A Phase 2 interventional study of M281 in Hemolytic Disease of the Fetus and Newborn, sponsored by Janssen Research & Development, LLC. Completed at 19 sites in 9 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN). The effectiveness of the investigational drug M281 will be measured by looking at the percentage of participants with live birth at or after gestational age (GA) 32 weeks and without a need for an intrauterine transfusion (IUT) throughout their entire pregnancy.
Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: M281
Participants will receive once weekly intravenous (IV) infusions of M281
Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs)
An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab.
Time frame: From baseline (Gestational Age [GA] Week 14) up to Postpartum (PP) Week 24 (up to 50 weeks)
Number of Neonates/Infants With Adverse Events (AEs)
An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Time frame: From Birth (PP Day 0) up to PP Week 96
Number of Maternal Participants With Treatment-emergent Serious Adverse Events (TESAEs)
SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TESAEs were any SAEs occurring after the initiation of the first infusion of nipocalimab.
Time frame: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Number of Neonates/Infants With Serious Adverse Events (SAEs)
SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Time frame: From Birth (PP Day 0) up to PP Week 96
Number of Maternal Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs)
Number of maternal participants with TEAESIs were reported. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. All infections requiring anti-infective (that is, oral or intravenous antibacterial, antiviral, or antifungal) treatment and with hypoalbuminemia greater than or equal to (\>=) Grade 3 (less than \[\<\]20 gram per liter \[g/L\] by National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 criteria were considered an AESI for maternal participants. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab.
Time frame: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Number of Neonates/Infants With Adverse Events of Special Interest (AESIs)
Number of neonates/infants with TEAESIs were reported. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. All infections requiring anti-infective (that is, oral or intravenous antibacterial, antiviral, or antifungal) treatment, unexpected/unusual childhood illnesses and Immunoglobulin G (IgG) concentrations \<200 milligrams per deciliter (mg/dL) at Week 24 through Week 47 or \<300 mg/dL at Week 48 through Week 96 were considered an AESI for neonates and infants.
Time frame: From birth (PP Day 0) up to PP Week 96
Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline
Absolute value of ECG parameter - mean ventricular rate at baseline in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities.
Time frame: Baseline (GA Week 14)
Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at GA Week 36
Absolute value of ECG parameter - mean ventricular rate at GA Week 36 in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities.
Time frame: GA Week 36
Maternal Participants: Change From Baseline in ECG Parameter- Mean Ventricular Rate
Change from baseline in ECG parameter- mean ventricular rate in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities.
Time frame: Baseline (GA Week 14) and GA Week 36
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time
Laboratory parameters included hematology, chemistry, blood Lipids panel, and Immunoglobulin G (IgG) parameters. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab. Here, HDL: high-density lipoprotein, LDL: low-density lipoprotein. The during-pregnancy value of albumin \<20 g/L was from a local laboratory and was \>=20 g/L when analyzed at the central laboratory for the same time point.
Time frame: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Number of Neonates or Infants With Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time
Laboratory parameters included total bilirubin and biomarker included immunoglobulin G (IgG).
Time frame: From Birth (PP Day 0) up to PP Week 96
Maternal Participants: Absolute Value of Vital Signs - Body Temperature at Baseline
Absolute value of vital signs - body temperature at baseline in maternal participants was reported.
Time frame: Baseline (GA Week 14)
Maternal Participants: Absolute Value of Vital Signs - Body Temperature at GA Week 36
Absolute value of vital signs - body temperature at GA Week 36 in maternal participants was reported.
Time frame: GA Week 36
Maternal Participants: Absolute Value of Vital Signs - Body Temperature at PP Week 24
Absolute value of vital signs - body temperature at PP Week 24 in maternal participants was reported.
Time frame: PP Week 24
Maternal Participants: Change From Baseline in Vital Sign - Body Temperature
Change from baseline in vital signs- body temperature in maternal participants was reported.
Time frame: Baseline (GA Week 14), GA Week 36, and PP Week 24
Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at Baseline
Absolute value of vital signs -respiratory rate at baseline in maternal participants was reported.
Time frame: Baseline (GA Week 14)
Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at GA Week 36
Absolute value of vital signs -respiratory rate at GA Week 36 in maternal participants was reported.
Time frame: GA Week 36
Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24
Absolute value of vital signs - respiratory rate at PP Week 24 in maternal participants was reported.
Time frame: PP Week 24
Maternal Participants: Change From Baseline in Vital Sign - Respiratory Rate
Change from baseline in vital signs- respiratory rate in maternal participants was reported.
Time frame: Baseline (GA Week 14), GA Week 36, and PP Week 24
Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at Baseline
Absolute value of vital signs - pulse rate at baseline in maternal participants was reported.
Time frame: Baseline (GA Week 14)
Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at GA Week 36
Absolute value of vital signs -pulse rate at GA Week 36 in maternal participants was reported.
Time frame: GA Week 36
Maternal Participants: Absolute Value of Vital Signs -Pulse Rate at PP Week 24
Absolute value of vital signs -pulse rate at PP Week 24 in maternal participants was reported.
Time frame: PP Week 24
Maternal Participants: Change From Baseline in Vital Sign - Pulse Rate
Change from baseline in vital signs -pulse rate in maternal participants was reported.
Time frame: Baseline (GA Week 14), GA Week 36, and PP Week 24
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline
Absolute value of vital signs - SBP and DBP at baseline in maternal participants was reported.
Time frame: Baseline (GA Week 14)
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at GA Week 36
Absolute value of vital signs -SBP and DBP at GA Week 36 in maternal participants was reported.
Time frame: GA Week 36
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24
Absolute value of vital signs - SBP and DBP at PP Week 24 in maternal participants was reported.
Time frame: PP Week 24
Maternal Participants: Change From Baseline in Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change from baseline in vital signs -SBP and DBP in maternal participants were reported.
Time frame: Baseline (GA Week 14), GA Week 36, and PP Week 24
Maternal Participants: Absolute Value of Vital Signs - Body Weight at Baseline
Absolute value of vital signs - body weight at baseline in maternal participants was reported.
Time frame: Baseline (GA Week 14)
Maternal Participants: Absolute Value of Vital Signs - Body Weight at GA Week 36
Absolute value of vital signs -body weight at GA Week 36 in maternal participants was reported.
Time frame: GA Week 36
Maternal Participants: Absolute Value of Vital Signs - Body Weight at PP Week 24
Absolute value of vital signs included body weight at PP Week 24 in maternal participants was reported.
Time frame: PP Week 24
Maternal Participants: Change From Baseline in Vital Sign - Body Weight
Change from baseline in vital signs- body weight in maternal participants was reported.
Time frame: Baseline (GA Week 14), GA Week 36, and PP Week 24
Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at Baseline
Absolute value in vital signs parameter -body temperature at baseline was reported for all neonates/infants.
Time frame: Baseline (PP Day 0)
Neonates/Infants: Absolute Value of Vital Signs - Body Temperature at PP Week 1
Absolute value of vital signs parameter -body temperature at PP Week 1 was reported for all neonates/infants.
Time frame: PP Week 1
Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 4
Absolute value in vital signs parameter - body temperature at PP Week 4 was reported for all neonates/infants.
Time frame: PP Week 4
Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 24
Absolute value in vital signs parameter -body temperature at PP Week 24 was reported for all neonates/infants.
Time frame: PP Week 24
Neonates/Infants: Change From Baseline in Vital Signs - Body Temperature
Change from baseline in vital signs- body temperature were reported for all neonates/infants.
Time frame: Baseline (PP Day 0), PP Weeks 1, 4, and 24
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at Baseline
Absolute value of vital signs parameter- body weight at baseline was reported for all neonates/infants.
Time frame: Baseline (PP Day 0)
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 1
Absolute value of vital signs parameter - body weight at PP Week 1 was reported for all neonates/infants.
Time frame: PP Week 1
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 4
Absolute value of vital signs parameter - body weight at PP Week 4 was reported for all neonates/infants.
Time frame: PP Week 4
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 24
Absolute value of vital signs parameter - body weight at PP Week 24 was reported for all neonates/infants.
Time frame: PP Week 24
Neonates/Infants: Change From Baseline in Vital Signs -Body Weight
Change from baseline in vital signs - body weight were reported for all neonates/infants.
Time frame: Baseline (PP Day 0), PP Weeks 1, 4, and 24
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at Baseline
Absolute value of vital signs parameter -respiratory rate at baseline was reported for all neonates/infants.
