Trial Outcomes & Findings for An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD (NCT NCT04201262)

NCT ID: NCT04201262

Last Updated: 2025-10-14

Results Overview

An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the independent relapse adjudication committee.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

58 participants

Primary outcome timeframe

Baseline up to 2.25 years (end of the Primary Treatment Period)

Results posted on

2025-10-14

Participant Flow

This study utilized the placebo group from Study ECU-NMO-301 (NCT01892345) as an external placebo control.

Participant milestones

Participant milestones
Measure
Ravulizumab
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Primary Treatment Period
STARTED
58
47
Primary Treatment Period
Received at Least 1 Dose of Study Drug
58
47
Primary Treatment Period
COMPLETED
56
44
Primary Treatment Period
NOT COMPLETED
2
3
Long-term Extension Period
STARTED
56
0
Long-term Extension Period
Received at Least 1 Dose of Study Drug
56
0
Long-term Extension Period
COMPLETED
55
0
Long-term Extension Period
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Ravulizumab
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Primary Treatment Period
Adverse Event
1
2
Primary Treatment Period
Physician Decision
1
1
Long-term Extension Period
Death
1
0

Baseline Characteristics

An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ravulizumab
n=58 Participants
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
n=47 Participants
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Total
n=105 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
51 Participants
n=5 Participants
44 Participants
n=7 Participants
95 Participants
n=5 Participants
Age, Categorical
>=65 years
7 Participants
n=5 Participants
3 Participants
n=7 Participants
10 Participants
n=5 Participants
Sex: Female, Male
Female
52 Participants
n=5 Participants
42 Participants
n=7 Participants
94 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
5 Participants
n=7 Participants
11 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants
n=5 Participants
3 Participants
n=7 Participants
12 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
45 Participants
n=5 Participants
41 Participants
n=7 Participants
86 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
n=5 Participants
3 Participants
n=7 Participants
7 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
21 Participants
n=5 Participants
15 Participants
n=7 Participants
36 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=5 Participants
8 Participants
n=7 Participants
14 Participants
n=5 Participants
Race (NIH/OMB)
White
29 Participants
n=5 Participants
24 Participants
n=7 Participants
53 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 2.25 years (end of the Primary Treatment Period)

Population: The full analysis set (FAS) included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).

An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the independent relapse adjudication committee.

Outcome measures

Outcome measures
Measure
Ravulizumab
n=58 Participants
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
n=47 Participants
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period
0 Participants
20 Participants

SECONDARY outcome

Timeframe: Baseline up to 2.25 years (end of the Primary Treatment Period)

Population: The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).

The adjudicated On-trial ARR was computed as the total number of relapses divided by the total number of participant years in the study period. A central independent committee was used to adjudicate all On-trial Relapses as determined by the treating physician. Results reported as adjusted adjudicated On-trial ARR based on a Poisson regression centered on the mean historical ARR in the 24 months prior to screening.

Outcome measures

Outcome measures
Measure
Ravulizumab
n=58 Participants
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
n=47 Participants
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Adjudicated On-trial Annualized Relapse Rate (ARR) in the Primary Treatment Period
0.000 relapses/year on study
Since there were no relapses, data could not be estimated.
0.350 relapses/year on study
Interval 0.199 to 0.616

SECONDARY outcome

Timeframe: Baseline up to 2.25 years (end of the Primary Treatment Period)

Population: The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).

The HAI is a rating scale developed to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. The scale ranges from 0 to 9, with 0 being the best score (asymptomatic; fully ambulatory with no assistance) and 9 being the worst (restricted to wheelchair; unable to transfer self independently). Clinically important change is conditional on the baseline value: worsening if the baseline HAI is 0 and at least 2 points increase or if the baseline HAI is \>0 and at least 1 point increase; improvement if the baseline value is at least 2 and at least 1 point decrease; and stable if baseline is 0 or 1 and a 0- or 1-point increase or decrease or baseline is at least 2 and not change.

