Trial Outcomes & Findings for A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (NCT NCT03842189)

NCT ID: NCT03842189

Last Updated: 2026-01-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: From baseline (Gestational Age [GA] Week 14) up to Postpartum (PP) Week 24 (up to 50 weeks)
• Results posted on: 2026-01-28

Participant Flow

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.

Initial drug dose was 30 milligrams per kilogram(mg/kg) based on baseline weight (BLW). Per protocol amendments, dose increased to 45 mg/kg BLW, later adjusted to 45 mg/kg based on time-adjusted weight (weight at most recent biweekly visit) to allow dosing interval without loss of receptor occupancy to account for weight increases during pregnancy.

Participant milestones

Measure	Group 1 (Maternal): 30 mg/kg BLW Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kg TAW Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 1 (Neonates and Infants): 30 mg/kg BLW Neonates and infants born to mothers from Group 1 were followed up for safety from postpartum (PP) Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Neonates and infants born to mothers from Group 2 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 3 (Neonates and Infants): 45 mg/kg BLW Neonates and infants born to mothers from Group 3 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 4 (Neonates and Infants): 45 mg/kg TAW Neonates and infants born to mothers from Group 4 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.
Overall Study STARTED	3	2	4	4	3	2	4	3
Overall Study COMPLETED	3	2	4	4	3	2	3	3
Overall Study NOT COMPLETED	0	0	0	0	0	0	1	0

Reasons for withdrawal

Measure	Group 1 (Maternal): 30 mg/kg BLW Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kg TAW Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 1 (Neonates and Infants): 30 mg/kg BLW Neonates and infants born to mothers from Group 1 were followed up for safety from postpartum (PP) Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Neonates and infants born to mothers from Group 2 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 3 (Neonates and Infants): 45 mg/kg BLW Neonates and infants born to mothers from Group 3 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 4 (Neonates and Infants): 45 mg/kg TAW Neonates and infants born to mothers from Group 4 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.
Overall Study Lost to Follow-up	0	0	0	0	0	0	1	0

Baseline Characteristics

The total column presents the mean and standard deviation for only maternal participants.

Baseline characteristics by cohort

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kg TAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 1 (Neonates and Infants): 30 mg/kg BLW n=3 Participants Neonates and infants born to mothers from Group 1 were followed up for safety from postpartum (PP) Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW n=2 Participants Neonates and infants born to mothers from Group 2 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 3 (Neonates and Infants): 45 mg/kg BLW n=4 Participants Neonates and infants born to mothers from Group 3 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 4 (Neonates and Infants): 45 mg/kg TAW n=3 Participants Neonates and infants born to mothers from Group 4 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Total n=25 Participants Total of all reporting groups
Sex: Female, Male Male	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants	0 Participants n=11 Participants	1 Participants n=12 Participants	4 Participants n=4 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Age, Continuous	38.7 Years STANDARD_DEVIATION 1.53 • n=158 Participants • The total column presents the mean and standard deviation for only maternal participants.	37.0 Years STANDARD_DEVIATION 1.41 • n=157 Participants • The total column presents the mean and standard deviation for only maternal participants.	38.3 Years STANDARD_DEVIATION 4.43 • n=315 Participants • The total column presents the mean and standard deviation for only maternal participants.	30.8 Years STANDARD_DEVIATION 4.19 • n=153 Participants • The total column presents the mean and standard deviation for only maternal participants.	0 Years STANDARD_DEVIATION 0 • n=11 Participants • The total column presents the mean and standard deviation for only maternal participants.	0 Years STANDARD_DEVIATION 0 • n=12 Participants • The total column presents the mean and standard deviation for only maternal participants.	0 Years STANDARD_DEVIATION 0 • n=4 Participants • The total column presents the mean and standard deviation for only maternal participants.	0 Years STANDARD_DEVIATION 0 • n=5 Participants • The total column presents the mean and standard deviation for only maternal participants.	35.8 Years STANDARD_DEVIATION 4.76 • n=4 Participants • The total column presents the mean and standard deviation for only maternal participants.
Sex: Female, Male Female	3 Participants n=158 Participants	2 Participants n=157 Participants	4 Participants n=315 Participants	4 Participants n=153 Participants	3 Participants n=11 Participants	1 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=158 Participants	2 Participants n=157 Participants	4 Participants n=315 Participants	4 Participants n=153 Participants	3 Participants n=11 Participants	2 Participants n=12 Participants	3 Participants n=4 Participants	3 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	1 Participants n=4 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants	1 Participants n=11 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	2 Participants n=158 Participants	2 Participants n=157 Participants	4 Participants n=315 Participants	4 Participants n=153 Participants	2 Participants n=11 Participants	2 Participants n=12 Participants	4 Participants n=4 Participants	3 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment Australia	0 Participants n=158 Participants	0 Participants n=157 Participants	2 Participants n=315 Participants	1 Participants n=153 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	2 Participants n=4 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment Belgium	1 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants	1 Participants n=11 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment Germany	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	2 Participants n=153 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment Netherlands	0 Participants n=158 Participants	0 Participants n=157 Participants	1 Participants n=315 Participants	1 Participants n=153 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	1 Participants n=4 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment Sweden	0 Participants n=158 Participants	1 Participants n=157 Participants	1 Participants n=315 Participants	0 Participants n=153 Participants	0 Participants n=11 Participants	1 Participants n=12 Participants	1 Participants n=4 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment United Kingdom	0 Participants n=158 Participants	1 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants	0 Participants n=11 Participants	1 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	2 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants	0 Participants n=153 Participants	2 Participants n=11 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: From baseline (Gestational Age [GA] Week 14) up to Postpartum (PP) Week 24 (up to 50 weeks)

Population: Safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs)	3 Participants	2 Participants	4 Participants	4 Participants	13 Participants

PRIMARY outcome

Timeframe: From Birth (PP Day 0) up to PP Week 96

Population: Neonates or infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Number of Neonates/Infants With Adverse Events (AEs)	3 Participants	2 Participants	4 Participants	3 Participants	12 Participants

PRIMARY outcome

Timeframe: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)

Population: Safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Number of Maternal Participants With Treatment-emergent Serious Adverse Events (TESAEs)	2 Participants	0 Participants	1 Participants	2 Participants	5 Participants

PRIMARY outcome

Timeframe: From Birth (PP Day 0) up to PP Week 96

Population: Neonates or infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Number of Neonates/Infants With Serious Adverse Events (SAEs)	2 Participants	1 Participants	1 Participants	2 Participants	6 Participants

PRIMARY outcome

Timeframe: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)

Population: Safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Number of Maternal Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs) Hypoalbuminemia <20 g/L	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Maternal Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs) Infections: Treatment with Oral /Intravenous	1 Participants	1 Participants	1 Participants	2 Participants	5 Participants
Number of Maternal Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs) Overall AESIs	1 Participants	1 Participants	1 Participants	2 Participants	5 Participants

PRIMARY outcome

Timeframe: From birth (PP Day 0) up to PP Week 96

Population: Neonates or infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Number of Neonates/Infants With Adverse Events of Special Interest (AESIs) Overall AESI	1 Participants	2 Participants	0 Participants	1 Participants	4 Participants
Number of Neonates/Infants With Adverse Events of Special Interest (AESIs) IgG Concentrations <200 mg/dL	1 Participants	2 Participants	0 Participants	0 Participants	3 Participants
Number of Neonates/Infants With Adverse Events of Special Interest (AESIs) Infections: Treatment with Oral /Intravenous	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Neonates/Infants With Adverse Events of Special Interest (AESIs) Unexpected/Unusual Childhood Illnesses	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (GA Week 14)

Population: The full analysis set (FAS) included all maternal participants who received any dose of nipocalimab.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline	77.0 Beats per minute Standard Deviation 10.58	77.5 Beats per minute Standard Deviation 3.54	63.0 Beats per minute Standard Deviation 5.35	76.3 Beats per minute Standard Deviation 8.42	72.5 Beats per minute Standard Deviation 9.41

PRIMARY outcome

Timeframe: GA Week 36

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=8 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at GA Week 36	89.0 Beats per minute Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	77.0 Beats per minute Standard Deviation 21.21	80.7 Beats per minute Standard Deviation 7.51	77.0 Beats per minute Standard Deviation 21.21	79.9 Beats per minute Standard Deviation 12.71

PRIMARY outcome

Timeframe: Baseline (GA Week 14) and GA Week 36

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=8 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Change From Baseline in ECG Parameter- Mean Ventricular Rate	8.0 Beats per minute Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	-0.5 Beats per minute Standard Deviation 24.75	16.7 Beats per minute Standard Deviation 7.37	8.0 Beats per minute Standard Deviation 22.63	9.1 Beats per minute Standard Deviation 15.08

PRIMARY outcome

Timeframe: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)

Population: The safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab. Here, n (number analyzed): number of participants evaluable for each category. n=0 signifies no participant was available for the analysis.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time Post Birth: LDL >2.586 mmol/L	—	1 Participants	2 Participants	3 Participants	6 Participants
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time During pregnancy: Cholesterol >9.025 millimoles per liter (mmol/L)	1 Participants	2 Participants	3 Participants	2 Participants	8 Participants
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time During pregnancy: LDL >5.793 mmol/L	—	0 Participants	1 Participants	2 Participants	3 Participants
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time During pregnancy: HDL Cholesterol <1.2413 mmol/L	—	0 Participants	0 Participants	0 Participants	0 Participants
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time During pregnancy: Triglycerides >5.114 mmol/L	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time During pregnancy: Albumin <20 grams per Liter (g/L)	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time During pregnancy: Immunoglobulin G <1 g/L	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time Post Birth: Cholesterol >5.172 mmol/L	3 Participants	2 Participants	4 Participants	2 Participants	11 Participants
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time Post Birth: HDL <1.0344 mmol/L	—	0 Participants	1 Participants	0 Participants	1 Participants
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time Post Birth: Triglycerides >1.6935 mmol/L	1 Participants	1 Participants	3 Participants	2 Participants	7 Participants
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time Post Birth: Albumin <20 g/L	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time Post Birth: Immunoglobulin G <1 g/L	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Birth (PP Day 0) up to PP Week 96

Population: The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Only those categories in which at least one neonates or Infants had data were reported in this outcome measure.

