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    Clinical Trial Results:
    A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

    Summary
    EudraCT number
    		 2017-004958-42
    Trial protocol
    		 GB   BE   NL   SE   ES  
    Global end of trial date
    05 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Aug 2025
    First version publication date
    07 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MOM-M281-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03842189
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Aug 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate the safety in maternal subjects and neonate/infant of nipocalimab administered to pregnant women who were at high risk for early onset severe-hemolytic disease of the fetus and newborn (EOS-HDFN) and to evaluate the effectiveness of nipocalimab as measured by percentage of maternal subjects with live birth at or after gestational age Week 32 and without an intrauterine transfusion (IUT) throughout their entire pregnancy.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Apr 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    13
    EEA total number of subjects
    7
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    13
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 14 pregnancies (obstetrical history of early onset severe fetal anemia, hydrops or stillbirth related to hemolytic disease of fetus/newborn at GA Week <=24, anti-D>=32 or anti-Kell>=4, pregnant with antigen-positive fetus) enrolled. 1 subject had 2 pregnancies and counted twice; second enrollment data was provided. Results for 13 subjects reported.

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

    Period 1
    Period 1 title
    Maternal: GA Week (W)14 to PP W24
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 (Maternal): 30 mg/kg BLW
    Arm description
    		 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]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nipocalimab
    Investigational medicinal product code
    JNJ-80202135
    Other name
    M281
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Maternal subjects received a single dose IV infusions of nipocalimab 30 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.

    Arm title
    		 Group 2 (Maternal): 30 to 45 mg/kg BLW
    Arm description
    		 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]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nipocalimab
    Investigational medicinal product code
    JNJ-80202135
    Other name
    M281
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Maternal subjects received a single dose of IV infusions 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.

    Arm title
    		 Group 3 (Maternal): 45 mg/kg BLW
    Arm description
    		 Maternal subjects 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 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]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nipocalimab
    Investigational medicinal product code
    JNJ-80202135
    Other name
    M281
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Maternal subjects received a single dose IV infusions 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.

    Arm title
    		 Group 4 (Maternal): 45 mg/kg TAW
    Arm description
    		 Maternal subjects 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 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]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nipocalimab
    Investigational medicinal product code
    JNJ-80202135
    Other name
    M281
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Maternal subjects received a single dose IV infusions of nipocalimab 45 mg/kg based on 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.

    Number of subjects in period 1
    		Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW
    Started
    3
    2
    4
    4
    Completed
    3
    2
    4
    4
    Period 2
    Period 2 title
    Neonates/Infants: Birth(PP Day 0)-PP W96
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    ABC

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 (Neonates and Infants): 30 mg/kg BLW
    Arm description
    		 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.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW
    Arm description
    		 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.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 3 (Neonates and Infants): 45 mg/kg BLW
    Arm description
    		 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.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4 (Neonates and Infants): 45 mg/kg TAW
    Arm description
    		 Neonates and infants born to mothers from Group 4 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2 [1]
    		Group 1 (Neonates and Infants): 30 mg/kg BLW Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Group 3 (Neonates and Infants): 45 mg/kg BLW Group 4 (Neonates and Infants): 45 mg/kg TAW
    Started
    3
    2
    4
    3
    Completed
    3
    2
    3
    3
    Not completed
    0
    0
    1
    0
         Lost to follow-up
    -
    -
    1
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only eligible subjects were entered the specified period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1 (Maternal): 30 mg/kg BLW
    Reporting group description
    		 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]).

    Reporting group title
    Group 2 (Maternal): 30 to 45 mg/kg BLW
    Reporting group description
    		 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]).

    Reporting group title
    Group 3 (Maternal): 45 mg/kg BLW
    Reporting group description
    		 Maternal subjects 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 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]).

    Reporting group title
    Group 4 (Maternal): 45 mg/kg TAW
    Reporting group description
    		 Maternal subjects 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 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]).

    Reporting group values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW Total
    Number of subjects
    		 3 2 4 4
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.7 ( 1.53 ) 37.0 ( 1.41 ) 38.3 ( 4.43 ) 30.8 ( 4.19 ) -
    Gender categorical
    Units: Subjects
        Male
    		 0 0 0 0 0
        Female
    		 3 2 4 4 13
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 0 0 1
        Not Hispanic or Latino
    		 2 2 4 4 12
    Race
    Units: Subjects
        White
    		 2 2 4 4 12
        Unknown or Not Reported
    		 1 0 0 0 1
    Subject analysis sets

    Subject analysis set title
    All Maternal Subjects
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Maternal subjects of Group 1 (30 milligrams per kilograms [mg/kg] baseline weight [BLW]), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg time-adjusted weight [TAW]) who received a single dose of intravenous (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 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]).

    Subject analysis set title
    All Neonates and Infants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All neonates and infants born to mothers from 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) were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any study drug.

    Subject analysis sets values
    		 All Maternal Subjects All Neonates and Infants
    Number of subjects
    13
    12
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Male
    0
    0
        Female
    0
    0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0
    0
        Not Hispanic or Latino
    0
    0
    Race
    Units: Subjects
        White
    0
    0
        Unknown or Not Reported
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Group 1 (Maternal): 30 mg/kg BLW
    Reporting group description
    		 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]).

    Reporting group title
    Group 2 (Maternal): 30 to 45 mg/kg BLW
    Reporting group description
    		 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]).

    Reporting group title
    Group 3 (Maternal): 45 mg/kg BLW
    Reporting group description
    		 Maternal subjects 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 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]).

    Reporting group title
    Group 4 (Maternal): 45 mg/kg TAW
    Reporting group description
    		 Maternal subjects 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 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]).
    Reporting group title
    Group 1 (Neonates and Infants): 30 mg/kg BLW
    Reporting group description
    		 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.

    Reporting group title
    Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW
    Reporting group description
    		 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.

    Reporting group title
    Group 3 (Neonates and Infants): 45 mg/kg BLW
    Reporting group description
    		 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.

    Reporting group title
    Group 4 (Neonates and Infants): 45 mg/kg TAW
    Reporting group description
    		 Neonates and infants born to mothers from Group 4 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any nipocalimab study drug.

    Subject analysis set title
    All Maternal Subjects
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Maternal subjects of Group 1 (30 milligrams per kilograms [mg/kg] baseline weight [BLW]), Group 2 (30 to 45 mg/kg BLW), Group 3 (45 mg/kg BLW), and Group 4 (45 mg/kg time-adjusted weight [TAW]) who received a single dose of intravenous (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 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]).

    Subject analysis set title
    All Neonates and Infants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All neonates and infants born to mothers from 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) were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any study drug.

    Primary: Number of Maternal Subjects With Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Maternal Subjects With Treatment-emergent Adverse Events (TEAEs) [1]
    End point description
    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 subjects who had received at least 1 dose of nipocalimab.
    End point type
    Primary
    End point timeframe
    From Baseline (GA Week 14) up to PP Week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Subjects
    3
    2
    4
    4
    13
    No statistical analyses for this end point

    Primary: Number of Maternal Subjects With Treatment-emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Maternal Subjects With Treatment-emergent Serious Adverse Events (TESAEs) [2]
    End point description
    SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalisation or prolongation of existing hospitalisation, 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 subjects who had received at least 1 dose of nipocalimab.
    End point type
    Primary
    End point timeframe
    From Baseline (GA Week 14) up to PP Week 24
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Subjects
    2
    0
    1
    2
    5
    No statistical analyses for this end point

    Primary: Number of Neonates/Infants With Adverse Events (AEs)

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    End point title
    		 Number of Neonates/Infants With Adverse Events (AEs) [3]
    End point description
    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 subjects who received at least 1 dose of nipocalimab in the study pregnancy.
    End point type
    Primary
    End point timeframe
    From Birth (PP Day 0) up to PP Week 96
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Neonates and Infants): 30 mg/kg BLW Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Group 3 (Neonates and Infants): 45 mg/kg BLW Group 4 (Neonates and Infants): 45 mg/kg TAW All Neonates and Infants
    Number of subjects analysed
    3
    2
    4
    3
    12
    Units: Subjects
    3
    2
    4
    3
    12
    No statistical analyses for this end point

    Primary: Number of Maternal Subjects With Treatment-emergent Adverse Events of Special Interest (TEAESIs)

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    End point title
    		 Number of Maternal Subjects With Treatment-emergent Adverse Events of Special Interest (TEAESIs) [4]
    End point description
    Number of maternal subjects 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 to less than (<)20 gram per liter (g/L) by the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 criteria were considered an AESI for maternal subjects. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab. Safety analysis set included all maternal subjects who had received at least 1 dose of nipocalimab.
    End point type
    Primary
    End point timeframe
    From Baseline (GA Week 14) up to PP Week 24
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Subjects
        Infections: Treatment with Oral /Intravenous
    1
    1
    1
    2
    5
        Hypoalbuminemia <20 g/L
    0
    0
    0
    0
    0
        Overall AESIs
    1
    1
    1
    2
    5
    No statistical analyses for this end point

    Primary: Number of Neonates/Infants With Serious Adverse Events (SAEs)

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    End point title
    		 Number of Neonates/Infants With Serious Adverse Events (SAEs) [5]
    End point description
    SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalisation or prolongation of existing hospitalisation, 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 subjects who received at least 1 dose of nipocalimab in the study pregnancy.
    End point type
    Primary
    End point timeframe
    From Birth (PP Day 0) up to PP Week 96
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Neonates and Infants): 30 mg/kg BLW Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Group 3 (Neonates and Infants): 45 mg/kg BLW Group 4 (Neonates and Infants): 45 mg/kg TAW All Neonates and Infants
    Number of subjects analysed
    3
    2
    4
    3
    12
    Units: Subjects
    2
    1
    1
    2
    6
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline

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    End point title
    		 Maternal Subjects: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline [6]
    End point description
    Absolute value of ECG parameter - mean ventricular rate at baseline in maternal subjects 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 subjects who received any dose of nipocalimab.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Beats per minute
        arithmetic mean (standard deviation)
    77.0 ( 10.58 )
    77.5 ( 3.54 )
    63.0 ( 5.35 )
    76.3 ( 8.42 )
    72.5 ( 9.41 )
    No statistical analyses for this end point

    Primary: Number of Neonates/Infants With Adverse Events of Special Interest (AESIs)

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    End point title
    		 Number of Neonates/Infants With Adverse Events of Special Interest (AESIs) [7]
    End point description
    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 antiinfective (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 subjects who received at least 1 dose of nipocalimab in the study pregnancy. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    From birth (PP Day 0) up to PP Week 96
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    12
    Units: Subjects
        IgG Concentrations
    4
        Infections: Treatment with Oral /Intravenous
    2
        Unexpected/Unusual Childhood Illnesses
    0
        Overall AESI
    4
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at GA Week 36

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    End point title
    		 Maternal Subjects: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at GA Week 36 [8]
    End point description
    Absolute value of ECG parameter - mean ventricular rate at GA Week 36 in maternal subjects 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 subjects who received any dose of nipocalimab. Here, 'N' overall (number of subjects analysed) signifies the number of subjects evaluable for this endpoint. Here, 99999 denotes standard deviation (SD) could not be calculated for a single subject.
    End point type
    Primary
    End point timeframe
    GA Week 36
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    1
    2
    3
    2
    8
    Units: Beats per minute
        arithmetic mean (standard deviation)
    89.0 ( 99999 )
    77.0 ( 21.21 )
    80.7 ( 7.51 )
    77.0 ( 21.21 )
    79.9 ( 12.71 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Change From Baseline in ECG Parameter- Mean Ventricular Rate

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    End point title
    		 Maternal Subjects: Change From Baseline in ECG Parameter- Mean Ventricular Rate [9]
    End point description
    Change from baseline in ECG parameter- mean ventricular rate in maternal subjects 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 subjects who received any dose of nipocalimab. Here, 'N' overall (number of subjects analysed) signifies the number of subjects evaluable for this endpoint. Here, 99999 denotes SD could not be calculated for a single subject.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14) and GA Week 36
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    1
    2
    3
    2
    8
    Units: Beats per minute
        arithmetic mean (standard deviation)
    8.0 ( 99999 )
    -0.5 ( 24.75 )
    16.7 ( 7.37 )
    8.0 ( 22.63 )
    9.1 ( 15.08 )
    No statistical analyses for this end point

    Primary: Number of Maternal Subjects With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time

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    End point title
    		 Number of Maternal Subjects With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time [10]
    End point description
    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. The safety analysis set included all maternal subjects who had received at least 1 dose of nipocalimab. Here, 'n' (number analysed) signifies the number of subjects evaluable for each category. Only those categories in which at least one subject had data were reported in this endpoint. Here, DP: During pregnancy, Ch: cholesterol, HDL: high-density lipoprotein, LDL: low-density lipoprotein, PB: post birth, Tri: triglycerides, mmol/L: millimoles per litre, and g/L: grams per litre. 99999 signifies no subject available for the analysis.
    End point type
    Primary
    End point timeframe
    From Baseline (GA Week 14) up to PP Week 24
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Subjects
        DP :Ch >9.025 mmol/ L (n=3, 2, 4, 4, 13)
    1
    2
    3
    2
    8
        DP :LDL >5.793 mmol/ L (n=0, 1, 2, 4, 7)
    99999
    0
    1
    2
    3
        DP :HDL <1.2413 mmol/L (n=0, 1, 2, 4, 7)
    99999
    0
    0
    0
    0
        DP : Tri >5.114 mmol/ L (n=3, 2, 4, 4, 13)
    0
    0
    1
    1
    2
        DP : Albumin <20 g/L (n=3, 2, 4, 4, 13)
    0
    0
    0
    1
    1
        DP : Ig G <1 g/L (n=3, 2, 4, 4, 13)
    1
    0
    1
    0
    2
        PB: Ch >5.172 mmol/ L (n=3, 2, 4, 4, 13)
    3
    2
    4
    2
    11
        PB:LDL >2.586 mmol/ L (n=0, 1, 2, 4, 7)
    99999
    1
    2
    3
    6
        PB:HDL <1.0344mmol/ L (n=0, 1, 2, 4, 7)
    99999
    0
    1
    0
    1
        PB: Tri >1.6935 mmol/ L (n=3, 2, 4, 4, 13)
    1
    1
    3
    2
    7
        PB : Albumin <20 g/L (n=3, 2, 4, 4, 13)
    0
    0
    0
    0
    0
        PB: IgG < 1 g/L (n=3, 2, 4, 4, 13)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Neonates or Infants With Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time

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    End point title
    		 Number of Neonates or Infants With Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time [11]
    End point description
    Laboratory parameters included total bilirubin and biomarker included immunoglobulin G (IgG). The safety analysis set included all maternal subjects who had received at least 1 dose of nipocalimab. Only those categories in which at least one neonates or Infants had data were reported in this endpoint.
    End point type
    Primary
    End point timeframe
    From Birth (PP Day 0) up to PP Week 96
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Neonates and Infants): 30 mg/kg BLW Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Group 3 (Neonates and Infants): 45 mg/kg BLW Group 4 (Neonates and Infants): 45 mg/kg TAW All Neonates and Infants
    Number of subjects analysed
    3
    2
    4
    3
    12
    Units: Subjects
        Total Bilirubin >136.8 mmol/ L
    1
    1
    3
    3
    8
        Immunoglobulin G < 1 g/L
    1
    0
    0
    0
    1
        Immunoglobulin G < 2 g/L
    2
    2
    4
    2
    10
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Body Temperature at Baseline

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Body Temperature at Baseline [12]
    End point description
    Absolute value of vital signs - body temperature at baseline in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14)
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Degree Celsius
        arithmetic mean (standard deviation)
    36.6 ( 0.1 )
    37.0 ( 0.5 )
    37.2 ( 0.5 )
    36.8 ( 0.8 )
    36.9 ( 0.6 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Body Temperature at GA Week 36

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Body Temperature at GA Week 36 [13]
    End point description
    Absolute value of vital signs - body temperature at GA Week 36 in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' overall (number of subjects analysed) signifies the number of subjects evaluable for this endpoint. Here, 99999 denotes SD could not be calculated for a single subject.
    End point type
    Primary
    End point timeframe
    GA Week 36
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    1
    2
    3
    1
    7
    Units: Degree Celsius
        arithmetic mean (standard deviation)
    36.7 ( 99999 )
    36.8 ( 0.0 )
    37.1 ( 0.5 )
    36.0 ( 99999 )
    36.8 ( 0.5 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Change From Baseline in Vital Sign - Body Temperature

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    End point title
    		 Maternal Subjects: Change From Baseline in Vital Sign - Body Temperature [14]
    End point description
    Change from baseline in vital signs- body temperature in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analysed) signifies the number of subjects evaluable for specified timepoints. Here, 99999 denotes SD could not be calculated for a single subject.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14), GA Week 36, and PP Week 24
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    2
    2
    4
    4
    12
    Units: Degree Celsius
    arithmetic mean (standard deviation)
        GA Week 36 (n=1, 2, 3, 1, 7)
    0.0 ( 99999 )
    -0.2 ( 0.5 )
    -0.2 ( 0.0 )
    0.2 ( 99999 )
    -0.1 ( 0.3 )
        PP Week 24 (n= 2, 2, 4, 4, 12)
    -0.1 ( 0.1 )
    -0.2 ( 0.2 )
    -0.5 ( 0.7 )
    -0.1 ( 1.0 )
    -0.2 ( 0.7 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Body Temperature at PP Week 24

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Body Temperature at PP Week 24 [15]
    End point description
    Absolute value of vital signs - body temperature at PP Week 24 in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 24
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    2
    2
    4
    4
    12
    Units: Degree Celsius
        arithmetic mean (standard deviation)
    36.5 ( 0.1 )
    36.8 ( 0.3 )
    36.8 ( 0.3 )
    36.7 ( 0.5 )
    36.7 ( 0.3 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Respiratory Rate at Baseline

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Respiratory Rate at Baseline [16]
    End point description
    Absolute value of vital signs -respiratory rate at baseline in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14)
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Breaths per minute
        arithmetic mean (standard deviation)
    17.0 ( 1.7 )
    19.0 ( 1.4 )
    15.5 ( 3.4 )
    18.0 ( 2.8 )
    17.2 ( 2.7 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24 [17]
    End point description
    Absolute value of vital signs - respiratory rate at PP Week 24 in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 24
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    2
    2
    4
    4
    12
    Units: Breaths per minute
        arithmetic mean (standard deviation)
    16.5 ( 2.1 )
    15.5 ( 2.1 )
    15.8 ( 3.9 )
    17.3 ( 3.6 )
    16.3 ( 3.0 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Respiratory Rate at GA Week 36

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Respiratory Rate at GA Week 36 [18]
    End point description
    Absolute value of vital signs -respiratory rate at GA Week 36 in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' overall (number of subjects analysed) signifies the number of subjects evaluable for this endpoint. Here, 99999 denotes SD could not be calculated for a single subject.
    End point type
    Primary
    End point timeframe
    GA Week 36
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    1
    2
    3
    1
    7
    Units: Breaths per minute
        arithmetic mean (standard deviation)
    20.0 ( 99999 )
    18.0 ( 0.0 )
    16.3 ( 3.2 )
    17.0 ( 99999 )
    17.4 ( 2.3 )
    No statistical analyses for this end point

