A Randomized Study Comparing the Efficacy and Safety of R... | NCT02292771 | Trialant
NCT02292771
Sponsor
GlaxoSmithKline
Status
Terminated
Last Update Posted
Jul 29, 2020Actual
Enrollment
97Actual
Phase
Phase 3
Conditions
Obstetric Labour, Premature
Interventions
Retosiban
Atosiban
Placebo matching retosiban
Placebo matching atosiban
Countries
Belgium
Germany
Israel
Italy
Mexico
South Korea
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02292771
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
200721
Secondary IDs
ID
Type
Description
Link
2014-001826-13
EudraCT Number
Brief Title
A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour
Official Title
Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jul 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was stopped due to the feasibility of recruiting the study in a timely manner
Expanded Access Info
No
Start Date
Mar 16, 2015Actual
Primary Completion Date
Aug 25, 2017Actual
Completion Date
Aug 25, 2017Actual
First Submitted Date
Nov 13, 2014
First Submission Date that Met QC Criteria
Nov 13, 2014
First Posted Date
Nov 17, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 21, 2018
Results First Submitted that Met QC Criteria
Sep 7, 2018
Results First Posted Date
Sep 10, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 14, 2020
Last Update Posted Date
Jul 29, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Name
Class
PPD Development, LP
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective of this study is to demonstrate the superiority of retosiban to prolong pregnancy in females with spontaneous preterm labor compared with atosiban. This objective is based on the hypothesis that prolonging the time to delivery in the absence of harm may benefit the newborn, particularly in women who experience spontaneous preterm labor at early gestational ages (GA). This study is designed to test this hypothesis through a direct comparison with atosiban, a mixed oxytocin vasopressin antagonist indicated for short-term use to delay imminent preterm birth in women between 24^0/7 and 33^6/7 weeks' gestation in preterm labor. This is a randomized, double-blind, double-dummy study, which consists of 6 phases: Screening, Inpatient Randomized Treatment, Post Infusion Assessment, Delivery, Maternal Post Delivery Assessment, and Neonatal Medical Review. Approximately 330 females will be randomly assigned to retosiban or atosiban treatment in a 1:1 ratio. The duration of any one subject's (maternal or neonatal) participation in the study will be variable and dependent on GA at study entry and the date of delivery.
Detailed Description
Not provided
Conditions Module
Conditions
Obstetric Labour, Premature
Keywords
Spontaneous Preterm Labor
retosiban
GSK221149
atosiban
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
97Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Retosiban + Atosiban Placebo
Experimental
Participants will receive retosiban 6 milligrams (mg) intravenous (IV) loading dose over 5 minutes, followed by a 6mg/hour continuous infusion over 48 hours. For subjects with an inadequate response after the first hour of treatment, investigators will administer another 6mg IV loading dose and increase the infusion rate to 12 mg/hour for the remainder of the 48-hour treatment period. Participants will also receive placebo infusion matched for the atosiban loading (bolus) dose and continuous infusion to ensure blinding.
Drug: Retosiban
Drug: Placebo matching atosiban
Atosiban + Retosiban Placebo
Active Comparator
Participants will receive atosiban in 3 successive stages: an initial bolus dose (6.75 mg) over 1 minute, immediately followed by a continuous infusion at 18 mg/hour for 3 hours, followed by a 6 mg/hour infusion for the remainder of the 48-hour treatment period. Participants will also receive placebo infusion matched for retosiban loading (bolus) dose and continuous infusion to ensure blinding.
Drug: Atosiban
Drug: Placebo matching retosiban
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Retosiban
Drug
Solution for infusion, consisting of a clear colorless solution of retosiban at a concentration of 15 milligram/milliliter (mg/mL) in 56% volume/volume ethanol/acetate buffer concentrate supplied in 5 mL vial containing 75mg retosiban.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Time to Delivery From the Start of Investigational Product (IP) Administration
Time to delivery is the number of days from the first dose of study treatment until delivery. The time to delivery was calculated as the days between the delivery and start time of the study treatment infusion using the formula: Time to delivery (days) = (date and time of delivery minus date and time of start of infusion) divided by (24 multiplied by 60). The adjusted mean number of days to delivery along with standard error has been presented. Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.
Up to 17 weeks
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Births Prior to 37 0/7 Weeks Gestation
Gestational age (GA) at birth (weeks) is defined as the GA when the baby is born. Participants were considered to have delivered prior to 37 0/7 weeks, that is preterm , if the GA at birth is less than 37 0/7 weeks. The number of participants who delivered prior to 37 0/7 weeks gestation has been presented. Logistic regression model was used to calculate p-values.
Other Outcomes
Not provided
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 labor (Note: This protocol includes pregnant adolescents, aged 12 to 17 years, as appropriate, based on national or local regulations.).
Gestational age between 24^0/7 and 33^6/7 weeks as determined by known fertilization date, either in vitro fertilization or intrauterine insemination, last menstrual period confirmed by the earliest ultrasound prior to 24^0/7 weeks' gestation, or the earliest ultrasound alone prior to 24^0/7 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.
Subjects must be diagnosed with preterm labor according to both of the following criteria:
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:
Cervical dilation >=2 centimeter (cm) and <=4 cm by digital cervical examination or If <2 cm dilation by digital cervical examination, a cervical change consisting of an increase of at least 25% effacement or 1 cm dilation
Treatment naïve subjects and subjects not adequately responding to tocolytics other than atosiban (e.g., transfers from other care units) during their current episode of preterm labor may be eligible for the study. Historical failure of a tocolytic treatment in a previous episode of preterm labor is not a required inclusion criterion. Tocolytic failure is defined by progressive cervical changes or continuing uterine contractions.
Exclusion Criteria:
Fever with a temperature greater than 100.4°fahrenheit (F) (38°Celcius [C]) for more than 1 hour or >=101°F (38.3°C) 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 (e.g., 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 (amniotic fluid index [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, 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 or urine drug screen findings suggestive of substance abuse that may either be implicated as the cause of preterm labor (e.g., abuse of cocaine or methamphetamines) or have the potential to complicate the pregnancy outcome (e.g., alcohol abuse or opioid addiction).
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.
Women with documented active hepatitis B or hepatitis C viral infection, unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of sensitivity to the IPs or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK)/PPD medical monitor, contraindicates their participation.
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
45 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Bruges
8000
Belgium
GSK Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
From 330 planned participants 97 were randomized to receive either retosiban or atosiban intravenous (IV) infusion in a ratio of 1:1. The study was terminated early due to feasibility.
