Trial Outcomes & Findings for A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis (NCT NCT04951622)
NCT ID: NCT04951622
Last Updated: 2025-11-13
Results Overview
Average change from baseline over multiple timepoints (Weeks 22, 23, and 24) was reported in this outcome measure. The MG-ADL provided a rapid assessment of the participant's MG symptom severity of 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, eyelid droop) rated on a 4-point scale ranging from 0 (normal) to 3 (severe). MG-ADL total score was sum of 8 individual items, which ranging from 0 to 24. A higher score indicated greater symptom severity. Baseline was defined as the average of the screening and Day 1 total scores.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
219 participants
Primary outcome timeframe
Baseline, Weeks 22, 23, and 24
Results posted on
2025-11-13
Participant Flow
Results are currently reported for primary completion date (PCD, 17-Nov-2023). For open-label extension (OLE) phase, data for participants that were enrolled in OLE phase until the PCD is presented. OLE phase is still ongoing and complete results will be posted upon study completion.
Participant milestones
| Measure |
OLE Phase: Placebo to Nipocalimab
Present study participants who received placebo and completed DB phase entered OLE phase and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. Participants who discontinued DB treatment phase due to use of rescue medication for myasthenia gravis exacerbation or crisis were also eligible to enter the OLE phase.
|
OLE Phase: Nipocalimab
Present study participants who received nipocalimab and completed DB phase entered OLE phase and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. Participants who discontinued DB treatment phase due to use of rescue medication for myasthenia gravis exacerbation or crisis were also eligible to enter the OLE phase.
|
OLE Phase: Nipocalimab (MOM-M281-004 and MOM-M281-005)
Participants who received nipocalimab in studies MOM-M281-004 (NCT03772587) and MOM-M281-005 (NCT03896295) entered OLE phase of the present study and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1.
|
Double Blind (DB) Phase: Placebo
During double blind (DB) phase, participants of present study received placebo matching to nipocalimab intravenous (IV) infusion as a loading dose on Day 1 (Week 0) followed by placebo matching to nipocalimab IV infusion as maintenance dose once every 2 weeks (q2w) from Week 2 up to Week 24.
|
DB Phase: Nipocalimab
During DB phase, participants of present study received nipocalimab 30 milligrams per kilogram (mg/kg) IV infusion as a loading dose on Day 1 (Week 0) followed by nipocalimab 15 mg/kg IV infusion as maintenance dose once q2w from Week 2 up to Week 24.
|
|---|---|---|---|---|---|
|
DB Phase: Day 1 (Week 0) to Week 24
STARTED
|
0
|
0
|
0
|
99
|
100
|
|
DB Phase: Day 1 (Week 0) to Week 24
Treated
|
0
|
0
|
0
|
98
|
98
|
|
DB Phase: Day 1 (Week 0) to Week 24
COMPLETED
|
0
|
0
|
0
|
82
|
87
|
|
DB Phase: Day 1 (Week 0) to Week 24
NOT COMPLETED
|
0
|
0
|
0
|
17
|
13
|
|
OLE: Week 24 (OLE Day 1) up to 2 Years
STARTED
|
88
|
88
|
20
|
0
|
0
|
|
OLE: Week 24 (OLE Day 1) up to 2 Years
Treated
|
88
|
88
|
19
|
0
|
0
|
|
OLE: Week 24 (OLE Day 1) up to 2 Years
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
OLE: Week 24 (OLE Day 1) up to 2 Years
NOT COMPLETED
|
88
|
88
|
20
|
0
|
0
|
Reasons for withdrawal
| Measure |
OLE Phase: Placebo to Nipocalimab
Present study participants who received placebo and completed DB phase entered OLE phase and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. Participants who discontinued DB treatment phase due to use of rescue medication for myasthenia gravis exacerbation or crisis were also eligible to enter the OLE phase.
|
OLE Phase: Nipocalimab
Present study participants who received nipocalimab and completed DB phase entered OLE phase and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. Participants who discontinued DB treatment phase due to use of rescue medication for myasthenia gravis exacerbation or crisis were also eligible to enter the OLE phase.
