| Primary | Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs) | An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab. | Safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab. | Posted | | Count of Participants | | Participants | | From baseline (Gestational Age [GA] Week 14) up to Postpartum (PP) Week 24 (up to 50 weeks) | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). | | OG002 | 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]). | | OG003 | Group 4 (Maternal): 45 mg/kgTAW | 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]). | | OG004 | 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]). |
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| Primary | Number of Neonates/Infants With Adverse Events (AEs) | An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. | Neonates or infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Posted | | Count of Participants | | Participants | | From Birth (PP Day 0) up to PP Week 96 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Number of Maternal Participants With Treatment-emergent Serious Adverse Events (TESAEs) | SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TESAEs were any SAEs occurring after the initiation of the first infusion of nipocalimab. | Safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab. | Posted | | Count of Participants | | Participants | | From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks) | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | Group 2 (Maternal): 30 to 45 mg/kg BLW |
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| Primary | Number of Neonates/Infants With Serious Adverse Events (SAEs) | SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. | Neonates or infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Posted | | Count of Participants | | Participants | | From Birth (PP Day 0) up to PP Week 96 | | | | ID | Title | Description |
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| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 |
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| Primary | Number of Maternal Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs) | Number of maternal participants with TEAESIs were reported. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. All infections requiring anti-infective (that is, oral or intravenous antibacterial, antiviral, or antifungal) treatment and with hypoalbuminemia greater than or equal to (>=) Grade 3 (less than [<]20 gram per liter [g/L] by National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 criteria were considered an AESI for maternal participants. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab. | Safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab. | Posted | | Count of Participants | | Participants | | From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks) | | | | ID | Title | Description |
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| OG000 | 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]). |
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| Primary | Number of Neonates/Infants With Adverse Events of Special Interest (AESIs) | Number of neonates/infants with TEAESIs were reported. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. All infections requiring anti-infective (that is, oral or intravenous antibacterial, antiviral, or antifungal) treatment, unexpected/unusual childhood illnesses and Immunoglobulin G (IgG) concentrations <200 milligrams per deciliter (mg/dL) at Week 24 through Week 47 or <300 mg/dL at Week 48 through Week 96 were considered an AESI for neonates and infants. | Neonates or infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Posted | | Count of Participants | | Participants | | From birth (PP Day 0) up to PP Week 96 | | | | ID | Title | Description |
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| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. |
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| Primary | Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline | Absolute value of ECG parameter - mean ventricular rate at baseline in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities. | The full analysis set (FAS) included all maternal participants who received any dose of nipocalimab. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (GA Week 14) | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at GA Week 36 | Absolute value of ECG parameter - mean ventricular rate at GA Week 36 in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities. | 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. | Posted | | Mean | Standard Deviation | Beats per minute | | GA Week 36 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Change From Baseline in ECG Parameter- Mean Ventricular Rate | Change from baseline in ECG parameter- mean ventricular rate in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities. | 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. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (GA Week 14) and GA Week 36 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time | Laboratory parameters included hematology, chemistry, blood Lipids panel, and Immunoglobulin G (IgG) parameters. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab. Here, HDL: high-density lipoprotein, LDL: low-density lipoprotein. The during-pregnancy value of albumin <20 g/L was from a local laboratory and was >=20 g/L when analyzed at the central laboratory for the same time point. | 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. | Posted | | Count of Participants | | Participants | | From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks) | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | Group 2 (Maternal): 30 to 45 mg/kg BLW |