    Primary: Maternal Subject: Change From Baseline in Vital Sign - Respiratory Rate

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    End point title
    		 Maternal Subject: Change From Baseline in Vital Sign - Respiratory Rate [19]
    End point description
    Change from baseline in vital signs- respiratory rate in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint. Here, 'n' (number analysed) signifies the number of subjects evaluable for specified timepoints. Here, 99999 denotes SD could not be calculated for a single subject.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14), GA Week 36, and PP Week 24
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    2
    2
    4
    4
    12
    Units: Breaths per minute
    arithmetic mean (standard deviation)
        GA Week 36 (n=1, 2, 3, 1, 7)
    2.0 ( 99999 )
    -1.0 ( 1.4 )
    1.0 ( 1.0 )
    1.0 ( 99999 )
    0.6 ( 1.4 )
        PP Week 24 (n=2, 2, 4, 4, 12)
    0.0 ( 0.0 )
    -3.5 ( 0.7 )
    0.3 ( 1.3 )
    -0.8 ( 3.0 )
    -0.8 ( 2.2 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs -Pulse Rate at PP Week 24

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs -Pulse Rate at PP Week 24 [20]
    End point description
    Absolute value of vital signs -pulse rate at PP Week 24 in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 24
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    2
    2
    4
    4
    12
    Units: Beats per minute
        arithmetic mean (standard deviation)
    73.0 ( 2.8 )
    75.0 ( 4.2 )
    69.8 ( 10.2 )
    77.8 ( 4.1 )
    73.8 ( 6.9 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Pulse Rate at GA Week 36

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Pulse Rate at GA Week 36 [21]
    End point description
    Absolute value of vital signs -pulse rate at GA Week 36 in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' overall (number of subjects analysed) signifies the number of subjects evaluable for this endpoint. Here, 99999 denotes SD could not be calculated for a single subject.
    End point type
    Primary
    End point timeframe
    GA Week 36
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    1
    2
    3
    1
    7
    Units: Beats per minute
        arithmetic mean (standard deviation)
    88.0 ( 99999 )
    95.0 ( 17.0 )
    84.0 ( 9.5 )
    100.0 ( 99999 )
    90.0 ( 11.0 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Pulse Rate at Baseline

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Pulse Rate at Baseline [22]
    End point description
    Absolute value of vital signs - pulse rate at baseline in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14)
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Beats per minute
        arithmetic mean (standard deviation)
    81.3 ( 8.7 )
    81.0 ( 8.5 )
    67.5 ( 4.2 )
    73.5 ( 8.9 )
    74.6 ( 8.8 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Change From Baseline in Vital Sign -Pulse Rate

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    End point title
    		 Maternal Subjects: Change From Baseline in Vital Sign -Pulse Rate [23]
    End point description
    Change from baseline in vital signs -pulse rate in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint. Here, 'n' (number analysed) signifies the number of subjects evaluable for specified timepoints. Here, 99999 denotes SD could not be calculated for a single subject.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14), GA Week 36, and PP Week 24
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    2
    2
    4
    4
    12
    Units: Breaths per minute
    arithmetic mean (standard deviation)
        GA Week 36 (n=1, 2, 3, 1, 7)
    -3.0 ( 99999 )
    14.0 ( 8.5 )
    15.0 ( 6.1 )
    29.0 ( 99999 )
    14.1 ( 10.5 )
        PP Week 24 (n=2, 2, 4, 4, 12)
    -3.5 ( 6.4 )
    -6.0 ( 4.2 )
    2.3 ( 8.5 )
    4.3 ( 11.4 )
    0.6 ( 8.8 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline [24]
    End point description
    Absolute value of vital signs - SBP and DBP at baseline in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14)
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Millimeter of mercury (mmHg)
    arithmetic mean (standard deviation)
        SBP
    112.0 ( 11.3 )
    100.5 ( 3.5 )
    102.3 ( 4.6 )
    104.8 ( 12.4 )
    105.0 ( 9.2 )
        DBP
    68.7 ( 3.5 )
    59.5 ( 3.5 )
    63.3 ( 6.9 )
    64.5 ( 10.8 )
    64.3 ( 7.3 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at GA Week 36

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at GA Week 36 [25]
    End point description
    Absolute value of vital signs -SBP and DBP at GA Week 36 in maternal subject was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint. Here, 99999 denotes SD could not be calculated for a single subject.
    End point type
    Primary
    End point timeframe
    GA Week 36
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    1
    2
    3
    2
    8
    Units: mmHg
    arithmetic mean (standard deviation)
        SBP
    134.0 ( 99999 )
    105.0 ( 8.5 )
    107.3 ( 9.6 )
    110.5 ( 7.8 )
    110.9 ( 11.7 )
        DBP
    70.0 ( 99999 )
    73.0 ( 5.7 )
    66.3 ( 4.2 )
    69.0 ( 5.7 )
    69.1 ( 4.7 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PPWeek 24

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PPWeek 24 [26]
    End point description
    Absolute value of vital signs - SBP and DBP at PP Week 24 in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 24
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    2
    2
    4
    4
    12
    Units: mmHg
    arithmetic mean (standard deviation)
        SBP
    117.5 ( 14.8 )
    110.5 ( 14.8 )
    112.3 ( 4.0 )
    118.8 ( 9.9 )
    115.0 ( 9.2 )
        DBP
    73.5 ( 10.6 )
    69.5 ( 6.4 )
    71.3 ( 6.2 )
    71.8 ( 1.7 )
    71.5 ( 5.2 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Change From Baseline in Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

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    End point title
    		 Maternal Subjects: Change From Baseline in Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [27]
    End point description
    Change from baseline in vital signs - SBP and DBP in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint. Here, 'n' (number analysed) signifies the number of subjects evaluable for specified categories and timepoints. Here, 99999 denotes SD could not be calculated for a single subject.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14), GA Week 36, and PP Week 24
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    2
    2
    4
    4
    12
    Units: mmHg
    arithmetic mean (standard deviation)
        SBP: GA Week 36 (n=1, 2, 3, 2, 8)
    15.0 ( 99999 )
    4.5 ( 4.9 )
    5.0 ( 13.0 )
    5.0 ( 22.6 )
    6.1 ( 11.7 )
        SBP: PP Week 24 (n=2, 2, 4, 4, 12)
    9.0 ( 1.4 )
    10.0 ( 11.3 )
    10.0 ( 4.2 )
    14.0 ( 7.0 )
    11.2 ( 5.9 )
        DBP: GA Week 36 (n=1, 2, 3, 2, 8)
    -2.0 ( 99999 )
    13.5 ( 2.1 )
    3.0 ( 9.8 )
    6.5 ( 23.3 )
    5.9 ( 11.6 )
        DBP: PP Week 24 (n=2, 2, 4, 4, 12)
    6.5 ( 7.8 )
    10.0 ( 2.8 )
    8.0 ( 10.2 )
    7.3 ( 11.8 )
    7.8 ( 8.6 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Body Weight at GA Week 36

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Body Weight at GA Week 36 [28]
    End point description
    Absolute value of vital signs -body weight at GA Week 36 in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' overall (number of subjects analysed) signifies the number of subjects evaluable for this endpoint. Here, 99999 denotes SD could not be calculated for a single subject.
    End point type
    Primary
    End point timeframe
    GA Week 36
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    1
    2
    3
    2
    8
    Units: Kilograms
        arithmetic mean (standard deviation)
    130.6 ( 99999 )
    77.6 ( 15.6 )
    80.8 ( 7.9 )
    87.3 ( 14.9 )
    87.8 ( 19.9 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs - Body Weight at Baseline

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs - Body Weight at Baseline [29]
    End point description
    Absolute value of vital signs - body weight at baseline in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14)
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Kilograms (kg)
        arithmetic mean (standard deviation)
    76.0 ( 29.7 )
    64.0 ( 12.7 )
    71.8 ( 8.8 )
    75.8 ( 18.0 )
    72.8 ( 16.7 )
    No statistical analyses for this end point

    Primary: Maternal Subject: Change From Baseline in Vital Sign -Body Weight

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    End point title
    		 Maternal Subject: Change From Baseline in Vital Sign -Body Weight [30]
    End point description
    Change from baseline in vital signs- body weight in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint. Here, 'n' (number analysed) signifies the number of subjects evaluable for specified timepoints. Here, 99999 denotes SD could not be calculated for a single subject.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14), GA Week 36, and PP Week 24
    Notes
    [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    2
    2
    4
    4
    12
    Units: Kilograms
    arithmetic mean (standard deviation)
        GA Week 36 (n=1, 2, 3, 2, 8)
    20.6 ( 99999 )
    13.6 ( 3.0 )
    8.6 ( 2.9 )
    7.7 ( 1.4 )
    11.1 ( 5.0 )
        PP Week 24 (n=2, 2, 4, 4, 12)
    1.0 ( 2.4 )
    5.6 ( 0.8 )
    -0.5 ( 4.6 )
    2.2 ( 2.9 )
    1.7 ( 3.6 )
    No statistical analyses for this end point

    Primary: Maternal Subjects: Absolute Value of Vital Signs -Body Weight at PP Week 24

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    End point title
    		 Maternal Subjects: Absolute Value of Vital Signs -Body Weight at PP Week 24 [31]
    End point description
    Absolute value of vital signs - body weight at PP Week 24 in maternal subjects was reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 24
    Notes
    [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    2
    2
    4
    4
    12
    Units: Kilograms
        arithmetic mean (standard deviation)
    60.1 ( 8.0 )
    69.5 ( 13.4 )
    71.3 ( 11.1 )
    78.0 ( 20.1 )
    71.4 ( 14.3 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 1

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    End point title
    		 Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 1 [32]
    End point description
    Absolute value in 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 subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 1
    Notes
    [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    8
    Units: Degree Celsius
        arithmetic mean (standard deviation)
    37.0 ( 0.2 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at Baseline