Laboratory parameters included total bilirubin and biomarker included immunoglobulin G (IgG).

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Number of Neonates or Infants With Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time Immunoglobulin G < 2 g/L	2 Participants	2 Participants	4 Participants	2 Participants	10 Participants
Number of Neonates or Infants With Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time Total Bilirubin >136.8 mmol/L	1 Participants	1 Participants	3 Participants	3 Participants	8 Participants
Number of Neonates or Infants With Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time Immunoglobulin G < 1 g/L	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline (GA Week 14)

Population: The FAS included all maternal participants who received any dose of nipocalimab.

Absolute value of vital signs - body temperature at baseline in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Body Temperature at Baseline	36.6 Degree Celsius Standard Deviation 0.1	37.0 Degree Celsius Standard Deviation 0.5	37.2 Degree Celsius Standard Deviation 0.5	36.8 Degree Celsius Standard Deviation 0.8	36.9 Degree Celsius Standard Deviation 0.6

PRIMARY outcome

Timeframe: GA Week 36

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Absolute value of vital signs - body temperature at GA Week 36 in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=7 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Body Temperature at GA Week 36	36.7 Degree Celsius Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	36.8 Degree Celsius Standard Deviation 0.0	37.1 Degree Celsius Standard Deviation 0.5	36.0 Degree Celsius Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	36.8 Degree Celsius Standard Deviation 0.5

PRIMARY outcome

Timeframe: PP Week 24

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Absolute value of vital signs - body temperature at PP Week 24 in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Body Temperature at PP Week 24	36.5 Degree Celsius Standard Deviation 0.1	36.8 Degree Celsius Standard Deviation 0.3	36.8 Degree Celsius Standard Deviation 0.3	36.7 Degree Celsius Standard Deviation 0.5	36.7 Degree Celsius Standard Deviation 0.3

PRIMARY outcome

Timeframe: Baseline (GA Week 14), GA Week 36, and PP Week 24

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and n (number analyzed) signifies number of participants evaluable at specified timepoints.

Change from baseline in vital signs- body temperature in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Change From Baseline in Vital Sign - Body Temperature GA Week 36	0.0 Degree Celsius Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	-0.2 Degree Celsius Standard Deviation 0.5	-0.2 Degree Celsius Standard Deviation 0.0	0.2 Degree Celsius Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	-0.1 Degree Celsius Standard Deviation 0.3
Maternal Participants: Change From Baseline in Vital Sign - Body Temperature PP Week 24	-0.1 Degree Celsius Standard Deviation 0.1	-0.2 Degree Celsius Standard Deviation 0.2	-0.5 Degree Celsius Standard Deviation 0.7	-0.1 Degree Celsius Standard Deviation 1.0	-0.2 Degree Celsius Standard Deviation 0.7

PRIMARY outcome

Timeframe: Baseline (GA Week 14)

Population: The FAS included all maternal participants who received any dose of nipocalimab.

Absolute value of vital signs -respiratory rate at baseline in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at Baseline	17.0 breaths per minute Standard Deviation 1.7	19.0 breaths per minute Standard Deviation 1.4	15.5 breaths per minute Standard Deviation 3.4	18.0 breaths per minute Standard Deviation 2.8	17.2 breaths per minute Standard Deviation 2.7

PRIMARY outcome

Timeframe: GA Week 36

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Absolute value of vital signs -respiratory rate at GA Week 36 in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=7 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at GA Week 36	20.0 Breaths per minute Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	18.0 Breaths per minute Standard Deviation 0.0	16.3 Breaths per minute Standard Deviation 3.2	17.0 Breaths per minute Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	17.4 Breaths per minute Standard Deviation 2.3

PRIMARY outcome

Timeframe: PP Week 24

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Absolute value of vital signs - respiratory rate at PP Week 24 in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24	16.5 Breaths per minute Standard Deviation 2.1	15.5 Breaths per minute Standard Deviation 2.1	15.8 Breaths per minute Standard Deviation 3.9	17.3 Breaths per minute Standard Deviation 3.6	16.3 Breaths per minute Standard Deviation 3.0

PRIMARY outcome

Timeframe: Baseline (GA Week 14), GA Week 36, and PP Week 24

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies number of participants evaluable at specified timepoints.

Change from baseline in vital signs- respiratory rate in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Change From Baseline in Vital Sign - Respiratory Rate GA Week 36	2.0 Breaths per minute Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	-1.0 Breaths per minute Standard Deviation 1.4	1.0 Breaths per minute Standard Deviation 1.0	1.0 Breaths per minute Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.6 Breaths per minute Standard Deviation 1.4
Maternal Participants: Change From Baseline in Vital Sign - Respiratory Rate PP Week 24	0.0 Breaths per minute Standard Deviation 0.0	-3.5 Breaths per minute Standard Deviation 0.7	0.3 Breaths per minute Standard Deviation 1.3	-0.8 Breaths per minute Standard Deviation 3.0	-0.8 Breaths per minute Standard Deviation 2.2

PRIMARY outcome

Timeframe: Baseline (GA Week 14)

Population: The FAS included all maternal participants who received any dose of nipocalimab.

Absolute value of vital signs - pulse rate at baseline in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at Baseline	81.3 Beats per minute Standard Deviation 8.7	81.0 Beats per minute Standard Deviation 8.5	67.5 Beats per minute Standard Deviation 4.2	73.5 Beats per minute Standard Deviation 8.9	74.6 Beats per minute Standard Deviation 8.8

PRIMARY outcome

Timeframe: GA Week 36

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Absolute value of vital signs -pulse rate at GA Week 36 in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=7 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at GA Week 36	88.0 beats per minute Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	95.0 beats per minute Standard Deviation 17.0	84.0 beats per minute Standard Deviation 9.5	100.0 beats per minute Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	90.0 beats per minute Standard Deviation 11.0

PRIMARY outcome

Timeframe: PP Week 24

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Absolute value of vital signs -pulse rate at PP Week 24 in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs -Pulse Rate at PP Week 24	73.0 Beats per minute Standard Deviation 2.8	75.0 Beats per minute Standard Deviation 4.2	69.8 Beats per minute Standard Deviation 10.2	77.8 Beats per minute Standard Deviation 4.1	73.8 Beats per minute Standard Deviation 6.9

PRIMARY outcome

Timeframe: Baseline (GA Week 14), GA Week 36, and PP Week 24

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified timepoints.

Change from baseline in vital signs -pulse rate in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Change From Baseline in Vital Sign - Pulse Rate GA Week 36	-3.0 Beats per minute Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	14.0 Beats per minute Standard Deviation 8.5	15.0 Beats per minute Standard Deviation 6.1	29.0 Beats per minute Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	14.1 Beats per minute Standard Deviation 10.5
Maternal Participants: Change From Baseline in Vital Sign - Pulse Rate PP Week 24	-3.5 Beats per minute Standard Deviation 6.4	-6.0 Beats per minute Standard Deviation 4.2	2.3 Beats per minute Standard Deviation 8.5	4.3 Beats per minute Standard Deviation 11.4	0.6 Beats per minute Standard Deviation 8.8

PRIMARY outcome

Timeframe: Baseline (GA Week 14)

Population: The FAS included all maternal participants who received any dose of nipocalimab.

Absolute value of vital signs - SBP and DBP at baseline in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline SBP	112.0 Millimeter of mercury Standard Deviation 11.3	100.5 Millimeter of mercury Standard Deviation 3.5	102.3 Millimeter of mercury Standard Deviation 4.6	104.8 Millimeter of mercury Standard Deviation 12.4	105.0 Millimeter of mercury Standard Deviation 9.2
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline DBP	68.7 Millimeter of mercury Standard Deviation 3.5	59.5 Millimeter of mercury Standard Deviation 3.5	63.3 Millimeter of mercury Standard Deviation 6.9	64.5 Millimeter of mercury Standard Deviation 10.8	64.3 Millimeter of mercury Standard Deviation 7.3

PRIMARY outcome

Timeframe: GA Week 36

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Absolute value of vital signs -SBP and DBP at GA Week 36 in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=8 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at GA Week 36 SBP	134.0 Millimeter of mercury (mmHg) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	105.0 Millimeter of mercury (mmHg) Standard Deviation 8.5	107.3 Millimeter of mercury (mmHg) Standard Deviation 9.6	110.5 Millimeter of mercury (mmHg) Standard Deviation 7.8	110.9 Millimeter of mercury (mmHg) Standard Deviation 11.7
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at GA Week 36 DBP	70.0 Millimeter of mercury (mmHg) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	73.0 Millimeter of mercury (mmHg) Standard Deviation 5.7	66.3 Millimeter of mercury (mmHg) Standard Deviation 4.2	69.0 Millimeter of mercury (mmHg) Standard Deviation 5.7	69.1 Millimeter of mercury (mmHg) Standard Deviation 4.7

PRIMARY outcome

Timeframe: PP Week 24

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Absolute value of vital signs - SBP and DBP at PP Week 24 in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24 SBP	117.5 Millimeters of mercury Standard Deviation 14.8	110.5 Millimeters of mercury Standard Deviation 14.8	112.3 Millimeters of mercury Standard Deviation 4.0	118.8 Millimeters of mercury Standard Deviation 9.9	115.0 Millimeters of mercury Standard Deviation 9.2
Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24 DBP	73.5 Millimeters of mercury Standard Deviation 10.6	69.5 Millimeters of mercury Standard Deviation 6.4	71.3 Millimeters of mercury Standard Deviation 6.2	71.8 Millimeters of mercury Standard Deviation 1.7	71.5 Millimeters of mercury Standard Deviation 5.2

PRIMARY outcome

Timeframe: Baseline (GA Week 14), GA Week 36, and PP Week 24

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and n (number analyzed): number of participants evaluable for specified categories and timepoints.