Outcome measures

Outcome measures
Measure
Ravulizumab
n=58 Participants
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
n=47 Participants
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score at the End of Primary Treatment Period
Clinical Improvement
4 Participants
4 Participants
Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score at the End of Primary Treatment Period
Stable
52 Participants
32 Participants
Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score at the End of Primary Treatment Period
Clinical Worsening
2 Participants
11 Participants

SECONDARY outcome

Timeframe: Baseline, up to 2.25 years (end of the Primary Treatment Period)

Population: The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).

The EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. It consists of 2 parts; the EQ-5D descriptive system and the EQ-5D visual analogue scale (VAS). The EQ-5D descriptive system includes 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: "no problem" (level 1), "some problems" (level 2), "extreme problems" (level 3). The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. The 5 dimensional 3-level systems was converted into single index utility score that ranges from less than 0 to 1, with higher scores representing a better health status.

Outcome measures

Outcome measures
Measure
Ravulizumab
n=58 Participants
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
n=47 Participants
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Change From Baseline in European Quality of Life Health 5-dimension Questionnaire (EQ-5D) Index Score at the End of Primary Treatment Period
0.005 units on a scale
Standard Deviation 0.1522
-0.043 units on a scale
Standard Deviation 0.2115

SECONDARY outcome

Timeframe: Baseline, up to 2.25 years (end of the Primary Treatment Period)

Population: The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).

The EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. It consists of 2 parts; the EQ-5D descriptive system and the EQ-5D visual analogue scale (VAS). The EQ-5D VAS is an overall health state scale where the participant selects a number between 0 to 100 to describe the condition of their health, with 100 being 'The best health state you can imagine' and 0 being 'The worst health state you can imagine'. An increase in score indicates improvement.

Outcome measures

Outcome measures
Measure
Ravulizumab
n=58 Participants
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
n=47 Participants
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score at the End of Primary Treatment Period
2.6 units on a scale
Standard Deviation 14.07
0.6 units on a scale
Standard Deviation 16.39

SECONDARY outcome

Timeframe: Baseline up to 2.25 years (end of the Primary Treatment Period)

Population: The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).

Disease-related disability was measured by the EDSS. The EDSS is an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments. Clinically important worsening was defined as an increase in EDSS score conditional on the baseline value: If the baseline EDSS was 0 and at least 2-point increase; if the baseline is 1 to 5, and at least 1-point increase; if the baseline is \> 5 and at least 0.5 increase.

Outcome measures

Outcome measures
Measure
Ravulizumab
n=58 Participants
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
n=47 Participants
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) Score at the End of Primary Treatment Period
No clinically important worsening
52 Participants
36 Participants
Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) Score at the End of Primary Treatment Period
Clinically important worsening
6 Participants
11 Participants

SECONDARY outcome

Timeframe: Baseline up to 2.25 years (end of the Primary Treatment Period)

Population: The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo).

An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. TEAEs were AEs with a start date on or after the date of the first dose of study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Outcome measures

Outcome measures
Measure
Ravulizumab
n=58 Participants
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
n=47 Participants
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Study Drug Discontinuation in the Primary Treatment Period
Any TEAEs
53 Participants
45 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Study Drug Discontinuation in the Primary Treatment Period
TESAEs
8 Participants
26 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Study Drug Discontinuation in the Primary Treatment Period
TEAEs Leading to Study Drug Discontinuation
1 Participants
2 Participants

SECONDARY outcome

Timeframe: Predose and end of infusion (EOI) at Week 26

Population: Pharmacokinetics/pharmacodynamics (PK/PD) analysis set included participants who received at least 1 dose of study drug and who had at least 1 evaluable PK or PD result. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure
Ravulizumab
n=56 Participants
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Serum Ravulizumab Concentration
Week 26: Predose
760.3 micrograms (µg)/milliliter (mL)
Standard Deviation 202.75
Serum Ravulizumab Concentration
Week 26: EOI
1836.4 micrograms (µg)/milliliter (mL)
Standard Deviation 355.39

SECONDARY outcome

Timeframe: Baseline, Week 26 (Predose and EOI)