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    End point title
    		 Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at Baseline [33]
    End point description
    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 subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (PP Day 0)
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    10
    Units: Degree Celsius
        arithmetic mean (standard deviation)
    36.7 ( 0.2 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 4

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    End point title
    		 Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 4 [34]
    End point description
    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 subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 4
    Notes
    [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    10
    Units: Degree Celsius
        arithmetic mean (standard deviation)
    37.0 ( 0.4 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 24

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    End point title
    		 Neonates/Infants: Absolute Value in Vital Signs - Body Temperature at PP Week 24 [35]
    End point description
    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 subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 24
    Notes
    [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    10
    Units: Degree Celsius
        arithmetic mean (standard deviation)
    37.0 ( 0.5 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Change From Baseline in Vital Signs - Body Temperature

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    End point title
    		 Neonates/Infants: Change From Baseline in Vital Signs - Body Temperature [36]
    End point description
    Change from baseline in vital signs parameter- body temperature was reported for all neonates/ infants. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint and 'n' (number analysed) signifies the number of neonates or infants evaluable for specified timepoints. Per plan, pooled data for all neonates and infants was collected and analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (PP Day 0), PP Weeks 1, 4, and 24
    Notes
    [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    8
    Units: Degree Celsius
    arithmetic mean (standard deviation)
        PP Week 1 (n=6)
    0.2 ( 0.2 )
        PP Week 4 (n=8)
    0.5 ( 0.4 )
        PP Week 24 (n=8)
    0.3 ( 0.7 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 4

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    End point title
    		 Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 4 [37]
    End point description
    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 subjects who received at least 1 dose of nipocalimab in the study pregnancy. Per plan, pooled data for all neonates and infants was collected and analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 4
    Notes
    [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    12
    Units: Kilograms
        arithmetic mean (standard deviation)
    3.3 ( 0.8 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 1

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    End point title
    		 Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 1 [38]
    End point description
    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 subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 1
    Notes
    [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    10
    Units: Kilograms
        arithmetic mean (standard deviation)
    2.5 ( 0.6 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value of Vital Signs - Body Weight at Baseline

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    End point title
    		 Neonates/Infants: Absolute Value of Vital Signs - Body Weight at Baseline [39]
    End point description
    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 subjects who received at least 1 dose of nipocalimab in the study pregnancy. Per plan, pooled data for all neonates and infants was collected and analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (PP Day 0)
    Notes
    [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    12
    Units: Kilograms
        arithmetic mean (standard deviation)
    2.7 ( 0.7 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 4

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    End point title
    		 Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 4 [40]
    End point description
    Absolute value of vital signs parameter included respiratory rate at PP Week 4 was reported for all neonates/infants. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 4
    Notes
    [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    8
    Units: Breaths per minute
        arithmetic mean (standard deviation)
    54.0 ( 14.9 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Change From Baseline in Vital Signs -Body Weight

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    End point title
    		 Neonates/Infants: Change From Baseline in Vital Signs -Body Weight [41]
    End point description
    Change from baseline in vital signs included body weight was reported for all neonates/infants. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'n' (number analysed) signifies the number of neonates or infants evaluable for specified timepoints. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (PP Day 0), PP Weeks 1, 4, and 24
    Notes
    [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    12
    Units: Kilograms
    arithmetic mean (standard deviation)
        PP Week 1 (n=10)
    -0.1 ( 0.1 )
        PP Week 4 (n=12)
    0.6 ( 0.4 )
        PP Week 24 (n=12)
    4.7 ( 0.9 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at Baseline

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    End point title
    		 Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at Baseline [42]
    End point description
    Absolute value of vital signs parameter included respiratory rate at baseline was reported for all neonates/infants. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (PP Day 0)
    Notes
    [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    10
    Units: breaths per minute
        arithmetic mean (standard deviation)
    43.9 ( 8.1 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 1

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    End point title
    		 Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 1 [43]
    End point description
    Absolute value of vital signs parameter included respiratory rate at PP Week 1 was reported for all neonates/infants. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 1
    Notes
    [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    8
    Units: breaths per minute
        arithmetic mean (standard deviation)
    42.3 ( 12.7 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 24

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    End point title
    		 Neonates/Infants: Absolute Value of Vital Signs - Body Weight at PP Week 24 [44]
    End point description
    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 subjects who received at least 1 dose of nipocalimab in the study pregnancy. Per plan, pooled data for all neonates and infants was collected and analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 24
    Notes
    [44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    12
    Units: Kilograms
        arithmetic mean (standard deviation)
    7.4 ( 1.2 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 1

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    End point title
    		 Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 1 [45]
    End point description
    Absolute value of vital signs parameter included SBP and DBP at PP Week 1 were reported for all neonates/infants. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 1
    Notes
    [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    4
    Units: milliliter of mercury
    arithmetic mean (standard deviation)
        SBP
    66.3 ( 6.1 )
        DBP
    42.5 ( 9.3 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline

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    End point title
    		 Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline [46]
    End point description
    Absolute value of vital signs parameter included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at baseline were reported for all neonates/infants. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (PP Day 0)
    Notes
    [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    7
    Units: milliliter of mercury
    arithmetic mean (standard deviation)
        SBP
    66.7 ( 11.2 )
        DBP
    34.9 ( 5.7 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Change From Baseline in Vital Signs - Respiratory Rate

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    End point title
    		 Neonates/Infants: Change From Baseline in Vital Signs - Respiratory Rate [47]
    End point description
    Change from baseline in vital signs -respiratory rate up to PP Week 24 were reported for all neonates/infants. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint and 'n' (number analysed) signifies the number of neonates or infants evaluable for specified timepoints. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (PP Day 0), PP Weeks 1, 4, and 24
    Notes
    [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    8
    Units: breaths per minute
    arithmetic mean (standard deviation)
        PP Week 1 (n=6)
    -3.8 ( 8.0 )
        PP Week 4 (n=8)
    13.0 ( 16.9 )
        PP Week 24 (n=8)
    -5.6 ( 17.6 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24

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    End point title
    		 Neonates/Infants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24 [48]
    End point description
    Absolute value of vital signs parameter included respiratory rate at PP Week 24 was reported for all neonates/infants. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 24
    Notes
    [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    10
    Units: Breaths per minute
        arithmetic mean (standard deviation)
    37.6 ( 11.1 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24

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    End point title
    		 Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 24 [49]
    End point description
    Absolute value of vital signs parameter included SBP and DBP at PP Week 24 were reported for all neonates/infants. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 24
    Notes
    [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    5
    Units: milliliter of mercury
    arithmetic mean (standard deviation)
        SBP
    106.8 ( 19.8 )
        DBP
    73.8 ( 22.4 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 4

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    End point title
    		 Neonates/Infants: Absolute Value of Vital Sign - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at PP Week 4 [50]
    End point description
    Absolute value of vital signs parameter included SBP and DBP at PP Week 4 were reported for all neonates/infants. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    PP Week 4
    Notes
    [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    4
    Units: milliliter of mercury
    arithmetic mean (standard deviation)
        SBP
    83.3 ( 18.3 )
        DBP
    44.8 ( 17.7 )
    No statistical analyses for this end point

    Primary: Neonates/Infants: Change From Baseline in Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

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    End point title
    		 Neonates/Infants: Change From Baseline in Vital Signs - Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [51]
    End point description
    Change from baseline in vital signs included SBP and DBP were reported for all neonates/infants. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'N' (overall number of subjects analysed) signifies the number of neonates or infants evaluable for this endpoint and 'n' (number analysed) signifies the number of neonates or infants evaluable for specified categories and timepoints. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (PP Day 0), PP Weeks 1, 4, and 24
    Notes
    [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    4
    Units: milliliter of mercury
    arithmetic mean (standard deviation)
        SBP: PP Week 1 (n=4)
    3.3 ( 16.4 )
        SBP: PP Week 4 (n=4)
    22.8 ( 22.8 )
        SBP: PP Week 24 (n=3)
    41.3 ( 9.7 )
        DBP: PP Week 1 (n=4)
    7.0 ( 9.1 )
        DBP: PP Week 4 (n=4)
    11.8 ( 21.8 )
        DBP: PP Week 24 (n=3)
    39.0 ( 7.0 )
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments

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    End point title
    		 Percentage of Maternal Subjects With Intrauterine Growth Restriction (IUGR) Based on Ultrasound Assessments [52]
    End point description
    Percentage of maternal subjects 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 endpoint provided the incidence of fetus with IUGR at delivery. IUGR was 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 subjects who received any dose of nipocalimab. Here, 'n' (number analysed) signifies the number of subjects evaluable for specified timepoints and 99999 signifies that no subjects were available for the analysis.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14), GA Weeks 16, 18, 22, 24, 26, 28, 30, 32, 34, and 36
    Notes
    [52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Percentage of maternal subjects
    number (not applicable)
        Baseline (n= 2, 0, 3, 3, 8)
    0
    99999
    0
    0
    0
        GA Week 16 (n= 1, 2, 3, 4, 10)
    0
    0
    0
    0
    0
        GA Week 18 (n= 1, 2, 4, 4, 11)
    0
    0
    0
    0
    0
        GA Week 20 (n= 2, 1, 4, 4, 11)
    50.0
    0
    0
    0
    9.1
        GA Week 22 (n= 2, 1, 4, 3, 10)
    0
    0
    0
    0
    0
        GA Week 24 (n= 3, 1, 4, 3, 11)
    0
    0
    0
    0
    0
        GA Week 26 (n= 3, 2, 4, 3, 12)
    0
    50.0
    0
    0
    8.3
        GA Week 28 (n= 3, 2, 4, 3, 12)
    0
    50.0
    0
    0
    8.3
        GA Week 30 (n= 2, 2, 3, 3, 10)
    0
    0
    0
    0
    0
        GA Week 32 (n= 2, 1, 4, 3, 10)
    0
    100.0
    0
    0
    10.0
        GA Week 34 (n= 2, 1, 4, 2, 9)
    0
    0
    0
    0
    0
        GA Week 36 (n= 1, 2, 3, 2, 8)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects with Abnormal Amniotic Fluid Values: Amniotic Fluid Index (AFI) at Baseline

