An Extension Study of MOM-M281-004 to Evaluate the Safety... | NCT03896295

ID	Type	Description	Link
2018-003618-41	EudraCT Number

Label	Type	Description	Intervention Names
M281	Experimental		Drug: M281

Name	Type	Description	Arm Group Labels	Other Names
M281	Drug	M281 injection administered as intravenous infusion	M281

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Number of participants with TEAEs were reported. An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug in this study.	Up to 257 days post-baseline (Baseline is Day 1)
Number of Participants With Serious Adverse Events (SAEs)	An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.	Up to 257 days post-baseline
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs)	Number of participants with treatment-emergent AESIs were reported. Severe infections and hypoalbuminemia (Grade 3 or higher according to the Common Terminology Criteria for Adverse Events [CTCAE] v5.0) were considered as AESIs.	Up to 257 days post-baseline
Number of Participants With Treatment-emergent Abnormal Vital Signs	Number of participants with treatment-emergent abnormal vital signs including pulse rate (less than or equal to [<=] 50 beats per minutes [bpm] with greater than or equal to [>=] 15 bpm decrease from baseline, >= 120 bpm with >=15 bpm increase from baseline), systolic blood pressure (SBP) (<= 90 millimeters of mercury [mmHg] with >= 20 mmHg decrease from baseline, >= 160 mmHg with >= 20 mmHg increase from baseline) and diastolic blood pressure (DBP) (<= 50 mmHg with >=15 mmHg decrease from baseline, >=100 mmHg with >=15 mmHg decrease from baseline) were reported.

Measure	Description	Time Frame
Change From Baseline in Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over Time	The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.

Facility	Status	City	State	ZIP	Country	Contacts
Momenta Investigational Site		Phoenix	Arizona	85013	United States
Momenta Investigational Site

ID	Title	Description
FG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 1, 2019	Dec 7, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Number of participants with TEAEs were reported. An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug in this study.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Count of Participants

Participants

Up to 257 days post-baseline (Baseline is Day 1)

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG002	Nipocalimab (All Participants)	Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Units	Counts
Participants	OG0007 OG00130 OG00237

Title

Denominators

Categories

Title	Measurements
	OG0004 OG00118 OG00222

Primary

Number of Participants With Serious Adverse Events (SAEs)

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.

Posted

Count of Participants

Participants

Up to 257 days post-baseline

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg every Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs)

Number of participants with treatment-emergent AESIs were reported. Severe infections and hypoalbuminemia (Grade 3 or higher according to the Common Terminology Criteria for Adverse Events [CTCAE] v5.0) were considered as AESIs.

Posted

Count of Participants

Participants

Up to 257 days post-baseline

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg every Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Number of Participants With Treatment-emergent Abnormal Vital Signs

Number of participants with treatment-emergent abnormal vital signs including pulse rate (less than or equal to [<=] 50 beats per minutes [bpm] with greater than or equal to [>=] 15 bpm decrease from baseline, >= 120 bpm with >=15 bpm increase from baseline), systolic blood pressure (SBP) (<= 90 millimeters of mercury [mmHg] with >= 20 mmHg decrease from baseline, >= 160 mmHg with >= 20 mmHg increase from baseline) and diastolic blood pressure (DBP) (<= 50 mmHg with >=15 mmHg decrease from baseline, >=100 mmHg with >=15 mmHg decrease from baseline) were reported.

Posted

Count of Participants

Participants

Up to 257 days post-baseline

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg every Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Number of Participants With Abnormalities in Physical Examinations

Number of participants with abnormalities in physical examinations (abdomen, head, ears, eyes, nose, throat, and sinuses, lungs, neurological, skin, blood and lymphatic system, cardiovascular, chest, gastrointestinal, general appearance and musculoskeletal) were reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this outcome measure (OM). Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg every Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Change From Baseline in Chemistry Laboratory Parameters: Albumin and Protein

Change from baseline in chemistry laboratory parameters: albumin and protein were reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this outcome measure (OM). As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

grams per liter (g/L)

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen

Change from baseline in chemistry laboratory parameters: bicarbonate, calcium, chloride, cholesterol, glucose, phosphate, potassium, sodium, triglycerides, urate and urea nitrogen were reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

millimoles per liter (mmol/L)

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase

Change from baseline in chemistry laboratory parameters alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

units per liter (U/L)

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Change From Baseline in Chemistry Laboratory Parameters: Bilirubin, Creatinine and Direct Bilirubin

Change from baseline in chemistry laboratory parameters: bilirubin, creatinine and direct bilirubin were reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

micromoles per liter (micromol/L)