Population: The PK/PD analysis set included participants who received at least 1 dose of study drug and who had at least 1 evaluable PK or PD result. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure
Ravulizumab
n=55 Participants
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Change From Baseline in Serum Free C5 Concentration at Week 26
Change at Week 26: Predose
-119.02 µg/mL
Standard Deviation 42.857
Change From Baseline in Serum Free C5 Concentration at Week 26
Change at Week 26: EOI
-119.32 µg/mL
Standard Deviation 42.512

SECONDARY outcome

Timeframe: Baseline, Weeks 26, 50, 82, and 106

Population: The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Here, 'Number analyzed' = participants evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure
Ravulizumab
n=58 Participants
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Placebo (ECU-NMO-301)
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period
Baseline · Positive
5 Participants
Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period
Baseline · Negative
53 Participants
Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period
Week 26 · Positive
1 Participants
Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period
Week 26 · Negative
54 Participants
Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period
Week 50 · Positive
0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period
Week 50 · Negative
52 Participants
Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period
Week 82 · Positive
0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period
Week 82 · Negative
15 Participants
Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period
Week 106 · Positive
0 Participants
Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period
Week 106 · Negative
1 Participants

Adverse Events

Primary Treatment Period: Placebo

Serious events: 26 serious events
Other events: 43 other events
Deaths: 0 deaths

Primary Treatment Period: Ravulizumab

Serious events: 8 serious events
Other events: 53 other events
Deaths: 0 deaths

Long-Term Extension: Ravulizumab

Serious events: 9 serious events
Other events: 49 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Primary Treatment Period: Placebo
n=47 participants at risk
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Primary Treatment Period: Ravulizumab
n=58 participants at risk
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Long-Term Extension: Ravulizumab
n=56 participants at risk
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Myelitis transverse
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Blood and lymphatic system disorders
Pancytopenia
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Cardiac disorders
Myocardial ischaemia
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Abdominal pain
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Pancreatitis
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Hepatobiliary disorders
Cholecystitis acute
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Encephalitis meningococcal
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Infection
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Intervertebral discitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Meningococcal sepsis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Pneumonia
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Bronchitis
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Gastroenteritis viral
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Herpes zoster
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Influenza
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Pneumococcal infection
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Viral upper respiratory tract infection
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Rib fracture
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Muscular weakness
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Neuromyelitis optica spectrum disorder
34.0%
16/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Paraesthesia
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Somnolence
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Syncope
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Suicidal ideation
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Confusional state
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Pleurisy
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Vascular disorders
Orthostatic hypotension
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Cardiac disorders
Cardiac failure
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Cardiac disorders
Hypertensive heart disease
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Cellulitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Ankle fracture
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Ulna fracture
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Neuromyelitis optica pseudo relapse
2.1%
1/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Vascular disorders
Deep vein thrombosis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Cataract
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.