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    End point title
    		 Percentage of Maternal Subjects with Abnormal Amniotic Fluid Values: Amniotic Fluid Index (AFI) at Baseline [53]
    End point description
    Percentage of maternal subjects 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 subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14)
    Notes
    [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    3
    12
    Units: Percentage of maternal subjects
        number (not applicable)
    0
    50.0
    50.0
    0
    25.0
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects with Abnormal Amniotic Fluid Values: AFI at GA Week 26

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    End point title
    		 Percentage of Maternal Subjects with Abnormal Amniotic Fluid Values: AFI at GA Week 26 [54]
    End point description
    Percentage of maternal subjects 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 subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    GA Week 26
    Notes
    [54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    1
    0 [55]
    4
    3
    8
    Units: Percentage of maternal subjects
        number (not applicable)
    0
    25.0
    0
    25.0
    Notes
    [55] - Data was not collected and analysed as no subject was available for the analysis.
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects with Abnormal Amniotic Fluid Values: AFI at GA Week 36

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    End point title
    		 Percentage of Maternal Subjects with Abnormal Amniotic Fluid Values: AFI at GA Week 36 [56]
    End point description
    Percentage of maternal subjects 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 subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    GA Week 36
    Notes
    [56] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    1
    1
    3
    2
    7
    Units: Percentage of maternal subjects
        number (not applicable)
    0
    0
    33.3
    0
    14.3
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects with Abnormal Amniotic Fluid Values: Max Vertical Pocket (MVP) at Baseline

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    End point title
    		 Percentage of Maternal Subjects with Abnormal Amniotic Fluid Values: Max Vertical Pocket (MVP) at Baseline [57]
    End point description
    Percentage of maternal subjects with abnormal amniotic fluid values: max 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 subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14)
    Notes
    [57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    1
    1
    4
    3
    9
    Units: Percentage of maternal subjects
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects with Abnormal Amniotic Fluid Values: MVP at GA Week 18

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    End point title
    		 Percentage of Maternal Subjects with Abnormal Amniotic Fluid Values: MVP at GA Week 18 [58]
    End point description
    Percentage of maternal subjects 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 subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    GA Week 18
    Notes
    [58] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    2
    2
    4
    4
    12
    Units: Percentage of maternal subjects
        number (not applicable)
    0
    0
    0
    25.0
    8.3
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects with Abnormal Amniotic Fluid Values: MVP at GA Week 22

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    End point title
    		 Percentage of Maternal Subjects with Abnormal Amniotic Fluid Values: MVP at GA Week 22 [59]
    End point description
    Percentage of maternal subjects 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 subjects who received any dose of nipocalimab. Here, 'N' (overall number of subjects analysed) signifies the number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    GA Week 22
    Notes
    [59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    3
    12
    Units: Percentage of maternal subjects
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Neonates/Infants with Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score

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    End point title
    		 Number of Neonates/Infants with Appearance, Pulse, Grimace Response, Activity, Respiration (Apgar) Score [60]
    End point description
    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 subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'n' (number analysed) signifies the number of neonates or infants evaluable for specified timepoints. Per plan, pooled data for all neonates and infants was collected and analyzed for this endpoint.
    End point type
    Primary
    End point timeframe
    1, 5, and 10 minutes after birth at PP Day 0
    Notes
    [60] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    12
    Units: Subjects
        1 minute: <5 Score (n=12)
    2
        1 minute: 5-7 Score (n=12)
    1
        1 minute: 8-10 Score (n=12)
    9
        5 minute: <5 Score (n=12)
    0
        5 minute: 5-7 Score (n=12)
    1
        5 minute: 8-10 Score (n=12)
    11
        5 minute: <5 Score (n=7)
    0
        10 minute: 5-7 Score (n=7)
    1
        10 minute: 8-10 Score (n=7)
    6
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects With Live Birth at or After Gestational Age (GA) Week 32 and Without an Intrauterine Transfusion (IUT) Throughout Their Entire Pregnancies

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    End point title
    		 Percentage of Maternal Subjects With Live Birth at or After Gestational Age (GA) Week 32 and Without an Intrauterine Transfusion (IUT) Throughout Their Entire Pregnancies [61]
    End point description
    Percentage of maternal subjects with live birth at or after GA Week 32 and without an IUT throughout their entire pregnancies were reported. The FAS included all maternal subjects who received any dose of nipocalimab.
    End point type
    Primary
    End point timeframe
    From baseline (GA Week 14) up to GA Week 37
    Notes
    [61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Percentage of Maternal Subjects
        number (confidence interval 95%)
    33.3 (0.8 to 90.6)
    50.0 (1.3 to 98.7)
    75.0 (19.4 to 99.4)
    50.0 (6.8 to 93.2)
    53.8 (25.1 to 80.8)
    No statistical analyses for this end point

    Primary: Number of Maternal Subjects With Concomitant Medications and Therapies

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    End point title
    		 Number of Maternal Subjects With Concomitant Medications and Therapies [62]
    End point description
    Number of maternal subjects with concomitant medications and therapies were reported. Safety analysis set included all maternal subjects who received at least 1 dose of nipocalimab.
    End point type
    Primary
    End point timeframe
    Baseline (GA Week 14) up to PP Week 24
    Notes
    [62] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Subjects
    3
    2
    4
    4
    13
    No statistical analyses for this end point

    Primary: Number of Neonates/Infants With Concomitant Medications and Therapies

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    End point title
    		 Number of Neonates/Infants With Concomitant Medications and Therapies [63]
    End point description
    Number of neonates/infants with concomitant medications and therapies were reported. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy.
    End point type
    Primary
    End point timeframe
    From birth (PP Day 0) up to PP Week 96
    Notes
    [63] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    12
    Units: Subjects
    12
    No statistical analyses for this end point

    Secondary: Percentage of Maternal Subjects With Live Birth

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    End point title
    		 Percentage of Maternal Subjects With Live Birth
    End point description
    Percentage of maternal subjects with live birth were reported. The FAS included all maternal subjects who received any dose of nipocalimab.
    End point type
    Secondary
    End point timeframe
    From baseline (GA Week 14) up to GA Week 37
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Percentage of maternal subjects
        number (not applicable)
    100
    100
    100
    75
    92.3
    No statistical analyses for this end point

    Secondary: Percentage of Maternal Subjects Without an Intrauterine Transfusion (IUT) Before Gestational Age (GA) Week 24

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    End point title
    		 Percentage of Maternal Subjects Without an Intrauterine Transfusion (IUT) Before Gestational Age (GA) Week 24
    End point description
    Percentage of maternal subjects without an IUT before GA Week 24 were reported. The FAS included all maternal subjects who received any dose of nipocalimab.
    End point type
    Secondary
    End point timeframe
    Baseline (GA Week 14) up to GA Week 24
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Percentage of maternal subjects
        number (not applicable)
    100
    100
    100
    75
    92.3
    No statistical analyses for this end point

    Secondary: Median Number of Intrauterine Transfusion (IUT) Per Maternal Subjects

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    End point title
    		 Median Number of Intrauterine Transfusion (IUT) Per Maternal Subjects
    End point description
    Median number of intrauterine transfusion (IUT) per maternal subjects were reported. The FAS included all maternal subjects who received any dose of nipocalimab.
    End point type
    Secondary
    End point timeframe
    From baseline (GA Week 14) up to GA Week 37
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: IUTs per maternal subject
        median (full range (min-max))
    4 (3 to 5)
    5 (5 to 5)
    3 (3 to 3)
    1 (1 to 1)
    3 (1 to 5)
    No statistical analyses for this end point

    Secondary: Maternal Subjects : Gestational Age (GA) at First Intrauterine Transfusion (IUT)

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    End point title
    		 Maternal Subjects : Gestational Age (GA) at First Intrauterine Transfusion (IUT)
    End point description
    Gestational age (GA) at first IUT for maternal subjects were reported. The FAS included all maternal subjects who received any dose of nipocalimab. Per plan, pooled data for all maternal subjects was collected and analysed for this endpoint.
    End point type
    Secondary
    End point timeframe
    From baseline (GA Week 14) up to GA Week 37
    End point values
    		 All Maternal Subjects
    Number of subjects analysed
    13
    Units: weeks
        median (full range (min-max))
    27 (22 to 31)
    No statistical analyses for this end point

    Secondary: Frequency of Intrauterine Transfusions (IUTs) on Maternal Subjects

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    End point title
    		 Frequency of Intrauterine Transfusions (IUTs) on Maternal Subjects
    End point description
    Frequency of intrauterine transfusions (IUTs) on maternal subjects 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 subjects who received any dose of nipocalimab.
    End point type
    Secondary
    End point timeframe
    From baseline (GA Week 14) up to GA Week 37
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: IUT/week
        median (full range (min-max))
    0.52 (0.48 to 0.57)
    0.56 (0.56 to 0.56)
    0.43 (0.43 to 0.43)
    0.70 (0.64 to 0.78)
    0.56 (0.43 to 0.78)
    No statistical analyses for this end point

    Secondary: Percentage of Maternal Subjects With Fetal Hydrops in Utero or Post Birth

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    End point title
    		 Percentage of Maternal Subjects With Fetal Hydrops in Utero or Post Birth
    End point description
    Percentage of maternal subjects with fetal hydrops in utero or post birth were reported. The FAS included all maternal subjects who received any dose of nipocalimab. Here, 'N' overall (number of subjects analysed) signifies the number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From birth (PP Day 0) up to PP Week 24
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: Percentage of maternal subjects
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Maternal Subjects: Gestational Age at Time of Delivery