Time frame: Baseline (PP Day 0)
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 1
Absolute value of vital signs parameter - respiratory rate at PP Week 1 was reported for all neonates/infants.
Time frame: PP Week 1
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 4
Absolute value of vital signs parameter - respiratory rate at PP Week 4 was reported for all neonates/infants.
Time frame: PP Week 4
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24
Absolute value of vital signs parameter- respiratory rate at PP Week 24 was reported for all neonates/infants.
Time frame: PP Week 24
Neonates/Infants: Change From Baseline in Vital Signs - Respiratory Rate
Change from baseline in vital signs -respiratory rate was reported for all neonates/infants.
Time frame: Baseline (PP Day 0), PP Weeks 1, 4, and 24
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline
Absolute value of vital signs parameter - SBP and DBP at baseline were reported for all neonates/infants.
Time frame: Baseline (PP Day 0)
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 1
Absolute value of vital signs parameter - SBP and DBP at PP Week 1 were reported for all neonates/infants.
Time frame: PP Week 1
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 4
Absolute value of vital signs parameter -SBP and DBP at PP Week 4 were reported for all neonates/infants.
Time frame: PP Week 4
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24
Absolute value of vital signs parameter -SBP and DBP at PP Week 24 were reported for all neonates/infants.
Time frame: PP Week 24
Neonates/Infants: Change From Baseline in Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change from baseline in vital signs- SBP and DBP were reported for all neonates/infants.
Time frame: Baseline (PP Day 0), PP Weeks 1, 4, and 24
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments
Percentage of maternal participants with intrauterine growth restriction (IUGR) based on ultrasound assessments and guidelines from American College of Obstetricians and Gynecologists, and Society for Maternal-Fetal Medicine was reported. This outcome measure provided the incidence of with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve.
Time frame: Baseline (GA Week 14), GA Weeks 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: Amniotic Fluid Index (AFI) at Baseline
Percentage of maternal participants with abnormal amniotic fluid values: amniotic fluid index (AFI) at baseline was reported. The amniotic fluid volume abnormality was categorized as an AFI \<5 centimeter (cm) or \>24 cm.
Time frame: Baseline (GA Week 14)
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: AFI at GA Week 26
Percentage of maternal participants with abnormal amniotic fluid values: AFI at GA Week 26 was reported. The amniotic fluid volume abnormality was categorized as an AFI \<5 cm or \>24 cm.
Time frame: GA Week 26
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: AFI at GA Week 36
Percentage of maternal participants with abnormal amniotic fluid values: AFI at GA Week 36 was reported. The amniotic fluid volume abnormality was categorized as an AFI \<5 cm or \>24 cm.
Time frame: GA Week 36
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: Maximum Vertical Pocket (MVP) at Baseline
Percentage of maternal participants with abnormal amniotic fluid values: maximum vertical pocket (MVP) at baseline was reported. The amniotic fluid volume abnormality was categorized as MVP \<2 cm or \>8 cm.
Time frame: From Baseline (GA Week 14)
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: MVP at GA Week 18
Percentage of maternal participants with abnormal amniotic fluid values: MVP at GA Week 18 was reported. The amniotic fluid volume abnormality was categorized as MVP \<2 cm or \>8 cm.
Time frame: GA Week 18
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: MVP at GA Week 22
Percentage of maternal participants with abnormal amniotic fluid values: MVP at GA Week 22 was reported. The amniotic fluid volume abnormality was categorized as MVP \<2 cm or \>8 cm.
Time frame: GA Week 22
Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score
Number of neonates/infants with Apgar score from 1 to 10 minutes of life were reported. The system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The score is reported at 1 minute and 5 minutes after birth for all infants, and at 5-minute intervals thereafter until 20 minutes for infants with a score less than 7. This is using an Apgar scale which ranges from minimum total score of 0 and maximum total score of 10, with higher score representing a better outcome.
Time frame: 1, 5, and 10 minutes after birth at PP Day 0
Number of Maternal Participants With Concomitant Medications and Therapies
Number of maternal participants with concomitant medications and therapies were reported.
Time frame: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Number of Neonates/Infants With Concomitant Medications and Therapies
Number of neonates/infants with concomitant medications and therapies were reported.
Time frame: From birth (PP Day 0) up to PP Week 96
Percentage of Maternal Participants With Live Birth at or After Gestational Age (GA) Week 32 and Without an Intrauterine Transfusion (IUT) Throughout Their Entire Pregnancies
Percentage of maternal participants with live birth at or after GA Week 32 and without an IUT throughout their entire pregnancies were reported.
Time frame: From baseline (GA Week 14) up to GA Week 37
Percentage of Maternal Participants With Live Birth
Percentage of maternal participants with live birth were reported.
Time frame: From baseline (GA Week 14) up to GA Week 37
Percentage of Maternal Participants Without an Intrauterine Transfusion (IUT) Before Gestational Age (GA) Week 24
Percentage of maternal participants without an IUT before GA Week 24 were reported.
Time frame: From baseline (GA Week 14) up to GA Week 24
Maternal Participants : Gestational Age (GA) at First Intrauterine Transfusion (IUT)
Gestational age (GA) at first IUT for maternal participants were reported.
Time frame: From baseline (GA Week 14) up to GA Week 37
Median Number of Intrauterine Transfusion (IUT) Per Maternal Participant
Median number of intrauterine transfusion (IUT) per maternal participants were reported.
Time frame: From baseline (GA Week 14) up to GA Week 37
Frequency of Intrauterine Transfusions (IUTs) on Maternal Participants
Frequency of intrauterine transfusions (IUTs) on maternal participants were reported. Frequency of IUTs was defined as total number of IUTs divided by the (date of delivery - date of first IUT +1)/7.
Time frame: From baseline (GA Week 14) up to GA Week 37
Percentage of Maternal Participants With Fetal Hydrops in Utero or Post Birth
Percentage of maternal participants with fetal hydrops in utero or post birth were reported.
Time frame: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)
Maternal Participants: Gestational Age at Time of Delivery
Gestational age at time of delivery for maternal participants were reported.
Time frame: From baseline (GA Week 14) up to GA Week 37
Percentage of Neonates Who Required Phototherapy
Percentage of neonates who required phototherapy were reported.
Time frame: From birth (PP Day 0) up to PP Week 24
Percentage of Neonates Who Required Exchange Transfusions
Percentage of neonates who required exchange transfusions were reported.
Time frame: From birth (PP Day 0) up to PP Week 24
Duration of Postnatal Phototherapy Required by Neonates
Duration of postnatal phototherapy required by neonates were reported.
Time frame: From birth (PP Day 0) up to PP Week 24
Percentage of Neonates Who Required Simple Transfusions in the First 12 Weeks of Life
Percentage of neonates who required simple transfusions in the first 12 weeks of life were reported.
Time frame: From birth (PP Day 0) up to PP Week 12
Number of Simple Transfusions Required by Neonate in the First 12 Weeks of Life
Number of simple transfusions required by neonate in the first 12 weeks of life were reported.
Time frame: From birth (PP Day 0) up to PP Week 12
Maternal Serum Unoccupied Neonatal Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes by Nipocalimab
Maternal serum unoccupied neonatal concentration of Participants Fc Receptor \[FcRn\] receptor occupancy (RO) in Monocytes by nipocalimab were reported.
Time frame: Baseline (GA Week 14), GA Week 16, GA Week 36, PP Day 0, PP Week 4, and PP Week 24
Serum Unoccupied Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes of Neonate by Nipocalimab
Serum unoccupied FcRn RO in monocytes of neonate by Nipocalimab were reported.
Time frame: From birth (PP Day 0) up to PP Week 24
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE
Change from baseline in serum concentration of total immunoglobulin G (IgG) and subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE were reported.
Time frame: IgG: Baseline (GA Week 14), GA Week 16, GA Week 36, birth (PP Day 0), PP Week 4, and PP Week 24; IgG1, IgG2, IgG3, IgG4, IgA, IgM, and IgE: baseline (GA Week 14), GA Week 36
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE
Change from baseline in serum concentration of total IgG, IgA, IgM, and IgE were reported in neonates/infants were reported.
Time frame: Baseline (PP Day 0), PP Weeks 4, 24, 96
Serum Concentrations of Nipocalimab in Maternal Participants
Serum concentrations of Nipocalimab in maternal participants were reported.