Recruitment Details
ZINN was a randomized, double-blind, double-dummy multicenter study to compare efficacy and safety of retosiban versus atosiban in female participants aged 12 to 45 years with an uncomplicated singleton pregnancy in preterm labor with intact membranes between 24 0/7 and 33 6/7 weeks gestation.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
SAP
No
Yes
No
Statistical Analysis Plan
Oct 4, 2017
Nov 27, 2017
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Brazil
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Retosiban + Atosiban Placebo
Atosiban
Drug
Clear, colorless solution for injection in a 0.9-mL vial containing 6.75 mg of atosiban. Clear, colorless concentrate for solution for infusion in a 5-mL vial containing 37.5 mg atosiban.
Atosiban + Retosiban Placebo
Placebo matching retosiban
Drug
A placebo infusion containing 0.9% sodium chloride (NaCl) matched for retosiban loading (bolus) dose and continuous infusion.
Atosiban + Retosiban Placebo
Placebo matching atosiban
Drug
A placebo infusion containing 0.9% NaCl matched for the atosiban loading (bolus) dose and continuous infusion.
Retosiban + Atosiban Placebo
Up to 13 weeks
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. Logistic regression model was used to calculate p-values.
Up to 17 weeks
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. Log of length of stay was calculated as treatment plus GA at randomization plus established progesterone use based on Analysis of covariance (ANCOVA) model. The p-value was calculated using t-test method. Neonatal ITT Population comprised of all neonates whose mothers were the randomized participants who have been exposed to study treatment, that is, mothers from the ITT Population.
Up to 28 days post estimated date of delivery (EDD) of 40 0/7 weeks gestation
Number of Neonates With 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, Respiratory Distress Syndrome (RDS), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity (ROP), Intraventricular Hemorrhage (IVH), white matter injury and cerebellar hemorrhage.
Up to 28 weeks after EDD (40 weeks gestation)
Number of Neonates With Any 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, BPD, NEC or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, ROP, IVH, white matter injury and cerebellar hemorrhage. Number of neonates with any composite neonatal morbidity and mortality component, excluding RDS has been presented.
Up to 28 weeks after EDD (40 weeks gestation)
Number of Neonates With Each Individual Component of 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, BPD, NEC or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, ROP, IVH, cerebellar hemorrhage and white matter injury included Periventricular Leukomalacia PVL), porencephalic cyst, and persistent ventriculomegaly. Number of neonates with with each individual component of the composite neonatal morbidity and mortality has been presented.
Up to 28 weeks after EDD (40 weeks gestation)
Length of Stay in Specialized Care Unit
Length of neonatal stay in specialized care unit like Intensive Care Unit (ICU) or Neonatal Intensive Care Unit (NICU) are reported.
Up to 28 days post EDD (40 0/7 weeks gestation)
Number of Newborn Participants With Hospital Readmission
Newborn hospital readmission following hospitalization for birth was obtained from the newborn's medical records. Only those participants with data available at the specified data points were analyzed.
Up to 28 days of EDD (40 0/7 weeks gestation)
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.
Up to 4 weeks
Number of Participants With Births Prior to 32 0/7 Weeks Gestation
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.
Up to 8 weeks
Number of Participants With Births Prior to 35 0/7 Weeks Gestation
Number of participants who delivered prior to 35 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 35 0/7 week's gestation and delivered were included.
Up to 11 weeks
Number of Participants With Births <=7 Days From the First Study Treatment
Number of participants who delivered in less than or equal to 7 days from first dose of study treatment has been presented.
Up to 7 days
Number of Participants With Births <=48 Hours From the First Study Treatment
Number of participants who delivered in less than or equal to 48 hours from first dose of study treatment has been presented.
Up to 48 hours
Number of Participants With Births <=24 Hours From the First Study Treatment
Number of participants who delivered in less than or equal to 24 hours from first dose of study treatment has been presented.
Up to 24 hours
Number of Maternal Participants With Non-serious 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 may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. Maternal Safety Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment. The number of maternal participants who experienced at least one non-serious AE and one SAE has been presented.
Up to 6 weeks after delivery
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants
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).
Baseline and up to 1 week
Change From Baseline in Heart Rate in Maternal Participants
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).
Baseline and up to 1 week
Change From Baseline in Respiratory Rate in Maternal Participants
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).
Baseline and up to 1 week
Change From Baseline in Temperature in Maternal Participants
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).
Baseline and up to 1 week
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants
Blood samples were collected for the evaluation of change in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes count. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Baseline and up to 1 week
Change From Baseline in Erythrocytes in Maternal Participants
Blood samples were collected for the evaluation of change in erythrocytes from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Baseline and up to 1 week
Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC) in Maternal Participants
Blood samples were collected for the evaluation of change in hemoglobin levels and MCHC from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus. NA indicates standard deviation was not calculable for a single data point.
Baseline and up to 1 week
Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) in Maternal Participants
Blood samples were collected for the evaluation of change in MCV and MPV from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Baseline and up to 1 week
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants
Blood samples were collected for the evaluation of change in ALP, ALT, AST, GGT and LDH from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Baseline and up to 1 week
Change From Baseline in Albumin and Protein Levels in Maternal Participants
Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Baseline and up to 1 week
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants
Blood samples were collected for the evaluation of change from Baseline in levels of calcium, chloride, carbon dioxide, glucose, potassium, magnesium, phosphate, and sodium. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Baseline and up to 1 week
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants
Blood samples were collected for the evaluation of change from Baseline in levels of direct bilirubin, bilirubin, indirect bilirubin, creatinine and urate. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Baseline and up to 1 week
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.
Up to 6 weeks post-delivery
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.
Up to 6 weeks post-delivery
Number of Participants With Fetal Non-serious 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 non-serious AE and one SAE has been presented.
Up to 17 weeks
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.
Up to 17 weeks
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.Only those participants with data available at the specified data points were analyzed.
Up to 5 minutes after birth
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. Only those participants with data available at the specified data points were analyzed.
Up to 17 weeks
Head Circumference of Neonates
The head circumference was determined from the neonate birth record. Only those participants with data available at the specified data points were analyzed.
Up to 17 weeks
Number of Neonatal Participants With Non-serious 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 non-serious AE and one SAE has been presented. Neonatal Safety Population consisted of neonates whose mothers received randomized treatment.
Up to 28 days after the EDD of 40 weeks gestation
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.
Up to 28 days after EDD of 40 weeks gestation
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.
Up to 28 days after EDD of 40 weeks gestation
Maternal Length of Stay in Hospital
The length of hospital stay associated with hospital admission for preterm labor and term labor/term delivery was collected from review of medical records. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Up to 28 days post EDD (40 0/7 weeks gestation)
Number of Participants Admitted to Particular Hospital Unit
Maternal healthcare resource utilization associated with an episode of preterm labor and normal term delivery were collected from the review of medical records. The number of participants who were admitted to a particular hospital unit like general ward, private/semi-private room, recovery, and other has been presented.