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Change From Baseline in Hematology Laboratory Parameter: Erythrocytes (Red Blood Cell)

Change from baseline in erythrocytes (red blood cells) (hematology laboratory parameter) was reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

10^12 cells count per Liter

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes

Change from baseline in hematology laboratory parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes were reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

10^9 cells count per Liter

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration

Change from baseline in erythrocytes mean corpuscular hemoglobin (HGB) concentration (hematology laboratory parameter) were reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

grams per Liter (g/L)

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB)

Change from baseline in erythrocytes mean corpuscular HGB (hematology laboratory parameter) was reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

picograms (pg)

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Change From Baseline in Hematology Laboratory Parameter: Erythrocytes Mean Corpuscular Volume

Change from baseline in erythrocytes mean corpuscular volume (hematology laboratory parameter) was reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

femtoliters (fL)

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Change From Baseline in Hematology Laboratory Parameter: Hematocrit

Change from baseline in hematocrit (hematology laboratory parameter) was reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

liter of cells per liter of blood (L/L)

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Change From Baseline in Hematology Laboratory Parameter: Hemoglobin

Change from baseline in hemoglobin (hematology laboratory parameter) was reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

g/L

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Change From Baseline in Urinalysis Laboratory Parameter: pH

Change from baseline in pH (urinalysis laboratory parameter) was reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG002

Primary

Change From Baseline in Urinalysis Laboratory Parameter: Specific Gravity

Change from baseline in specific gravity (urinalysis laboratory parameter) was reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

ratio

Baseline up to Week 12

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values

Number of participants with treatment-emergent abnormal ECG values for variables including mean heart rate (abnormally low refers to less than or equal to [<=] 50 beats per minute [bpm], abnormally high refers greater than or equal to [>=] 120 bpm), PR interval (abnormally low refers to < 120 and abnormally high refers to >200 milliseconds [msec]), RR interval (abnormally low refers to <600 msec and abnormally high refers to >1200 msec) and QRS duration (abnormally > 120) were reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Count of Participants

Participants

Up to 257 days post-baseline

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg every Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every Q2W.
OG001	Nipocalimab-Nipocalimab

Primary

Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Scores

Number of participants with C-SSRS scores were reported. C-SSRS is a clinician-administered questionnaire designed to solicit occurrence, severity, and frequency of suicide-related ideation and behaviors. Total score ranges from 1 to 10, score of 0 was assigned (0="no event that can be assessed based on C-SSRS"). Higher total scores indicate greater severity. Maximum score assigned for each participant was summarized into one of 3 categories: no suicidal ideation or behavior (0), suicidal ideation (1 to 5): higher score indicates more suicidal ideation, suicidal behavior (6 to 10): higher score indicates more suicidal behavior. Suicidal ideation includes participants who did not have suicidal ideation or behavior at baseline and had suicidal ideation without behavior at some time point post-baseline. Suicidal behavior includes participants who did not have suicidal ideation or behavior at baseline and had suicidal behavior at some time point post-baseline (baseline=Day 1).

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Count of Participants

Participants

Up to 257 days post-baseline

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Secondary

Change From Baseline in Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over Time

The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.

The full analysis set (FAS) included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

score on a scale

Baseline up to Weeks 4, 8, 12, 24, End of treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Secondary

Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or Greater Than or Equal to (>=) 8-point Improvement in Total MG-ADL Score Over Time

Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or greater than or equal to (>=) 8-point improvement in total MG-ADL score over time were reported. MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.

The FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Count of Participants

Participants

Weeks 4, 8, 12, 24, End of treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Secondary

Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score Over Time

The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.

The FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

score on a scale

Baseline up to Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab

Secondary

Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score Over Time

The MG-QoL15r was used to assess the participant's limitations related to living with MG. It consists of 15 questions and each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation.

Posted

Mean

Standard Deviation

score on a scale

Baseline up to Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab

Secondary

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Rating Score Over Time

The CGI-S scale is the clinician/physician's global assessment of participants illness severity of MG and is rated by answering on 8-point scale. Considering total clinical experience, participant is assessed on severity of illness according to: 0=not performed; 1=normal, not at all ill; 2=borderline illness; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. Higher scores indicated more severity of illness. Values of 0 (not assessed) were excluded from analysis. CGI-S permits global evaluation of participant's condition at given time.