Time frame: Pre dose and post dose: GA Week 14 and GA Week 24; Birth (PP Day 0), PP Week 4 and PP Week 24
Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants
The 45-item PedsQL infant Scales (ages 13-24 months) included physical functioning, physical symptoms, emotional functioning, social functioning, and cognitive functioning. Health summary score for psychosocial (sum of all items over number of items: emotional, social, cognitive functioning scales) and physical (sum of the items over number of items: physical functioning and symptoms scales), as well as a total score (sum of all items over number of items answered on all scales). Items were reverse-scored and linearly transformed to 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0). PedsQL a validated scale ranging from 0 -100, higher scores = a better quality of life.
Time frame: PP Week 96
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants
The ASQ-3 assesses young child's (2-66 months) development based on age and included 6 questions in each area of child development: communication, gross motor, fine motor, problem solving, and personal-social skills. Parents answered either yes (10 points), sometimes (5 points) or not yet (0 points) to each question to complete ASQ-3 and each domain score could range from 0 to 60 points which higher score signifying stronger development.
Time frame: At PP 6 month, PP 12 month, and PP 24 month
Enrolled population included 13 maternal participants and 12 neonates born to maternal participants. There was one stillbirth which was not considered enrolled. Only livebirths were included in analyses and presented below.
| Milestone | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW |
|---|---|---|---|---|---|---|---|---|
| Started | 3 | 2 | 4 | 4 | 3 | 2 | 4 | 3 |
| Completed | 3 | 2 | 4 | 4 | 3 | 2 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab.
| Participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs) | 3 | 2 | 4 | 4 | 13 |
An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
| Participants | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Number of Neonates/Infants With Adverse Events (AEs) | 3 | 2 | 4 | 3 | 12 |
SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TESAEs were any SAEs occurring after the initiation of the first infusion of nipocalimab.
| Participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Number of Maternal Participants With Treatment-emergent Serious Adverse Events (TESAEs) | 2 | 0 | 1 | 2 | 5 |
SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
| Participants | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Number of Neonates/Infants With Serious Adverse Events (SAEs) | 2 | 1 | 1 | 2 | 6 |
Number of maternal participants with TEAESIs were reported. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. All infections requiring anti-infective (that is, oral or intravenous antibacterial, antiviral, or antifungal) treatment and with hypoalbuminemia greater than or equal to (\>=) Grade 3 (less than \[\<\]20 gram per liter \[g/L\] by National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 criteria were considered an AESI for maternal participants. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab.
| Participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Infections: Treatment with Oral /Intravenous | 1 | 1 | 1 | 2 | 5 |
| Hypoalbuminemia <20 g/L | 0 | 0 | 0 | 0 | 0 |
| Overall AESIs | 1 | 1 | 1 | 2 | 5 |
Number of neonates/infants with TEAESIs were reported. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. All infections requiring anti-infective (that is, oral or intravenous antibacterial, antiviral, or antifungal) treatment, unexpected/unusual childhood illnesses and Immunoglobulin G (IgG) concentrations \<200 milligrams per deciliter (mg/dL) at Week 24 through Week 47 or \<300 mg/dL at Week 48 through Week 96 were considered an AESI for neonates and infants.
| Participants | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| IgG Concentrations <200 mg/dL | 1 | 2 | 0 | 0 | 3 |
| Infections: Treatment with Oral /Intravenous | 0 | 1 | 0 | 1 | 2 |
| Unexpected/Unusual Childhood Illnesses | 0 | 0 | 0 | 0 | 0 |
| Overall AESI | 1 | 2 | 0 | 1 | 4 |
Absolute value of ECG parameter - mean ventricular rate at baseline in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities.
| Beats per minute | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline | 77.0 ± 10.58 | 77.5 ± 3.54 | 63.0 ± 5.35 | 76.3 ± 8.42 | 72.5 ± 9.41 |
Absolute value of ECG parameter - mean ventricular rate at GA Week 36 in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities.
| Beats per minute | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at GA Week 36 | 89.0 ± NA | 77.0 ± 21.21 | 80.7 ± 7.51 | 77.0 ± 21.21 | 79.9 ± 12.71 |
Change from baseline in ECG parameter- mean ventricular rate in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities.
| Beats per minute | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Change From Baseline in ECG Parameter- Mean Ventricular Rate | 8.0 ± NA | -0.5 ± 24.75 | 16.7 ± 7.37 | 8.0 ± 22.63 | 9.1 ± 15.08 |
Laboratory parameters included hematology, chemistry, blood Lipids panel, and Immunoglobulin G (IgG) parameters. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab. Here, HDL: high-density lipoprotein, LDL: low-density lipoprotein. The during-pregnancy value of albumin \<20 g/L was from a local laboratory and was \>=20 g/L when analyzed at the central laboratory for the same time point.
| Participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| During pregnancy: Cholesterol >9.025 millimoles per liter (mmol/L) | 1 | 2 | 3 | 2 | 8 |
| During pregnancy: LDL >5.793 mmol/L | — | 0 | 1 | 2 | 3 |
| During pregnancy: HDL Cholesterol <1.2413 mmol/L | — | 0 | 0 | 0 | 0 |
| During pregnancy: Triglycerides >5.114 mmol/L | 0 | 0 | 1 | 1 | 2 |
| During pregnancy: Albumin <20 grams per Liter (g/L) | 0 | 0 | 0 | 1 | 1 |
| During pregnancy: Immunoglobulin G <1 g/L | 1 | 0 | 1 | 0 | 2 |
| Post Birth: Cholesterol >5.172 mmol/L | 3 | 2 | 4 | 2 | 11 |
| Post Birth: LDL >2.586 mmol/L | — | 1 | 2 | 3 | 6 |
| Post Birth: HDL <1.0344 mmol/L | — | 0 | 1 | 0 | 1 |
| Post Birth: Triglycerides >1.6935 mmol/L | 1 | 1 | 3 | 2 | 7 |
| Post Birth: Albumin <20 g/L | 0 | 0 | 0 | 0 | 0 |
| Post Birth: Immunoglobulin G <1 g/L | 0 | 0 | 0 | 0 | 0 |
Laboratory parameters included total bilirubin and biomarker included immunoglobulin G (IgG).
| Participants | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Total Bilirubin >136.8 mmol/L | 1 | 1 | 3 | 3 | 8 |
| Immunoglobulin G < 1 g/L | 1 | 0 | 0 | 0 | 1 |
| Immunoglobulin G < 2 g/L | 2 | 2 | 4 | 2 | 10 |
Absolute value of vital signs - body temperature at baseline in maternal participants was reported.
| Degree Celsius | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Vital Signs - Body Temperature at Baseline | 36.6 ± 0.1 | 37.0 ± 0.5 | 37.2 ± 0.5 | 36.8 ± 0.8 | 36.9 ± 0.6 |
Absolute value of vital signs - body temperature at GA Week 36 in maternal participants was reported.
| Degree Celsius | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Vital Signs - Body Temperature at GA Week 36 | 36.7 ± NA | 36.8 ± 0.0 | 37.1 ± 0.5 | 36.0 ± NA | 36.8 ± 0.5 |
Absolute value of vital signs - body temperature at PP Week 24 in maternal participants was reported.
| Degree Celsius | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Vital Signs - Body Temperature at PP Week 24 | 36.5 ± 0.1 | 36.8 ± 0.3 | 36.8 ± 0.3 | 36.7 ± 0.5 | 36.7 ± 0.3 |
Change from baseline in vital signs- body temperature in maternal participants was reported.
| Degree Celsius | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| GA Week 36 | 0.0 ± NA | -0.2 ± 0.5 | -0.2 ± 0.0 | 0.2 ± NA | -0.1 ± 0.3 |
| PP Week 24 | -0.1 ± 0.1 | -0.2 ± 0.2 | -0.5 ± 0.7 | -0.1 ± 1.0 | -0.2 ± 0.7 |
Absolute value of vital signs -respiratory rate at baseline in maternal participants was reported.
| breaths per minute | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at Baseline | 17.0 ± 1.7 | 19.0 ± 1.4 | 15.5 ± 3.4 | 18.0 ± 2.8 | 17.2 ± 2.7 |
Absolute value of vital signs -respiratory rate at GA Week 36 in maternal participants was reported.
| Breaths per minute | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at GA Week 36 | 20.0 ± NA | 18.0 ± 0.0 | 16.3 ± 3.2 | 17.0 ± NA | 17.4 ± 2.3 |
Absolute value of vital signs - respiratory rate at PP Week 24 in maternal participants was reported.