|
OLE Phase: Nipocalimab (MOM-M281-004 and MOM-M281-005)
Participants who received nipocalimab in studies MOM-M281-004 (NCT03772587) and MOM-M281-005 (NCT03896295) entered OLE phase of the present study and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1.
|
Double Blind (DB) Phase: Placebo
During double blind (DB) phase, participants of present study received placebo matching to nipocalimab intravenous (IV) infusion as a loading dose on Day 1 (Week 0) followed by placebo matching to nipocalimab IV infusion as maintenance dose once every 2 weeks (q2w) from Week 2 up to Week 24.
|
DB Phase: Nipocalimab
During DB phase, participants of present study received nipocalimab 30 milligrams per kilogram (mg/kg) IV infusion as a loading dose on Day 1 (Week 0) followed by nipocalimab 15 mg/kg IV infusion as maintenance dose once q2w from Week 2 up to Week 24.
|
|---|---|---|---|---|---|
|
DB Phase: Day 1 (Week 0) to Week 24
Adverse Event
|
0
|
0
|
0
|
7
|
5
|
|
DB Phase: Day 1 (Week 0) to Week 24
Protocol Violation
|
0
|
0
|
0
|
2
|
2
|
|
DB Phase: Day 1 (Week 0) to Week 24
Death
|
0
|
0
|
0
|
2
|
1
|
|
DB Phase: Day 1 (Week 0) to Week 24
Disease relapse
|
0
|
0
|
0
|
0
|
1
|
|
DB Phase: Day 1 (Week 0) to Week 24
Progressive Disease
|
0
|
0
|
0
|
1
|
1
|
|
DB Phase: Day 1 (Week 0) to Week 24
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
DB Phase: Day 1 (Week 0) to Week 24
Lack of Efficacy
|
0
|
0
|
0
|
2
|
0
|
|
DB Phase: Day 1 (Week 0) to Week 24
Randomized by mistake
|
0
|
0
|
0
|
1
|
0
|
|
DB Phase: Day 1 (Week 0) to Week 24
Subject refused further study treatment
|
0
|
0
|
0
|
1
|
0
|
|
DB Phase: Day 1 (Week 0) to Week 24
Other
|
0
|
0
|
0
|
0
|
1
|
|
DB Phase: Day 1 (Week 0) to Week 24
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
|
DB Phase: Day 1 (Week 0) to Week 24
Failure to meet randomization criteria
|
0
|
0
|
0
|
0
|
1
|
|
OLE: Week 24 (OLE Day 1) up to 2 Years
Adverse Event
|
5
|
0
|
2
|
0
|
0
|
|
OLE: Week 24 (OLE Day 1) up to 2 Years
Death
|
0
|
1
|
1
|
0
|
0
|
|
OLE: Week 24 (OLE Day 1) up to 2 Years
Withdrawal by Subject
|
1
|
5
|
1
|
0
|
0
|
|
OLE: Week 24 (OLE Day 1) up to 2 Years
Lack of Efficacy
|
3
|
7
|
0
|
0
|
0
|
|
OLE: Week 24 (OLE Day 1) up to 2 Years
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
OLE: Week 24 (OLE Day 1) up to 2 Years
Physician Decision
|
1
|
1
|
0
|
0
|
0
|
|
OLE: Week 24 (OLE Day 1) up to 2 Years
Ongoing
|
77
|
74
|
15
|
0
|
0
|
|
OLE: Week 24 (OLE Day 1) up to 2 Years
Met eligibility criteria but discontinued during the screening period (not treated)
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Baseline characteristics by cohort
| Measure |
Double Blind (DB) Phase: Placebo
n=98 Participants
During double blind (DB) phase, participants of present study received placebo matching to nipocalimab intravenous (IV) infusion as a loading dose on Day 1 (Week 0) followed by placebo matching to nipocalimab IV infusion as maintenance dose once every 2 weeks (q2w) from Week 2 up to Week 24.
|
DB Phase: Nipocalimab
n=98 Participants
During DB phase, participants of present study received nipocalimab 30 milligrams per kilogram (mg/kg) IV infusion as a loading dose on Day 1 (Week 0) followed by nipocalimab 15 mg/kg IV infusion as maintenance dose once q2w from Week 2 up to Week 24.