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| Primary | Number of Neonates or Infants With Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time | Laboratory parameters included total bilirubin and biomarker included immunoglobulin G (IgG). | 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. | Posted | | Count of Participants | | Participants | | From Birth (PP Day 0) up to PP Week 96 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Body Temperature at Baseline | Absolute value of vital signs - body temperature at baseline in maternal participants was reported. | The FAS included all maternal participants who received any dose of nipocalimab. | Posted | | Mean | Standard Deviation | Degree Celsius | | Baseline (GA Week 14) | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Body Temperature at GA Week 36 | Absolute value of vital signs - body temperature at GA Week 36 in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Degree Celsius | | GA Week 36 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Body Temperature at PP Week 24 | Absolute value of vital signs - body temperature at PP Week 24 in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Degree Celsius | | PP Week 24 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Change From Baseline in Vital Sign - Body Temperature | Change from baseline in vital signs- body temperature in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Degree Celsius | | Baseline (GA Week 14), GA Week 36, and PP Week 24 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at Baseline | Absolute value of vital signs -respiratory rate at baseline in maternal participants was reported. | The FAS included all maternal participants who received any dose of nipocalimab. | Posted | | Mean | Standard Deviation | breaths per minute | | Baseline (GA Week 14) | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at GA Week 36 | Absolute value of vital signs -respiratory rate at GA Week 36 in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Breaths per minute | | GA Week 36 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24 | Absolute value of vital signs - respiratory rate at PP Week 24 in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Breaths per minute | | PP Week 24 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Change From Baseline in Vital Sign - Respiratory Rate | Change from baseline in vital signs- respiratory rate in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline (GA Week 14), GA Week 36, and PP Week 24 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at Baseline | Absolute value of vital signs - pulse rate at baseline in maternal participants was reported. | The FAS included all maternal participants who received any dose of nipocalimab. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (GA Week 14) | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at GA Week 36 | Absolute value of vital signs -pulse rate at GA Week 36 in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | beats per minute | | GA Week 36 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
|
| Primary | Maternal Participants: Absolute Value of Vital Signs -Pulse Rate at PP Week 24 | Absolute value of vital signs -pulse rate at PP Week 24 in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Beats per minute | | PP Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
|
| Primary | Maternal Participants: Change From Baseline in Vital Sign - Pulse Rate | Change from baseline in vital signs -pulse rate in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (GA Week 14), GA Week 36, and PP Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline | Absolute value of vital signs - SBP and DBP at baseline in maternal participants was reported. | The FAS included all maternal participants who received any dose of nipocalimab. | Posted | | Mean | Standard Deviation | Millimeter of mercury | | Baseline (GA Week 14) | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at GA Week 36 | Absolute value of vital signs -SBP and DBP at GA Week 36 in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Millimeter of mercury (mmHg) | | GA Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24 | Absolute value of vital signs - SBP and DBP at PP Week 24 in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | PP Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Change From Baseline in Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Change from baseline in vital signs -SBP and DBP in maternal participants were reported. | 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. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (GA Week 14), GA Week 36, and PP Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Body Weight at Baseline | Absolute value of vital signs - body weight at baseline in maternal participants was reported. | The FAS included all maternal participants who received any dose of nipocalimab. | Posted | | Mean | Standard Deviation | Kilograms | | Baseline (GA Week 14) | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Body Weight at GA Week 36 | Absolute value of vital signs -body weight at GA Week 36 in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Kilograms | | GA Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Absolute Value of Vital Signs - Body Weight at PP Week 24 | Absolute value of vital signs included body weight at PP Week 24 in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Kilograms | | PP Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Maternal Participants: Change From Baseline in Vital Sign - Body Weight | Change from baseline in vital signs- body weight in maternal participants was reported. | 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. | Posted | | Mean | Standard Deviation | Kilograms | | Baseline (GA Week 14), GA Week 36, and PP Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at Baseline | Absolute value in vital signs parameter -body temperature at baseline was reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Degree Celsius | | Baseline (PP Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Neonates/Infants: Absolute Value of Vital Signs - Body Temperature at PP Week 1 | Absolute value of vital signs parameter -body temperature at PP Week 1 was reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Degree Celsius | | PP Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 4 | Absolute value in vital signs parameter - body temperature at PP Week 4 was reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Degree Celsius | | PP Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 24 | Absolute value in vital signs parameter -body temperature at PP Week 24 was reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Degree Celsius | | PP Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Neonates/Infants: Change From Baseline in Vital Signs - Body Temperature | Change from baseline in vital signs- body temperature were reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Degree Celsius | | Baseline (PP Day 0), PP Weeks 1, 4, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | Group 3 (Neonates and Infants): 45 mg/kg BLW |
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| Primary | Neonates/Infants: Absolute Value of Vital Signs - Body Weight at Baseline | Absolute value of vital signs parameter- body weight at baseline was reported for all neonates/infants. | Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Posted | | Mean | Standard Deviation | Kilograms | | Baseline (PP Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 1 | Absolute value of vital signs parameter - body weight at PP Week 1 was reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Kilograms | | PP Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 4 | Absolute value of vital signs parameter - body weight at PP Week 4 was reported for all neonates/infants. | Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Posted | | Mean | Standard Deviation | Kilograms | | PP Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. | |