| Breaths per minute | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24 | 16.5 ± 2.1 | 15.5 ± 2.1 | 15.8 ± 3.9 | 17.3 ± 3.6 | 16.3 ± 3.0 |
Change from baseline in vital signs- respiratory rate in maternal participants was reported.
| Breaths per minute | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| GA Week 36 | 2.0 ± NA | -1.0 ± 1.4 | 1.0 ± 1.0 | 1.0 ± NA | 0.6 ± 1.4 |
| PP Week 24 | 0.0 ± 0.0 | -3.5 ± 0.7 | 0.3 ± 1.3 | -0.8 ± 3.0 | -0.8 ± 2.2 |
Absolute value of vital signs - pulse rate at baseline in maternal participants was reported.
| Beats per minute | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at Baseline | 81.3 ± 8.7 | 81.0 ± 8.5 | 67.5 ± 4.2 | 73.5 ± 8.9 | 74.6 ± 8.8 |
Absolute value of vital signs -pulse rate at GA Week 36 in maternal participants was reported.
| beats per minute | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at GA Week 36 | 88.0 ± NA | 95.0 ± 17.0 | 84.0 ± 9.5 | 100.0 ± NA | 90.0 ± 11.0 |
Absolute value of vital signs -pulse rate at PP Week 24 in maternal participants was reported.
| Beats per minute | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Vital Signs -Pulse Rate at PP Week 24 | 73.0 ± 2.8 | 75.0 ± 4.2 | 69.8 ± 10.2 | 77.8 ± 4.1 | 73.8 ± 6.9 |
Change from baseline in vital signs -pulse rate in maternal participants was reported.
| Beats per minute | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| GA Week 36 | -3.0 ± NA | 14.0 ± 8.5 | 15.0 ± 6.1 | 29.0 ± NA | 14.1 ± 10.5 |
| PP Week 24 | -3.5 ± 6.4 | -6.0 ± 4.2 | 2.3 ± 8.5 | 4.3 ± 11.4 | 0.6 ± 8.8 |
Absolute value of vital signs - SBP and DBP at baseline in maternal participants was reported.
| Millimeter of mercury | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| SBP | 112.0 ± 11.3 | 100.5 ± 3.5 | 102.3 ± 4.6 | 104.8 ± 12.4 | 105.0 ± 9.2 |
| DBP | 68.7 ± 3.5 | 59.5 ± 3.5 | 63.3 ± 6.9 | 64.5 ± 10.8 | 64.3 ± 7.3 |
Absolute value of vital signs -SBP and DBP at GA Week 36 in maternal participants was reported.
| Millimeter of mercury (mmHg) | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| SBP | 134.0 ± NA | 105.0 ± 8.5 | 107.3 ± 9.6 | 110.5 ± 7.8 | 110.9 ± 11.7 |
| DBP | 70.0 ± NA | 73.0 ± 5.7 | 66.3 ± 4.2 | 69.0 ± 5.7 | 69.1 ± 4.7 |
Absolute value of vital signs - SBP and DBP at PP Week 24 in maternal participants was reported.
| Millimeters of mercury | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| SBP | 117.5 ± 14.8 | 110.5 ± 14.8 | 112.3 ± 4.0 | 118.8 ± 9.9 | 115.0 ± 9.2 |
| DBP | 73.5 ± 10.6 | 69.5 ± 6.4 | 71.3 ± 6.2 | 71.8 ± 1.7 | 71.5 ± 5.2 |
Change from baseline in vital signs -SBP and DBP in maternal participants were reported.
| Millimeters of mercury | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| SBP: GA Week 36 | 15.0 ± NA | 4.5 ± 4.9 | 5.0 ± 13.0 | 5.0 ± 22.6 | 6.1 ± 11.7 |
| SBP: PP Week 24 | 9.0 ± 1.4 | 10.0 ± 11.3 | 10.0 ± 4.2 | 14.0 ± 7.0 | 11.2 ± 5.9 |
| DBP: GA Week 36 | -2.0 ± NA | 13.5 ± 2.1 | 3.0 ± 9.8 | 6.5 ± 23.3 | 5.9 ± 11.6 |
| DBP: PP Week 24 | 6.5 ± 7.8 | 10.0 ± 2.8 | 8.0 ± 10.2 | 7.3 ± 11.8 | 7.8 ± 8.6 |
Absolute value of vital signs - body weight at baseline in maternal participants was reported.
| Kilograms | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Vital Signs - Body Weight at Baseline | 76.0 ± 29.7 | 64.0 ± 12.7 | 71.8 ± 8.8 | 75.8 ± 18.0 | 72.8 ± 16.7 |
Absolute value of vital signs -body weight at GA Week 36 in maternal participants was reported.
| Kilograms | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Vital Signs - Body Weight at GA Week 36 | 130.6 ± NA | 77.6 ± 15.6 | 80.8 ± 7.9 | 87.3 ± 14.9 | 87.8 ± 19.9 |
Absolute value of vital signs included body weight at PP Week 24 in maternal participants was reported.
| Kilograms | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Absolute Value of Vital Signs - Body Weight at PP Week 24 | 60.1 ± 8.0 | 69.5 ± 13.4 | 71.3 ± 11.1 | 78.0 ± 20.1 | 71.4 ± 14.3 |
Change from baseline in vital signs- body weight in maternal participants was reported.
| Kilograms | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| GA Week 36 | 20.6 ± NA | 13.6 ± 3.0 | 8.6 ± 2.9 | 7.7 ± 1.4 | 11.1 ± 5.0 |
| PP Week 24 | 1.0 ± 2.4 | 5.6 ± 0.8 | -0.5 ± 4.6 | 2.2 ± 2.9 | 1.7 ± 3.6 |
Absolute value in vital signs parameter -body temperature at baseline was reported for all neonates/infants.
| Degree Celsius | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at Baseline | 36.7 ± 0.4 | 36.8 ± 0.1 | 36.5 ± 0.1 | 36.7 ± 0.1 | 36.7 ± 0.2 |
Absolute value of vital signs parameter -body temperature at PP Week 1 was reported for all neonates/infants.
| Degree Celsius | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Neonates/Infants: Absolute Value of Vital Signs - Body Temperature at PP Week 1 | 37.1 ± 0.3 | 36.9 ± NA | 36.8 ± 0.1 | 37.1 ± 0.2 | 37.0 ± 0.2 |
Absolute value in vital signs parameter - body temperature at PP Week 4 was reported for all neonates/infants.
| Degree Celsius | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 4 | 36.8 ± 0.5 | 37.1 ± NA | 37.0 ± 0.5 | 37.2 ± 0.1 | 37.0 ± 0.4 |
Absolute value in vital signs parameter -body temperature at PP Week 24 was reported for all neonates/infants.
| Degree Celsius | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 24 | 36.5 ± 0.3 | 36.5 ± NA | 37.1 ± 0.4 | 37.5 ± 0.5 | 37.0 ± 0.5 |
Change from baseline in vital signs- body temperature were reported for all neonates/infants.
| Degree Celsius | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| PP Week 1 | 0.2 ± 0.4 | 0.1 ± NA | 0.3 ± 0.1 | 0.3 ± NA | 0.2 ± 0.2 |
| PP Week 4 | 0.2 ± 0.1 | 0.4 ± NA | 0.6 ± 0.6 | 0.6 ± 0.1 | 0.5 ± 0.4 |
| PP Week 24 | -0.4 ± 0.4 | -0.2 ± NA | 0.6 ± 0.5 | 1.0 ± 0.6 | 0.3 ± 0.7 |
Absolute value of vital signs parameter- body weight at baseline was reported for all neonates/infants.
| Kilograms | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Neonates/Infants: Absolute Value of Vital Signs - Body Weight at Baseline | 2.4 ± 1.6 | 2.8 ± 0.4 | 2.8 ± 0.2 | 2.8 ± 0.4 | 2.7 ± 0.7 |
Absolute value of vital signs parameter - body weight at PP Week 1 was reported for all neonates/infants.
| Kilograms | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 1 | 1.6 ± 1.1 | 2.8 ± 0.5 | 2.7 ± 0.2 | 2.6 ± 0.3 | 2.5 ± 0.6 |
Absolute value of vital signs parameter - body weight at PP Week 4 was reported for all neonates/infants.
| Kilograms | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 4 | 2.6 ± 1.3 | 3.6 ± 1.1 | 3.4 ± 0.1 | 3.7 ± 0.7 | 3.3 ± 0.8 |
Absolute value of vital signs parameter - body weight at PP Week 24 was reported for all neonates/infants.