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    End point title
    		 Maternal Subjects: Gestational Age at Time of Delivery
    End point description
    Gestational age at time of delivery for maternal subjects were reported. The FAS included all maternal subjects who received any dose of nipocalimab.
    End point type
    Secondary
    End point timeframe
    From baseline (GA Week 14) up to GA Week 37
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: weeks
        median (full range (min-max))
    36 (29 to 37)
    36 (35 to 37)
    36 (36 to 37)
    35 (23 to 37)
    36 (23 to 37)
    No statistical analyses for this end point

    Secondary: Percentage of Neonates Who Required Phototherapy

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    End point title
    		 Percentage of Neonates Who Required Phototherapy
    End point description
    Percentage of neonates who required phototherapy were reported. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy.
    End point type
    Secondary
    End point timeframe
    From birth (PP Day 0) up to PP Week 24
    End point values
    		 Group 1 (Neonates and Infants): 30 mg/kg BLW Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Group 3 (Neonates and Infants): 45 mg/kg BLW Group 4 (Neonates and Infants): 45 mg/kg TAW All Neonates and Infants
    Number of subjects analysed
    3
    2
    4
    3
    12
    Units: Percentage of neonates
        number (not applicable)
    100
    50
    100
    100
    91.7
    No statistical analyses for this end point

    Secondary: Percentage of Neonates Who Required Exchange Transfusions

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    End point title
    		 Percentage of Neonates Who Required Exchange Transfusions
    End point description
    Percentage of neonates who required exchange transfusions were reported. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy.
    End point type
    Secondary
    End point timeframe
    From birth (PP Day 0) up to PP Week 24
    End point values
    		 Group 1 (Neonates and Infants): 30 mg/kg BLW Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Group 3 (Neonates and Infants): 45 mg/kg BLW Group 4 (Neonates and Infants): 45 mg/kg TAW All Neonates and Infants
    Number of subjects analysed
    3
    2
    4
    3
    12
    Units: Percentage of neonates
        number (not applicable)
    0
    0
    0
    33.3
    8.3
    No statistical analyses for this end point

    Secondary: Duration of Postnatal Phototherapy Required by Neonates

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    End point title
    		 Duration of Postnatal Phototherapy Required by Neonates
    End point description
    Duration of postnatal phototherapy required by neonates were reported. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy.
    End point type
    Secondary
    End point timeframe
    From birth (PP Day 0) up to PP Week 24
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Neonates and Infants
    Number of subjects analysed
    3
    2
    4
    3
    12
    Units: hours
        median (full range (min-max))
    96.0 (84.00 to 301.07)
    46.68 (46.68 to 46.68)
    100.88 (12.00 to 173.95)
    86.98 (72.00 to 127.33)
    86.98 (12.00 to 301.07)
    No statistical analyses for this end point

    Secondary: Percentage of Neonates Who Required Simple Transfusions in the First 12 Weeks of Life

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    End point title
    		 Percentage of Neonates Who Required Simple Transfusions in the First 12 Weeks of Life
    End point description
    Percentage of neonates who required simple transfusions in the first 12 weeks of life were reported. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy.
    End point type
    Secondary
    End point timeframe
    From birth (PP Day 0) up to PP Week 12
    End point values
    		 Group 1 (Neonates and Infants): 30 mg/kg BLW Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Group 3 (Neonates and Infants): 45 mg/kg BLW Group 4 (Neonates and Infants): 45 mg/kg TAW All Neonates and Infants
    Number of subjects analysed
    3
    2
    4
    3
    12
    Units: Percentage of neonates
        number (not applicable)
    66.7
    50.0
    50.0
    33.3
    50.0
    No statistical analyses for this end point

    Secondary: Number of Simple Transfusions Required by Neonate in the First 12 Weeks of Life

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    End point title
    		 Number of Simple Transfusions Required by Neonate in the First 12 Weeks of Life
    End point description
    Number of simple transfusions required by neonates in the first 12 weeks of life were reported. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy.
    End point type
    Secondary
    End point timeframe
    From birth (PP Day 0) up to PP Week 12
    End point values
    		 Group 1 (Neonates and Infants): 30 mg/kg BLW Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Group 3 (Neonates and Infants): 45 mg/kg BLW Group 4 (Neonates and Infants): 45 mg/kg TAW All Neonates and Infants
    Number of subjects analysed
    3
    2
    4
    3
    12
    Units: simple transfusions
        median (full range (min-max))
    4.5 (3 to 6)
    4.0 (4 to 4)
    1.0 (1 to 1)
    1.0 (1 to 1)
    2.0 (1 to 6)
    No statistical analyses for this end point

    Secondary: Maternal Serum Unoccupied Neonatal Concentration of Subjects Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes by Nipocalimab

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    End point title
    		 Maternal Serum Unoccupied Neonatal Concentration of Subjects Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes by Nipocalimab
    End point description
    Maternal serum unoccupied neonatal concentration of subjects Fc receptor [FcRn] receptor occupancy (RO) in monocytes by nipocalimab were reported. The pharmacodynamics (PD) evaluable analysis set included all maternal subjects who received at least 1 dose of nipocalimab and had at least 1 valid post-dose PD (RO or IgG) assessment. Here, 'n' (number analysed) signifies the number of subjects evaluable for specified timepoints. Here, n=0 signifies that no subjects were available for the analysis. Here, 99999 denoted for SD could not be calculated for a single subject. 9999 signifies no subject available for the analysis at that timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline (GA Week 14), GA Week 16, GA Week 36, PP Day 0, PP Week 4, and PP Week 24
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: percentage of receptors unoccupied
    arithmetic mean (standard deviation)
        Baseline (n= 3, 2, 4, 4, 13)
    100.00 ( 0.000 )
    100.00 ( 0.000 )
    100.00 ( 0.000 )
    100.00 ( 0.000 )
    100.00 ( 0.000 )
        GA Week 16 (n= 3, 2, 3, 4, 12)
    2.80 ( 0.346 )
    2.50 ( 1.556 )
    4.20 ( 3.816 )
    -0.15 ( 6.276 )
    2.12 ( 4.103 )
        GA Week 36 (n= 1, 1, 2, 2, 6)
    12.20 ( 99999 )
    3.80 ( 99999 )
    5.40 ( 1.838 )
    3.75 ( 1.202 )
    5.72 ( 3.420 )
        PP Day 0 (n= 2, 2, 4, 4, 12)
    126.75 ( 6.859 )
    21.00 ( 22.486 )
    68.83 ( 43.253 )
    39.30 ( 43.856 )
    60.67 ( 48.532 )
        PP Week 4 (n= 2, 0, 4, 4, 10)
    107.55 ( 68.943 )
    9999 ( 9999 )
    130.78 ( 49.901 )
    121.55 ( 54.002 )
    122.44 ( 49.09 )
        PP Week 24 (n= 2, 2, 4, 4, 12)
    99.60 ( 5.091 )
    98.45 ( 15.486 )
    114.15 ( 28.333 )
    117.20 ( 29.816 )
    110.13 ( 23.549 )
    No statistical analyses for this end point

    Secondary: Maternal Subjects: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE

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    End point title
    		 Maternal Subjects: Change From Baseline in Serum Concentration of Total Immunoglobulin G (IgG) and Subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE
    End point description
    Change from baseline in serum concentration of total immunoglobulin G (IgG) and subclasses (IgG1, IgG2, IgG3, IgG4), IgA, IgM, and IgE were reported. The PD evaluable analysis set included all maternal subjects who received at least 1 dose of nipocalimab and had at least 1 valid post-dose PD (RO or IgG) assessment. Here, 'n' (number analysed) signifies the number of subjects evaluable for specified categories and timepoints. Here, 99999 signifies that no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    IgG: Baseline (GA Week 14), GA Week 16, GA Week 36, birth (PP Day 0), PP Week 4, and PP Week 24; IgG1, IgG2, IgG3, IgG4, IgA, IgM, and IgE: baseline (GA Week 14), GA Week 36
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW All Maternal Subjects
    Number of subjects analysed
    3
    2
    4
    4
    13
    Units: grams/liter (g/L)
    arithmetic mean (standard deviation)
        IgG: GA Week 16 (n=3, 2, 4, 4,13)
    -8.12 ( 2.235 )
    -7.31 ( 0.813 )
    -6.51 ( 1.285 )
    -8.19 ( 1.018 )
    -7.52 ( 1.464 )
        IgG: GA Week 36 (n=2, 2. 4, 3, 11)
    -7.52 ( 1.549 )
    -5.26 ( 2.574 )
    -5.83 ( 2.380 )
    -8.34 ( 1.305 )
    -6.72 ( 2.146 )
        IgG: birth (PP Day 0)(n=2, 2, 4, 4, 12)
    -0.40 ( 0.884 )
    -2.64 ( 0.148 )
    -2.45 ( 1.016 )
    -4.38 ( 2.771 )
    -2.78 ( 2.111 )
        IgG: PP Week4 (n=2, 0, 4, 4, 10)
    1.88 ( 1.803 )
    99999 ( 99999 )
    -0.17 ( 0.638 )
    1.10 ( 3.455 )
    0.75 ( 2.277 )
        IgG: PP Week 24 (n=2, 2, 4, 4, 12)
    2.56 ( 0.255 )
    2.02 ( 0.622 )
    1.34 ( 0.411 )
    2.61 ( 1.101 )
    2.08 ( 0.873 )
        IgG1: GA Week 36 (n=2, 2, 3, 3, 10)
    -4.35 ( 1.386 )
    -3.94 ( 1.464 )
    -3.45 ( 1.421 )
    -5.46 ( 1.006 )
    -4.33 ( 1.356 )
        IgG2: GA Week 36 (n=2, 2, 3, 3, 10)
    -2.48 ( 0.085 )
    -1.29 ( 0.629 )
    -1.91 ( 1.013 )
    -2.31 ( 1.192 )
    -2.02 ( 0.888 )
        IgG3: GA Week 36 (n=2, 2, 3, 3, 10)
    -0.25 ( 0.045 )
    -0.23 ( 0.228 )
    -0.24 ( 0.195 )
    -0.38 ( 0.124 )
    -0.28 ( 0.151 )
        IgG4: GA Week 36 (n=2, 2, 3, 3, 10)
    -0.39 ( 0.209 )
    -0.06 ( 0.045 )
    -0.13 ( 0.066 )
    -0.28 ( 0.140 )
    -0.21 ( 0.163 )
        IgA: GA Week 36 (n=2, 2, 3, 3, 10)
    0.17 ( 0.163 )
    0.11 ( 0.191 )
    0.20 ( 0.382 )
    0.05 ( 0.015 )
    0.13 ( 0.208 )
        IgM: GA Week 36 (n=2, 2, 3, 3, 10)
    0.01 ( 0.120 )
    -0.06 ( 0.049 )
    0.01 ( 0.072 )
    -0.12 ( 0.075 )
    -0.04 ( 0.087 )
        IgE: GA Week 36 (n=2, 2, 3, 3, 10)
    -0.31 ( 0.420 )
    0.00 ( 0.003 )
    0.01 ( 0.012 )
    0.00 ( 0.086 )
    -0.06 ( 0.197 )
    No statistical analyses for this end point

    Secondary: Serum Unoccupied Concentration of Subjects Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes of Neonate by Nipocalimab

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    End point title
    		 Serum Unoccupied Concentration of Subjects Fc Receptor [FcRn] Receptor Occupancy (RO) in Monocytes of Neonate by Nipocalimab
    End point description
    Serum unoccupied FcRn RO in monocytes of neonate by Nipocalimab were reported. The PD evaluable set neonates included all neonate/infant subjects who had at least 1 valid PD (RO or IgG) assessment. Here, 'N' overall (number of subjects analysed) signifies the number of subjects evaluable for this endpoint. Here, 99999 denoted for SD could not be calculated for a single neonate/infant.
    End point type
    Secondary
    End point timeframe
    From birth (PP Day 0) up to PP Week 24
    End point values
    		 Group 1 (Neonates and Infants): 30 mg/kg BLW Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Group 3 (Neonates and Infants): 45 mg/kg BLW Group 4 (Neonates and Infants): 45 mg/kg TAW All Neonates and Infants
    Number of subjects analysed
    1
    2
    3
    2
    8
    Units: percentage of receptor unoccupied
        arithmetic mean (standard deviation)
    118.20 ( 99999 )
    70.60 ( 19.233 )
    80.87 ( 18.029 )
    74.50 ( 33.093 )
    81.38 ( 23.295 )
    No statistical analyses for this end point

    Secondary: Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE

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    End point title
    		 Neonates/Infants: Change From Baseline in Serum Concentration of Total IgG, IgA, IgM, and IgE
    End point description
    Change from baseline in serum concentration of total IgG, IgA, IgM, and IgE in neonates/infants were reported. PD evaluable set - neonates included all neonate/infant subjects who had at least 1 valid PD (RO or IgG) assessment. Here, 'n' (number analysed) signifies the number of subjects evaluable for specified categories and timepoints. Here, 9999 signifies that no subjects were available for the analysis and '99999' signifies that SD could not be calculated for a single subject.
    End point type
    Secondary
    End point timeframe
    Baseline (PP Day 0) up to PP Week 96
    End point values
    		 Group 1 (Neonates and Infants): 30 mg/kg BLW Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Group 3 (Neonates and Infants): 45 mg/kg BLW Group 4 (Neonates and Infants): 45 mg/kg TAW All Neonates and Infants
    Number of subjects analysed
    3
    2
    4
    3
    12
    Units: grams/liter (g/L)
    arithmetic mean (standard deviation)
        IgG: PP Week 4 (n=1, 1, 3, 2, 7)
    4.61 ( 99999 )
    -2.16 ( 99999 )
    0.37 ( 2.521 )
    -0.87 ( 0.559 )
    0.26 ( 2.594 )
        IgG: PP Week 24 (n=1, 1, 4, 1, 7)
    -7.59 ( 99999 )
    -0.09 ( 99999 )
    0.78 ( 2.675 )
    1.68 ( 99999 )
    -0.41 ( 3.723 )
        IgG: PP Week 96 (n=0, 1, 3, 2, 6)
    9999 ( 9999 )
    -1.41 ( 99999 )
    5.55 ( 2.866 )
    4.62 ( 1.683 )
    4.08 ( 3.361 )
        IgA: PP Week 4 (n=1, 0, 2, 1, 4)
    0.00 ( 99999 )
    9999 ( 9999 )
    0.00 ( 0.000 )
    0.03 ( 99999 )
    0.01 ( 0.015 )
        IgA: PP Week 24 (n=1, 1, 3, 1, 6)
    0.02 ( 99999 )
    0.07 ( 99999 )
    0.23 ( 0.127 )
    -0.87 ( 99999 )
    0.15 ( 0.121 )
        IgA: PP Week 96 (n=0, 1, 2 , 2, 5)
    9999 ( 9999 )
    0.28 ( 99999 )
    0.47 ( 0.297 )
    0.29 ( 0.035 )
    0.36 ( 0.181 )
        IgM: PP Week 4 (n=1, 0, 2, 2, 5)
    0.10 ( 99999 )
    9999 ( 9999 )
    0.17 ( 0.092 )
    0.34 ( 0.071 )
    0.22 ( 0.125 )
        IgM: PP Week 24 (n=1, 1, 3, 1, 6)
    0.32 ( 99999 )
    0.26 ( 99999 )
    0.61 ( 0.078 )
    0.44 ( 99999 )
    0.48 ( 0.166 )
        IgM: PP Week 96 (n=0, 1, 2, 2, 5)
    9999 ( 9999 )
    0.53 ( 99999 )
    1.04 ( 0.014 )
    0.86 ( 0.368 )
    0.87 ( 0.278 )
        IgE: PP Week 4 (n=1, 0, 3, 2, 6)
    0.00 ( 99999 )
    -2.16 ( 99999 )
    0.00 ( 0.007 )
    0.00 ( 0.000 )
    0.00 ( 0.004 )
        IgE: PP Week 24 (n=1, 1, 3, 1, 6)
    0.01 ( 99999 )
    0.00 ( 99999 )
    0.37 ( 0.059 )
    0.02 ( 99999 )
    0.02 ( 0.040 )
        IgE: PP Week 96 (n=0, 1, 2, 2, 5)
    9999 ( 9999 )
    0.02 ( 99999 )
    0.02 ( 0.008 )
    0.03 ( 0.027 )
    0.02 ( 0.016 )
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Nipocalimab in Maternal Subjects

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    End point title
    		 Serum Concentrations of Nipocalimab in Maternal Subjects
    End point description
    Serum concentrations of nipocalimab in maternal subjects were reported. Pharmacokinetic evaluable analysis set included all maternal subjects 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 analysed) signifies the number of subjects evaluable for specifie timepoints. Here, '9999' signifies that no subjects were available for the analysis and '99999' signifies that SD could not be calculated for a single subject.
    End point type
    Secondary
    End point timeframe
    Pre dose and post dose: GA Week 14 and GA Week 24; Birth (PP Day 0), PP Week 4 and PP Week 24
    End point values
    		 Group 1 (Maternal): 30 mg/kg BLW Group 2 (Maternal): 30 to 45 mg/kg BLW Group 3 (Maternal): 45 mg/kg BLW Group 4 (Maternal): 45 mg/kg TAW
    Number of subjects analysed
    3
    2
    4
    4
    Units: mcg/mL
    arithmetic mean (standard deviation)
        GA Week 14: Pre-dose (n=3, 2, 4, 4)
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        GA Week 14: Post-dose (n=3, 2, 4, 4)
    726.00 ( 138.01 )
    577.00 ( 110.31 )
    947.75 ( 193.17 )
    928.50 ( 159.05 )
        GA Week 24: Pre-dose (n=2, 2, 4, 3)
    58.25 ( 43.63 )
    71.15 ( 19.87 )
    197.25 ( 73.27 )
    205.00 ( 82.18 )
        GA Week 24: Post-dose (n=2, 2, 4, 3)
    736.50 ( 101.12 )
    629.00 ( 90.51 )
    1051.25 ( 196.49 )
    1246.67 ( 202.32 )
        PP Day 0 (n=2, 1, 3, 4)
    0.01 ( 0.02 )
    100.0 ( 99999 )
    14.54 ( 25.16 )
    278.96 ( 547.41 )
        PP Week 4 (n=2, 0, 4, 4)
    0.00 ( 0.00 )
    9999 ( 9999 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        PP Week 24 (n=2, 2, 4, 3)
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    0.00 ( 0.00 )
    No statistical analyses for this end point

    Secondary: Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants

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    End point title
    		 Pediatric Quality of Life Inventory (PedsQL) Total and Sub Scale Score in Neonates/Infants
    End point description
    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. Neonates/ infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in study pregnancy. Per plan, pooled data for all neonates and infants was collected and analysed for this endpoint.
    End point type
    Secondary
    End point timeframe
    PP Week 96
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    12
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Overall Total Score
    86.39 ( 8.35 )
        Psychosocial Health Total Score
    82.69 ( 10.47 )
        Physical Health Total Score
    91.45 ( 8.78 )
        Physical Functioning Score
    93.75 ( 9.59 )
        Physical Symptoms Score
    89.38 ( 10.07 )
        Emotional Functioning Score
    76.82 ( 14.50 )
        Social Functioning Score
    95.00 ( 9.64 )
        Cognitive Functioning Score
    83.68 ( 12.90 )
    No statistical analyses for this end point

