants With Births Prior to 37 0/7 Weeks Gestation

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.

Maternal ITT Population

Posted

Number

Participants

Up to 13 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts

Secondary

Number of Participants With Births at Term

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.

Maternal ITT Population

Posted

Number

Participants

Up to 17 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Length of Neonatal Hospital Stay

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.

Neonatal ITT Population

Posted

Mean

Standard Deviation

Days

Up to 28 days post EDD of 40 0/7 weeks gestation

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Number of Participants With Births Prior to 35 0/7 Weeks Gestation

The number of participants who delivered prior to 35 0/7 weeks gestation has been presented.

Maternal ITT Population

Posted

Number

Participants

Up to 11 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Number of Participants With Births Prior to 32 0/7 Weeks Gestation

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.

Maternal ITT Population

Posted

Number

Participants

Up to 8 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Number of Participants With Births Prior to 28 0/7 Weeks Gestation

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.

Maternal ITT Population

Posted

Number

Participants

Up to 4 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Number of Participants With Births <=7 Days From the First Study Treatment

The number of participants who delivered in less than or equal to 7 days from first dose of study treatment has been presented.

Maternal ITT Population

Posted

Number

Participants

Up to 7 days

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Number of Participants With Births at <=48 Hours From the First Study Treatment

The number of participants who delivered in less than or equal to 48 hours from first dose of study treatment has been presented.

Maternal ITT Population

Posted

Number

Participants

Up to 48 hours

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Number of Participants With Births at <=24 Hours From the First Study Treatment

The number of participants who delivered in less than or equal to 24 hours from first dose of study treatment has been presented.

Maternal ITT Population

Posted

Number

Participants

Up to 24 hours

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Number of Neonates With Any of the Co-primary Composite Neonatal Morbidity and Mortality, Excluding RDS

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.

Neonatal ITT Population

Posted

Number

Participants

Up to 28 weeks after EDD (40 weeks gestation)

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Number of Neonates With Each Individual Component of the Composite Neonatal Morbidity and Mortality

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.

Neonatal ITT Population

Posted

Number

Participants

Up to 28 days after the EDD of 40 0/7 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Number of Neonatal Participants With Admission to a Particular Hospital Unit

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.

Neonatal Safety Population

Posted

Number

Participants

Up to 28 days post EDD (40 0/7 weeks gestation)

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Length of Stay in Specialized Care Unit

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.

Neonatal Safety Population.

Posted

Mean

Standard Deviation

Days

Up to 28 days post EDD (40 0/7 weeks gestation)

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Number of Newborn Participants With Hospital Readmission

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.

Neonatal Safety Population

Posted

Number

Participants

Up to 28 days of EDD (40 0/7 weeks gestation)

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Length of Stay Following Readmission to Hospital

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.

Neonatal Safety Population

Posted

Median

Full Range

Days

Up to 28 days after EDD (40 0/7 weeks gestation)

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Number of Participants With Ambulatory Surgery

Information regarding participants who had ambulatory surgery was collected from the newborn medical records. The number of neonatal participants with ambulatory surgery is presented.

Neonatal Safety Population

Posted

Number

Participants

Up to 28 days post EDD (40 0/7 weeks gestation)

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Time to Treatment Failure

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.

Maternal ITT Population

Posted

Mean

Standard Deviation

Days

Up to 17 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Number of Participants Who Received Any Putative Tocolytic

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.

Maternal Safety Population

Posted

Number

Participants

Up to 17 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units

Secondary

Number of Participants With Subsequent Preterm Labor

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.

Maternal Safety Population

Posted

Number

Participants

Up to 11 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Number of Maternal Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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.

Maternal Safety Population

Posted

Number

Participants

Up to 6 weeks after delivery

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

millimeter of mercury (mmHg)

Baseline and up to 9 days

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Change From Baseline in Heart Rate

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

beats per minute

Baseline and up to 9 days

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Change From Baseline in Temperature

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

degree Celsius

Baseline and up to 1 week

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Change From Baseline in Respiratory Rate

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

breaths per minute

Baseline and up to 1 week

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Change From Baseline in Hematocrit Levels

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

Proportion of red blood cells in blood

Baseline and up to 1 week

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts

Secondary

Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC)

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

grams per liter (g/L)

Baseline and up to 1 week

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

Billion cells per liter (L)

Baseline and up to 1 week

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV)

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

femtoliter (fL)

Baseline and up to 1 week

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Change From Baseline in Erythrocyte Level

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

Trillion cells per liter

Baseline and up to 1 week

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

International Units per liter (IU/L)

Baseline and up to 1 week

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Change From Baseline in Albumin and Protein Levels

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

grams per liter (g/L)

Baseline and up to 1 week

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Change From Baseline in Anion Gap, Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

millimoles per liter (mmol/L)

Baseline and up to 1 week

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels

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).

Maternal Safety Population

Posted

Mean

Standard Deviation

micromoles per liter (µmol/L)

Baseline and up to 1 week

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Number of Participants Who Discontinued Study Treatment Due to Clinical and Laboratory Toxicities

Number of maternal participants who discontinued study treatment due to clinical and laboratory toxicities is presented.

Maternal Safety Population

Posted

Number

Participants

Up to 48 hours post-infusion

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Number of Maternal Participants With a Score of 12 or Higher on the Edinburgh Postnatal Depression Scale (EPDS)

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.

Maternal Safety Population

Posted

Number

Participants

Up to 6 weeks post delivery

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Number of Maternal Participants With AEs of Special Interest (AESI).