Up to 28 days post EDD (40 0/7 weeks gestation)
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).
Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion
Volume of Distribution of Retosiban
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).
Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion
Brussels
1200
Belgium
GSK Investigational Site
Freiburg im Breisgau
Baden-Wurttemberg
79106
Germany
GSK Investigational Site
Jena
Thuringia
07743
Germany
GSK Investigational Site
Hamburg
22087
Germany
GSK Investigational Site
Haifa
31048
Israel
GSK Investigational Site
Holon
58100
Israel
GSK Investigational Site
Kfar Saba
44281
Israel
GSK Investigational Site
Petah Tikva
49100
Israel
GSK Investigational Site
Safed
13100
Israel
GSK Investigational Site
Tel Aviv
64239
Israel
GSK Investigational Site
Siena
Tuscany
53100
Italy
GSK Investigational Site
Monza
20052
Italy
GSK Investigational Site
Monterrey
Nuevo León
64460
Mexico
GSK Investigational Site
Ciudad Obregón
Sonora
85000
Mexico
GSK Investigational Site
Seoul
120-752
South Korea
GSK Investigational Site
Seoul
135-081
South Korea
GSK Investigational Site
Sungnam
463712
South Korea
GSK Investigational Site
Zaragoza
50009
Spain
GSK Investigational Site
Uppsala
SE-75185
Sweden
GSK Investigational Site
Sheffield
S10 2JF
United Kingdom
FG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
FG00047 subjects
FG00150 subjects
COMPLETED
FG00043 subjects
FG00148 subjects
NOT COMPLETED
FG0004 subjects
FG0012 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
Lost to Follow-up
FG0002 subjects
FG0011 subjects
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00047
BG00150
BG00297
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
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.
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00027.7± 6.15
BG00127.1± 5.66
BG00227.4± 5.88
Sex: Female, Male
Maternal ITT Population
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00047
BG00150
BG002
Race/Ethnicity, Customized
Maternal ITT Population
Number
Count of Participants
Title
Denominators
Categories
White/Caucasian/European Heritage
Title
Measurements
BG00021
BG00131
BG002
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 From the Start of Investigational Product (IP) Administration
Time to delivery is the number of days from the first dose of study treatment until delivery. The time to delivery was calculated as the days between the delivery and start time of the study treatment infusion using the formula: Time to delivery (days) = (date and time of delivery minus date and time of start of infusion) divided by (24 multiplied by 60). The adjusted mean number of days to delivery along with standard error has been presented. Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.
Maternal ITT Population
Posted
Mean
Standard Error
Days
Up to 17 weeks
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG00032.51± 2.990
OG00133.71± 2.531
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Finite mixture model
0.3797
Mean Difference (Final Values)
-1.20
2-Sided
95
-8.879
6.479
Superiority
Secondary
Number of Participants With Births Prior to 37 0/7 Weeks Gestation
Gestational age (GA) at birth (weeks) is defined as the GA when the baby is born. Participants were considered to have delivered prior to 37 0/7 weeks, that is preterm , if the GA at birth is less than 37 0/7 weeks. The number of participants who delivered prior to 37 0/7 weeks gestation has been presented. Logistic regression model was used to calculate p-values.
Maternal ITT Population
Posted
Number
Participants
Up to 13 weeks
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
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. Logistic regression model was used to calculate p-values.
Maternal ITT Population
Posted
Number
Participants
Up to 17 weeks
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
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. Log of length of stay was calculated as treatment plus GA at randomization plus established progesterone use based on Analysis of covariance (ANCOVA) model. The p-value was calculated using t-test method. Neonatal ITT Population comprised of all neonates whose mothers were the randomized participants who have been exposed to study treatment, that is, mothers from the ITT Population.
Neonatal ITT Population
Posted
Least Squares Mean
95% Confidence Interval
Days
Up to 28 days post estimated date of delivery (EDD) of 40 0/7 weeks gestation
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Number of Neonates With 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, Respiratory Distress Syndrome (RDS), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity (ROP), Intraventricular Hemorrhage (IVH), white matter injury and cerebellar hemorrhage.
Neonatal ITT Population
Posted
Number
Participants
Up to 28 weeks after EDD (40 weeks gestation)
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Number of Neonates With Any 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, BPD, NEC or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, ROP, IVH, white matter injury and cerebellar hemorrhage. Number of neonates with any composite neonatal morbidity and mortality component, excluding RDS has been presented.
Neonatal ITT Population
Posted
Number
Participants
Up to 28 weeks after EDD (40 weeks gestation)
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Number of Neonates With Each Individual Component of 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, BPD, NEC or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, ROP, IVH, cerebellar hemorrhage and white matter injury included Periventricular Leukomalacia PVL), porencephalic cyst, and persistent ventriculomegaly. Number of neonates with with each individual component of the composite neonatal morbidity and mortality has been presented.
Neonatal ITT Population
Posted
Number
Participants
Up to 28 weeks after EDD (40 weeks gestation)
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Length of Stay in Specialized Care Unit
Length of neonatal stay in specialized care unit like Intensive Care Unit (ICU) or Neonatal Intensive Care Unit (NICU) are reported.
Neonatal Safety Population
Posted
Median
Full Range
Days
Up to 28 days post EDD (40 0/7 weeks gestation)
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
Counts
Participants
Secondary
Number of Newborn Participants With Hospital Readmission
Newborn hospital readmission following hospitalization for birth was obtained from the newborn's medical records. Only those participants with data available at the specified data points were analyzed.
Neonatal Safety Population
Posted
Number
Participants
Up to 28 days of EDD (40 0/7 weeks gestation)
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
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
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
Counts
Secondary
Number of Participants With Births Prior to 32 0/7 Weeks Gestation
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
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
Counts
Secondary
Number of Participants With Births Prior to 35 0/7 Weeks Gestation
Number of participants who delivered prior to 35 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 35 0/7 week's gestation and delivered were included.
Maternal ITT Population
Posted
Number
Participants
Up to 11 weeks
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
Counts
Secondary
Number of Participants With Births <=7 Days From the First Study Treatment
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
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
Counts
Participants
Secondary
Number of Participants With Births <=48 Hours From the First Study Treatment
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
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
Counts
Participants
Secondary
Number of Participants With Births <=24 Hours From the First Study Treatment
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
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
Counts
Participants
Secondary
Number of Maternal Participants With Non-serious 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 may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. Maternal Safety Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment. The number of maternal participants who experienced at least one non-serious AE and one SAE has been presented.
Maternal Safety Population
Posted
Number
Participants
Up to 6 weeks after delivery
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.