Change from baseline in vital signs -SBP and DBP in maternal participants were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Change From Baseline in Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: GA Week 36	15.0 Millimeters of mercury Standard Deviation NA "NA signifies that SD could not be calculated for a single participant.	4.5 Millimeters of mercury Standard Deviation 4.9	5.0 Millimeters of mercury Standard Deviation 13.0	5.0 Millimeters of mercury Standard Deviation 22.6	6.1 Millimeters of mercury Standard Deviation 11.7
Maternal Participants: Change From Baseline in Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: PP Week 24	9.0 Millimeters of mercury Standard Deviation 1.4	10.0 Millimeters of mercury Standard Deviation 11.3	10.0 Millimeters of mercury Standard Deviation 4.2	14.0 Millimeters of mercury Standard Deviation 7.0	11.2 Millimeters of mercury Standard Deviation 5.9
Maternal Participants: Change From Baseline in Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: GA Week 36	-2.0 Millimeters of mercury Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	13.5 Millimeters of mercury Standard Deviation 2.1	3.0 Millimeters of mercury Standard Deviation 9.8	6.5 Millimeters of mercury Standard Deviation 23.3	5.9 Millimeters of mercury Standard Deviation 11.6
Maternal Participants: Change From Baseline in Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: PP Week 24	6.5 Millimeters of mercury Standard Deviation 7.8	10.0 Millimeters of mercury Standard Deviation 2.8	8.0 Millimeters of mercury Standard Deviation 10.2	7.3 Millimeters of mercury Standard Deviation 11.8	7.8 Millimeters of mercury Standard Deviation 8.6

PRIMARY outcome

Timeframe: Baseline (GA Week 14)

Population: The FAS included all maternal participants who received any dose of nipocalimab.

Absolute value of vital signs - body weight at baseline in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Body Weight at Baseline	76.0 Kilograms Standard Deviation 29.7	64.0 Kilograms Standard Deviation 12.7	71.8 Kilograms Standard Deviation 8.8	75.8 Kilograms Standard Deviation 18.0	72.8 Kilograms Standard Deviation 16.7

PRIMARY outcome

Timeframe: GA Week 36

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Absolute value of vital signs -body weight at GA Week 36 in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=8 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Body Weight at GA Week 36	130.6 Kilograms Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	77.6 Kilograms Standard Deviation 15.6	80.8 Kilograms Standard Deviation 7.9	87.3 Kilograms Standard Deviation 14.9	87.8 Kilograms Standard Deviation 19.9

PRIMARY outcome

Timeframe: PP Week 24

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Absolute value of vital signs included body weight at PP Week 24 in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Absolute Value of Vital Signs - Body Weight at PP Week 24	60.1 Kilograms Standard Deviation 8.0	69.5 Kilograms Standard Deviation 13.4	71.3 Kilograms Standard Deviation 11.1	78.0 Kilograms Standard Deviation 20.1	71.4 Kilograms Standard Deviation 14.3

PRIMARY outcome

Timeframe: Baseline (GA Week 14), GA Week 36, and PP Week 24

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants evaluable for specified timepoints.

Change from baseline in vital signs- body weight in maternal participants was reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Change From Baseline in Vital Sign - Body Weight GA Week 36	20.6 Kilograms Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	13.6 Kilograms Standard Deviation 3.0	8.6 Kilograms Standard Deviation 2.9	7.7 Kilograms Standard Deviation 1.4	11.1 Kilograms Standard Deviation 5.0
Maternal Participants: Change From Baseline in Vital Sign - Body Weight PP Week 24	1.0 Kilograms Standard Deviation 2.4	5.6 Kilograms Standard Deviation 0.8	-0.5 Kilograms Standard Deviation 4.6	2.2 Kilograms Standard Deviation 2.9	1.7 Kilograms Standard Deviation 3.6

PRIMARY outcome

Timeframe: Baseline (PP Day 0)

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies number of neonates or infants evaluable for this outcome measure.

Absolute value in vital signs parameter -body temperature at baseline was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=10 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at Baseline	36.7 Degree Celsius Standard Deviation 0.4	36.8 Degree Celsius Standard Deviation 0.1	36.5 Degree Celsius Standard Deviation 0.1	36.7 Degree Celsius Standard Deviation 0.1	36.7 Degree Celsius Standard Deviation 0.2

PRIMARY outcome

Timeframe: PP Week 1

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies number of neonates or infants evaluable for this outcome measure.

Absolute value of vital signs parameter -body temperature at PP Week 1 was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=8 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Signs - Body Temperature at PP Week 1	37.1 Degree Celsius Standard Deviation 0.3	36.9 Degree Celsius Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	36.8 Degree Celsius Standard Deviation 0.1	37.1 Degree Celsius Standard Deviation 0.2	37.0 Degree Celsius Standard Deviation 0.2

PRIMARY outcome

Timeframe: PP Week 4

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies number of neonates or infants evaluable for this outcome measure.

Absolute value in vital signs parameter - body temperature at PP Week 4 was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=10 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 4	36.8 Degree Celsius Standard Deviation 0.5	37.1 Degree Celsius Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	37.0 Degree Celsius Standard Deviation 0.5	37.2 Degree Celsius Standard Deviation 0.1	37.0 Degree Celsius Standard Deviation 0.4

PRIMARY outcome

Timeframe: PP Week 24

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies number of neonates or infants evaluable for this outcome measure.

Absolute value in vital signs parameter -body temperature at PP Week 24 was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=10 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 24	36.5 Degree Celsius Standard Deviation 0.3	36.5 Degree Celsius Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	37.1 Degree Celsius Standard Deviation 0.4	37.5 Degree Celsius Standard Deviation 0.5	37.0 Degree Celsius Standard Deviation 0.5

PRIMARY outcome

Timeframe: Baseline (PP Day 0), PP Weeks 1, 4, and 24

Population: Neonates/infants analysis set: all live births to maternal participants who received at least 1 dose of nipocalimab. N (overall number of participants analyzed): number of neonate/infants evaluable, n (number analyzed): number of neonates/infants evaluable at specified timepoints. Only neonates/infants that had both baseline and post-baseline data available at a timepoint were analyzed. 2 participants with post-baseline but no baseline data were excluded.

Change from baseline in vital signs- body temperature were reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=8 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Change From Baseline in Vital Signs - Body Temperature PP Week 1	0.2 Degree Celsius Standard Deviation 0.4	0.1 Degree Celsius Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	0.3 Degree Celsius Standard Deviation 0.1	0.3 Degree Celsius Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	0.2 Degree Celsius Standard Deviation 0.2
Neonates/Infants: Change From Baseline in Vital Signs - Body Temperature PP Week 4	0.2 Degree Celsius Standard Deviation 0.1	0.4 Degree Celsius Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	0.6 Degree Celsius Standard Deviation 0.6	0.6 Degree Celsius Standard Deviation 0.1	0.5 Degree Celsius Standard Deviation 0.4
Neonates/Infants: Change From Baseline in Vital Signs - Body Temperature PP Week 24	-0.4 Degree Celsius Standard Deviation 0.4	-0.2 Degree Celsius Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	0.6 Degree Celsius Standard Deviation 0.5	1.0 Degree Celsius Standard Deviation 0.6	0.3 Degree Celsius Standard Deviation 0.7

PRIMARY outcome

Timeframe: Baseline (PP Day 0)

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy.

Absolute value of vital signs parameter- body weight at baseline was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at Baseline	2.4 Kilograms Standard Deviation 1.6	2.8 Kilograms Standard Deviation 0.4	2.8 Kilograms Standard Deviation 0.2	2.8 Kilograms Standard Deviation 0.4	2.7 Kilograms Standard Deviation 0.7

PRIMARY outcome

Timeframe: PP Week 1

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies the number of neonates or infants evaluable for this outcome measure.

Absolute value of vital signs parameter - body weight at PP Week 1 was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=10 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 1	1.6 Kilograms Standard Deviation 1.1	2.8 Kilograms Standard Deviation 0.5	2.7 Kilograms Standard Deviation 0.2	2.6 Kilograms Standard Deviation 0.3	2.5 Kilograms Standard Deviation 0.6

PRIMARY outcome

Timeframe: PP Week 4

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy.

Absolute value of vital signs parameter - body weight at PP Week 4 was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 4	2.6 Kilograms Standard Deviation 1.3	3.6 Kilograms Standard Deviation 1.1	3.4 Kilograms Standard Deviation 0.1	3.7 Kilograms Standard Deviation 0.7	3.3 Kilograms Standard Deviation 0.8

PRIMARY outcome

Timeframe: PP Week 24

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy.

Absolute value of vital signs parameter - body weight at PP Week 24 was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 24	6.4 Kilograms Standard Deviation 1.4	7.4 Kilograms Standard Deviation 1.6	7.6 Kilograms Standard Deviation 1.0	8.1 Kilograms Standard Deviation 0.6	7.4 Kilograms Standard Deviation 1.2

PRIMARY outcome

Timeframe: Baseline (PP Day 0), PP Weeks 1, 4, and 24

Population: Neonates/infants analysis set: all live births to maternal participants who received at least 1 dose of nipocalimab. 'n' (number analyzed): number of neonates/infants evaluable at specified timepoints.