| Kilograms | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 24 | 6.4 ± 1.4 | 7.4 ± 1.6 | 7.6 ± 1.0 | 8.1 ± 0.6 | 7.4 ± 1.2 |
Change from baseline in vital signs - body weight were reported for all neonates/infants.
| Kilograms | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| PP Week 1 | -0.1 ± 0.0 | 0.0 ± 0.1 | -0.1 ± 0.1 | -0.1 ± 0.1 | -0.1 ± 0.1 |
| PP Week 4 | 0.2 ± 0.3 | 0.8 ± 0.7 | 0.6 ± 0.4 | 0.9 ± 0.3 | 0.6 ± 0.4 |
| PP Week 24 | 4.0 ± 0.3 | 4.5 ± 1.2 | 4.8 ± 1.1 | 5.3 ± 0.8 | 4.7 ± 0.9 |
Absolute value of vital signs parameter -respiratory rate at baseline was reported for all neonates/infants.
| Breaths per minute | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at Baseline | 39.0 ± 7.1 | 47.0 ± 2.8 | 42.0 ± 5.2 | 49.5 ± 17.7 | 43.9 ± 8.1 |
Absolute value of vital signs parameter - respiratory rate at PP Week 1 was reported for all neonates/infants.
| Breaths per minute | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 1 | 36.0 ± 17.0 | 52.0 ± NA | 35.3 ± 1.2 | 54.0 ± 15.6 | 42.3 ± 12.7 |
Absolute value of vital signs parameter - respiratory rate at PP Week 4 was reported for all neonates/infants.
| Breaths per minute | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 4 | 69.0 ± 19.8 | 68.0 ± NA | 46.5 ± 5.5 | 40.0 ± NA | 54.0 ± 14.9 |
Absolute value of vital signs parameter- respiratory rate at PP Week 24 was reported for all neonates/infants.
| Breaths per minute | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24 | 29.0 ± 9.9 | 32.0 ± NA | 45.3 ± 12.3 | 35.0 ± 7.8 | 37.6 ± 11.1 |
Change from baseline in vital signs -respiratory rate was reported for all neonates/infants.
| breaths per minute | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| PP Week 1 | -10.0 ± NA | 3.0 ± NA | -7.3 ± 7.0 | 6.0 ± NA | -3.8 ± 8.0 |
| PP Week 4 | 30.0 ± 26.9 | 23.0 ± NA | 4.5 ± 8.4 | 3.0 ± NA | 13.0 ± 16.9 |
| PP Week 24 | -12.0 ± NA | -13.0 ± NA | 3.3 ± 16.0 | -16.5 ± 27.6 | -5.6 ± 17.6 |
Absolute value of vital signs parameter - SBP and DBP at baseline were reported for all neonates/infants.
| Millimeters of mercury | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| SBP | 73.7 ± 7.4 | — | 61.5 ± 19.1 | 61.5 ± 4.9 | 66.7 ± 11.2 |
| DBP | 39.0 ± 2.6 | — | 32.0 ± 5.7 | 31.5 ± 7.8 | 34.9 ± 5.7 |
Absolute value of vital signs parameter - SBP and DBP at PP Week 1 were reported for all neonates/infants.
| Millimeters of mercury | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| SBP | 62.5 ± 2.1 | — | 75.0 ± NA | 65.0 ± NA | 66.3 ± 6.1 |
| DBP | 50.0 ± 1.4 | — | 39.0 ± NA | 31.0 ± NA | 42.5 ± 9.3 |
Absolute value of vital signs parameter -SBP and DBP at PP Week 4 were reported for all neonates/infants.
| Millimeters of mercury | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| SBP | 61.0 ± NA | — | 76.0 ± NA | 98.0 ± 4.2 | 83.3 ± 18.3 |
| DBP | 31.0 ± NA | — | 30.0 ± NA | 59.0 ± 11.3 | 44.8 ± 17.7 |
Absolute value of vital signs parameter -SBP and DBP at PP Week 24 were reported for all neonates/infants.
| Millimeters of mercury | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| SBP | 101.0 ± NA | — | 113.0 ± 36.8 | 103.5 ± 9.2 | 106.8 ± 19.8 |
| DBP | 68.0 ± NA | — | 92.5 ± 26.2 | 58.0 ± 9.9 | 73.8 ± 22.4 |
Change from baseline in vital signs- SBP and DBP were reported for all neonates/infants.
| Millimeters of mercury | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| SBP: PP Week 1 | -7.0 ± 4.2 | — | 27.0 ± NA | 0.0 ± NA | 3.3 ± 16.4 |
| SBP: PP Week 4 | -10.0 ± NA | — | 28.0 ± NA | 36.5 ± 9.2 | 22.8 ± 22.8 |
| SBP: PP Week 24 | 33.0 ± NA | — | 39.0 ± NA | 52.0 ± NA | 41.3 ± 9.7 |
| DBP: PP Week 1 | 11.5 ± 4.9 | — | 11.0 ± NA | -6.0 ± NA | 7.0 ± 9.1 |
| DBP: PP Week 4 | -10.0 ± NA | — | 2.0 ± NA | 27.5 ± 19.1 | 11.8 ± 21.8 |
| DBP: PP Week 24 | 32.0 ± NA | — | 46.0 ± NA | 39.0 ± NA | 39.0 ± 7.0 |
Percentage of maternal participants with intrauterine growth restriction (IUGR) based on ultrasound assessments and guidelines from American College of Obstetricians and Gynecologists, and Society for Maternal-Fetal Medicine was reported. This outcome measure provided the incidence of with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve.
| Percentage of maternal participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Baseline | 0 | — | 0 | 0 | 0 |
| GA Week 16 | 0 | 0 | 0 | 0 | 0 |
| GA Week 18 | 0 | 0 | 0 | 0 | 0 |
| GA Week 20 | 50.0 | 0 | 0 | 0 | 9.1 |
| GA Week 22 | 0 | 0 | 0 | 0 | 0 |
| GA Week 24 | 0 | 0 | 0 | 0 | 0 |
| GA Week 26 | 0 | 50.0 | 0 | 0 | 8.3 |
| GA Week 28 | 0 | 50.0 | 0 | 0 | 8.3 |
| GA Week 30 | 0 | 0 | 0 | 0 | 0 |
| GA Week 32 | 0 | 100.0 | 0 | 0 | 10.0 |
| GA Week 34 | 0 | 0 | 0 | 0 | 0 |
| GA Week 36 | 0 | 0 | 0 | 0 | 0 |
Percentage of maternal participants with abnormal amniotic fluid values: amniotic fluid index (AFI) at baseline was reported. The amniotic fluid volume abnormality was categorized as an AFI \<5 centimeter (cm) or \>24 cm.
| Percentage of maternal participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: Amniotic Fluid Index (AFI) at Baseline | 0 | 50.0 | 50.0 | 0 | 25.0 |
Percentage of maternal participants with abnormal amniotic fluid values: AFI at GA Week 26 was reported. The amniotic fluid volume abnormality was categorized as an AFI \<5 cm or \>24 cm.
| Percentage of maternal participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: AFI at GA Week 26 | 0 | — | 25.0 | 0 | 12.5 |
Percentage of maternal participants with abnormal amniotic fluid values: AFI at GA Week 36 was reported. The amniotic fluid volume abnormality was categorized as an AFI \<5 cm or \>24 cm.
| Percentage of maternal participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: AFI at GA Week 36 | 0 | 0 | 33.3 | 0 | 14.3 |
Percentage of maternal participants with abnormal amniotic fluid values: maximum vertical pocket (MVP) at baseline was reported. The amniotic fluid volume abnormality was categorized as MVP \<2 cm or \>8 cm.
| Percentage of maternal participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: Maximum Vertical Pocket (MVP) at Baseline | 0 | 0 | 0 | 0 | 0 |
Percentage of maternal participants with abnormal amniotic fluid values: MVP at GA Week 18 was reported. The amniotic fluid volume abnormality was categorized as MVP \<2 cm or \>8 cm.
| Percentage of maternal participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: MVP at GA Week 18 | 0 | 0 | 0 | 25.0 | 8.3 |
Percentage of maternal participants with abnormal amniotic fluid values: MVP at GA Week 22 was reported. The amniotic fluid volume abnormality was categorized as MVP \<2 cm or \>8 cm.