OG001
Atosiban
Secondary
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants
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 1 week
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Change From Baseline in Heart Rate in Maternal Participants
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 1 week
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Change From Baseline in Respiratory Rate in Maternal Participants
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
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Change From Baseline in Temperature in Maternal Participants
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
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants
Blood samples were collected for the evaluation of change in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes count. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Maternal Safety Population
Posted
Mean
Standard Deviation
Billion cells per liter (L)
Baseline and up to 1 week
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Change From Baseline in Erythrocytes in Maternal Participants
Blood samples were collected for the evaluation of change in erythrocytes from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Maternal Safety Population
Posted
Mean
Standard Deviation
Trillion cells per liter
Baseline and up to 1 week
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC) in Maternal Participants
Blood samples were collected for the evaluation of change in hemoglobin levels and MCHC from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus. NA indicates standard deviation was not calculable for a single data point.
Maternal Safety Population
Posted
Mean
Standard Deviation
grams per liter (g/L)
Baseline and up to 1 week
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) in Maternal Participants
Blood samples were collected for the evaluation of change in MCV and MPV from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Maternal Safety Population
Posted
Mean
Standard Deviation
femtoliter (fL)
Baseline and up to 1 week
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants
Blood samples were collected for the evaluation of change in ALP, ALT, AST, GGT and LDH from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Maternal Safety Population
Posted
Mean
Standard Deviation
International Units per liter (IU/L)
Baseline and up to 1 week
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Change From Baseline in Albumin and Protein Levels in Maternal Participants
Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Maternal Safety Population
Posted
Mean
Standard Deviation
grams per liter (g/L)
Baseline and up to 1 week
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants
Blood samples were collected for the evaluation of change from Baseline in levels of calcium, chloride, carbon dioxide, glucose, potassium, magnesium, phosphate, and sodium. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Maternal Safety Population
Posted
Mean
Standard Deviation
millimoles per liter (mmol/L)
Baseline and up to 1 week
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants
Blood samples were collected for the evaluation of change from Baseline in levels of direct bilirubin, bilirubin, indirect bilirubin, creatinine and urate. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.
Maternal Safety Population
Posted
Mean
Standard Deviation
micromoles per liter (µmol/L)
Baseline and up to 1 week
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
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
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
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
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Number of Participants With Fetal Non-serious 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 non-serious AE and one SAE has been presented.
Maternal Safety Population
Posted
Number
Participants
Up to 17 weeks
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
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
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
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.Only those participants with data available at the specified data points were analyzed.
Neonatal ITT Population
Posted
Mean
Standard Deviation
Score on APGAR scale
Up to 5 minutes after birth
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
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. Only those participants with data available at the specified data points were analyzed.
Neonatal ITT Population
Posted
Mean
Standard Deviation
grams (g)
Up to 17 weeks
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
Counts
Secondary
Head Circumference of Neonates
The head circumference was determined from the neonate birth record. Only those participants with data available at the specified data points were analyzed.
Neonatal ITT Population
Posted
Mean
Standard Deviation
centimeters (cm)
Up to 17 weeks
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
Counts
Participants
Secondary
Number of Neonatal Participants With Non-serious 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 non-serious 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
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.
OG001
Atosiban
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
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
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
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Maternal Length of Stay in Hospital
The length of hospital stay associated with hospital admission for preterm labor and term labor/term delivery was collected from review of medical records. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Maternal Safety Population
Posted
Median
Full Range
Days
Up to 28 days post EDD (40 0/7 weeks gestation)
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Secondary
Number of Participants Admitted to Particular Hospital Unit
Maternal healthcare resource utilization associated with an episode of preterm labor and normal term delivery were collected from the review of medical records. The number of participants who were admitted to a particular hospital unit like general ward, private/semi-private room, recovery, and other has been presented.
Maternal Safety Population
Posted
Number
Participants
Up to 28 days post EDD (40 0/7 weeks gestation)
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.
OG001
Atosiban
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
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
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
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
Time Frame
Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until Day 894.
Description
SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment. One participant was withdrawn prior to delivery and was not included in the summary.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
0
47
7
47
34
47
EG001
Atosiban (Maternal)
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
0
50
9
50
25
50
EG002
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.
0
47
4
47
6
47
EG003
Atosiban (Fetal)
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
0
50
2
50
6
50
EG004
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.
0
46
10
46
23
46
EG005
Atosiban (Neonatal)
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
1
50
11
50
17
50
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Postpartum haemorrhage
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0013 events3 affected50 at risk
EG0020 events0 affected47 at risk
EG0030 events0 affected50 at risk
EG004
Preterm premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0012 events2 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Normal labour
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Premature labour
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Premature separation of placenta
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Oligohydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0022 events2 affected47 at risk
EG003
Hydrops foetalis
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected47 at risk
EG003
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Amniotic cavity infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Haematoma infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Bacterial disease carrier
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Retroperitoneal haematoma
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Visual impairment
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Hyperbilirubinaemia neonatal
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Abdominal wound dehiscence
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Foetal monitoring abnormal
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Foetal heart rate disorder
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected47 at risk
EG003
Foetal heart rate deceleration abnormality
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected47 at risk
EG003
Congenital hydronephrosis
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Ankyloglossia congenital
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Atrial septal defect
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Cataract congenital
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Pyloric stenosis
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Ventricular septal defect
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Neonatal respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Choking
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Meconium aspiration syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Sudden infant death syndrome
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Milk allergy
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Foetal heart rate disorder
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG0034 events4 affected50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
Foetal heart rate deceleration abnormality
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG00215 events3 affected47 at risk
EG003
Bradycardia foetal
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected47 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0011 events1 affected50 at risk
EG0021 events1 affected47 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Tachycardia foetal
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0023 events1 affected47 at risk
EG003
Foetal hypokinesia
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0022 events2 affected47 at risk
EG003
Oligohydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Postpartum haemorrhage
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0012 events2 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Polyhydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Premature labour