Posted

Mean

Standard Deviation

score on a scale

Baseline up to Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Secondary

Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score

Number of participants with improvement of illness based on CGI-I scale score over time were reported. The CGI-I scale is the clinician/physician's global assessment of the change in severity of the patient's generalized myasthenia gravis (gMG) since starting this study. The rating is given on a 7-point scale with lower scores indicating greater improvement (1= Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 =Minimally worse; 6 = Much worse; 7 = Very much worse. Values of 0 (not assessed) were excluded from analysis. Higher score indicates more severity.

Posted

Count of Participants

Participants

Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Secondary

Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time

Number of participants with change from baseline in MGFA classification score over time were reported. The MGFA was used to assess the participant's MG severity. MGFA classification identifies the subgroup participants with MG who share distinct clinical features or severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV are designed: "a" if the predominant weakness is affecting limb/axial weakness or both; subclass "b" if the predominant weakness is affecting oropharyngeal or respiratory muscles or both. In the MGFA classification, lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III).

Posted

Count of Participants

Participants

Weeks 8, 24 and End of Treatment (EoT) (up to 253 days post-baseline)

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Secondary

Number of Participants With Anti-drug Antibodies (ADA) to Nipocalimab

Number of participants with ADA to nipocalimab were reported. The presence of ADA to nipocalimab in serum was determined by a sensitive and drug-tolerant electrochemiluminescence immunoassay (ECLIA) method.

The FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Count of Participants

Participants

Up to 257 days post-baseline

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Secondary

Number of Participants With Neutralizing Antibodies (NAbs) to Nipocalimab

Number of participants with NAbs were reported. Neutralizing antibodies to nipocalimab were assessed using a non-cell based competitive ligand binding ECLIA assay.

FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were positive for antibodies to nipocalimab. Per planned analysis, both individual arms and an arm for all (total) participants is presented.

Posted

Count of Participants

Participants

Up to 257 days post-baseline

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Primary

Number of Participants With Below/Above Normal Values of Coagulation Laboratory Parameter

Number of participants with at least one value above upper limit of normal (>ULN) or below the lower limit of normal (< LLN) value of coagulation parameters (activated partial thromboplastin time [APTT] and prothrombin time [PT]) were reported. The lab reference range for APTT is 25.1 to 36.5 seconds. The lab reference range for PT is 9.4 to 12.5 seconds.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Count of Participants

Participants

Up to 257 days post-baseline

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Secondary

Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time

Change from baseline in serum immunoglobulin (Ig)G concentration over time was reported.

The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' included the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Posted

Mean

Standard Deviation

g/L

Baseline to Weeks 2, 4, 8, 12, 24, up to 253 days post-baseline, up to 257 days post-baseline

ID	Title	Description
OG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
OG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronavirus Infection	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Covid-19 Pneumonia	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected30 at risk
Gliosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Myasthenia Gravis	Nervous system disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected30 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Vertigo Positional	Ear and labyrinth disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected30 at risk
Conjunctival Haemorrhage	Eye disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Conjunctival Hyperaemia	Eye disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected30 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected30 at risk
Toothache	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected30 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Asthenia	General disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Feeling Hot	General disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Oedema Peripheral	General disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected7 at risk EG0013 affected30 at risk
Peripheral Swelling	General disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Pyrexia	General disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Herpes Zoster	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Oral Herpes	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Otitis Media	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Pharyngitis	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Sinusitis	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected30 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Foreign Body	Injury, poisoning and procedural complications	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Wound	Injury, poisoning and procedural complications	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Blood Creatine Phosphokinase Increased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Blood Immunoglobulin G Decreased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected7 at risk EG0014 affected30 at risk
Blood Potassium Decreased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Hepatic Enzyme Increased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected30 at risk
Lymphocyte Count Decreased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected30 at risk
Neutrophil Count Increased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected30 at risk
Platelet Count Decreased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
White Blood Cell Count Increased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Vitamin B6 Deficiency	Metabolism and nutrition disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected30 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Headache	Nervous system disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected30 at risk
Myasthenia Gravis	Nervous system disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected30 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Depressed Mood	Psychiatric disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected30 at risk
Adenomyosis	Reproductive system and breast disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Aphonia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Increased Viscosity of Upper Respiratory Secretion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected30 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected30 at risk

ID	Term
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010257	Paraneoplastic Syndromes
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D019636	Neurodegenerative Diseases
D020511	Neuromuscular Junction Diseases
D009468	Neuromuscular Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).
BG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo-Nipocalimab	Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	0	7	1	7	4	7
EG001	Nipocalimab-Nipocalimab	Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	1	30	4	30	17	30