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| Primary | Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 24 | Absolute value of vital signs parameter - body weight at PP Week 24 was reported for all neonates/infants. | Neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Posted | | Mean | Standard Deviation | Kilograms | | PP Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. | |
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| Primary | Neonates/Infants: Change From Baseline in Vital Signs -Body Weight | Change from baseline in vital signs - body weight were reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Kilograms | | Baseline (PP Day 0), PP Weeks 1, 4, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at Baseline | Absolute value of vital signs parameter -respiratory rate at baseline was reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline (PP Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 1 | Absolute value of vital signs parameter - respiratory rate at PP Week 1 was reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Breaths per minute | | PP Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 4 | Absolute value of vital signs parameter - respiratory rate at PP Week 4 was reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Breaths per minute | | PP Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24 | Absolute value of vital signs parameter- respiratory rate at PP Week 24 was reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Breaths per minute | | PP Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Neonates/Infants: Change From Baseline in Vital Signs - Respiratory Rate | Change from baseline in vital signs -respiratory rate was reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | breaths per minute | | Baseline (PP Day 0), PP Weeks 1, 4, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | Group 3 (Neonates and Infants): 45 mg/kg BLW |
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| Primary | Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline | Absolute value of vital signs parameter - SBP and DBP at baseline were reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (PP Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | Group 3 (Neonates and Infants): 45 mg/kg BLW | |
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| Primary | Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 1 | Absolute value of vital signs parameter - SBP and DBP at PP Week 1 were reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | PP Week 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | Group 3 (Neonates and Infants): 45 mg/kg BLW |
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| Primary | Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 4 | Absolute value of vital signs parameter -SBP and DBP at PP Week 4 were reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | PP Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | Group 3 (Neonates and Infants): 45 mg/kg BLW |
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| Primary | Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24 | Absolute value of vital signs parameter -SBP and DBP at PP Week 24 were reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | PP Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | Group 3 (Neonates and Infants): 45 mg/kg BLW |
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| Primary | Neonates/Infants: Change From Baseline in Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Change from baseline in vital signs- SBP and DBP were reported for all neonates/infants. | 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. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (PP Day 0), PP Weeks 1, 4, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 |
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| Primary | Percentage of Maternal Participants With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments | Percentage of maternal participants with intrauterine growth restriction (IUGR) based on ultrasound assessments and guidelines from American College of Obstetricians and Gynecologists, and Society for Maternal-Fetal Medicine was reported. This outcome measure provided the incidence of with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve. | 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. | Posted | | Number | | Percentage of maternal participants | | Baseline (GA Week 14), GA Weeks 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | Group 2 (Maternal): 30 to 45 mg/kg BLW |
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| Primary | Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: Amniotic Fluid Index (AFI) at Baseline | Percentage of maternal participants with abnormal amniotic fluid values: amniotic fluid index (AFI) at baseline was reported. The amniotic fluid volume abnormality was categorized as an AFI <5 centimeter (cm) or >24 cm. | 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. | Posted | | Number | | Percentage of maternal participants | | Baseline (GA Week 14) | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: AFI at GA Week 26 | Percentage of maternal participants with abnormal amniotic fluid values: AFI at GA Week 26 was reported. The amniotic fluid volume abnormality was categorized as an AFI <5 cm or >24 cm. | 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. | Posted | | Number | | Percentage of maternal participants | | GA Week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: AFI at GA Week 36 | Percentage of maternal participants with abnormal amniotic fluid values: AFI at GA Week 36 was reported. The amniotic fluid volume abnormality was categorized as an AFI <5 cm or >24 cm. | 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. | Posted | | Number | | Percentage of maternal participants | | GA Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: Maximum Vertical Pocket (MVP) at Baseline | Percentage of maternal participants with abnormal amniotic fluid values: maximum vertical pocket (MVP) at baseline was reported. The amniotic fluid volume abnormality was categorized as MVP <2 cm or >8 cm. | 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. | Posted | | Number | | Percentage of maternal participants | | From Baseline (GA Week 14) | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: MVP at GA Week 18 | Percentage of maternal participants with abnormal amniotic fluid values: MVP at GA Week 18 was reported. The amniotic fluid volume abnormality was categorized as MVP <2 cm or >8 cm. | 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. | Posted | | Number | | Percentage of maternal participants | | GA Week 18 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Percentage of Maternal Participants With Abnormal Amniotic Fluid Values: MVP at GA Week 22 | Percentage of maternal participants with abnormal amniotic fluid values: MVP at GA Week 22 was reported. The amniotic fluid volume abnormality was categorized as MVP <2 cm or >8 cm. | 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. | Posted | | Number | | Percentage of maternal participants | | GA Week 22 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Number of Neonates/Infants With Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score | Number of neonates/infants with Apgar score from 1 to 10 minutes of life were reported. The system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The score is reported at 1 minute and 5 minutes after birth for all infants, and at 5-minute intervals thereafter until 20 minutes for infants with a score less than 7. This is using an Apgar scale which ranges from minimum total score of 0 and maximum total score of 10, with higher score representing a better outcome. | 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. | Posted | | Count of Participants | | Participants | | 1, 5, and 10 minutes after birth at PP Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. |
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| Primary | Number of Maternal Participants With Concomitant Medications and Therapies | Number of maternal participants with concomitant medications and therapies were reported. | Safety analysis set included all maternal participants who received at least 1 dose of nipocalimab. | Posted | | Count of Participants | | Participants | | From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks) | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Primary | Number of Neonates/Infants With Concomitant Medications and Therapies | Number of neonates/infants with concomitant medications and therapies were reported. | The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Posted | | Count of Participants | | Participants | | From birth (PP Day 0) up to PP Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Percentage of Maternal Participants With Live Birth at or After Gestational Age (GA) Week 32 and Without an Intrauterine Transfusion (IUT) Throughout Their Entire Pregnancies | Percentage of maternal participants with live birth at or after GA Week 32 and without an IUT throughout their entire pregnancies were reported. | The FAS included all maternal participants who received any dose of nipocalimab. | Posted | | Number | 95% Confidence Interval | Percentage of maternal participants | | From baseline (GA Week 14) up to GA Week 37 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Secondary | Percentage of Maternal Participants With Live Birth | Percentage of maternal participants with live birth were reported. | The FAS included all maternal participants who received any dose of nipocalimab. | Posted | | Number | | Percentage of maternal participants | | From baseline (GA Week 14) up to GA Week 37 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Secondary | Percentage of Maternal Participants Without an Intrauterine Transfusion (IUT) Before Gestational Age (GA) Week 24 | Percentage of maternal participants without an IUT before GA Week 24 were reported. | FAS included all maternal participants who received any dose of nipocalimab. | Posted | | Number | | Percentage of maternal participants | | From baseline (GA Week 14) up to GA Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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]). | | OG001 | 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]). |
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| Secondary | Maternal Participants : Gestational Age (GA) at First Intrauterine Transfusion (IUT) | Gestational age (GA) at first IUT for maternal participants were reported. | 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. | Posted | | Median | Full Range | weeks | | From baseline (GA Week 14) up to GA Week 37 | | | | ID | Title | Description |
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| OG000 | Group 1 (Maternal): 30 mg/kg BLW | Maternal subjects 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 subjects were 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]). | | OG001 | Group 2 (Maternal): 30 to 45 mg/kg BLW | Maternal subjects received a single dose of 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 subjects were followed up for safety during the safety follow up period of 24 weeks after delivery at approximately GA Week 37 (up to Week 61 [PP Week 24]). |
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| Secondary | Median Number of Intrauterine Transfusion (IUT) Per Maternal Participant | Median number of intrauterine transfusion (IUT) per maternal participants were reported. | The FAS included all maternal participants who received any dose of nipocalimab. | Posted | | Median | Full Range | IUTs per maternal participant | | From baseline (GA Week 14) up to GA Week 37 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Secondary | Frequency of Intrauterine Transfusions (IUTs) on Maternal Participants | Frequency of intrauterine transfusions (IUTs) on maternal participants were reported. Frequency of IUTs was defined as total number of IUTs divided by the (date of delivery - date of first IUT +1)/7. | The FAS included all maternal participants who received any dose of nipocalimab. | Posted | | Median | Full Range | IUT/week | | From baseline (GA Week 14) up to GA Week 37 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Secondary | Percentage of Maternal Participants With Fetal Hydrops in Utero or Post Birth | Percentage of maternal participants with fetal hydrops in utero or post birth were reported. | 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. | Posted | | Number | | Percentage of maternal participants | | From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks) | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Secondary | Maternal Participants: Gestational Age at Time of Delivery | Gestational age at time of delivery for maternal participants were reported. | FAS included all maternal participants who received any dose of nipocalimab. | Posted | | Median | Full Range | Weeks | | From baseline (GA Week 14) up to GA Week 37 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Secondary | Percentage of Neonates Who Required Phototherapy | Percentage of neonates who required phototherapy were reported. | The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Posted | | Number | | Percentage of neonates | | From birth (PP Day 0) up to PP Week 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