Change from baseline in vital signs - body weight were reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Change From Baseline in Vital Signs -Body Weight PP Week 1	-0.1 Kilograms Standard Deviation 0.0	0.0 Kilograms Standard Deviation 0.1	-0.1 Kilograms Standard Deviation 0.1	-0.1 Kilograms Standard Deviation 0.1	-0.1 Kilograms Standard Deviation 0.1
Neonates/Infants: Change From Baseline in Vital Signs -Body Weight PP Week 4	0.2 Kilograms Standard Deviation 0.3	0.8 Kilograms Standard Deviation 0.7	0.6 Kilograms Standard Deviation 0.4	0.9 Kilograms Standard Deviation 0.3	0.6 Kilograms Standard Deviation 0.4
Neonates/Infants: Change From Baseline in Vital Signs -Body Weight PP Week 24	4.0 Kilograms Standard Deviation 0.3	4.5 Kilograms Standard Deviation 1.2	4.8 Kilograms Standard Deviation 1.1	5.3 Kilograms Standard Deviation 0.8	4.7 Kilograms Standard Deviation 0.9

PRIMARY outcome

Timeframe: Baseline (PP Day 0)

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies the number of neonates or infants evaluable for this outcome measure.

Absolute value of vital signs parameter -respiratory rate at baseline was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=10 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at Baseline	39.0 Breaths per minute Standard Deviation 7.1	47.0 Breaths per minute Standard Deviation 2.8	42.0 Breaths per minute Standard Deviation 5.2	49.5 Breaths per minute Standard Deviation 17.7	43.9 Breaths per minute Standard Deviation 8.1

PRIMARY outcome

Timeframe: PP Week 1

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies the number of neonates or infants evaluable for this outcome measure.

Absolute value of vital signs parameter - respiratory rate at PP Week 1 was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=8 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 1	36.0 Breaths per minute Standard Deviation 17.0	52.0 Breaths per minute Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	35.3 Breaths per minute Standard Deviation 1.2	54.0 Breaths per minute Standard Deviation 15.6	42.3 Breaths per minute Standard Deviation 12.7

PRIMARY outcome

Timeframe: PP Week 4

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies the number of neonates or infants evaluable for this outcome measure.

Absolute value of vital signs parameter - respiratory rate at PP Week 4 was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=8 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 4	69.0 Breaths per minute Standard Deviation 19.8	68.0 Breaths per minute Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	46.5 Breaths per minute Standard Deviation 5.5	40.0 Breaths per minute Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	54.0 Breaths per minute Standard Deviation 14.9

PRIMARY outcome

Timeframe: PP Week 24

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies the number of neonates or infants evaluable for this outcome measure.

Absolute value of vital signs parameter- respiratory rate at PP Week 24 was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=10 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24	29.0 Breaths per minute Standard Deviation 9.9	32.0 Breaths per minute Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	45.3 Breaths per minute Standard Deviation 12.3	35.0 Breaths per minute Standard Deviation 7.8	37.6 Breaths per minute Standard Deviation 11.1

PRIMARY outcome

Timeframe: Baseline (PP Day 0), PP Weeks 1, 4, and 24

Population: Neonates/infants analysis set: all live births to maternal participants who received at least 1 dose of nipocalimab. N (overall number of participants analyzed): number of neonate/infants evaluable, n (number analyzed): number of neonates/infants evaluable at specified timepoints. Only neonates/infants that had both baseline and post-baseline data available at a timepoint were analyzed. 2 participants with post-baseline but no baseline data were excluded.

Change from baseline in vital signs -respiratory rate was reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=9 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Change From Baseline in Vital Signs - Respiratory Rate PP Week 1	-10.0 breaths per minute Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	3.0 breaths per minute Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	-7.3 breaths per minute Standard Deviation 7.0	6.0 breaths per minute Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	-3.8 breaths per minute Standard Deviation 8.0
Neonates/Infants: Change From Baseline in Vital Signs - Respiratory Rate PP Week 4	30.0 breaths per minute Standard Deviation 26.9	23.0 breaths per minute Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	4.5 breaths per minute Standard Deviation 8.4	3.0 breaths per minute Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	13.0 breaths per minute Standard Deviation 16.9
Neonates/Infants: Change From Baseline in Vital Signs - Respiratory Rate PP Week 24	-12.0 breaths per minute Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	-13.0 breaths per minute Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	3.3 breaths per minute Standard Deviation 16.0	-16.5 breaths per minute Standard Deviation 27.6	-5.6 breaths per minute Standard Deviation 17.6

PRIMARY outcome

Timeframe: Baseline (PP Day 0)

Population: Neonates/infants analysis set: all live births to maternal participants who received at least 1 dose of nipocalimab. Here, 'N' (overall number of participants analyzed): number of neonate/infants evaluable. N=0 in 'Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW' arm signifies that no data was collected because participants did not complete the scheduled assessments.

Absolute value of vital signs parameter - SBP and DBP at baseline were reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=7 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline SBP	73.7 Millimeters of mercury Standard Deviation 7.4	—	61.5 Millimeters of mercury Standard Deviation 19.1	61.5 Millimeters of mercury Standard Deviation 4.9	66.7 Millimeters of mercury Standard Deviation 11.2
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline DBP	39.0 Millimeters of mercury Standard Deviation 2.6	—	32.0 Millimeters of mercury Standard Deviation 5.7	31.5 Millimeters of mercury Standard Deviation 7.8	34.9 Millimeters of mercury Standard Deviation 5.7

PRIMARY outcome

Timeframe: PP Week 1

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies the number of neonates or infants evaluable for this outcome measure. N=0 in 'Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW' arm signifies that no data was collected because participants did not complete the scheduled assessments.

Absolute value of vital signs parameter - SBP and DBP at PP Week 1 were reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=4 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 1 SBP	62.5 Millimeters of mercury Standard Deviation 2.1	—	75.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	65.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	66.3 Millimeters of mercury Standard Deviation 6.1
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 1 DBP	50.0 Millimeters of mercury Standard Deviation 1.4	—	39.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	31.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant	42.5 Millimeters of mercury Standard Deviation 9.3

PRIMARY outcome

Timeframe: PP Week 4

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies the number of neonates or infants evaluable for this outcome measure. N=0 in 'Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW' arm signifies that no data was collected because participants did not complete the scheduled assessments.

Absolute value of vital signs parameter -SBP and DBP at PP Week 4 were reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=4 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 4 SBP	61.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	—	76.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	98.0 Millimeters of mercury Standard Deviation 4.2	83.3 Millimeters of mercury Standard Deviation 18.3
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 4 DBP	31.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	—	30.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	59.0 Millimeters of mercury Standard Deviation 11.3	44.8 Millimeters of mercury Standard Deviation 17.7

PRIMARY outcome

Timeframe: PP Week 24

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies the number of neonates or infants evaluable for this outcome measure. N=0 in 'Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW' arm signifies that no data was collected because participants did not complete the scheduled assessments.

Absolute value of vital signs parameter -SBP and DBP at PP Week 24 were reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=5 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24 SBP	101.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	—	113.0 Millimeters of mercury Standard Deviation 36.8	103.5 Millimeters of mercury Standard Deviation 9.2	106.8 Millimeters of mercury Standard Deviation 19.8
Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24 DBP	68.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	—	92.5 Millimeters of mercury Standard Deviation 26.2	58.0 Millimeters of mercury Standard Deviation 9.9	73.8 Millimeters of mercury Standard Deviation 22.4

PRIMARY outcome

Timeframe: Baseline (PP Day 0), PP Weeks 1, 4, and 24

Population: Neonates/infants analysis set was a use. N: number of neonate/infants evaluable, n (number analyzed): number of neonates/infants evaluable at specified timepoints. Only neonates/infants with both baseline and post-baseline data at a timepoint were analyzed. 2 participants with post-baseline but no baseline data were excluded. N=0 in 'Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW' arm signifies no data was collected because participants did not complete the scheduled assessments.

Change from baseline in vital signs- SBP and DBP were reported for all neonates/infants.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=5 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Change From Baseline in Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: PP Week 1	11.5 Millimeters of mercury Standard Deviation 4.9	—	11.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	-6.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	7.0 Millimeters of mercury Standard Deviation 9.1
Neonates/Infants: Change From Baseline in Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: PP Week 4	-10.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	—	2.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	27.5 Millimeters of mercury Standard Deviation 19.1	11.8 Millimeters of mercury Standard Deviation 21.8
Neonates/Infants: Change From Baseline in Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: PP Week 24	32.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	—	46.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	39.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	39.0 Millimeters of mercury Standard Deviation 7.0
Neonates/Infants: Change From Baseline in Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: PP Week 1	-7.0 Millimeters of mercury Standard Deviation 4.2	—	27.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	0.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	3.3 Millimeters of mercury Standard Deviation 16.4
Neonates/Infants: Change From Baseline in Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: PP Week 4	-10.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	—	28.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	36.5 Millimeters of mercury Standard Deviation 9.2	22.8 Millimeters of mercury Standard Deviation 22.8
Neonates/Infants: Change From Baseline in Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: PP Week 24	33.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	—	39.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	52.0 Millimeters of mercury Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	41.3 Millimeters of mercury Standard Deviation 9.7

PRIMARY outcome

Timeframe: Baseline (GA Week 14), GA Weeks 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, n (number analyzed) signifies number of participants evaluable at specified timepoints and n=0 signifies that no participants were available for the analysis.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments GA Week 16	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments GA Week 20	50.0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	9.1 Percentage of maternal participants
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments GA Week 24	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments GA Week 28	0 Percentage of maternal participants	50.0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	8.3 Percentage of maternal participants
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments GA Week 32	0 Percentage of maternal participants	100.0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	10.0 Percentage of maternal participants
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments GA Week 36	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments Baseline	0 Percentage of maternal participants	—	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments GA Week 18	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments GA Week 22	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments GA Week 26	0 Percentage of maternal participants	50.0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	8.3 Percentage of maternal participants
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments GA Week 30	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants
Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments GA Week 34	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants

PRIMARY outcome

Timeframe: Baseline (GA Week 14)

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: Amniotic Fluid Index (AFI) at Baseline	0 Percentage of maternal participants	50.0 Percentage of maternal participants	50.0 Percentage of maternal participants	0 Percentage of maternal participants	25.0 Percentage of maternal participants

PRIMARY outcome

Timeframe: GA Week 26

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure. Data was not collected and analyzed for Group 2 as no participant was available for the analysis at the specified timepoint.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=8 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: AFI at GA Week 26	0 Percentage of maternal participants	—	25.0 Percentage of maternal participants	0 Percentage of maternal participants	12.5 Percentage of maternal participants

PRIMARY outcome

Timeframe: GA Week 36

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=7 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: AFI at GA Week 36	0 Percentage of maternal participants	0 Percentage of maternal participants	33.3 Percentage of maternal participants	0 Percentage of maternal participants	14.3 Percentage of maternal participants

PRIMARY outcome

Timeframe: From Baseline (GA Week 14)

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=9 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: Maximum Vertical Pocket (MVP) at Baseline	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants

PRIMARY outcome

Timeframe: GA Week 18

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: MVP at GA Week 18	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	25.0 Percentage of maternal participants	8.3 Percentage of maternal participants

PRIMARY outcome

Timeframe: GA Week 22

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: MVP at GA Week 22	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants	0 Percentage of maternal participants

PRIMARY outcome

Timeframe: 1, 5, and 10 minutes after birth at PP Day 0

Population: Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, n (number analyzed): number of neonates or infants evaluable for each arm at specified time points.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score 1 minute: 5-7 Score	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score 5 minute: 8-10 Score	3 Participants	2 Participants	4 Participants	2 Participants	11 Participants
Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score 10 minute: <5 Score	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score 1 minute: <5 Score	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score 1 minute: 8-10 Score	2 Participants	2 Participants	3 Participants	2 Participants	9 Participants
Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score 5 minute: <5 Score	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score 5 minute: 5-7 Score	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score 10 minute: 5-7 Score	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score 10 minute: 8-10 Score	1 Participants	2 Participants	2 Participants	1 Participants	6 Participants

PRIMARY outcome

Timeframe: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)

Population: Safety analysis set included all maternal participants who received at least 1 dose of nipocalimab.

Number of maternal participants with concomitant medications and therapies were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Number of Maternal Participants With Concomitant Medications and Therapies	3 Participants	2 Participants	4 Participants	4 Participants	13 Participants

PRIMARY outcome

Timeframe: From birth (PP Day 0) up to PP Week 96

Population: The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy.

Number of neonates/infants with concomitant medications and therapies were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Number of Neonates/Infants With Concomitant Medications and Therapies	3 Participants	2 Participants	4 Participants	3 Participants	12 Participants

PRIMARY outcome

Timeframe: From baseline (GA Week 14) up to GA Week 37

Population: The FAS included all maternal participants who received any dose of nipocalimab.

Percentage of maternal participants with live birth at or after GA Week 32 and without an IUT throughout their entire pregnancies were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
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 Percentage of maternal participants Interval 0.8 to 90.6	50.0 Percentage of maternal participants Interval 1.3 to 98.7	75.0 Percentage of maternal participants Interval 19.4 to 99.4	50.0 Percentage of maternal participants Interval 6.8 to 93.2	53.8 Percentage of maternal participants Interval 25.1 to 80.8

SECONDARY outcome

Timeframe: From baseline (GA Week 14) up to GA Week 37

Population: The FAS included all maternal participants who received any dose of nipocalimab.

Percentage of maternal participants with live birth were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Maternal Participants With Live Birth	100 Percentage of maternal participants	100 Percentage of maternal participants	100 Percentage of maternal participants	75 Percentage of maternal participants	92.3 Percentage of maternal participants

SECONDARY outcome

Timeframe: From baseline (GA Week 14) up to GA Week 24

Population: FAS included all maternal participants who received any dose of nipocalimab.

Percentage of maternal participants without an IUT before GA Week 24 were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Maternal Participants Without an Intrauterine Transfusion (IUT) Before Gestational Age (GA) Week 24	100 Percentage of maternal participants	100 Percentage of maternal participants	100 Percentage of maternal participants	75 Percentage of maternal participants	92.3 Percentage of maternal participants

SECONDARY outcome

Timeframe: From baseline (GA Week 14) up to GA Week 37

Population: The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Gestational age (GA) at first IUT for maternal participants were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=2 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=6 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants : Gestational Age (GA) at First Intrauterine Transfusion (IUT)	25 weeks Interval 24.0 to 25.0	28 weeks Interval 28.0 to 28.0	29 weeks Interval 29.0 to 29.0	27 weeks Interval 22.0 to 31.0	27 weeks Interval 22.0 to 31.0

SECONDARY outcome

Timeframe: From baseline (GA Week 14) up to GA Week 37

Population: The FAS included all maternal participants who received any dose of nipocalimab.

Median number of intrauterine transfusion (IUT) per maternal participants were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Median Number of Intrauterine Transfusion (IUT) Per Maternal Participant	4 IUTs per maternal participant Interval 3.0 to 5.0	5 IUTs per maternal participant Interval 5.0 to 5.0	3 IUTs per maternal participant Interval 3.0 to 3.0	1 IUTs per maternal participant Interval 1.0 to 1.0	3 IUTs per maternal participant Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: From baseline (GA Week 14) up to GA Week 37

Population: The FAS included all maternal participants who received any dose of nipocalimab.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Frequency of Intrauterine Transfusions (IUTs) on Maternal Participants	0.52 IUT/week Interval 0.48 to 0.57	0.56 IUT/week Interval 0.56 to 0.56	0.43 IUT/week Interval 0.43 to 0.43	0.70 IUT/week Interval 0.64 to 0.78	0.56 IUT/week Interval 0.43 to 0.78

SECONDARY outcome

Timeframe: From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks)

Population: FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Percentage of maternal participants with fetal hydrops in utero or post birth were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Maternal Participants With Fetal Hydrops in Utero or Post Birth	0 Percentage of maternal participants Interval 0.0 to 84.2	0 Percentage of maternal participants Interval 0.0 to 84.2	0 Percentage of maternal participants Interval 0.0 to 60.2	0 Percentage of maternal participants Interval 0.0 to 60.2	0 Percentage of maternal participants Interval 0.0 to 26.5

SECONDARY outcome

Timeframe: From baseline (GA Week 14) up to GA Week 37

Population: FAS included all maternal participants who received any dose of nipocalimab.

Gestational age at time of delivery for maternal participants were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Gestational Age at Time of Delivery	36 Weeks Interval 29.0 to 37.0	36 Weeks Interval 35.0 to 37.0	36 Weeks Interval 36.0 to 37.0	35 Weeks Interval 23.0 to 37.0	36 Weeks Interval 23.0 to 37.0

SECONDARY outcome

Timeframe: From birth (PP Day 0) up to PP Week 24

Population: The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy.

Percentage of neonates who required phototherapy were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Neonates Who Required Phototherapy	100 Percentage of neonates	50 Percentage of neonates	100 Percentage of neonates	100 Percentage of neonates	91.7 Percentage of neonates

SECONDARY outcome

Timeframe: From birth (PP Day 0) up to PP Week 24

Population: The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy.

Percentage of neonates who required exchange transfusions were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Neonates Who Required Exchange Transfusions	0 Percentage of neonates	0 Percentage of neonates	0 Percentage of neonates	33.3 Percentage of neonates	8.3 Percentage of neonates

SECONDARY outcome

Timeframe: From birth (PP Day 0) up to PP Week 24

Population: The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Duration of postnatal phototherapy required by neonates were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=11 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Duration of Postnatal Phototherapy Required by Neonates	96.0 hours Interval 84.0 to 301.07	46.68 hours Interval 46.68 to 46.68	100.87 hours Interval 12.0 to 173.95	86.98 hours Interval 72.0 to 127.33	86.98 hours Interval 12.0 to 301.07

SECONDARY outcome

Timeframe: From birth (PP Day 0) up to PP Week 12

Population: The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy.

Percentage of neonates who required simple transfusions in the first 12 weeks of life were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Percentage of Neonates Who Required Simple Transfusions in the First 12 Weeks of Life	66.7 Percentage of neonates	50.0 Percentage of neonates	50.0 Percentage of neonates	33.3 Percentage of neonates	50.0 Percentage of neonates

SECONDARY outcome

Timeframe: From birth (PP Day 0) up to PP Week 12

Population: The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy.

Number of simple transfusions required by neonate in the first 12 weeks of life were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Number of Simple Transfusions Required by Neonate in the First 12 Weeks of Life	4.5 Simple transfusions Interval to 6.0	4.0 Simple transfusions Interval 4.0 to 4.0	1.0 Simple transfusions Interval 1.0 to 1.0	1.0 Simple transfusions Interval 1.0 to 1.0	2.0 Simple transfusions Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: Baseline (GA Week 14), GA Week 16, GA Week 36, PP Day 0, PP Week 4, and PP Week 24

Population: The pharmacodynamics (PD) evaluable analysis set included all maternal participants who received at least 1 dose of nipocalimab and had at least 1 valid post-dose PD (RO or IgG) assessment. Here, ''n' (number analyzed) signifies number of participants evaluable for specified timepoints. Here, n = 0 indicates that no laboratory measurements were collected at that specific time point as no participant was available for the analysis.