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Preterm premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Cephalhaematoma
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Hyperbilirubinaemia neonatal
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Neonatal respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0004 events4 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Transient tachypnoea of the newborn
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Choking
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Respiratory acidosis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Respiratory disorder neonatal
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Use of accessory respiratory muscles
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Infantile colic
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00012 events10 affected47 at risk
EG0015 events5 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Regurgitation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Abdominal rigidity
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0004 events4 affected47 at risk
EG0013 events3 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0012 events2 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Cervicitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0012 events2 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0012 events2 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0013 events3 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0012 events2 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Candida infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Vaginitis gardnerella
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Pyuria
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Skin candida
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0012 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Ureaplasma infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Testicular retraction
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0004 events2 affected47 at risk
EG0012 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Breast engorgement
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Uterine atony
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Vulval oedema
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Polycythaemia neonatorum
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0004 events4 affected47 at risk
EG0012 events2 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Anaemia of pregnancy
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Auditory disorder
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Generalised oedema
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0013 events3 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Asthenia
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Peripheral swelling
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Suprapubic pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Eyelid haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0008 events8 affected47 at risk
EG0013 events3 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0013 events3 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Syncope
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Haematoma
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Escherichia test positive
Investigations
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Psychiatric evaluation abnormal
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0012 events2 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Candida test positive
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Klebsiella test positive
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
White blood cell count increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0012 events2 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Abdominal wound dehiscence
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Acne infantile
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Congenital hydronephrosis
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Renal pain
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected47 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C522194
GSK221149A
C047046
atosiban
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
97
Male
BG0000
BG0010
BG0020
52
American Indian or Alaskan Native
Title
Measurements
BG0007
BG0014
BG00211
East Asian Heritage
Title
Measurements
BG0009
BG0014
BG00213
Arabic/North African Heritage
Title
Measurements
BG00011
BG00110
BG00221
African American/African Heritage
Title
Measurements
BG0000
BG0013
BG0023
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG00025
OG00128
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.9520
Odds Ratio (OR)
1.0
2-Sided
95
0.44
2.18
Superiority
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG00021
OG00122
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.9520
Odds Ratio (OR)
1.0
2-Sided
95
0.46
2.29
Superiority
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG0004.98(3.54 to 6.99)
OG0014.38(3.15 to 6.09)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.5672
Ratio
1.14
Standard Error of the Mean
0.222
2-Sided
95
0.73
1.76
Superiority
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG0003
OG0012
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.5066
Odds Ratio (OR)
1.9
2-Sided
95
0.30
11.71
Superiority
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Fetal death
Title
Measurements
OG0000
OG0010
Neonatal death
Title
Measurements
OG0000
OG0011
RDS
Title
Measurements
OG0003
OG0011
BPD
Title
Measurements
OG0000
OG0010
NEC or isolated perforation
Title
Measurements
OG0000
OG0010
Sepsis
Title
Measurements
OG0000
OG0010
Meningitis
Title
Measurements
OG0000
OG0010
ROP
Title
Measurements
OG0000
OG0010
IVH
Title
Measurements
OG0000
OG0010
PVL
Title
Measurements
OG0000
OG0010
Porencephalic Cyst
Title
Measurements
OG0000
OG0010
Persistent Ventriculomegaly
Title
Measurements
OG0000
OG0010
Cerebellar Hemorrhage
Title
Measurements
OG0000
OG0010
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG00013.65(3.5 to 57.5)
OG00112.49(7.6 to 21.8)
Counts
Participants
OG00046
OG00150
Title
Denominators
Categories
Title
Measurements
OG0002
OG0013
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.7790
Odds Ratio (OR)
0.8
2-Sided
95
0.12
4.84
Superiority
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG00014
OG00114
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.6646
Odds Ratio (OR)
1.2
2-Sided
95
0.51
2.90
Superiority
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG00010
OG0017
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.1432
Odds Ratio (OR)
2.3
2-Sided
95
0.75
7.24
Superiority
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG0006
OG0016
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.5250
Odds Ratio (OR)
1.5
2-Sided
95
0.43
5.15
Superiority
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG0003
OG0016
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.4682
Odds Ratio (OR)
0.6
2-Sided
95
0.13
2.58
Superiority
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Non-serious AE
Title
Measurements
OG00034
OG00125
SAE
Title
Measurements
OG0007
OG0019
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
DBP; Day 1: 15 to 30 minutes, n=42,45
ParticipantsOG00042
ParticipantsOG00145
Title
Measurements
OG000-3.6± 10.96
OG001-0.7± 8.95
DBP; Day 1: 4 to 8 hours, n=42,43
ParticipantsOG00042
ParticipantsOG00143
Title
Measurements
OG000-4.3± 11.07
OG001
DBP; Day 1: 20 to 24 hours, n=38,41
ParticipantsOG00038
ParticipantsOG00141
Title
Measurements
OG000-5.7± 9.31
OG001
DBP; Day 2, n=40,42
ParticipantsOG00040
ParticipantsOG00142
Title
Measurements
OG000-4.4± 9.57
OG001
DBP; Post-infusion assessment, n=35,41
ParticipantsOG00035
ParticipantsOG00141
Title
Measurements
OG000-1.6± 8.63
OG001
SBP; Day 1: 15 to 30 minutes, n=42,45
ParticipantsOG00042
ParticipantsOG00145
Title
Measurements
OG000-2.5± 9.53
OG001
SBP; Day 1: 4 to 8 hours, n=42,43
ParticipantsOG00042
ParticipantsOG00143
Title
Measurements
OG000-4.3± 9.05
OG001
SBP; Day 1: 20 to 24 hours, n=38,41
ParticipantsOG00038
ParticipantsOG00141
Title
Measurements
OG000-4.1± 10.16
OG001
SBP; Day 2, n=40,42
ParticipantsOG00040
ParticipantsOG00142
Title
Measurements
OG000-3.9± 11.53
OG001
SBP; Post-infusion assessment, n=35,41
ParticipantsOG00035
ParticipantsOG00141
Title
Measurements
OG000-1.5± 11.04
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Day 1: 15 to 30 minutes, n=42,46
ParticipantsOG00042
ParticipantsOG00146
Title
Measurements
OG000-3.0± 12.65
OG001-0.8± 10.45
Day 1: 4 to 8 hours, n=42, 43
ParticipantsOG00042
ParticipantsOG00143
Title
Measurements
OG000-5.0± 13.69
OG001
Day 1: 20 to 24 hours, n=38, 41
ParticipantsOG00038
ParticipantsOG00141
Title
Measurements
OG000-1.2± 14.44
OG001
Day 2, n=39, 41
ParticipantsOG00039
ParticipantsOG00141
Title
Measurements
OG000-2.2± 11.81
OG001
Post-infusion assessment, n=35, 41
ParticipantsOG00035
ParticipantsOG00141
Title
Measurements
OG000-2.7± 12.90
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Day 1: 15 to 30 minutes, n=25, 28
ParticipantsOG00025
ParticipantsOG00128
Title
Measurements
OG0000.3± 2.82
OG001-0.6± 1.93
Day 1: 4 to 8 hours, n=23, 24
ParticipantsOG00023
ParticipantsOG00124
Title
Measurements
OG0000.0± 1.65
OG001
Day 1: 20 to 24 hours, n=21, 21
ParticipantsOG00021
ParticipantsOG00121
Title
Measurements
OG0000.2± 1.87
OG001
Day 2, n=23, 24
ParticipantsOG00023
ParticipantsOG00124
Title
Measurements
OG000-0.3± 1.64
OG001
Post-infusion assessment, n=22, 23
ParticipantsOG00022
ParticipantsOG00123
Title
Measurements
OG000-0.3± 2.15
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Day 1: 15 to 30 minutes, n=41, 43
ParticipantsOG00041
ParticipantsOG00143
Title
Measurements
OG000-0.02± 0.379
OG0010.02± 0.467
Day 1: 4 to 8 hours, n=40, 42
ParticipantsOG00040
ParticipantsOG00142
Title
Measurements
OG000-0.06± 0.359
OG001
Day 1: 20 to 24 hours, n=37, 41
ParticipantsOG00037
ParticipantsOG00141
Title
Measurements
OG000-0.07± 0.366
OG001
Day 2, n=40, 42
ParticipantsOG00040
ParticipantsOG00142
Title
Measurements
OG000-0.07± 0.467
OG001
Post-infusion assessment, n=35, 41
ParticipantsOG00035
ParticipantsOG00141
Title
Measurements
OG000-0.18± 0.334
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Basophils;Day2,n=21,23
ParticipantsOG00021
ParticipantsOG00123
Title
Measurements
OG0000.003± 0.0362
OG0010.010± 0.0304
Basophils;Post-infusion assessment,n=24,28
ParticipantsOG00024
ParticipantsOG00128
Title
Measurements
OG0000.001± 0.0315
OG001
Basophils;early withdrawal,n=1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-0.020± NANA indicates standard deviation was not calculable for a single data point.