Other adverse events

Other adverse events
Measure
Primary Treatment Period: Placebo
n=47 participants at risk
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Primary Treatment Period: Ravulizumab
n=58 participants at risk
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Long-Term Extension: Ravulizumab
n=56 participants at risk
Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 2.63 years.
Ear and labyrinth disorders
Tinnitus
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Blood and lymphatic system disorders
Anaemia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Blood and lymphatic system disorders
Iron deficiency anaemia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Blood and lymphatic system disorders
Lymphadenopathy
2.1%
1/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Blood and lymphatic system disorders
Leukopenia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Cardiac disorders
Tachycardia
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Cardiac disorders
Bradycardia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Cardiac disorders
Extrasystoles
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Cardiac disorders
Pericardial effusion
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Ear and labyrinth disorders
Vertigo
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.4%
3/56 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Ear and labyrinth disorders
Ear pain
4.3%
2/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Ear and labyrinth disorders
Paraesthesia ear
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Ear and labyrinth disorders
Eustachian tube dysfunction
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Endocrine disorders
Thyroid cyst
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Endocrine disorders
Thyroid mass
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Blepharitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Conjunctivitis allergic
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Eye disorder
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Eye pain
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Ocular discomfort
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Ocular hyperaemia
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Vision blurred
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Visual impairment
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Cataract
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Conjunctival haemorrhage
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Photophobia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Retinal degeneration
2.1%
1/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Constipation
6.4%
3/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
6.9%
4/58 • Number of events 5 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Abdominal distension
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Migraine
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 4 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Vomiting
17.0%
8/47 • Number of events 10 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
6.9%
4/58 • Number of events 5 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Diarrhoea
12.8%
6/47 • Number of events 14 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
8.9%
5/56 • Number of events 6 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Gastrooesophageal reflux disease
6.4%
3/47 • Number of events 5 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 4 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Nausea
25.5%
12/47 • Number of events 17 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.4%
3/56 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Alveolar bone resorption
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Anal incontinence
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Dry mouth
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Dyspepsia
8.5%
4/47 • Number of events 4 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Food poisoning
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Gastric ulcer
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Blood glucose increased
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Periodontal disease
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Stomatitis
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Abdominal pain
4.3%
2/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Abdominal pain upper
6.4%
3/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Abdominal tenderness
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Angular cheilitis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Aphthous ulcer
2.1%
1/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Colitis microscopic
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Gingival pain
2.1%
1/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Intestinal obstruction
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Lip blister
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Lip pain
2.1%
1/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Mouth ulceration
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Presbyoesophagus
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Toothache
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Hepatobiliary disorders
Hepatic steatosis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Hepatobiliary disorders
Cholecystitis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Hepatobiliary disorders
Cholelithiasis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Hepatobiliary disorders
Hepatic function abnormal
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Immune system disorders
Allergy to arthropod bite
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Immune system disorders
Seasonal allergy
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
COVID-19
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
24.1%
14/58 • Number of events 15 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
28.6%
16/56 • Number of events 16 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Urinary tract infection
19.1%
9/47 • Number of events 12 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
10.3%
6/58 • Number of events 7 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
10.7%
6/56 • Number of events 14 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Cystitis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
8.6%
5/58 • Number of events 7 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Upper respiratory tract infection
12.8%
6/47 • Number of events 10 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
8.6%
5/58 • Number of events 5 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
10.7%
6/56 • Number of events 12 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Nasopharyngitis
17.0%
8/47 • Number of events 12 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
7.1%
4/56 • Number of events 6 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Sinusitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Conjunctivitis
8.5%
4/47 • Number of events 8 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Oral herpes
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
7.1%
4/56 • Number of events 6 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Periodontitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Bronchitis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Cellulitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Gingivitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Herpes simplex
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Laryngitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Nasal herpes
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Paronychia
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Post-acute COVID-19 syndrome
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Rhinitis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Stenotrophomonas infection
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Alcohol poisoning
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Tinea pedis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 6 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Tinea versicolour
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Tooth infection
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Viral pharyngitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Vulvovaginal candidiasis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Bacterial vaginosis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Body tinea
2.1%
1/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Chronic tonsillitis
2.1%
1/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Diarrhoea infectious
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Ear infection
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Gastroenteritis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Influenza
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Lower respiratory tract infection
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Mastitis bacterial
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Nail infection
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Oesophageal candidiasis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Onychomycosis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Oral candidiasis
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Otitis externa
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Pharyngitis
6.4%
3/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Pneumonia
6.4%
3/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Post procedural infection
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Tooth abscess
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Viral upper respiratory tract infection
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Vulvovaginal mycotic infection
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Cartilage injury
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Concussion
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Joint dislocation
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Ligament sprain
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Limb injury
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Muscle strain
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Rib fracture
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Skin abrasion
4.3%