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.

Maternal Safety Population

Posted

Number

Participants

Up to 6 weeks post-delivery

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Number of Maternal Participants With Disease Related AEs (DRE)

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.

Maternal Safety Population

Posted

Number

Participants

Up to 6 weeks post-delivery

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts

Secondary

Number of Fetal Participants With AEs and SAEs Prior to Delivery

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.

Maternal Safety Population

Posted

Number

Participants

Up to 17 weeks post-infusion

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Number of Participants With Fetal Acidosis

The number of participants with fetal acidosis is presented.

Maternal Safety Population

Posted

Number

Participants

Up to 16 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Fetal AESI

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.

Maternal Safety Population

Posted

Number

Participants

Up to 17 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts

Secondary

Neonatal APGAR Scores

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.

Neonatal ITT Population

Posted

Mean

Standard Deviation

Score on APGAR scale

Up to 5 minutes after birth

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Weight of Neonates

The weight of neonates was obtained from the neonate birth record. The mean weight of neonates and standard deviation has been presented.

Neonatal ITT Population

Posted

Mean

Standard Deviation

grams (g)

Up to 17 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts
Participants

Secondary

Head Circumference of Neonates

The head circumference was determined from the neonate birth record.

Neonatal ITT Population

Posted

Mean

Standard Deviation

centimeters (cm)

Up to 17 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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

Units	Counts
Participants

Secondary

Number of Neonatal Participants With AEs and SAEs

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.

Neonatal Safety Population

Posted

Number

Participants

Up to 28 days after the EDD of 40 weeks gestation

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Number of Neonatal Participants With AESI

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.

Neonatal Safety Population

Posted

Number

Participants

Up to 28 days after EDD of 40 weeks gestation

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Number of Neonatal Participants With DRE

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.

Neonatal Safety Population

Posted

Number

Participants

Up to 28 days after EDD of 40 weeks gestation

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Maternal Length of Stay in Hospital

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.

Maternal Safety Population

Posted

Mean

Standard Deviation

Days

Up to 28 days post EDD (40 0/7 weeks gestation)

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Number of Participants With Hospital Admissions Related to Preterm Labor and Preterm Delivery

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).

Maternal Safety Population

Posted

Number

Participants

Up to 28 days after EDD (40 0/7 weeks of gestation)

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Number of Participants Admitted to Particular Hospital Unit

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.

Maternal Safety Population

Posted

Number

Participants

Up to 28 days post EDD (40 0/7 weeks gestation)

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Units	Counts

Secondary

Number of Participants With Different Modes of Transportation to Hospital

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).

Maternal Safety Population

Posted

Number

Participants

Up to 28 days post EDD (40 0/7 weeks gestation)

ID	Title	Description
OG000	Placebo	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.
OG001	Retosiban	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.

Secondary

Retosiban Clearance

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).

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).

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters per hour

Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion

ID	Title	Description
OG000	Retosiban	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.

Units	Counts
Participants	OG000

Secondary

Volume of Distribution of Retosiban

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters

Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion

ID	Title	Description
OG000	Retosiban	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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo (Maternal)	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.	13	0	13	6	13
EG001	Retosiban (Maternal)	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.	10	0	10	6	10
EG002	Placebo (Fetal)	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.	13	0	13	3	13
EG003	Retosiban (Fetal)	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.	10	1	10	5	10
EG004	Placebo (Neonatal)	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.	13	3	13	8	13
EG005	Retosiban (Neonatal)	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.	10	5	10	7	10

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Umbilical cord prolapse	Pregnancy, puerperium and perinatal conditions	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG0031 affected10 at risk EG004
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Meconium plug syndrome	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Neonatal respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Ankyloglossia congenital	Congenital, familial and genetic disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Congenital hypothyroidism	Congenital, familial and genetic disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Group B streptococcus neonatal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Tracheitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Selective eating disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected10 at risk EG0020 affected13 at risk EG0030 affected10 at risk EG0040 affected13 at risk EG0050 affected10 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Abscess limb	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected10 at risk EG0020 affected13 at risk EG003
Amniotic cavity infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected10 at risk EG0020 affected13 at risk EG003
Bacterial vulvovaginitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected10 at risk EG0020 affected13 at risk EG003
Kidney infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected10 at risk EG0020 affected13 at risk EG003
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected10 at risk EG0020 affected13 at risk EG003
Blood calcium decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Blood glucose decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Liver function test increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0011 affected10 at risk EG0020 affected13 at risk EG003
Oligohydramnios	Pregnancy, puerperium and perinatal conditions	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Uterine contractions abnormal	Pregnancy, puerperium and perinatal conditions	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected10 at risk EG0020 affected13 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected10 at risk EG0020 affected13 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected10 at risk EG0020 affected13 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Foetal heart rate disorder	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0022 affected13 at risk EG003
Foetal heart rate deceleration abnormality	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0021 affected13 at risk EG003
Hyperbilirubinaemia neonatal	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Neonatal respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Bronchopulmonary dysplasia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Necrotising colitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Device related infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Feeding intolerance	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Intraventricular haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Motor dysfunction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Seborrhoea	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Granuloma	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Body temperature fluctuation	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Oedema genital	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected13 at risk EG0010 affected10 at risk EG0020 affected13 at risk EG003

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Title	Description
BG000	Placebo	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.
BG001	Retosiban	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.
BG002	Total	Total of all reporting groups