OG001
Eosinophils;Day2,n=21,23
ParticipantsOG00021
ParticipantsOG00123
Title
Measurements
OG000-0.010± 0.0626
OG001
Eosinophils;Post-infusion assessment,n=24,28
ParticipantsOG00024
ParticipantsOG00128
Title
Measurements
OG0000.023± 0.0442
OG001
Eosinophils;early withdrawal,n=1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000.030± NANA indicates standard deviation was not calculable for a single data point.
OG001
Lymphocytes;Day2,n=21,23
ParticipantsOG00021
ParticipantsOG00123
Title
Measurements
OG0000.186± 0.9115
OG001
Lymphocytes;Post-infusion assessment,n=24,28
ParticipantsOG00024
ParticipantsOG00128
Title
Measurements
OG0000.348± 0.8611
OG001
Lymphocytes;early withdrawal,n=1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000.270± NANA indicates standard deviation was not calculable for a single data point.
OG001
Monocytes;Day2,n=21,23
ParticipantsOG00021
ParticipantsOG00123
Title
Measurements
OG0000.082± 0.2222
OG001
Monocytes;Post-infusion assessment,n=24,28
ParticipantsOG00024
ParticipantsOG00128
Title
Measurements
OG0000.222± 0.1904
OG001
Monocytes;early withdrawal,n=1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-0.160± NANA indicates standard deviation was not calculable for a single data point.
OG001
Neutrophils;Day2,n=21,23
ParticipantsOG00021
ParticipantsOG00123
Title
Measurements
OG0000.102± 2.6712
OG001
Neutrophils;Post-infusion assessment,n=24,28
ParticipantsOG00024
ParticipantsOG00128
Title
Measurements
OG000-1.865± 2.9246
OG001
Neutrophils;early withdrawal,n=1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-0.710± NANA indicates standard deviation was not calculable for a single data point.
OG001
Platelets;Day2,n=22,25
ParticipantsOG00022
ParticipantsOG00125
Title
Measurements
OG0000.0± 25.95
OG001
Platelets;Post-infusion assessment,n=24,31
ParticipantsOG00024
ParticipantsOG00131
Title
Measurements
OG00021.5± 63.14
OG001
Platelets;early withdrawal,n=1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-33.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
Leukocytes;Day2,n=23,25
ParticipantsOG00023
ParticipantsOG00125
Title
Measurements
OG0000.17± 2.785
OG001
Leukocytes;Post-infusion assessment,n=25,30
ParticipantsOG00025
ParticipantsOG00130
Title
Measurements
OG000-1.18± 2.492
OG001
Leukocytes;early withdrawal,n=1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-0.60± NANA indicates standard deviation was not calculable for a single data point.
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Day 2, n=23, 27
ParticipantsOG00023
ParticipantsOG00127
Title
Measurements
OG000-0.22± 0.284
OG001-0.29± 0.261
Post-infusion assessment, n=25, 31
ParticipantsOG00025
ParticipantsOG00131
Title
Measurements
OG0000.06± 0.257
OG001
Early withdrawal, n =1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-0.20± NANA indicates standard deviation was not calculable for a single data point.
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Hemoglobin; Day2, n=23, 27
ParticipantsOG00023
ParticipantsOG00127
Title
Measurements
OG000-5.4± 7.81
OG001-8.4± 6.86
Hemoglobin; Post-infusion assessment, n=25, 31
ParticipantsOG00025
ParticipantsOG00131
Title
Measurements
OG0000.8± 7.55
OG001
Hemoglobin; early withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-8.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
MCHC; Day 2, n=23, 27
ParticipantsOG00023
ParticipantsOG00127
Title
Measurements
OG0001.0± 9.41
OG001
MCHC; Post-infusion assessment, n=25, 31
ParticipantsOG00025
ParticipantsOG00131
Title
Measurements
OG0001.0± 7.36
OG001
MCHC; early withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-3.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
MCV; Day 2, n=23, 27
ParticipantsOG00023
ParticipantsOG00127
Title
Measurements
OG0000.3± 2.67
OG001-0.4± 1.82
MCV; Post-infusion assessment, n=25, 31
ParticipantsOG00025
ParticipantsOG00131
Title
Measurements
OG000-1.2± 2.17
OG001
MCV; early withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-1.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
MPV; Day 2, n=22, 25
ParticipantsOG00022
ParticipantsOG00125
Title
Measurements
OG0000.05± 0.607
OG001
MPV, Post-infusion assessment, n=24, 31
ParticipantsOG00024
ParticipantsOG00131
Title
Measurements
OG000-0.10± 0.639
OG001
MPV, early withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000.00± NANA indicates standard deviation was not calculable for a single data point.