Maternal serum unoccupied neonatal concentration of Participants Fc Receptor [FcRn] receptor occupancy (RO) in Monocytes by nipocalimab were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Serum Unoccupied Neonatal Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes by Nipocalimab Baseline	100.00 percentage of receptors unoccupied Standard Deviation 0.000	100.00 percentage of receptors unoccupied Standard Deviation 0.000	100.00 percentage of receptors unoccupied Standard Deviation 0.000	100.00 percentage of receptors unoccupied Standard Deviation 0.000	100.00 percentage of receptors unoccupied Standard Deviation 0.000
Maternal Serum Unoccupied Neonatal Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes by Nipocalimab GA Week 16	2.80 percentage of receptors unoccupied Standard Deviation 0.346	2.50 percentage of receptors unoccupied Standard Deviation 1.556	4.20 percentage of receptors unoccupied Standard Deviation 3.816	-0.15 percentage of receptors unoccupied Standard Deviation 6.276	2.12 percentage of receptors unoccupied Standard Deviation 4.103
Maternal Serum Unoccupied Neonatal Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes by Nipocalimab GA Week 36	12.20 percentage of receptors unoccupied Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	3.80 percentage of receptors unoccupied Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	5.40 percentage of receptors unoccupied Standard Deviation 1.838	3.75 percentage of receptors unoccupied Standard Deviation 1.202	5.72 percentage of receptors unoccupied Standard Deviation 3.420
Maternal Serum Unoccupied Neonatal Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes by Nipocalimab PP Day 0	126.75 percentage of receptors unoccupied Standard Deviation 6.859	21.00 percentage of receptors unoccupied Standard Deviation 22.486	68.83 percentage of receptors unoccupied Standard Deviation 43.253	39.30 percentage of receptors unoccupied Standard Deviation 43.856	60.67 percentage of receptors unoccupied Standard Deviation 48.532
Maternal Serum Unoccupied Neonatal Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes by Nipocalimab PP Week 4	107.55 percentage of receptors unoccupied Standard Deviation 68.943	—	130.78 percentage of receptors unoccupied Standard Deviation 49.901	121.55 percentage of receptors unoccupied Standard Deviation 54.002	122.44 percentage of receptors unoccupied Standard Deviation 49.09
Maternal Serum Unoccupied Neonatal Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes by Nipocalimab PP Week 24	99.60 percentage of receptors unoccupied Standard Deviation 5.091	98.45 percentage of receptors unoccupied Standard Deviation 15.486	114.15 percentage of receptors unoccupied Standard Deviation 28.333	117.20 percentage of receptors unoccupied Standard Deviation 29.816	110.13 percentage of receptors unoccupied Standard Deviation 23.549

SECONDARY outcome

Timeframe: From birth (PP Day 0) up to PP Week 24

Population: The PD evaluable set neonates included all neonate/infant participants who had at least 1 valid PD (RO or IgG) assessment. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Serum unoccupied FcRn RO in monocytes of neonate by Nipocalimab were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=8 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Serum Unoccupied Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes of Neonate by Nipocalimab	118.20 percentage of receptors unoccupied Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	70.60 percentage of receptors unoccupied Standard Deviation 19.233	80.87 percentage of receptors unoccupied Standard Deviation 18.029	74.50 percentage of receptors unoccupied Standard Deviation 33.093	81.38 percentage of receptors unoccupied Standard Deviation 23.295

SECONDARY outcome

Timeframe: 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

Population: Pharmacodynamics (PD) evaluable analysis set included all maternal participants who received at least 1 dose of nipocalimab and had at least 1 valid post-dose PD (RO or IgG) assessment. Here, 'n' (number analyzed) signifies number of participants evaluable at each timepoint for respective category. Here, n = 0 indicates that no laboratory measurements were collected at that specific time point as no participant was available for the analysis.

Change from baseline in serum concentration of total immunoglobulin G (IgG) and subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=13 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE IgG: PP Week 24	2.56 grams/liter (g/L) Standard Deviation 0.255	2.02 grams/liter (g/L) Standard Deviation 0.622	1.34 grams/liter (g/L) Standard Deviation 0.411	2.61 grams/liter (g/L) Standard Deviation 1.101	2.08 grams/liter (g/L) Standard Deviation 0.873
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE IgG1: GA Week 36	-4.35 grams/liter (g/L) Standard Deviation 1.386	-3.94 grams/liter (g/L) Standard Deviation 1.464	-3.45 grams/liter (g/L) Standard Deviation 1.421	-5.46 grams/liter (g/L) Standard Deviation 1.006	-4.33 grams/liter (g/L) Standard Deviation 1.356
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE IgG: GA Week 16	-8.12 grams/liter (g/L) Standard Deviation 2.235	-7.31 grams/liter (g/L) Standard Deviation 0.813	-6.51 grams/liter (g/L) Standard Deviation 1.285	-8.19 grams/liter (g/L) Standard Deviation 1.018	-7.52 grams/liter (g/L) Standard Deviation 1.464
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE IgG: GA Week 36	-7.52 grams/liter (g/L) Standard Deviation 1.549	-5.26 grams/liter (g/L) Standard Deviation 2.574	-5.83 grams/liter (g/L) Standard Deviation 2.380	-8.34 grams/liter (g/L) Standard Deviation 1.305	-6.72 grams/liter (g/L) Standard Deviation 2.146
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE IgG: birth (PP Day 0)	-0.40 grams/liter (g/L) Standard Deviation 0.884	-2.64 grams/liter (g/L) Standard Deviation 0.148	-2.45 grams/liter (g/L) Standard Deviation 1.016	-4.38 grams/liter (g/L) Standard Deviation 2.771	-2.78 grams/liter (g/L) Standard Deviation 2.111
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE IgG: PP Week 4	1.88 grams/liter (g/L) Standard Deviation 1.803	—	-0.17 grams/liter (g/L) Standard Deviation 0.638	1.10 grams/liter (g/L) Standard Deviation 3.455	0.75 grams/liter (g/L) Standard Deviation 2.277
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE IgG2: GA Week 36	-2.48 grams/liter (g/L) Standard Deviation 0.085	-1.29 grams/liter (g/L) Standard Deviation 0.629	-1.91 grams/liter (g/L) Standard Deviation 1.013	-2.31 grams/liter (g/L) Standard Deviation 1.192	-2.02 grams/liter (g/L) Standard Deviation 0.888
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE IgG3: GA Week 36	-0.25 grams/liter (g/L) Standard Deviation 0.045	-0.23 grams/liter (g/L) Standard Deviation 0.228	-0.24 grams/liter (g/L) Standard Deviation 0.195	-0.38 grams/liter (g/L) Standard Deviation 0.124	-0.28 grams/liter (g/L) Standard Deviation 0.151
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE IgG4: GA Week 36	-0.39 grams/liter (g/L) Standard Deviation 0.209	-0.06 grams/liter (g/L) Standard Deviation 0.045	-0.13 grams/liter (g/L) Standard Deviation 0.066	-0.28 grams/liter (g/L) Standard Deviation 0.140	-0.21 grams/liter (g/L) Standard Deviation 0.163
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE IgA: GA Week 36	0.17 grams/liter (g/L) Standard Deviation 0.163	0.11 grams/liter (g/L) Standard Deviation 0.191	0.20 grams/liter (g/L) Standard Deviation 0.382	0.05 grams/liter (g/L) Standard Deviation 0.015	0.13 grams/liter (g/L) Standard Deviation 0.208
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE IgM: GA Week 36	0.01 grams/liter (g/L) Standard Deviation 0.120	-0.06 grams/liter (g/L) Standard Deviation 0.049	0.01 grams/liter (g/L) Standard Deviation 0.072	-0.12 grams/liter (g/L) Standard Deviation 0.075	-0.04 grams/liter (g/L) Standard Deviation 0.087
Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE IgE: GA Week 36	-0.31 grams/liter (g/L) Standard Deviation 0.420	0.00 grams/liter (g/L) Standard Deviation 0.003	0.01 grams/liter (g/L) Standard Deviation 0.012	0.00 grams/liter (g/L) Standard Deviation 0.086	-0.06 grams/liter (g/L) Standard Deviation 0.197

SECONDARY outcome

Timeframe: Baseline (PP Day 0), PP Weeks 4, 24, 96

Population: PD evaluable set - neonates included all neonate/infant participants who had at least 1 valid PD (RO or IgG) assessment. Here, 'n' (number analyzed): number of neonates or infants evaluable for each arm at specified time points. Here, n = 0 indicates that no laboratory measurements were collected at that specific time point as no participant was available for the analysis.