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| Secondary | Percentage of Neonates Who Required Exchange Transfusions | Percentage of neonates who required exchange transfusions were reported. | The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Posted | | Number | | Percentage of neonates | | From birth (PP Day 0) up to PP Week 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
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| Secondary | Duration of Postnatal Phototherapy Required by Neonates | Duration of postnatal phototherapy required by neonates were reported. | 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. | Posted | | Median | Full Range | hours | | From birth (PP Day 0) up to PP Week 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Percentage of Neonates Who Required Simple Transfusions in the First 12 Weeks of Life | Percentage of neonates who required simple transfusions in the first 12 weeks of life were reported. | The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Posted | | Number | | Percentage of neonates | | From birth (PP Day 0) up to PP Week 12 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Number of Simple Transfusions Required by Neonate in the First 12 Weeks of Life | Number of simple transfusions required by neonate in the first 12 weeks of life were reported. | The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Posted | | Median | Full Range | Simple transfusions | | From birth (PP Day 0) up to PP Week 12 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Maternal Serum Unoccupied Neonatal Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes by Nipocalimab | Maternal serum unoccupied neonatal concentration of Participants Fc Receptor [FcRn] receptor occupancy (RO) in Monocytes by nipocalimab were reported. | 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. | Posted | | Mean | Standard Deviation | percentage of receptors unoccupied | | Baseline (GA Week 14), GA Week 16, GA Week 36, PP Day 0, PP Week 4, and PP Week 24 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | Group 2 (Maternal): 30 to 45 mg/kg BLW | |
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| Secondary | Serum Unoccupied Concentration of Participants Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes of Neonate by Nipocalimab | Serum unoccupied FcRn RO in monocytes of neonate by Nipocalimab were reported. | 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. | Posted | | Mean | Standard Deviation | percentage of receptors unoccupied | | From birth (PP Day 0) up to PP Week 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Maternal Participants: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE | Change from baseline in serum concentration of total immunoglobulin G (IgG) and subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE were reported. | 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. | Posted | | Mean | Standard Deviation | grams/liter (g/L) | | 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 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 |
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| Secondary | Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE | Change from baseline in serum concentration of total IgG, IgA, IgM, and IgE were reported in neonates/infants were reported. | 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. | Posted | | Mean | Standard Deviation | grams/liter (g/L) | | Baseline (PP Day 0), PP Weeks 4, 24, 96 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | Group 3 (Neonates and Infants): 45 mg/kg BLW |
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| Secondary | Serum Concentrations of Nipocalimab in Maternal Participants | Serum concentrations of Nipocalimab in maternal participants were reported. | 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. | Posted | | Mean | Standard Deviation | mcg/mL | | Pre dose and post dose: GA Week 14 and GA Week 24; Birth (PP Day 0), PP Week 4 and PP Week 24 | | | | ID | Title | Description |
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| OG000 | 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]). | | OG001 | 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]). |
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| Secondary | Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants | The 45-item PedsQL infant Scales (ages 13-24 months) included physical functioning, physical symptoms, emotional functioning, social functioning, and cognitive functioning. Health summary score for psychosocial (sum of all items over number of items: emotional, social, cognitive functioning scales) and physical (sum of the items over number of items: physical functioning and symptoms scales), as well as a total score (sum of all items over number of items answered on all scales). Items were reverse-scored and linearly transformed to 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0). PedsQL a validated scale ranging from 0 -100, higher scores = a better quality of life. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | PP Week 96 | | | | ID | Title | Description |
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| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. |
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| Secondary | Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants | The ASQ-3 assesses young child's (2-66 months) development based on age and included 6 questions in each area of child development: communication, gross motor, fine motor, problem solving, and personal-social skills. Parents answered either yes (10 points), sometimes (5 points) or not yet (0 points) to each question to complete ASQ-3 and each domain score could range from 0 to 60 points which higher score signifying stronger development. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | At PP 6 month, PP 12 month, and PP 24 month | | | | ID | Title | Description |
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| OG000 | Group 1 (Neonates and Infants): 30 mg/kg BLW | Neonates and infants born to mothers from Group 1 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. | | OG001 | 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. | |
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