| Percentage of maternal participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: MVP at GA Week 22 | 0 | 0 | 0 | 0 | 0 |
Number of neonates/infants with Apgar score from 1 to 10 minutes of life were reported. The system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The score is reported at 1 minute and 5 minutes after birth for all infants, and at 5-minute intervals thereafter until 20 minutes for infants with a score less than 7. This is using an Apgar scale which ranges from minimum total score of 0 and maximum total score of 10, with higher score representing a better outcome.
| Participants | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| 1 minute: <5 Score | 1 | 0 | 0 | 1 | 2 |
| 1 minute: 5-7 Score | 0 | 0 | 1 | 0 | 1 |
| 1 minute: 8-10 Score | 2 | 2 | 3 | 2 | 9 |
| 5 minute: <5 Score | 0 | 0 | 0 | 0 | 0 |
| 5 minute: 5-7 Score | 0 | 0 | 0 | 1 | 1 |
| 5 minute: 8-10 Score | 3 | 2 | 4 | 2 | 11 |
| 10 minute: <5 Score | 0 | 0 | 0 | 0 | 0 |
| 10 minute: 5-7 Score | 0 | 0 | 0 | 1 | 1 |
| 10 minute: 8-10 Score | 1 | 2 | 2 | 1 | 6 |
Number of maternal participants with concomitant medications and therapies were reported.
| Participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Number of Maternal Participants With Concomitant Medications and Therapies | 3 | 2 | 4 | 4 | 13 |
Number of neonates/infants with concomitant medications and therapies were reported.
| Participants | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Number of Neonates/Infants With Concomitant Medications and Therapies | 3 | 2 | 4 | 3 | 12 |
Percentage of maternal participants with live birth at or after GA Week 32 and without an IUT throughout their entire pregnancies were reported.
| Percentage of maternal participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kgTAW | All Maternal Participants |
|---|---|---|---|---|---|
| Percentage of Maternal Participants With Live Birth at or After Gestational Age (GA) Week 32 and Without an Intrauterine Transfusion (IUT) Throughout Their Entire Pregnancies | 33.3 (0.8 to 90.6) | 50.0 (1.3 to 98.7) | 75.0 (19.4 to 99.4) | 50.0 (6.8 to 93.2) | 53.8 (25.1 to 80.8) |
Percentage of maternal participants with live birth were reported.
| Percentage of maternal participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | All Maternal Participants |
|---|---|---|---|---|---|
| Percentage of Maternal Participants With Live Birth | 100 | 100 | 100 | 75 | 92.3 |
Percentage of maternal participants without an IUT before GA Week 24 were reported.
| Percentage of maternal participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | All Maternal Participants |
|---|---|---|---|---|---|
| Percentage of Maternal Participants Without an Intrauterine Transfusion (IUT) Before Gestational Age (GA) Week 24 | 100 | 100 | 100 | 75 | 92.3 |
Gestational age (GA) at first IUT for maternal participants were reported.
| weeks | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | All Maternal Subjects |
|---|---|---|---|---|---|
| Maternal Participants : Gestational Age (GA) at First Intrauterine Transfusion (IUT) | 25 (24 to 25) | 28 (28 to 28) | 29 (29 to 29) | 27 (22 to 31) | 27 (22 to 31) |
Median number of intrauterine transfusion (IUT) per maternal participants were reported.
| IUTs per maternal participant | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | All Maternal Participants |
|---|---|---|---|---|---|
| Median Number of Intrauterine Transfusion (IUT) Per Maternal Participant | 4 (3 to 5) | 5 (5 to 5) | 3 (3 to 3) | 1 (1 to 1) | 3 (1 to 5) |
Frequency of intrauterine transfusions (IUTs) on maternal participants were reported. Frequency of IUTs was defined as total number of IUTs divided by the (date of delivery - date of first IUT +1)/7.
| IUT/week | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | All Maternal Participants |
|---|---|---|---|---|---|
| Frequency of Intrauterine Transfusions (IUTs) on Maternal Participants | 0.52 (0.48 to 0.57) | 0.56 (0.56 to 0.56) | 0.43 (0.43 to 0.43) | 0.70 (0.64 to 0.78) | 0.56 (0.43 to 0.78) |
Percentage of maternal participants with fetal hydrops in utero or post birth were reported.
| Percentage of maternal participants | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | All Maternal Participants |
|---|---|---|---|---|---|
| Percentage of Maternal Participants With Fetal Hydrops in Utero or Post Birth | 0 (0.0 to 84.2) | 0 (0.0 to 84.2) | 0 (0.0 to 60.2) | 0 (0.0 to 60.2) | 0 (0.0 to 26.5) |
Gestational age at time of delivery for maternal participants were reported.
| Weeks | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | All Maternal Participants |
|---|---|---|---|---|---|
| Maternal Participants: Gestational Age at Time of Delivery | 36 (29 to 37) | 36 (35 to 37) | 36 (36 to 37) | 35 (23 to 37) | 36 (23 to 37) |
Percentage of neonates who required phototherapy were reported.
| Percentage of neonates | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Percentage of Neonates Who Required Phototherapy | 100 | 50 | 100 | 100 | 91.7 |
Percentage of neonates who required exchange transfusions were reported.
| Percentage of neonates | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Percentage of Neonates Who Required Exchange Transfusions | 0 | 0 | 0 | 33.3 | 8.3 |
Duration of postnatal phototherapy required by neonates were reported.
| hours | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Duration of Postnatal Phototherapy Required by Neonates | 96.0 (84.00 to 301.07) | 46.68 (46.68 to 46.68) | 100.87 (12.00 to 173.95) | 86.98 (72.00 to 127.33) | 86.98 (12.00 to 301.07) |
Percentage of neonates who required simple transfusions in the first 12 weeks of life were reported.
| Percentage of neonates | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Maternal Participants |
|---|---|---|---|---|---|
| Percentage of Neonates Who Required Simple Transfusions in the First 12 Weeks of Life | 66.7 | 50.0 | 50.0 | 33.3 | 50.0 |
Number of simple transfusions required by neonate in the first 12 weeks of life were reported.
| Simple transfusions | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Number of Simple Transfusions Required by Neonate in the First 12 Weeks of Life | 4.5 (3. to 6) | 4.0 (4 to 4) | 1.0 (1 to 1) | 1.0 (1 to 1) | 2.0 (1 to 6) |
Maternal serum unoccupied neonatal concentration of Participants Fc Receptor \[FcRn\] receptor occupancy (RO) in Monocytes by nipocalimab were reported.
| percentage of receptors unoccupied | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | All Maternal Participants |
|---|---|---|---|---|---|
| Baseline | 100.00 ± 0.000 | 100.00 ± 0.000 | 100.00 ± 0.000 | 100.00 ± 0.000 | 100.00 ± 0.000 |
| GA Week 16 | 2.80 ± 0.346 | 2.50 ± 1.556 | 4.20 ± 3.816 | -0.15 ± 6.276 | 2.12 ± 4.103 |
| GA Week 36 | 12.20 ± NA | 3.80 ± NA | 5.40 ± 1.838 | 3.75 ± 1.202 | 5.72 ± 3.420 |
| PP Day 0 | 126.75 ± 6.859 | 21.00 ± 22.486 | 68.83 ± 43.253 | 39.30 ± 43.856 | 60.67 ± 48.532 |
| PP Week 4 | 107.55 ± 68.943 | — | 130.78 ± 49.901 | 121.55 ± 54.002 | 122.44 ± 49.09 |
| PP Week 24 | 99.60 ± 5.091 | 98.45 ± 15.486 | 114.15 ± 28.333 | 117.20 ± 29.816 | 110.13 ± 23.549 |
Serum unoccupied FcRn RO in monocytes of neonate by Nipocalimab were reported.
| percentage of receptors unoccupied | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Serum Unoccupied Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes of Neonate by Nipocalimab | 118.20 ± NA | 70.60 ± 19.233 | 80.87 ± 18.029 | 74.50 ± 33.093 | 81.38 ± 23.295 |
Change from baseline in serum concentration of total immunoglobulin G (IgG) and subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE were reported.