2/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Tooth fracture
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Chillblains
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Contusion
4.3%
2/47 • Number of events 6 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Fall
8.5%
4/47 • Number of events 8 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Fibula fracture
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Foot fracture
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Fractured sacrum
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Head injury
2.1%
1/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Injury
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Post procedural contusion
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Procedural complication
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Skin laceration
4.3%
2/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Stress fracture
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Thermal burn
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Thoracic vertebral fracture
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Wound
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Hepatic enzyme increased
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Lymphocyte count decreased
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Alanine aminotransferase increased
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Aspartate aminotransferase increased
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Blood creatinine increased
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Haemoglobin decreased
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
SARS-CoV-2 test positive
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Urinary occult blood
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Blood potassium decreased
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Blood pressure systolic increased
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Bone density decreased
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Cortisol decreased
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Electrocardiogram abnormal
2.1%
1/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Gardnerella test positive
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Neutrophil count decreased
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Weight decreased
6.4%
3/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Weight increased
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
White blood cell count decreased
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Metabolism and nutrition disorders
Hyperglycaemia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Metabolism and nutrition disorders
Hypercholesterolaemia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Metabolism and nutrition disorders
Hypokalaemia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Metabolism and nutrition disorders
Vitamin D deficiency
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Metabolism and nutrition disorders
Decreased appetite
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Metabolism and nutrition disorders
Dehydration
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Metabolism and nutrition disorders
Folate deficiency
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Metabolism and nutrition disorders
Hypophosphataemia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Metabolism and nutrition disorders
Hypoproteinaemia
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Metabolism and nutrition disorders
Iron deficiency
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Back pain
12.8%
6/47 • Number of events 9 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
12.1%
7/58 • Number of events 8 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Arthralgia
8.5%
4/47 • Number of events 9 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
10.3%
6/58 • Number of events 6 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Myalgia
6.4%
3/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Neck pain
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Pain in extremity
21.3%
10/47 • Number of events 11 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Joint swelling
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Limb discomfort
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Muscle spasms
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Pelvic deformity
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Periarthritis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Flank pain
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Fracture pain
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Muscular weakness
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Osteonecrosis
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Osteopenia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Osteoporosis
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Synovial disorder
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Headache
21.3%
10/47 • Number of events 17 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
25.9%
15/58 • Number of events 25 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
8.9%
5/56 • Number of events 6 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Dizziness
12.8%
6/47 • Number of events 6 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
6.9%
4/58 • Number of events 4 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Paraesthesia
6.4%
3/47 • Number of events 4 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Hypoaesthesia
8.5%
4/47 • Number of events 5 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Memory impairment
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Parosmia
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Presyncope
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Sensory disturbance
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Somnolence
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Syncope
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Burning sensation
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Dysgeusia
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Head discomfort
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Mental impairment
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Muscle contractions involuntary
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Muscle spasticity
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Neuralgia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Post herpetic neuralgia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Uhthoff's phenomenon
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Anxiety
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Insomnia
8.5%
4/47 • Number of events 4 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Depressed mood
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Depression
8.5%
4/47 • Number of events 5 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.4%
3/56 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Post-traumatic stress disorder
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Sleep talking
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Suicidal ideation
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Agitation
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Delusion
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Hallucination
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Obsessive-compulsive disorder
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Persistent depressive disorder
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Sleep disorder
4.3%
2/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Dysuria
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Acute kidney injury
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Haematuria
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Proteinuria
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Strangury
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 5 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Cystitis interstitial
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Glycosuria
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Nephrolithiasis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Pollakiuria
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Prerenal failure
2.1%
1/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Urethral syndrome
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Urinary incontinence
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Reproductive system and breast disorders
Menopausal symptoms
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Reproductive system and breast disorders
Vulvovaginal pruritus
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Reproductive system and breast disorders
Dysmenorrhoea
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Reproductive system and breast disorders
Endometrial hyperplasia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Reproductive system and breast disorders
Menstruation irregular
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Cough
12.8%
6/47 • Number of events 8 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.4%
3/56 • Number of events 4 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Epistaxis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
6.4%
3/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Sinus congestion
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Atelectasis
2.1%
1/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Dysphonia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
6.4%
3/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Productive cough
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Sinus disorder
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Tonsillolith
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Acne
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Purpura
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Alopecia
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Rash
8.5%
4/47 • Number of events 4 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Dermatitis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Dry skin
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Eczema
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Erythema