    Secondary: Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants

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    End point title
    		 Ages and Stages Questionnaires, Third Edition (ASQ-3) Total Domain Score in Neonates/Infants
    End point description
    The ASQ-3 assesses child's 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. Neonates/infants analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy. Here, 'n' (number analysed) signifies the number of subjects evaluable for specified categories and timepoints. Per plan, pooled data for all neonates and infants was collected and analysed for this endpoint.
    End point type
    Secondary
    End point timeframe
    At PP 6 month, PP 12 month, and PP 24 month
    End point values
    		 All Neonates and Infants
    Number of subjects analysed
    12
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Communication Total Score: 6-month (n=12)
    45.0 ( 8.0 )
        Communication Total Score: 12-month (n=11)
    42.3 ( 10.1 )
        Communication Total Score: 24-month (n=11)
    39.5 ( 13.9 )
        Gross Motor Total Score: 6-month (n=12)
    28.8 ( 9.8 )
        Gross Motor Total Score: 12-month (n=11)
    28.2 ( 19.4 )
        Gross Motor Total Score: 24-month (n=11)
    51.8 ( 11.0 )
        Fine Motor Total Score: 6-month (n=12)
    35.8 ( 13.3 )
        Fine Motor Total Score: 12-month (n=11)
    46.8 ( 8.4 )
        Fine Motor Total Score: 24-month (n=11)
    50.9 ( 7.0 )
        Problem Solving Total Score: 6-month (n=12)
    35.8 ( 11.4 )
        Problem Solving Total Score: 12-month (n=11)
    33.2 ( 12.1 )
        Problem Solving Total Score: 24-month (n=11)
    40.9 ( 9.4 )
        Personal-Social Total Score: 6-month (n=12)
    34.2 ( 12.9 )
        Personal-Social Total Score: 12-month (n=11)
    30.5 ( 11.3 )
        Personal-Social Total Score: 24-month (n=11)
    48.6 ( 10.5 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality: Maternal: Screening (GA Week 8) up to PP Week 24, Neonates/Infants: Birth (PP Day 0) up to PP Week 96; SAE and other AEs: Maternal: From baseline (GA Week 14) up to PP Week 24, Neonates/Infants: From birth (PP Day 0) up to PP Week 96
    Adverse event reporting additional description
    Maternal: Safety analysis set included all maternal subjects who have received at least 1 dose of nipocalimab. Neonates/Infants: SAEs/other AEs: Safety analysis set included all live births to maternal subjects who received at least 1 dose of nipocalimab in the study pregnancy.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Group 1 (Maternal): 30mg/kg BLW
    Reporting group description
    		 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 [PP Week 24]).

    Reporting group title
    Group 3 (Maternal): 45mg/kg BLW
    Reporting group description
    		 Maternal subjects 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 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]).

    Reporting group title
    Group 2 (Maternal): 30 to45 mg/kg BLW
    Reporting group description
    		 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]).

    Reporting group title
    Group 3 (Neonates and Infants): 45 mg/kg BLW
    Reporting group description
    		 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 study drug.

    Reporting group title
    Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW
    Reporting group description
    		 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 study drug.

    Reporting group title
    Group 1 (Neonates and Infants): 30 mg/kg BLW
    Reporting group description
    		 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 study drug.

    Reporting group title
    Group 4 (Neonates and Infants): 45 mg/kg TAW
    Reporting group description
    		 Neonates and infants born to mothers from Group 4 were followed up for safety from PP Day 0 up to 96 weeks. Neonates and infants in this group did not receive any study drug.

    Reporting group title
    Group 4 (Maternal): 45mg/kg TAW
    Reporting group description
    		 Maternal subjects 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 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]).

    Serious adverse events
    		 Group 1 (Maternal): 30mg/kg BLW Group 3 (Maternal): 45mg/kg BLW Group 2 (Maternal): 30 to45 mg/kg BLW Group 3 (Neonates and Infants): 45 mg/kg BLW Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Group 1 (Neonates and Infants): 30 mg/kg BLW Group 4 (Neonates and Infants): 45 mg/kg TAW Group 4 (Maternal): 45mg/kg TAW
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    2 / 4 (50.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Foetal Heart Rate Deceleration Abnormality
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Foetal Growth Restriction
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal Death
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature Separation of Placenta
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subchorionic Haematoma
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retained Placenta or Membranes
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Foetal Anaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia Neonatal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hyperbilirubinaemia Neonatal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Neonatal Respiratory Distress Syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1 (Maternal): 30mg/kg BLW Group 3 (Maternal): 45mg/kg BLW Group 2 (Maternal): 30 to45 mg/kg BLW Group 3 (Neonates and Infants): 45 mg/kg BLW Group 2 (Neonates and Infants): 30 to 45 mg/kg BLW Group 1 (Neonates and Infants): 30 mg/kg BLW Group 4 (Neonates and Infants): 45 mg/kg TAW Group 4 (Maternal): 45mg/kg TAW
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    2 / 2 (100.00%)
    4 / 4 (100.00%)
    2 / 2 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Superficial Vein Thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Varicose Vein
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Surgical and medical procedures
    Caesarean Section
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Epidural Anaesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Pregnancy, puerperium and perinatal conditions
    Premature Separation of Placenta
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Premature Baby
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Postpartum Haemorrhage
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Polyhydramnios
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Gestational Diabetes
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Foetal Hypokinesia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Small for Dates Baby
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Uterine Contractions During Pregnancy
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Catheter Site Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Chest Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Chest Discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Infusion Site Discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Puncture Site Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Peripheral Swelling
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Oedema Peripheral
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    2
    1
    2
    0
    0
    0
    0
    4
    Oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    2
    0
    Reproductive system and breast disorders
    Breast Mass
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Nasal Congestion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    2
    Snoring
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Psychiatric disorders
    Social Anxiety Disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Investigations
    Blood Bilirubin Increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Protein Total Decreased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Reticulocyte Count Decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Blood Immunoglobulin G Decreased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    2 / 2 (100.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    1
    2
    1
    1
    0
    Blood Potassium Increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Haemoglobin Decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Infusion Related Reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Procedural Hypotension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Procedural Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Wound Complication
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Palpitations
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    1
    Hypotonia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Syncope
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    3 / 3 (100.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    0
    1
    0
    13
    0
    1
    Anaemia Neonatal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    5
    0
    2
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Foetal Anaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear Discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Otorrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Vertigo
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Eye disorders
    Photopsia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Conjunctival Haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Retinopathy of Prematurity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal Distension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Paraesthesia Oral
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    2 / 2 (100.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    18
    0
    0
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Abdominal Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    2
    0
    1
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    Umbilical Hernia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    4
    1
    0
    Biliary Colic
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Jaundice
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    Non-Alcoholic Fatty Liver
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Alopecia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Hidradenitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Night Sweats
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Pruritus Allergic
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    Scar Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Telangiectasia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Pyelocaliectasis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Muscle Spasms
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Pain in Extremity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Back Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    2
    Arthralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Infections and infestations
    Asymptomatic Bacteriuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    Bacterial Vaginosis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Candida Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    Bacteriuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Bacterial Vulvovaginitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Conjunctivitis Bacterial
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Ear Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    Covid-19
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    3
    Streptococcal Urinary Tract Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Mastitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
         occurrences all number
    0
    3
    1
    1
    0
    0
    1
    1
    Otitis Media Acute
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    0
    Varicella
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Vulvovaginal Candidiasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    Metabolism and nutrition disorders
    Fluid Intake Reduced
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Oct 2018
    The purpose of this amendment was to add gestational age at delivery as a secondary endpoint Criteria for dose adjustment was changed to be based on M281 (nipocalimab) blood concentration in conjunction with an adverse fetal event caused by severe fetal anemia
    09 Jan 2019
    The purpose of this amendment was to changed eligibility criterion for anti-Kell alloantibody to titers >=4, based on evidence that titers as low as 4 could be associated with EOS-HDFN.
    22 Feb 2019
    The purpose of this amendment was to exclusion criteria were revised to better ensure subject safety.
    22 Apr 2019
    The purpose of this amendment was to clarified that DSMB would review all available data including data from MOM-281-103. Modified justification for study design in accordance with regulatory agency requests.
    18 Dec 2019
    The purpose of this amendment was to changed the name of the study drug to the US adopted name for the product.
    20 Jan 2020
    The purpose of this amendment was to changed IUT stopping rule to allow for continued nipocalimab in the event of IUT until fetal sampling at a subsequent IUT indicated no fetal red blood cells remaining in the fetal circulation, confirmed by laboratory assessment.
    12 Aug 2020
    The purpose of this amendment was to modified inclusion criterion #7 to clarify procedures to be followed if Screening serologies for measles mumps, rubella, and varicella are borderline or negative.
    29 Jan 2021
    The purpose of this amendment was to amended to include additional assessments for monitoring IgG, IgM, IgA, and IgE concentrations in infants at Weeks 48 and 96 due to an unexpected finding of immunoglobulin (IgG, IgM, IgA) serum concentrations below normal range or at low normal range in infants with available data at 6 months and 1-year post birth.
    21 Mar 2021
    The purpose of this amendment was to amended to due to drug-related elevations in total cholesterol and low-density lipoprotein (LDL) observed, the protocol was amended to include lipid monitoring for all participants(mothers and infants), and an exclusion criterion for participants with a recent significant cardiovascular event was added.
    21 Mar 2022
    The purpose of this amendment was to amended to the exclusion criteria were amended to exclude participants with any history of major adverse cardiovascular events, and any such events that occurred during the study were to be adjudicated.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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