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
ALP; Day 2, n=35, 35
ParticipantsOG00035
ParticipantsOG00135
Title
Measurements
OG000-10.1± 12.12
OG001-12.6± 13.07
ALP; Post-infusion assessment, n=30, 35
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG00014.1± 39.85
OG001
ALP; early withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-6.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
AST; Day 2, n=34, 35
ParticipantsOG00034
ParticipantsOG00135
Title
Measurements
OG000-0.9± 4.82
OG001
AST; Post-infusion assessmet, n=29, 35
ParticipantsOG00029
ParticipantsOG00135
Title
Measurements
OG000-1.3± 4.87
OG001
AST; early withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-3.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
ALT; Day 2, n= 35, 35
ParticipantsOG00035
ParticipantsOG00135
Title
Measurements
OG000-0.2± 2.53
OG001
ALT; Post-infusion assessment, n= 30, 35
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG0000.0± 6.34
OG001
ALT; early withdrawal, n= 1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-2.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
GGT; Day 2, n= 35, 35
ParticipantsOG00035
ParticipantsOG00135
Title
Measurements
OG000-0.4± 2.44
OG001
GGT; Post-infusion assessment, n=30, 35
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG00017.6± 79.05
OG001
GGT; eearly withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
LDH; Day 2, n=34, 35
ParticipantsOG00034
ParticipantsOG00135
Title
Measurements
OG000-9.7± 50.58
OG001
LDH; Post-infusion assessment, n=29, 35
ParticipantsOG00029
ParticipantsOG00135
Title
Measurements
OG000-2.4± 22.08
OG001
LDH; early withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-18.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Albumin; Day 2, n=35, 35
ParticipantsOG00035
ParticipantsOG00135
Title
Measurements
OG000-1.9± 2.28
OG001-2.0± 1.95
Albumin; Post-infusion assessment, n=30, 35
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG0000.3± 2.39
OG001
Albumin; early withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-4.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
Protein; Day 2, n=35, 35
ParticipantsOG00035
ParticipantsOG00135
Title
Measurements
OG000-3.7± 4.18
OG001
Protein; Post-infusion assessment, n=30, 35
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG0000.5± 4.73
OG001
Protein; early withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-5.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Calcium; Day 2, n=34, 35
ParticipantsOG00034
ParticipantsOG00135
Title
Measurements
OG000-0.097± 0.1125
OG001-0.078± 0.0884
Calcium; Post-infusion assessment, n=29, 35
ParticipantsOG00029
ParticipantsOG00135
Title
Measurements
OG0000.018± 0.0953
OG001
Calcium; early withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-0.120± NANA indicates standard deviation was not calculable for a single data point.
OG001
Chloride; Day 2, n=35, 35
ParticipantsOG00035
ParticipantsOG00135
Title
Measurements
OG0001.5± 2.02
OG001
Chloride; Post-infusion assessment, n=30, 35
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG000-1.5± 1.83
OG001
Chloride; early withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0002.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
Carbon dioxide; Day 2, n=34, 35
ParticipantsOG00034
ParticipantsOG00135
Title
Measurements
OG0000.7± 2.34
OG001
Carbon dioxide, Post-infusion assessment, n=29,35
ParticipantsOG00029
ParticipantsOG00135
Title
Measurements
OG0001.9± 2.06
OG001
Carbon dioxide, early withdrawal, n=1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-2.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
Glucose; Day 2, n=35,35
ParticipantsOG00035
ParticipantsOG00135
Title
Measurements
OG0000.13± 2.013
OG001
Glucose; Post-infusion assessment, n=30, 35
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG000-0.70± 1.994
OG001
Glucose; early withdrawal, n= 1, 1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000.70± NANA indicates standard deviation was not calculable for a single data point.
OG001
Potassium; Day 2, n= 34, 35
ParticipantsOG00034
ParticipantsOG00135
Title
Measurements
OG0000.06± 0.392
OG001
Potassium; Post-infusion assessment, n= 29, 35
ParticipantsOG00029
ParticipantsOG00135
Title
Measurements
OG0000.21± 0.362
OG001
Potassium; early withdrawal, n= 1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-0.10± NANA indicates standard deviation was not calculable for a single data point.
OG001
Magnesium; Day 2, n= 35,35
ParticipantsOG00035
ParticipantsOG00135
Title
Measurements
OG0000.073± 0.2098
OG001
Magnesium, Post-infusion assessment, n= 30,35
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG0000.026± 0.0760
OG001
Magnesium; early withdrawal, n= 1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-0.060± NANA indicates standard deviation was not calculable for a single data point.
OG001
Phosphate; Day 2, n= 35,35
ParticipantsOG00035
ParticipantsOG00135
Title
Measurements
OG000-0.101± 0.2684
OG001
Phosphate; Post-infusion assessment, n= 30,35
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG0000.041± 0.2267
OG001
Phosphate; early withdrawal, n= 1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000.100± NANA indicates standard deviation was not calculable for a single data point.
OG001
Sodium; Day 2, n= 35,35
ParticipantsOG00035
ParticipantsOG00135
Title
Measurements
OG0000.7± 2.13
OG001
Sodium; Post-infusion assessment, n= 30,35
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG000-1.1± 2.05
OG001
Sodium; early withdrawal, n= 1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-1.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Direct Bilirubin; Day2, n=35,35
ParticipantsOG00035
ParticipantsOG00135
Title
Measurements
OG000-0.3± 0.85
OG001-0.3± 0.66
Post-infusion assessment, n=30,35
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG000-0.5± 3.41
OG001
Direct Bilirubin;early withdrawal, n=1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
Bilirubin;Day2, n= 35,35
ParticipantsOG00035
ParticipantsOG00135
Title
Measurements
OG000-0.7± 2.52
OG001
Bilirubin; Post-infusion assessment, n= 30, 35
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG000-1.1± 8.24
OG001
Bilirubin; early withdrawal, n= 1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-2.0± NANA indicates standard deviation was not calculable for a single data point.
OG000-2.0± NANA indicates standard deviation was not calculable for a single data point.
OG001
Creatinine; Day2, n=35,34
ParticipantsOG00035
ParticipantsOG00134
Title
Measurements
OG0001.75± 6.765
OG001
Creatinine; Post-infusion assessment, n=30,33
ParticipantsOG00030
ParticipantsOG00133
Title
Measurements
OG0002.19± 4.437
OG001
Creatinine; early withdrawal, n=1,1
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000-0.90± NANA indicates standard deviation was not calculable for a single data point.
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG0004
OG0017
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG0005
OG0015
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Non-serious AE
Title
Measurements
OG0006
OG0016
SAE
Title
Measurements
OG0004
OG0012
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG0005
OG0015
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
one minute, n=46, 50
ParticipantsOG00046
ParticipantsOG00150
Title
Measurements
OG0008.2± 1.35
OG0018.4± 1.14
five minutes, n=46, 50
ParticipantsOG00046
ParticipantsOG00150
Title
Measurements
OG0009.1± 0.96
OG001
Participants
OG00046
OG00149
Title
Denominators
Categories
Title
Measurements
OG0002761.9± 567.84
OG0012844.4± 664.80
OG00043
OG00142
Title
Denominators
Categories
Title
Measurements
OG00032.95± 2.179
OG00133.00± 1.892
Participants were administered atosiban in 3 successive stages. An initial bolus dose of 6.75 mg using atosiban 6.75 mg/0.9 milliliter (mL) solution for injection, followed by continuous high dose infusion at 18 mg/hour for 3 hours, then a lower 6 mg/hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg/5 mL concentrate for solution.
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Non-serious AEs
Title
Measurements
OG00023
OG00117
SAEs
Title
Measurements
OG00010
OG00111
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG00019
OG00116
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Title
Measurements
OG0005
OG0013
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Preterm labor, n=13, 10
ParticipantsOG00013
ParticipantsOG00110
Title
Measurements
OG0005.549(1.32 to 72.00)
OG0017.487(0.87 to 37.82)
Term labor, n=25, 28
ParticipantsOG00025
ParticipantsOG00128
Title
Measurements
OG0003.146(0.17 to 62.71)
OG001
Units
Counts
Participants
OG00047
OG00150
Title
Denominators
Categories
Preterm labor, general ward
Title
Measurements
OG0009
OG0017
Preterm labor, private/semi-private room
Title
Measurements
OG0001
OG0010
Preterm, Other
Title
Measurements
OG0003
OG0014
Normal term labor, general ward
Title
Measurements
OG00016
OG00112
Normal term labor, ward-not specified
Title
Measurements
OG0002
OG0010
Normal term labor,private/semi-private room
Title
Measurements
OG0001
OG0017
Normal term labor, recovery
Title
Measurements
OG0001
OG0012
Normal term labor, Other
Title
Measurements
OG0005
OG0017
53
Title
Denominators
Categories
Title
Measurements
OG00083.4± 5.25
53
Title
Denominators
Categories
Title
Measurements
OG00068.6± 109
0 events
0 affected
46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0052 events2 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0044 events4 affected46 at risk
EG0053 events3 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
1 events
1 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
1 events
1 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
1 events
1 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
1 events
1 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0052 events2 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG00410 events10 affected46 at risk
EG0058 events8 affected50 at risk
0 events
0 affected
50 at risk
EG0043 events2 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0053 events2 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0041 events1 affected46 at risk
EG0050 events0 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0051 events1 affected50 at risk
0 events
0 affected
50 at risk
EG0040 events0 affected46 at risk
EG0050 events0 affected50 at risk
-3.7
± 10.28
-4.1
± 9.90
-2.6
± 9.93
1.3
± 10.12
-0.4
± 11.02
-3.3
± 12.21
-5.2
± 13.03
-3.0
± 11.35
-2.1
± 11.37
-3.0
± 13.65
-3.1
± 13.82
-2.3
± 13.44
-1.8
± 13.83
-0.8
± 2.33
-0.6
± 2.40
0.2
± 3.45
-1.3
± 2.70
0.00
± 0.507
-0.03
± 0.486
-0.06
± 0.353
-0.20
± 0.422
0.007
± 0.0181
0.030
± NA
NA indicates standard deviation was not calculable for a single data point.
-0.037
± 0.1181
0.066
± 0.1535
0.050
± NA
NA indicates standard deviation was not calculable for a single data point.
0.067
± 0.6017
0.233
± 0.8047
-1.770
± NA
NA indicates standard deviation was not calculable for a single data point.
0.044
± 0.2702
0.133
± 0.3467
0.410
± NA
NA indicates standard deviation was not calculable for a single data point.
0.559
± 3.3890
-0.670
± 2.7063
-3.550
± NA
NA indicates standard deviation was not calculable for a single data point.
-2.4
± 36.59
20.6
± 43.74
-58.0
± NA
NA indicates standard deviation was not calculable for a single data point.
0.72
± 2.905
-0.05
± 2.756
-4.80
± NA
NA indicates standard deviation was not calculable for a single data point.
0.05
± 0.236
-0.70
± NA
NA indicates standard deviation was not calculable for a single data point.
0.5
± 5.37
-19.0
± NA
NA indicates standard deviation was not calculable for a single data point.
0.9
± 6.85
0.4
± 8.98
24.0
± NA
NA indicates standard deviation was not calculable for a single data point.
-1.0
± 2.22
-5.0
± NA
NA indicates standard deviation was not calculable for a single data point.
0.06
± 0.553
-0.03
± 0.803
-1.40
± NA
NA indicates standard deviation was not calculable for a single data point.
5.9
± 15.87
-19.0
± NA
NA indicates standard deviation was not calculable for a single data point.
-1.7
± 3.07
-1.3
± 4.09
1.0
± NA
NA indicates standard deviation was not calculable for a single data point.
0.0
± 2.40
0.8
± 6.19
5.0
± NA
NA indicates standard deviation was not calculable for a single data point.
-0.9
± 3.08
2.3
± 4.39
0.0
± NA
NA indicates standard deviation was not calculable for a single data point.
-20.0
± 29.18
-5.4
± 30.93
-59.0
± NA
NA indicates standard deviation was not calculable for a single data point.
-0.2
± 2.26
-8.0
± NA
NA indicates standard deviation was not calculable for a single data point.
-3.3
± 3.69
0.0
± 4.05
-12.0
± NA
NA indicates standard deviation was not calculable for a single data point.
0.023
± 0.0861
-0.230
± NA
NA indicates standard deviation was not calculable for a single data point.
1.4
± 2.03
-1.3
± 2.63
8.0
± NA
NA indicates standard deviation was not calculable for a single data point.
0.3
± 2.63
1.9
± 2.67
6.0
± NA
NA indicates standard deviation was not calculable for a single data point.
1.51
± 2.156
-0.35
± 2.283
-5.20
± NA
NA indicates standard deviation was not calculable for a single data point.
-0.06
± 0.346
0.18
± 0.355
0.50
± NA
NA indicates standard deviation was not calculable for a single data point.
-0.003
± 0.0657
0.009
± 0.0772
0.030
± NA
NA indicates standard deviation was not calculable for a single data point.
-0.170
± 0.2357
0.094
± 0.2864
-0.120
± NA
NA indicates standard deviation was not calculable for a single data point.
0.1
± 1.69
-0.2
± 2.11
3.0
± NA
NA indicates standard deviation was not calculable for a single data point.
-0.1
± 0.73
0.0
± NA
NA indicates standard deviation was not calculable for a single data point.
-1.3
± 2.03
-0.5
± 2.01
-3.0
± NA
NA indicates standard deviation was not calculable for a single data point.
-1.1
± 1.98
-0.4
± 2.03
-3.0
± NA
NA indicates standard deviation was not calculable for a single data point.
0.04
± 5.336
0.72
± 4.680
-6.10
± NA
NA indicates standard deviation was not calculable for a single data point.