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Hyperkeratosis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Ingrowing nail
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Pruritus
8.5%
4/47 • Number of events 8 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Sensitive skin
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Urticaria
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Dermatitis allergic
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Dermatitis contact
4.3%
2/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Hyperhidrosis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Petechiae
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Pityriasis rosea
2.1%
1/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Rash maculo-papular
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Skin lesion
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Social circumstances
Menopause
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Vascular disorders
Hypertension
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Vascular disorders
Deep vein thrombosis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Vascular disorders
Lymphoedema
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Vascular disorders
Flushing
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Vascular disorders
Hypotension
4.3%
2/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Vascular disorders
Orthostatic hypotension
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Blood and lymphatic system disorders
Macrocytosis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Cardiac disorders
Heart failure with preserved ejection fraction
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Dry eye
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Eyelid ptosis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Eye disorders
Photopsia
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Abdominal fat apron
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Dental caries
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Dysphagia
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Faeces soft
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Gastritis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Haematochezia
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Hiatus hernia
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Pancreatic cyst
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Rectal polyp
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Herpes zoster
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.4%
3/56 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Localised infection
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Respiratory tract infection
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Bacterial vulvovaginitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Conjunctivitis viral
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Coronavirus infection
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Diverticulitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Eye infection
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Folliculitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Fungal skin infection
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Hordeolum
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Otitis media
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Pharyngitis streptococcal
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Postoperative wound infection
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Respiratory tract infection viral
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Subcutaneous abscess
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Immunisation reaction
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Animal bite
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Ankle fracture
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Arthropod bite
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Arthropod sting
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Hand fracture
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Procedural headache
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Pulmonary contusion
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Wound complication
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Antinuclear antibody positive
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Blood urea increased
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Culture cervix positive
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Protein urine present
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Red blood cell sedimentation rate increased
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Muscle contracture
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Synovial cyst
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Temporomandibular pain and dysfunction syndrome
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Foot deformity
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Plantar fasciitis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign soft tissue neoplasm
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Carpal tunnel syndrome
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Facial paralysis
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Migraine with aura
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Neuromyelitis optica pseudo relapse
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Partial seizures with secondary generalisation
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Nervous system disorders
Tremor
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Psychiatric disorders
Attention deficit hyperactivity disorder
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Cystitis-like symptom
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Renal and urinary disorders
Micturition urgency
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Reproductive system and breast disorders
Breast pain
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.6%
2/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Reproductive system and breast disorders
Intermenstrual bleeding
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Catarrh
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Cough variant asthma
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Paranasal sinus inflammation
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Pleural thickening
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Androgenetic alopecia
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Skin and subcutaneous tissue disorders
Pigmentation disorder
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Metabolism and nutrition disorders
Hyperlipidaemia
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Gastrointestinal disorders
Anorectal discomfort
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Asthenia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Axillary pain
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Chest discomfort
4.3%
2/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Chest pain
4.3%
2/47 • Number of events 12 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Chills
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 5 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Cyst
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Fatigue
10.6%
5/47 • Number of events 5 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Feeling cold
2.1%
1/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Gait disturbance
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Generalised oedema
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Induration
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Influenza like illness
2.1%
1/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Injection site reaction
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Malaise
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Non-cardiac chest pain
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Oedema
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Oedema peripheral
6.4%
3/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Pain
8.5%
4/47 • Number of events 7 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
3.4%
2/58 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Peripheral swelling
4.3%
2/47 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Pyrexia
8.5%
4/47 • Number of events 5 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
8.6%
5/58 • Number of events 6 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Swelling face
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Vaccination site pain
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
5.2%
3/58 • Number of events 3 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
General disorders
Vaccination site pruritus
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.7%
1/58 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Enterococcal bacteraemia
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Klebsiella bacteraemia
2.1%
1/47 • Number of events 2 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Infections and infestations
Otitis media chronic
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Injury, poisoning and procedural complications
Foreign body
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Investigations
Blood creatinine decreased
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Musculoskeletal and connective tissue disorders
Spinal retrolisthesis
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Product Issues
Medical device entrapment
0.00%
0/47 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
1.8%
1/56 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Reproductive system and breast disorders
Heavy menstrual bleeding
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
Reproductive system and breast disorders
Lactation insufficiency
2.1%
1/47 • Number of events 1 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/58 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
0.00%
0/56 • Up to approximately 4.9 years.
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was specified to be reported for primary analysis results only. Data were collected and are reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.

Additional Information

Alexion Pharmaceuticals, Inc.

Alexion Pharmaceuticals, Inc.

Phone: 855-752-2356

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place