Change from baseline in serum concentration of total IgG, IgA, IgM, and IgE were reported in neonates/infants were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE IgM: PP Week 4	0.10 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	—	0.17 grams/liter (g/L) Standard Deviation 0.092	0.34 grams/liter (g/L) Standard Deviation 0.071	0.22 grams/liter (g/L) Standard Deviation 0.125
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE IgM: PP Week 24	0.32 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.26 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.61 grams/liter (g/L) Standard Deviation 0.078	0.44 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.48 grams/liter (g/L) Standard Deviation 0.166
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE IgE: PP Week 24	0.01 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.00 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.03 grams/liter (g/L) Standard Deviation 0.059	0.02 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.02 grams/liter (g/L) Standard Deviation 0.040
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE IgE: PP Week 96	—	0.02 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.02 grams/liter (g/L) Standard Deviation 0.008	0.03 grams/liter (g/L) Standard Deviation 0.027	0.02 grams/liter (g/L) Standard Deviation 0.016
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE IgG: PP Week 24	-7.59 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	-0.09 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.78 grams/liter (g/L) Standard Deviation 2.675	1.68 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	-0.41 grams/liter (g/L) Standard Deviation 3.723
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE IgA: PP Week 4	0.00 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	—	0.00 grams/liter (g/L) Standard Deviation 0.000	0.03 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.01 grams/liter (g/L) Standard Deviation 0.015
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE IgA: PP Week 24	0.02 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.07 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.23 grams/liter (g/L) Standard Deviation 0.127	-0.87 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.15 grams/liter (g/L) Standard Deviation 0.121
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE IgG: PP Week 4	4.61 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	-2.16 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.37 grams/liter (g/L) Standard Deviation 2.521	-0.87 grams/liter (g/L) Standard Deviation 0.559	0.26 grams/liter (g/L) Standard Deviation 2.594
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE IgG: PP Week 96	—	-1.41 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	5.55 grams/liter (g/L) Standard Deviation 2.866	4.62 grams/liter (g/L) Standard Deviation 1.683	4.08 grams/liter (g/L) Standard Deviation 3.361
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE IgA: PP Week 96	—	0.28 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	0.47 grams/liter (g/L) Standard Deviation 0.297	0.29 grams/liter (g/L) Standard Deviation 0.035	0.36 grams/liter (g/L) Standard Deviation 0.181
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE IgM: PP Week 96	—	0.53 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant..	1.04 grams/liter (g/L) Standard Deviation 0.014	0.86 grams/liter (g/L) Standard Deviation 0.368	0.87 grams/liter (g/L) Standard Deviation 0.278
Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE IgE: PP Week 4	0.00 grams/liter (g/L) Standard Deviation NA "NA" signifies that SD could not be calculated for a single participant.	—	0.00 grams/liter (g/L) Standard Deviation 0.007	0.00 grams/liter (g/L) Standard Deviation 0.000	0.00 grams/liter (g/L) Standard Deviation 0.004

SECONDARY outcome

Timeframe: Pre dose and post dose: GA Week 14 and GA Week 24; Birth (PP Day 0), PP Week 4 and PP Week 24

Population: Pharmacokinetic evaluable analysis set included all maternal participants who received at least 1 dose of nipocalimab and had at least 1 valid post-dose blood sample drawn for PK analysis. Here, 'n' (number analyzed) signifies number of participants evaluable for specified timepoints. Here, n = 0 indicates that no laboratory measurements were collected at that specific time point as no participant was available for the analysis.

Serum concentrations of Nipocalimab in maternal participants were reported.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Serum Concentrations of Nipocalimab in Maternal Participants PP Week 4	0.00 mcg/mL Standard Deviation 0.00	—	0.00 mcg/mL Standard Deviation 0.00	0.00 mcg/mL Standard Deviation 0.00	—
Serum Concentrations of Nipocalimab in Maternal Participants PP Week 24	0.00 mcg/mL Standard Deviation 0.00	0.00 mcg/mL Standard Deviation 0.00	0.00 mcg/mL Standard Deviation 0.00	0.00 mcg/mL Standard Deviation 0.00	—
Serum Concentrations of Nipocalimab in Maternal Participants PP Day 0	0.01 mcg/mL Standard Deviation 0.02	100.0 mcg/mL Standard Deviation NA SD could not be calculated for a single participant.	14.54 mcg/mL Standard Deviation 25.16	278.96 mcg/mL Standard Deviation 547.41	—
Serum Concentrations of Nipocalimab in Maternal Participants GA Week 14: Pre-dose	0.00 mcg/mL Standard Deviation 0.00	0.00 mcg/mL Standard Deviation 0.00	0.00 mcg/mL Standard Deviation 0.00	0.00 mcg/mL Standard Deviation 0.00	—
Serum Concentrations of Nipocalimab in Maternal Participants GA Week 14: Post-dose	726.00 mcg/mL Standard Deviation 138.01	577.00 mcg/mL Standard Deviation 110.31	947.75 mcg/mL Standard Deviation 193.17	928.50 mcg/mL Standard Deviation 159.05	—
Serum Concentrations of Nipocalimab in Maternal Participants GA Week 24: Pre-dose	58.25 mcg/mL Standard Deviation 43.63	71.15 mcg/mL Standard Deviation 19.87	197.25 mcg/mL Standard Deviation 73.27	205.00 mcg/mL Standard Deviation 82.18	—
Serum Concentrations of Nipocalimab in Maternal Participants GA Week 24: Post-dose	736.50 mcg/mL Standard Deviation 101.12	629.00 mcg/mL Standard Deviation 90.51	1051.25 mcg/mL Standard Deviation 196.49	1246.67 mcg/mL Standard Deviation 202.32	—

SECONDARY outcome

Timeframe: PP Week 96

Population: The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' overall (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=1 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=1 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=8 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants Overall Total Score	86.67 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	86.67 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	88.15 Score on a scale Standard Deviation 13.95	84.44 Score on a scale Standard Deviation 6.26	86.39 Score on a scale Standard Deviation 8.35
Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants Psychosocial Health Total Score	78.85 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	88.46 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	86.86 Score on a scale Standard Deviation 15.21	77.88 Score on a scale Standard Deviation 8.22	82.69 Score on a scale Standard Deviation 10.47
Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants Physical Health Total Score	97.37 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	84.21 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	89.91 Score on a scale Standard Deviation 12.23	93.42 Score on a scale Standard Deviation 8.22	91.45 Score on a scale Standard Deviation 8.78
Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants Physical Functioning Score	100.00 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	88.89 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	90.74 Score on a scale Standard Deviation 16.04	96.30 Score on a scale Standard Deviation 3.21	93.75 Score on a scale Standard Deviation 9.59
Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants Physical Symptoms Score	95.00 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	80.00 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	89.17 Score on a scale Standard Deviation 10.10	90.83 Score on a scale Standard Deviation 13.77	89.38 Score on a scale Standard Deviation 10.07
Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants Emotional Functioning Score	62.50 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	95.83 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	81.25 Score on a scale Standard Deviation 17.80	70.83 Score on a scale Standard Deviation 7.22	76.82 Score on a scale Standard Deviation 14.50
Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants Social Functioning Score	100.00 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	100.00 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	91.67 Score on a scale Standard Deviation 14.43	95.00 Score on a scale Standard Deviation 8.66	95.00 Score on a scale Standard Deviation 9.64
Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants Cognitive Functioning Score	88.89 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	72.22 Score on a scale Standard Deviation NA "NA" signifies that standard deviation (SD) could not be calculated for a single participant.	91.67 Score on a scale Standard Deviation 14.43	77.78 Score on a scale Standard Deviation 12.11	83.68 Score on a scale Standard Deviation 12.90

SECONDARY outcome

Timeframe: At PP 6 month, PP 12 month, and PP 24 month

Population: The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'n': number of participants evaluable for each arm at specific time points.

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.

Outcome measures

Measure	Group 1 (Maternal): 30 mg/kg BLW n=3 Participants Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to 45 mg/kg BLW n=2 Participants Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45 mg/kg BLW n=4 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45 mg/kgTAW n=3 Participants Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow-up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	All Maternal Participants n=12 Participants Maternal participants of Group 1 (30 mg/kg BLW), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg TAW) who received a single dose of IV infusions of nipocalimab once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Communication Total Score: PP 24-month	45.0 Score on a scale Standard Deviation 15.0	37.5 Score on a scale Standard Deviation 24.7	48.3 Score on a scale Standard Deviation 2.9	26.7 Score on a scale Standard Deviation 2.9	39.5 Score on a scale Standard Deviation 13.9
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Communication Total Score: PP 6-month	36.7 Score on a scale Standard Deviation 5.8	40.0 Score on a scale Standard Deviation 7.1	48.8 Score on a scale Standard Deviation 6.3	51.7 Score on a scale Standard Deviation 2.9	45.0 Score on a scale Standard Deviation 8.0
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Communication Total Score: PP 12-month	45.0 Score on a scale Standard Deviation 15.0	40.0 Score on a scale Standard Deviation 7.1	43.3 Score on a scale Standard Deviation 11.5	40.0 Score on a scale Standard Deviation 10.0	42.3 Score on a scale Standard Deviation 10.1
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Gross Motor Total Score: PP 6-month	35.0 Score on a scale Standard Deviation 10.0	22.5 Score on a scale Standard Deviation 3.5	30.0 Score on a scale Standard Deviation 9.1	25.0 Score on a scale Standard Deviation 13.2	28.8 Score on a scale Standard Deviation 9.8
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Gross Motor Total Score: PP 12-month	31.7 Score on a scale Standard Deviation 17.6	40.0 Score on a scale Standard Deviation 28.3	21.7 Score on a scale Standard Deviation 18.9	23.3 Score on a scale Standard Deviation 23.6	28.2 Score on a scale Standard Deviation 19.4
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Gross Motor Total Score: PP 24-month	43.3 Score on a scale Standard Deviation 17.6	60.0 Score on a scale Standard Deviation 0.0	50.0 Score on a scale Standard Deviation 8.7	56.7 Score on a scale Standard Deviation 2.9	51.8 Score on a scale Standard Deviation 11.0
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Fine Motor Total Score: PP 6-Month	26.7 Score on a scale Standard Deviation 7.6	35.0 Score on a scale Standard Deviation 21.2	43.8 Score on a scale Standard Deviation 8.5	35.0 Score on a scale Standard Deviation 18.0	35.8 Score on a scale Standard Deviation 13.3
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Fine Motor Total Score: PP 12-Month	46.7 Score on a scale Standard Deviation 2.9	57.5 Score on a scale Standard Deviation 3.5	50.0 Score on a scale Standard Deviation 0.0	36.7 Score on a scale Standard Deviation 7.6	46.8 Score on a scale Standard Deviation 8.4
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Fine Motor Total Score: PP 24-Month	50.0 Score on a scale Standard Deviation 10.0	47.5 Score on a scale Standard Deviation 3.5	55.0 Score on a scale Standard Deviation 8.7	50.0 Score on a scale Standard Deviation 5.0	50.9 Score on a scale Standard Deviation 7.0
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Problem Solving Total Score: PP 6-Month	40.0 Score on a scale Standard Deviation 10.0	37.5 Score on a scale Standard Deviation 17.7	38.8 Score on a scale Standard Deviation 11.1	26.7 Score on a scale Standard Deviation 10.4	35.8 Score on a scale Standard Deviation 11.4
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Problem Solving Total Score: PP 12-Month	23.3 Score on a scale Standard Deviation 15.3	25.0 Score on a scale Standard Deviation 7.1	41.7 Score on a scale Standard Deviation 2.9	40.0 Score on a scale Standard Deviation 8.7	33.2 Score on a scale Standard Deviation 12.1
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Problem Solving Total Score: PP 24-Month	48.3 Score on a scale Standard Deviation 7.6	37.5 Score on a scale Standard Deviation 17.7	35.0 Score on a scale Standard Deviation 8.7	41.7 Score on a scale Standard Deviation 2.9	40.9 Score on a scale Standard Deviation 9.4
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Personal-Social Total Score: PP 6-Month	43.3 Score on a scale Standard Deviation 5.8	30.0 Score on a scale Standard Deviation 7.1	40.0 Score on a scale Standard Deviation 10.8	20.0 Score on a scale Standard Deviation 13.2	34.2 Score on a scale Standard Deviation 12.9
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Personal-Social Total Score: PP 12-Month	21.7 Score on a scale Standard Deviation 2.9	37.5 Score on a scale Standard Deviation 3.5	35.0 Score on a scale Standard Deviation 5.0	30.0 Score on a scale Standard Deviation 20.0	30.5 Score on a scale Standard Deviation 11.3
Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants Personal-Social Total Score: PP24-Month	48.3 Score on a scale Standard Deviation 10.4	45.0 Score on a scale Standard Deviation 21.2	50.0 Score on a scale Standard Deviation 13.2	50.0 Score on a scale Standard Deviation 5.0	48.6 Score on a scale Standard Deviation 10.5