|
OLE Phase: Nipocalimab (MOM-M281-004 and MOM-M281-005)
n=19 Participants
Participants who received nipocalimab in studies MOM-M281-004 (NCT03772587) and MOM-M281-005 (NCT03896295) entered OLE phase of the present study and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.7 Years
STANDARD_DEVIATION 15.60 • n=10 Participants
|
52.9 Years
STANDARD_DEVIATION 15.49 • n=10 Participants
|
52.7 Years
STANDARD_DEVIATION 17.69 • n=20 Participants
|
52.8 Years
STANDARD_DEVIATION 15.74 • n=45 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=10 Participants
|
66 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
132 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=10 Participants
|
32 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
83 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
5 Participants
n=20 Participants
|
21 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=10 Participants
|
87 Participants
n=10 Participants
|
14 Participants
n=20 Participants
|
190 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
4 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=10 Participants
|
28 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
57 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=10 Participants
|
66 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
150 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
5 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 22, 23, and 24Population: Primary efficacy analysis set included all randomized seropositive (with anti- acetylcholine receptor positive, anti muscle-specific kinase positive, and/or anti- lipoprotein-related protein receptor 4 positive) participants who received at least 1 dose (partial or complete) of any study intervention in the double-blind phase. Here, 'N' (overall number of participants analysed) signifies participants who were evaluable for this outcome measure.
Average change from baseline over multiple timepoints (Weeks 22, 23, and 24) was reported in this outcome measure. The MG-ADL provided a rapid assessment of the participant's MG symptom severity of 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, eyelid droop) rated on a 4-point scale ranging from 0 (normal) to 3 (severe). MG-ADL total score was sum of 8 individual items, which ranging from 0 to 24. A higher score indicated greater symptom severity. Baseline was defined as the average of the screening and Day 1 total scores.
Outcome measures
| Measure |
Double Blind (DB) Phase: Placebo
n=76 Participants
During double blind (DB) phase, participants of present study received placebo matching to nipocalimab intravenous (IV) infusion as a loading dose on Day 1 (Week 0) followed by placebo matching to nipocalimab IV infusion as maintenance dose once every 2 weeks (q2w) from Week 2 up to Week 24.
|
DB Phase: Nipocalimab
n=77 Participants
During DB phase, participants of present study received nipocalimab 30 milligrams per kilogram (mg/kg) IV infusion as a loading dose on Day 1 (Week 0) followed by nipocalimab 15 mg/kg IV infusion as maintenance dose once q2w from Week 2 up to Week 24.
|
|---|---|---|
|
Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24
|
-3.25 Score on a scale
Standard Error 0.335
|
-4.70 Score on a scale
Standard Error 0.329
|
SECONDARY outcome
Timeframe: Baseline, Weeks 22, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 22, 23, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 1 and 2Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 4 up to Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 22, 23, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment (DB phase Day 1) up to 4 years 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment (DB phase Day 1) up to 4 years 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment (DB phase Day 1) up to 4 years 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment (DB phase Day 1) up to 4 years 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment (DB phase Day 1) up to 4 years 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment (Day 1) up to 4 years 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 2 up to Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Weeks 22, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Weeks 22, and 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: DB Phase: Predose and 45 minutes post-dose on Day 1, Weeks 2, 4, 8, 12,16, 20, 24;OL Phase: Predose on Day 1, Weeks 8, 16, 24, 36, 48, 60, 72, 84, and 96Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment (Day 1) up to 4 years 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 4 years 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 4 years 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 4 years 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 4 years 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 4 years 9 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 4 years 9 monthsOutcome measures
Outcome data not reported
Adverse Events
Double Blind (DB) Phase: Placebo
Serious events: 14 serious events
Other events: 65 other events
Deaths: 2 deaths
DB Phase: Nipocalimab
Serious events: 9 serious events
Other events: 69 other events
Deaths: 1 deaths
OLE Phase: Placebo to Nipocalimab
Serious events: 10 serious events
Other events: 57 other events
Deaths: 1 deaths
OLE Phase: Nipocalimab
Serious events: 16 serious events
Other events: 59 other events
Deaths: 1 deaths
OLE Phase: Nipocalimab (MOMM281- 004 and MOM-M281-005)
Serious events: 7 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Double Blind (DB) Phase: Placebo
n=98 participants at risk
During double blind (DB) phase, participants of present study received placebo matching to nipocalimab intravenous (IV) infusion as a loading dose on Day 1 (Week 0) followed by placebo matching to nipocalimab IV infusion as maintenance dose once every 2 weeks (q2w) from Week 2 up to Week 24.