| grams/liter (g/L) | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | All Maternal Participants |
|---|---|---|---|---|---|
| IgG: GA Week 16 | -8.12 ± 2.235 | -7.31 ± 0.813 | -6.51 ± 1.285 | -8.19 ± 1.018 | -7.52 ± 1.464 |
| IgG: GA Week 36 | -7.52 ± 1.549 | -5.26 ± 2.574 | -5.83 ± 2.380 | -8.34 ± 1.305 | -6.72 ± 2.146 |
| IgG: birth (PP Day 0) | -0.40 ± 0.884 | -2.64 ± 0.148 | -2.45 ± 1.016 | -4.38 ± 2.771 | -2.78 ± 2.111 |
| IgG: PP Week 4 | 1.88 ± 1.803 | — | -0.17 ± 0.638 | 1.10 ± 3.455 | 0.75 ± 2.277 |
| IgG: PP Week 24 | 2.56 ± 0.255 | 2.02 ± 0.622 | 1.34 ± 0.411 | 2.61 ± 1.101 | 2.08 ± 0.873 |
| IgG1: GA Week 36 | -4.35 ± 1.386 | -3.94 ± 1.464 | -3.45 ± 1.421 | -5.46 ± 1.006 | -4.33 ± 1.356 |
| IgG2: GA Week 36 | -2.48 ± 0.085 | -1.29 ± 0.629 | -1.91 ± 1.013 | -2.31 ± 1.192 | -2.02 ± 0.888 |
| IgG3: GA Week 36 | -0.25 ± 0.045 | -0.23 ± 0.228 | -0.24 ± 0.195 | -0.38 ± 0.124 | -0.28 ± 0.151 |
| IgG4: GA Week 36 | -0.39 ± 0.209 | -0.06 ± 0.045 | -0.13 ± 0.066 | -0.28 ± 0.140 | -0.21 ± 0.163 |
| IgA: GA Week 36 | 0.17 ± 0.163 | 0.11 ± 0.191 | 0.20 ± 0.382 | 0.05 ± 0.015 | 0.13 ± 0.208 |
| IgM: GA Week 36 | 0.01 ± 0.120 | -0.06 ± 0.049 | 0.01 ± 0.072 | -0.12 ± 0.075 | -0.04 ± 0.087 |
| IgE: GA Week 36 | -0.31 ± 0.420 | 0.00 ± 0.003 | 0.01 ± 0.012 | 0.00 ± 0.086 | -0.06 ± 0.197 |
Change from baseline in serum concentration of total IgG, IgA, IgM, and IgE were reported in neonates/infants were reported.
| grams/liter (g/L) | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| IgG: PP Week 4 | 4.61 ± NA | -2.16 ± NA | 0.37 ± 2.521 | -0.87 ± 0.559 | 0.26 ± 2.594 |
| IgG: PP Week 24 | -7.59 ± NA | -0.09 ± NA | 0.78 ± 2.675 | 1.68 ± NA | -0.41 ± 3.723 |
| IgG: PP Week 96 | — | -1.41 ± NA | 5.55 ± 2.866 | 4.62 ± 1.683 | 4.08 ± 3.361 |
| IgA: PP Week 4 | 0.00 ± NA | — | 0.00 ± 0.000 | 0.03 ± NA | 0.01 ± 0.015 |
| IgA: PP Week 24 | 0.02 ± NA | 0.07 ± NA | 0.23 ± 0.127 | -0.87 ± NA | 0.15 ± 0.121 |
| IgA: PP Week 96 | — | 0.28 ± NA | 0.47 ± 0.297 | 0.29 ± 0.035 | 0.36 ± 0.181 |
| IgM: PP Week 4 | 0.10 ± NA | — | 0.17 ± 0.092 | 0.34 ± 0.071 | 0.22 ± 0.125 |
| IgM: PP Week 24 | 0.32 ± NA | 0.26 ± NA | 0.61 ± 0.078 | 0.44 ± NA | 0.48 ± 0.166 |
| IgM: PP Week 96 | — | 0.53 ± NA | 1.04 ± 0.014 | 0.86 ± 0.368 | 0.87 ± 0.278 |
| IgE: PP Week 4 | 0.00 ± NA | — | 0.00 ± 0.007 | 0.00 ± 0.000 | 0.00 ± 0.004 |
| IgE: PP Week 24 | 0.01 ± NA | 0.00 ± NA | 0.03 ± 0.059 | 0.02 ± NA | 0.02 ± 0.040 |
| IgE: PP Week 96 | — | 0.02 ± NA | 0.02 ± 0.008 | 0.03 ± 0.027 | 0.02 ± 0.016 |
Serum concentrations of Nipocalimab in maternal participants were reported.
| mcg/mL | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW |
|---|---|---|---|---|
| GA Week 14: Pre-dose | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± 0.00 |
| GA Week 14: Post-dose | 726.00 ± 138.01 | 577.00 ± 110.31 | 947.75 ± 193.17 | 928.50 ± 159.05 |
| GA Week 24: Pre-dose | 58.25 ± 43.63 | 71.15 ± 19.87 | 197.25 ± 73.27 | 205.00 ± 82.18 |
| GA Week 24: Post-dose | 736.50 ± 101.12 | 629.00 ± 90.51 | 1051.25 ± 196.49 | 1246.67 ± 202.32 |
| PP Day 0 | 0.01 ± 0.02 | 100.0 ± NA | 14.54 ± 25.16 | 278.96 ± 547.41 |
| PP Week 4 | 0.00 ± 0.00 | — | 0.00 ± 0.00 | 0.00 ± 0.00 |
| PP Week 24 | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± 0.00 |
The 45-item PedsQL infant Scales (ages 13-24 months) included physical functioning, physical symptoms, emotional functioning, social functioning, and cognitive functioning. Health summary score for psychosocial (sum of all items over number of items: emotional, social, cognitive functioning scales) and physical (sum of the items over number of items: physical functioning and symptoms scales), as well as a total score (sum of all items over number of items answered on all scales). Items were reverse-scored and linearly transformed to 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0). PedsQL a validated scale ranging from 0 -100, higher scores = a better quality of life.
| Score on a scale | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Overall Total Score | 86.67 ± NA | 86.67 ± NA | 88.15 ± 13.95 | 84.44 ± 6.26 | 86.39 ± 8.35 |
| Psychosocial Health Total Score | 78.85 ± NA | 88.46 ± NA | 86.86 ± 15.21 | 77.88 ± 8.22 | 82.69 ± 10.47 |
| Physical Health Total Score | 97.37 ± NA | 84.21 ± NA | 89.91 ± 12.23 | 93.42 ± 8.22 | 91.45 ± 8.78 |
| Physical Functioning Score | 100.00 ± NA | 88.89 ± NA | 90.74 ± 16.04 | 96.30 ± 3.21 | 93.75 ± 9.59 |
| Physical Symptoms Score | 95.00 ± NA | 80.00 ± NA | 89.17 ± 10.10 | 90.83 ± 13.77 | 89.38 ± 10.07 |
| Emotional Functioning Score | 62.50 ± NA | 95.83 ± NA | 81.25 ± 17.80 | 70.83 ± 7.22 | 76.82 ± 14.50 |
| Social Functioning Score | 100.00 ± NA | 100.00 ± NA | 91.67 ± 14.43 | 95.00 ± 8.66 | 95.00 ± 9.64 |
| Cognitive Functioning Score | 88.89 ± NA | 72.22 ± NA | 91.67 ± 14.43 | 77.78 ± 12.11 | 83.68 ± 12.90 |
The ASQ-3 assesses young child's (2-66 months) development based on age and included 6 questions in each area of child development: communication, gross motor, fine motor, problem solving, and personal-social skills. Parents answered either yes (10 points), sometimes (5 points) or not yet (0 points) to each question to complete ASQ-3 and each domain score could range from 0 to 60 points which higher score signifying stronger development.