Adverse Events

Group 1 (Maternal): 30mg/kg BLW

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 2 (Maternal): 30 to45 mg/kg BLW

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 3 (Maternal): 45mg/kg BLW

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 4 (Maternal): 45mg/kg TAW

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 1 (Neonates and Infants): 30 mg/kg BLW

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 3 (Neonates and Infants): 45 mg/kg BLW

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 4 (Neonates and Infants): 45 mg/kg TAW

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 (Maternal): 30mg/kg BLW n=3 participants at risk Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to45 mg/kg BLW n=2 participants at risk Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45mg/kg BLW n=4 participants at risk Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45mg/kg TAW n=4 participants at risk Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 1 (Neonates and Infants): 30 mg/kg BLW n=3 participants at risk Neonates and infants born to mothers from Group 1 were followed up for safety from postpartum (PP) Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW n=2 participants at risk Neonates and infants born to mothers from Group 2 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 3 (Neonates and Infants): 45 mg/kg BLW n=4 participants at risk Neonates and infants born to mothers from Group 3 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 4 (Neonates and Infants): 45 mg/kg TAW n=3 participants at risk Neonates and infants born to mothers from Group 4 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.
Blood and lymphatic system disorders Anaemia Neonatal	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Blood and lymphatic system disorders Foetal Anaemia	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Cardiac disorders Foetal Heart Rate Deceleration Abnormality	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Hepatobiliary disorders Hyperbilirubinaemia Neonatal	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Hepatobiliary disorders Jaundice	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Respiratory Syncytial Virus Infection	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Foetal Death	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Foetal Growth Restriction	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Premature Separation of Placenta	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Retained Placenta or Membranes	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Subchorionic Haematoma	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Respiratory, thoracic and mediastinal disorders Neonatal Respiratory Distress Syndrome	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.

Other adverse events

Measure	Group 1 (Maternal): 30mg/kg BLW n=3 participants at risk Maternal participants received a single dose intravenous (IV) infusion of nipocalimab 30 milligrams per kilograms (mg/kg) based on baseline weight (BLW), once weekly from gestation age (GA) Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[Postpartum {PP} Week 24\]).	Group 2 (Maternal): 30 to45 mg/kg BLW n=2 participants at risk Maternal participants received a single dose IV infusion of nipocalimab 30 mg/kg initially based on BLW followed by nipocalimab 45 mg/kg with increase in weight, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 3 (Maternal): 45mg/kg BLW n=4 participants at risk Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on BLW, once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 4 (Maternal): 45mg/kg TAW n=4 participants at risk Maternal participants received a single dose IV infusion of nipocalimab 45 mg/kg based on time-adjusted weight (TAW), once weekly from GA Week 14 to GA Week 35. The first infusion of nipocalimab was administered over 60 minutes, subsequent infusions were administered over 30 minutes. Maternal participants were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 \[PP Week 24\]).	Group 1 (Neonates and Infants): 30 mg/kg BLW n=3 participants at risk Neonates and infants born to mothers from Group 1 were followed up for safety from postpartum (PP) Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW n=2 participants at risk Neonates and infants born to mothers from Group 2 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 3 (Neonates and Infants): 45 mg/kg BLW n=4 participants at risk Neonates and infants born to mothers from Group 3 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.	Group 4 (Neonates and Infants): 45 mg/kg TAW n=3 participants at risk Neonates and infants born to mothers from Group 4 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	100.0% 3/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Blood and lymphatic system disorders Anaemia Neonatal	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Blood and lymphatic system disorders Foetal Anaemia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Cardiac disorders Bradycardia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Cardiac disorders Palpitations	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Cardiac disorders Tachycardia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Ear and labyrinth disorders Ear Discomfort	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Ear and labyrinth disorders Otorrhoea	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Eye disorders Conjunctival Haemorrhage	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Eye disorders Photopsia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Eye disorders Retinopathy of Prematurity	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Gastrointestinal disorders Abdominal Distension	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Gastrointestinal disorders Constipation	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Gastrointestinal disorders Nausea	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	100.0% 2/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Gastrointestinal disorders Paraesthesia Oral	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Gastrointestinal disorders Umbilical Hernia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Gastrointestinal disorders Vomiting	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
General disorders Catheter Site Pain	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
General disorders Chest Discomfort	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
General disorders Chest Pain	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
General disorders Chills	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
General disorders Infusion Site Discomfort	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
General disorders Non-Cardiac Chest Pain	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
General disorders Oedema	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
General disorders Oedema Peripheral	66.7% 2/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 2/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
General disorders Pain	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
General disorders Peripheral Swelling	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
General disorders Puncture Site Pain	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
General disorders Pyrexia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	66.7% 2/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Hepatobiliary disorders Biliary Colic	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	66.7% 2/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Hepatobiliary disorders Jaundice	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Hepatobiliary disorders Non-Alcoholic Fatty Liver	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Asymptomatic Bacteriuria	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Bacterial Vaginosis	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Bacterial Vulvovaginitis	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Bacteriuria	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Candida Infection	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Conjunctivitis Bacterial	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Covid-19	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 2/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Ear Infection	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Gastrointestinal Infection	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Mastitis	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Nasopharyngitis	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 2/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Otitis Media Acute	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Respiratory Syncytial Virus Infection	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Sinusitis	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Streptococcal Urinary Tract Infection	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Urinary Tract Infection	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Varicella	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Infections and infestations Vulvovaginal Candidiasis	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Injury, poisoning and procedural complications Procedural Hypotension	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Injury, poisoning and procedural complications Wound Complication	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Investigations Blood Bilirubin Increased	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Investigations Blood Immunoglobulin G Decreased	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	100.0% 2/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Investigations Blood Potassium Increased	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Investigations Haemoglobin Decreased	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Investigations Protein Total Decreased	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Investigations Reticulocyte Count Decreased	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Metabolism and nutrition disorders Fluid Intake Reduced	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 2/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 2/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Nervous system disorders Headache	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Nervous system disorders Hypotonia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Nervous system disorders Paraesthesia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Nervous system disorders Syncope	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Foetal Hypokinesia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Gestational Diabetes	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Polyhydramnios	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Postpartum Haemorrhage	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Premature Baby	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Premature Separation of Placenta	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Small for Dates Baby	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Pregnancy, puerperium and perinatal conditions Uterine Contractions During Pregnancy	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Psychiatric disorders Social Anxiety Disorder	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Renal and urinary disorders Dysuria	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 2/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Renal and urinary disorders Pyelocaliectasis	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Reproductive system and breast disorders Breast Mass	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 2/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Respiratory, thoracic and mediastinal disorders Snoring	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Skin and subcutaneous tissue disorders Night Sweats	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 2/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Skin and subcutaneous tissue disorders Pruritus Allergic	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	50.0% 1/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Skin and subcutaneous tissue disorders Scar Pain	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Skin and subcutaneous tissue disorders Telangiectasia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Surgical and medical procedures Caesarean Section	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Surgical and medical procedures Epidural Anaesthesia	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Vascular disorders Hypotension	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	33.3% 1/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Vascular disorders Superficial Vein Thrombosis	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.
Vascular disorders Varicose Vein	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	25.0% 1/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/2 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/4 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.	0.00% 0/3 • 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 Maternal: Safety analysis set included all maternal participants who have received at least 1 dose of nipocalimab. Neonates/Infants: Safety analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. For Group 2, pooled data for 30 mg/kg and 45 mg/kg was collected and analyzed as exposure to 30 mg/kg was very limited with minimal cumulative dosing and sample size was too small for meaningful separate analysis.

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