|
DB Phase: Nipocalimab
n=98 participants at risk
During DB phase, participants of present study received nipocalimab 30 milligrams per kilogram (mg/kg) IV infusion as a loading dose on Day 1 (Week 0) followed by nipocalimab 15 mg/kg IV infusion as maintenance dose once q2w from Week 2 up to Week 24.
|
OLE Phase: Placebo to Nipocalimab
n=88 participants at risk
Present study participants who received placebo and completed DB phase entered OLE phase and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. Participants who discontinued DB treatment phase due to use of rescue medication for myasthenia gravis exacerbation or crisis were also eligible to enter the OLE phase.
|
OLE Phase: Nipocalimab
n=88 participants at risk
Present study participants who received nipocalimab and completed DB phase entered OLE phase and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. Participants who discontinued DB treatment phase due to use of rescue medication for myasthenia gravis exacerbation or crisis were also eligible to enter the OLE phase.
|
OLE Phase: Nipocalimab (MOMM281- 004 and MOM-M281-005)
n=19 participants at risk
Participants who received nipocalimab in studies MOM-M281-004 (NCT03772587) and MOM-M281-005 (NCT03896295) entered OLE phase of the present study and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Cardiac disorders
Cardiac Arrest
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Cardiac disorders
Hypertensive Heart Disease
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Cardiac disorders
Myocardial Infarction
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Cardiac disorders
Myocardial Ischaemia
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Congenital, familial and genetic disorders
Grey Matter Heterotopia
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Eye disorders
Eyelid Pain
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Hepatobiliary disorders
Liver Disorder
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Immune system disorders
Anaphylactic Shock
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Immune system disorders
Haemophagocytic Lymphohistiocytosis
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Appendicitis
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Coronavirus Infection
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Covid-19
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Gastroenteritis Salmonella
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Herpes Zoster Oticus
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Perinephric Abscess
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Pneumonia Aspiration
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Sepsis
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid Tumour Benign
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Intracranial Mass
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Myasthenia Gravis
|
4.1%
4/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
3.1%
3/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
6.8%
6/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Myasthenia Gravis Crisis
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Non-Epileptic Paroxysmal Event
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Toxic Encephalopathy
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Psychiatric disorders
Suicidal Ideation
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Psychiatric disorders
Suicide Attempt
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Vascular disorders
Hypertension
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
Other adverse events
| Measure |
Double Blind (DB) Phase: Placebo
n=98 participants at risk
During double blind (DB) phase, participants of present study received placebo matching to nipocalimab intravenous (IV) infusion as a loading dose on Day 1 (Week 0) followed by placebo matching to nipocalimab IV infusion as maintenance dose once every 2 weeks (q2w) from Week 2 up to Week 24.
|
DB Phase: Nipocalimab
n=98 participants at risk
During DB phase, participants of present study received nipocalimab 30 milligrams per kilogram (mg/kg) IV infusion as a loading dose on Day 1 (Week 0) followed by nipocalimab 15 mg/kg IV infusion as maintenance dose once q2w from Week 2 up to Week 24.
|
OLE Phase: Placebo to Nipocalimab
n=88 participants at risk
Present study participants who received placebo and completed DB phase entered OLE phase and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. Participants who discontinued DB treatment phase due to use of rescue medication for myasthenia gravis exacerbation or crisis were also eligible to enter the OLE phase.
|
OLE Phase: Nipocalimab
n=88 participants at risk
Present study participants who received nipocalimab and completed DB phase entered OLE phase and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. Participants who discontinued DB treatment phase due to use of rescue medication for myasthenia gravis exacerbation or crisis were also eligible to enter the OLE phase.
|
OLE Phase: Nipocalimab (MOMM281- 004 and MOM-M281-005)
n=19 participants at risk
Participants who received nipocalimab in studies MOM-M281-004 (NCT03772587) and MOM-M281-005 (NCT03896295) entered OLE phase of the present study and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1.