| Score on a scale | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | All Neonates and Infants |
|---|---|---|---|---|---|
| Communication Total Score: PP 6-month | 36.7 ± 5.8 | 40.0 ± 7.1 | 48.8 ± 6.3 | 51.7 ± 2.9 | 45.0 ± 8.0 |
| Communication Total Score: PP 12-month | 45.0 ± 15.0 | 40.0 ± 7.1 | 43.3 ± 11.5 | 40.0 ± 10.0 | 42.3 ± 10.1 |
| Communication Total Score: PP 24-month | 45.0 ± 15.0 | 37.5 ± 24.7 | 48.3 ± 2.9 | 26.7 ± 2.9 | 39.5 ± 13.9 |
| Gross Motor Total Score: PP 6-month | 35.0 ± 10.0 | 22.5 ± 3.5 | 30.0 ± 9.1 | 25.0 ± 13.2 | 28.8 ± 9.8 |
| Gross Motor Total Score: PP 12-month | 31.7 ± 17.6 | 40.0 ± 28.3 | 21.7 ± 18.9 | 23.3 ± 23.6 | 28.2 ± 19.4 |
| Gross Motor Total Score: PP 24-month | 43.3 ± 17.6 | 60.0 ± 0.0 | 50.0 ± 8.7 | 56.7 ± 2.9 | 51.8 ± 11.0 |
| Fine Motor Total Score: PP 6-Month | 26.7 ± 7.6 | 35.0 ± 21.2 | 43.8 ± 8.5 | 35.0 ± 18.0 | 35.8 ± 13.3 |
| Fine Motor Total Score: PP 12-Month | 46.7 ± 2.9 | 57.5 ± 3.5 | 50.0 ± 0.0 | 36.7 ± 7.6 | 46.8 ± 8.4 |
| Fine Motor Total Score: PP 24-Month | 50.0 ± 10.0 | 47.5 ± 3.5 | 55.0 ± 8.7 | 50.0 ± 5.0 | 50.9 ± 7.0 |
| Problem Solving Total Score: PP 6-Month | 40.0 ± 10.0 | 37.5 ± 17.7 | 38.8 ± 11.1 | 26.7 ± 10.4 | 35.8 ± 11.4 |
| Problem Solving Total Score: PP 12-Month | 23.3 ± 15.3 | 25.0 ± 7.1 | 41.7 ± 2.9 | 40.0 ± 8.7 | 33.2 ± 12.1 |
| Problem Solving Total Score: PP 24-Month | 48.3 ± 7.6 | 37.5 ± 17.7 | 35.0 ± 8.7 | 41.7 ± 2.9 | 40.9 ± 9.4 |
| Personal-Social Total Score: PP 6-Month | 43.3 ± 5.8 | 30.0 ± 7.1 | 40.0 ± 10.8 | 20.0 ± 13.2 | 34.2 ± 12.9 |
| Personal-Social Total Score: PP 12-Month | 21.7 ± 2.9 | 37.5 ± 3.5 | 35.0 ± 5.0 | 30.0 ± 20.0 | 30.5 ± 11.3 |
| Personal-Social Total Score: PP24-Month | 48.3 ± 10.4 | 45.0 ± 21.2 | 50.0 ± 13.2 | 50.0 ± 5.0 | 48.6 ± 10.5 |
Collected over All-cause mortality: Maternal: Screening (GA Week 8) up to PP Week 24 (up to 56 weeks), Neonates/Infants: Birth (PP Day 0) up to PP Week 96; SAE and other AEs: Maternal: From baseline (GA Week 14) up to PP Week 24 (up to 50 weeks), Neonates/Infants: From birth (PP Day 0) up to PP Week 96. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 (Maternal): 30mg/kg BLW | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Group 2 (Maternal): 30 to45 mg/kg BLW | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Group 3 (Maternal): 45mg/kg BLW | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| Group 4 (Maternal): 45mg/kg TAW | 0/4 (0%) | 2/4 (50%) | 4/4 (100%) |
| Group 1 (Neonates and Infants): 30 mg/kg BLW | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | 0/2 (0%) | 1/2 (50%) | 2/2 (100%) |
| Group 3 (Neonates and Infants): 45 mg/kg BLW | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| Group 4 (Neonates and Infants): 45 mg/kg TAW | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Event | Group 1 (Maternal): 30mg/kg BLW | Group 2 (Maternal): 30 to45 mg/kg BLW | Group 3 (Maternal): 45mg/kg BLW | Group 4 (Maternal): 45mg/kg TAW | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW |
|---|---|---|---|---|---|---|---|---|
| Anaemia NeonatalBlood and lymphatic system disorders | 0/3 | 0/2 | 0/4 | 0/4 | 0/3 | 1/2 | 0/4 | 1/3 |
| JaundiceHepatobiliary disorders | 0/3 | 0/2 | 0/4 | 0/4 | 0/3 | 1/2 | 1/4 | 0/3 |
| Foetal AnaemiaBlood and lymphatic system disorders | 1/3 | 0/2 | 0/4 | 1/4 | 0/3 | 0/2 | 0/4 | 0/3 |
| Foetal Heart Rate Deceleration AbnormalityCardiac disorders | 1/3 | 0/2 | 0/4 | 0/4 | 0/3 | 0/2 | 0/4 | 0/3 |
| Hyperbilirubinaemia NeonatalHepatobiliary disorders | 0/3 | 0/2 | 0/4 | 0/4 | 1/3 | 0/2 | 0/4 | 0/3 |
| Respiratory Syncytial Virus InfectionInfections and infestations | 0/3 | 0/2 | 0/4 | 0/4 | 0/3 | 0/2 | 0/4 | 1/3 |
| Upper Respiratory Tract InfectionInfections and infestations | 0/3 | 0/2 | 0/4 | 0/4 | 0/3 | 0/2 | 0/4 | 1/3 |
| Foetal Growth RestrictionPregnancy, puerperium and perinatal conditions | 1/3 | 0/2 | 0/4 | 0/4 | 0/3 | 0/2 | 0/4 | 0/3 |
| Subchorionic HaematomaPregnancy, puerperium and perinatal conditions | 1/3 | 0/2 | 0/4 | 0/4 | 0/3 | 0/2 | 0/4 | 0/3 |
| Neonatal Respiratory Distress SyndromeRespiratory, thoracic and mediastinal disorders | 0/3 | 0/2 | 0/4 | 0/4 | 1/3 | 0/2 | 0/4 | 1/3 |
| Event | Group 1 (Maternal): 30mg/kg BLW | Group 2 (Maternal): 30 to45 mg/kg BLW | Group 3 (Maternal): 45mg/kg BLW | Group 4 (Maternal): 45mg/kg TAW | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW |
|---|---|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/3 | 0/2 | 1/4 | 1/4 | 3/3 | 0/2 | 1/4 | 0/3 |
| NauseaGastrointestinal disorders | 0/3 | 2/2 | 1/4 | 1/4 | 0/3 | 0/2 | 0/4 | 0/3 |
| Blood Immunoglobulin G DecreasedInvestigations | 1/3 | 0/2 | 0/4 | 0/4 | 1/3 | 2/2 | 1/4 | 1/3 |
| Oedema PeripheralGeneral disorders | 2/3 | 1/2 | 1/4 | 2/4 | 0/3 | 0/2 | 0/4 | 0/3 |
| PyrexiaGeneral disorders | 0/3 | 0/2 | 1/4 | 0/4 | 0/3 | 1/2 | 0/4 | 2/3 |
| HyperbilirubinaemiaHepatobiliary disorders | 0/3 | 0/2 | 0/4 | 0/4 | 2/3 | 0/2 | 1/4 | 1/3 |
| Anaemia NeonatalBlood and lymphatic system disorders | 0/3 | 0/2 | 0/4 | 0/4 | 0/3 | 1/2 | 0/4 | 1/3 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/3 | 0/2 | 0/4 | 0/4 | 0/3 | 1/2 | 0/4 | 0/3 |
| TachycardiaCardiac disorders | 0/3 | 1/2 | 0/4 | 0/4 | 0/3 | 0/2 | 0/4 | 0/3 |
| OtorrhoeaEar and labyrinth disorders | 0/3 | 0/2 | 0/4 | 0/4 | 0/3 | 1/2 | 0/4 | 0/3 |
| Age, Continuous(Years) | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 38.7 ± 1.53 | 37.0 ± 1.41 | 38.3 ± 4.43 | 30.8 ± 4.19 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 35.8 ± 4.76 |
| Sex: Female, Male(Participants) | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 3 | 2 | 4 | 4 | 3 | 1 | 0 | 0 | 17 |
| Male | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 3 | 8 |
| Race (NIH/OMB)(Participants) | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 2 | 2 | 4 | 4 | 3 | 2 | 3 | 3 | 23 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 |
| Not Hispanic or Latino | 2 | 2 | 4 | 4 | 2 | 2 | 4 | 3 | 23 |
| Region of Enrollment(Participants) | Group 1 (Maternal): 30 mg/kg BLW | Group 2 (Maternal): 30 to 45 mg/kg BLW | Group 3 (Maternal): 45 mg/kg BLW | Group 4 (Maternal): 45 mg/kg TAW | Group 1 (Neonates and Infants): 30 mg/kg BLW | Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW | Group 3 (Neonates and Infants): 45 mg/kg BLW | Group 4 (Neonates and Infants): 45 mg/kg TAW | Total |
|---|---|---|---|---|---|---|---|---|---|
| Australia | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 0 | 5 |
| Belgium | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 |
| Germany | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 4 |
| Netherlands | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 4 |
| Sweden | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 4 |
| United Kingdom | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
| United States | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 4 |
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