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Perioral Dermatitis
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
3/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Vascular disorders
Hypertension
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
4.5%
4/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
3/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
4.1%
4/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
3.4%
3/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Blood and lymphatic system disorders
White Blood Cell Disorder
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Cardiac disorders
Bundle Branch Block Left
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Cardiac disorders
Palpitations
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Endocrine disorders
Goitre
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Endocrine disorders
Thyroid Mass
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Eye disorders
Angle Closure Glaucoma
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Eye disorders
Eye Pain
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Eye disorders
Eyelid Ptosis
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
3/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
7.1%
7/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.7%
5/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
15.8%
3/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.1%
5/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
4.5%
4/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Asthenia
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Catheter Site Erythema
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Cyst
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Fatigue
|
3.1%
3/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
4.1%
4/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.7%
5/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
3.4%
3/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Inflammation
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Infusion Site Bruising
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Infusion Site Erythema
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Infusion Site Extravasation
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Malaise
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Oedema
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.2%
10/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
4.5%
4/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Pain
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Peripheral Swelling
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
3.4%
3/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Pyrexia
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
7.1%
7/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.7%
5/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Secretion Discharge
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Swelling
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
General disorders
Swelling Face
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Hepatobiliary disorders
Hepatic Cyst
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Bronchitis
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
15.8%
3/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Covid-19
|
9.2%
9/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
11.2%
11/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
8.0%
7/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
8.0%
7/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
26.3%
5/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Covid-19 Pneumonia
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Gastric Infection
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Gastrointestinal Viral Infection
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Helicobacter Infection
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Herpes Ophthalmic
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
10/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
9.2%
9/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
12.5%
11/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
11.4%
10/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Oral Herpes
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
3.4%
3/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Sinusitis
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.7%
5/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
3.4%
3/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Tooth Infection
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.2%
8/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
6.1%
6/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.2%
9/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.2%
9/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
26.3%
5/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.1%
5/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.2%
9/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
9.1%
8/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Viral Diarrhoea
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
3.4%
3/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
3.4%
3/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
15.8%
3/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Muscle Hernia
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Muscle Injury
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Skin Injury
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Wound
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Blood Cholesterol Increased
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
3.1%
3/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Intraocular Pressure Increased
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Low Density Lipoprotein Increased
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
3.4%
3/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Lymphocyte Count Decreased
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Monocyte Count Decreased
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Neutrophil Count Increased
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Sars-Cov-2 Test Positive
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Investigations
Weight Increased
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impaired
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
5/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
4.5%
4/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
4.5%
4/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.1%
5/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
8.2%
8/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
4.5%
4/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.2%
9/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Medial Tibial Stress Syndrome
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.1%
3/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
12.2%
12/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
3.4%
3/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
6.8%
6/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.1%
3/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.1%
5/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
4.5%
4/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
21.1%
4/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Spinal Deformity
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Diabetic Neuropathy
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Dizziness
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.1%
5/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Dizziness Postural
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Headache
|
17.3%
17/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
14.3%
14/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
11.4%
10/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.7%
5/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Migraine
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Myasthenia Gravis
|
9.2%
9/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
9.2%
9/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.7%
5/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
9.1%
8/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
21.1%
4/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Nervous system disorders
Tremor
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Psychiatric disorders
Depression
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Psychiatric disorders
Insomnia
|
2.0%
2/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.1%
5/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Reproductive system and breast disorders
Breast Haematoma
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
3/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
7.1%
7/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
4.5%
4/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
2.3%
2/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
10.5%
2/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
1.0%
1/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/98 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
1.1%
1/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
0.00%
0/88 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
5.3%
1/19 • DB: All-cause mortality: From screening (Day -28) to Week 24; SAE and other AEs: From Day 1 (Week 0) to Week 24; OLE: From Week 24 (OLE Day 1) up to 2 years
DB: SAE and Other AEs: Safety analysis set included all participants who received at least 1 dose (partial or complete) of any study intervention in the DB phase. All cause-mortality: Randomized analysis set included all participants who were randomized in the study. OLE: The safety analysis set included all participants who received at least 1 dose (partial or complete) of nipocalimab in the OLE phase. OLE phase analysis is until PCD and final results will be posted upon study completion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER