Trial Outcomes & Findings for An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients (NCT NCT02003144)
NCT ID: NCT02003144
Last Updated: 2022-08-23
Results Overview
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent adverse events (TEAEs) were defined as an AE with onset on or after the first study drug dose in Study ECU-NMO-302. A serious adverse event (SAE) was defined as an untoward medical occurrence that at any dose either results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
119 participants
Primary outcome timeframe
Baseline up to end of study (up to 6.5 years)
Results posted on
2022-08-23
Participant Flow
Participants who completed Study ECU-NMO-301 (NCT01892345) were eligible to participate in Study ECU-NMO-302. This is an open-label study in which all participants were administered intravenous eculizumab. However, to maintain the blind of Study ECU-NMO-301, all participants underwent a 4-week Blind Induction Phase before entering the Open-label Maintenance Phase.
Participant milestones
| Measure |
Placebo/Eculizumab
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 milligrams \[mg\]) plus matching placebo via intravenous (IV) infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|
|
Blind Induction Phase
STARTED
|
41
|
78
|
|
Blind Induction Phase
Received at Least 1 Dose of Study Drug
|
41
|
78
|
|
Blind Induction Phase
COMPLETED
|
41
|
78
|
|
Blind Induction Phase
NOT COMPLETED
|
0
|
0
|
|
Open Label Maintenance Phase
STARTED
|
41
|
78
|
|
Open Label Maintenance Phase
Received at Least 1 Dose of Study Drug
|
41
|
78
|
|
Open Label Maintenance Phase
COMPLETED
|
32
|
64
|
|
Open Label Maintenance Phase
NOT COMPLETED
|
9
|
14
|
Reasons for withdrawal
| Measure |
Placebo/Eculizumab
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 milligrams \[mg\]) plus matching placebo via intravenous (IV) infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|
|
Open Label Maintenance Phase
Other than specified
|
2
|
4
|
|
Open Label Maintenance Phase
Withdrawal by Subject
|
4
|
5
|
|
Open Label Maintenance Phase
Pregnancy
|
0
|
2
|
|
Open Label Maintenance Phase
Physician Decision
|
1
|
1
|
|
Open Label Maintenance Phase
Lost to Follow-up
|
0
|
1
|
|
Open Label Maintenance Phase
Adverse Event
|
2
|
1
|
Baseline Characteristics
An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
Baseline characteristics by cohort
| Measure |
Placebo/Eculizumab
n=41 Participants
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 mg) plus matching placebo via IV infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
n=78 Participants
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 13.82 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 13.77 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 13.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of study (up to 6.5 years)Population: The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent adverse events (TEAEs) were defined as an AE with onset on or after the first study drug dose in Study ECU-NMO-302. A serious adverse event (SAE) was defined as an untoward medical occurrence that at any dose either results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo/Eculizumab
n=41 Participants
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 mg) plus matching placebo via IV infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
n=78 Participants
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
TEAEs
|
41 Participants
|
70 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
SAEs
|
14 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of study (up to 6.5 years)Population: The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
The C-SSRS is a validated questionnaire to capture occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no). Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Planned) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; and Active Suicidal Ideation with Specific Plan and Intent. Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), and Completed Suicide. Suicidal Ideation or Behaviour: a "yes" answer to the following question: Self-injurious behaviour without suicidal intent.
Outcome measures
| Measure |
Placebo/Eculizumab
n=41 Participants
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 mg) plus matching placebo via IV infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
n=78 Participants
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|
|
Number of Participants With At Least 1 Post Baseline Columbia-Suicide Severity Rating Scale (C-SSRS) Assessment (Suicide-Related Thoughts or Behaviours) Abnormality
Suicidal Behavior
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least 1 Post Baseline Columbia-Suicide Severity Rating Scale (C-SSRS) Assessment (Suicide-Related Thoughts or Behaviours) Abnormality
Suicidal Ideation or Behavior
|
4 Participants
|
5 Participants
|
|
Number of Participants With At Least 1 Post Baseline Columbia-Suicide Severity Rating Scale (C-SSRS) Assessment (Suicide-Related Thoughts or Behaviours) Abnormality
Suicidal Ideation
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of study (up to 6.5 years)Population: The Extension Full Analysis Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302 and had a post-IP-infusion efficacy assessment.
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.
Outcome measures
| Measure |
Placebo/Eculizumab
n=41 Participants
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 mg) plus matching placebo via IV infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
n=78 Participants
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|
|
Number of Participants With An On-trial Relapse as Determined by The Treating Physician
|
5 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of study (up to 6.5 years)Population: The Extension Full Analysis Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302 and had a post-IP-infusion efficacy assessment.
The On-trial ARR was computed as the total number of relapses divided by the total number of participant years in the study period.
Outcome measures
| Measure |
Placebo/Eculizumab
n=41 Participants
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 mg) plus matching placebo via IV infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
n=78 Participants
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|
|
On-Trial Annualized Relapse Rate (ARR) as Determined by The Treating Physician
|
0.128 relapses/years on study
Standard Deviation 0.4576
|
0.061 relapses/years on study
Standard Deviation 0.2186
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 104 and 156Population: The Extension Full Analysis Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302 and had a post-IP-infusion efficacy assessment. Here, Number Analyzed signifies those participants who were evaluable at specified time points.
Disease-related disability was measured by the EDSS. The EDSS quantifies disability in 8 Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. The Functional Systems are pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other. The EDSS is an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments. A decrease in score indicates improvement. Baseline was defined as the last available assessment prior to the first study drug infusion in Study ECU-NMO-302.
Outcome measures
| Measure |
Placebo/Eculizumab
n=41 Participants
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 mg) plus matching placebo via IV infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
n=78 Participants
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Change from Baseline at Week 156
|
-0.38 units on a scale
Standard Deviation 1.003
|
-0.38 units on a scale
Standard Deviation 1.057
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Baseline
|
4.34 units on a scale
Standard Deviation 1.879
|
3.97 units on a scale
Standard Deviation 1.736
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Change from Baseline at Week 52
|
-0.24 units on a scale
Standard Deviation 0.721
|
0.01 units on a scale
Standard Deviation 0.571
|
|
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Change from Baseline at Week 104
|
-0.39 units on a scale
Standard Deviation 0.830
|
-0.11 units on a scale
Standard Deviation 0.536
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 104 and 156Population: The Extension Full Analysis Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302 and had a post-IP-infusion efficacy assessment. Here, Number Analyzed signifies those participants who were evaluable at specified time points.
Disease-related disability was measured by the mRS score. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered from a neurological disability. The scale ranges from 0 (no symptoms at all) to 6 (death) in whole-point increments. A decrease in score indicates improvement. Baseline was defined as the last available assessment prior to the first study drug infusion in Study ECU-NMO-302.
Outcome measures
| Measure |
Placebo/Eculizumab
n=41 Participants
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 mg) plus matching placebo via IV infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
n=78 Participants
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|
|
Change From Baseline in Modified Rankin Scale (mRS) Score
Baseline
|
2.39 units on a scale
Standard Deviation 1.358
|
1.88 units on a scale
Standard Deviation 1.269
|
|
Change From Baseline in Modified Rankin Scale (mRS) Score
Change from Baseline at Week 52
|
-0.27 units on a scale
Standard Deviation 0.932
|
-0.04 units on a scale
Standard Deviation 0.458
|
|
Change From Baseline in Modified Rankin Scale (mRS) Score
Change from Baseline at Week 104
|
-0.41 units on a scale
Standard Deviation 1.182
|
-0.14 units on a scale
Standard Deviation 0.543
|
|
Change From Baseline in Modified Rankin Scale (mRS) Score
Change from Baseline at Week 156
|
-0.62 units on a scale
Standard Deviation 1.446
|
-0.31 units on a scale
Standard Deviation 0.602
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 104 and 156Population: The Extension Full Analysis Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302 and had a post-IP-infusion efficacy assessment. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points.
The HAI evaluates gait and was used to assess the time and effort used by the participant to walk 25 feet (8 meters). The scale ranges from 0 to 9, with 0 being the best score (asymptomatic; fully active) and 9 being the worst (restricted to wheelchair; unable to transfer self independently). A decrease in score indicates improvement. Baseline is defined as the last available assessment prior to the first study drug infusion in Study ECU-NMO-302.
Outcome measures
| Measure |
Placebo/Eculizumab
n=40 Participants
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 mg) plus matching placebo via IV infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
n=66 Participants
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|
|
Change From Baseline in Hauser Ambulation Index (HAI) in Participants With Abnormal Baseline Ambulatory Function
Change from Baseline at Week 104
|
-0.57 units on a scale
Standard Deviation 1.777
|
0.07 units on a scale
Standard Deviation 1.033
|
|
Change From Baseline in Hauser Ambulation Index (HAI) in Participants With Abnormal Baseline Ambulatory Function
Change from Baseline at Week 156
|
-1.08 units on a scale
Standard Deviation 1.706
|
0.07 units on a scale
Standard Deviation 1.269
|
|
Change From Baseline in Hauser Ambulation Index (HAI) in Participants With Abnormal Baseline Ambulatory Function
Baseline
|
2.83 units on a scale
Standard Deviation 2.123
|
2.35 units on a scale
Standard Deviation 2.257
|
|
Change From Baseline in Hauser Ambulation Index (HAI) in Participants With Abnormal Baseline Ambulatory Function
Change from Baseline at Week 52
|
-0.44 units on a scale
Standard Deviation 1.132
|
0.08 units on a scale
Standard Deviation 0.816
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 104 and 156Population: The Extension Full Analysis Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302 and had a post-IP-infusion efficacy assessment. Here, Number Analyzed signifies those participants who were evaluable at specified time points.
The EQ-5D is a generic, standardized participant self-administered health status instrument. EQ-5D general health status can also be measured by a visual analog scale (EQ-5D VAS). EQ-5D-VAS recorded the participant's self-rated health on a vertical visual analog scale (VAS) that allowed the participants to indicate their health state that ranged from 0 (worst imaginable) to 100 (best imaginable). Baseline is defined as the last available assessment prior to the first study drug infusion in Study ECU-NMO-302.
Outcome measures
| Measure |
Placebo/Eculizumab
n=41 Participants
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 mg) plus matching placebo via IV infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
n=78 Participants
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|
|
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension Visual Analog Scale (EQ-5D VAS) Health Status Score
Baseline
|
62.00 units on a scale
Standard Deviation 22.012
|
72.27 units on a scale
Standard Deviation 20.941
|
|
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension Visual Analog Scale (EQ-5D VAS) Health Status Score
Change from Baseline at Week 52
|
2.22 units on a scale
Standard Deviation 13.294
|
-0.78 units on a scale
Standard Deviation 12.388
|
|
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension Visual Analog Scale (EQ-5D VAS) Health Status Score
Change from Baseline at Week 104
|
0.05 units on a scale
Standard Deviation 18.867
|
1.28 units on a scale
Standard Deviation 11.295
|
|
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension Visual Analog Scale (EQ-5D VAS) Health Status Score
Change from Baseline at Week 156
|
11.00 units on a scale
Standard Deviation 19.374
|
-4.13 units on a scale
Standard Deviation 18.421
|
SECONDARY outcome
Timeframe: Baseline, Weeks 52, 104 and 156Population: The Extension Full Analysis Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302 and had a post-IP-infusion efficacy assessment. Here, Number of Participants analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified time points.
The EDSS assesses multiple Kurtzke functional systems in the context of a standard neurological exam, including visual function. The visual score ranges from 0 to 6. A score of 0 implies the participant has normal visual function. Higher scores represent worse disability. Baseline is defined as the last available assessment prior to the first study drug infusion in Study EC-NMO-302.
Outcome measures
| Measure |
Placebo/Eculizumab
n=28 Participants
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 mg) plus matching placebo via IV infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
n=67 Participants
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|
|
Change From Baseline in Kurtzke Visual Functional System Scores (FSS) in Participants With Abnormal Baseline Visual Function
Baseline
|
3.75 units on a scale
Standard Deviation 2.030
|
3.60 units on a scale
Standard Deviation 2.031
|
|
Change From Baseline in Kurtzke Visual Functional System Scores (FSS) in Participants With Abnormal Baseline Visual Function
Change from Baseline at Week 52
|
-0.08 units on a scale
Standard Deviation 0.392
|
-0.06 units on a scale
Standard Deviation 0.569
|
|
Change From Baseline in Kurtzke Visual Functional System Scores (FSS) in Participants With Abnormal Baseline Visual Function
Change from Baseline at Week 104
|
-0.13 units on a scale
Standard Deviation 0.352
|
-0.10 units on a scale
Standard Deviation 0.651
|
|
Change From Baseline in Kurtzke Visual Functional System Scores (FSS) in Participants With Abnormal Baseline Visual Function
Change from Baseline at Week 156
|
0.00 units on a scale
Standard Deviation 0.000
|
-0.29 units on a scale
Standard Deviation 0.994
|
Adverse Events
Placebo/Eculizumab
Serious events: 14 serious events
Other events: 40 other events
Deaths: 0 deaths
Eculizumab/Eculizumab
Serious events: 26 serious events
Other events: 70 other events
Deaths: 0 deaths
Eculizumab (Combined Total)
Serious events: 40 serious events
Other events: 110 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Eculizumab
n=41 participants at risk
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 mg) plus matching placebo via IV infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
n=78 participants at risk
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab (Combined Total)
n=119 participants at risk
All participants who received at least 1 dose of eculizumab in the extension study. Participants received open-label eculizumab (1200 mg) every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|---|
|
Nervous system disorders
Aphasia
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
General disorders
Asthenia
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
General disorders
Chest pain
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Eye disorders
Glaucoma
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
General disorders
Oedema peripheral
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
4.9%
2/41 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.5%
3/119 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Urinary tract infection
|
4.9%
2/41 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
3.8%
3/78 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
4.2%
5/119 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.7%
2/119 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.6%
2/78 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.7%
2/119 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.6%
2/78 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.7%
2/119 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Bacterial sepsis
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
COVID-19
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Device related infection
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Gonorrhoea
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Infective tenosynovitis
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Osteomyelitis
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Pneumonia influenzal
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.7%
2/119 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Investigations
Blood pressure increased
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.6%
2/78 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.7%
2/119 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.7%
2/119 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Nervous system disorders
Neuromyelitis optica spectrum disorder
|
4.9%
2/41 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
3.8%
3/78 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
4.2%
5/119 • Number of events 8 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Nervous system disorders
Optic neuritis
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.6%
2/78 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.5%
3/119 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Nervous system disorders
Hemiparaesthesia
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Nervous system disorders
Mental impairment
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Nervous system disorders
Neuromuscular blockade
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Nervous system disorders
Neuromyelitis optica pseudo relapse
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic gestation
|
0.00%
0/36 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.4%
1/74 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.91%
1/110 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Psychiatric disorders
Catatonia
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Psychiatric disorders
Delirium
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/36 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.4%
1/74 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.91%
1/110 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.84%
1/119 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
Other adverse events
| Measure |
Placebo/Eculizumab
n=41 participants at risk
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-NMO-301 were administered eculizumab (900 mg) plus matching placebo via IV infusion on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab/Eculizumab
n=78 participants at risk
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-NMO-301 were administered eculizumab (1200 mg) via IV infusion on Day 1 and Week 2 and placebo at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (1200 mg) via IV infusion every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
Eculizumab (Combined Total)
n=119 participants at risk
All participants who received at least 1 dose of eculizumab in the extension study. Participants received open-label eculizumab (1200 mg) every 2 weeks starting at Week 4 and continued for up to 6.5 years.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.3%
3/41 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
7.7%
6/78 • Number of events 7 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
7.6%
9/119 • Number of events 10 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
4.9%
2/41 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
6.4%
5/78 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.9%
7/119 • Number of events 7 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.5%
8/41 • Number of events 17 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
7.7%
6/78 • Number of events 11 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
11.8%
14/119 • Number of events 28 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Gastrointestinal disorders
Constipation
|
9.8%
4/41 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
7.7%
6/78 • Number of events 7 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
8.4%
10/119 • Number of events 12 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Gastrointestinal disorders
Nausea
|
17.1%
7/41 • Number of events 17 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
3.8%
3/78 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
8.4%
10/119 • Number of events 21 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.8%
4/41 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.6%
2/78 • Number of events 9 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.0%
6/119 • Number of events 14 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Gastrointestinal disorders
Toothache
|
12.2%
5/41 • Number of events 7 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.0%
6/119 • Number of events 8 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Gastrointestinal disorders
Dental caries
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.1%
4/78 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
4.2%
5/119 • Number of events 6 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
General disorders
Pyrexia
|
14.6%
6/41 • Number of events 8 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
15.4%
12/78 • Number of events 19 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
15.1%
18/119 • Number of events 27 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
General disorders
Fatigue
|
9.8%
4/41 • Number of events 13 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
9.0%
7/78 • Number of events 7 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
9.2%
11/119 • Number of events 20 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
General disorders
Oedema peripheral
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.1%
4/78 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
4.2%
5/119 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
General disorders
Peripheral swelling
|
7.3%
3/41 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.6%
2/78 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
4.2%
5/119 • Number of events 6 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Nasopharyngitis
|
39.0%
16/41 • Number of events 35 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
16.7%
13/78 • Number of events 32 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
24.4%
29/119 • Number of events 67 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Upper respiratory tract infection
|
26.8%
11/41 • Number of events 24 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
21.8%
17/78 • Number of events 27 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
23.5%
28/119 • Number of events 51 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Urinary tract infection
|
26.8%
11/41 • Number of events 29 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
16.7%
13/78 • Number of events 30 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
20.2%
24/119 • Number of events 59 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Influenza
|
22.0%
9/41 • Number of events 14 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
12.8%
10/78 • Number of events 11 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
16.0%
19/119 • Number of events 25 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Cystitis
|
9.8%
4/41 • Number of events 6 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
6.4%
5/78 • Number of events 6 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
7.6%
9/119 • Number of events 12 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Oral herpes
|
9.8%
4/41 • Number of events 17 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.1%
4/78 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
6.7%
8/119 • Number of events 21 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Bronchitis
|
7.3%
3/41 • Number of events 6 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.1%
4/78 • Number of events 6 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.9%
7/119 • Number of events 12 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Herpes zoster
|
7.3%
3/41 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.6%
2/78 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
4.2%
5/119 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Pharyngitis
|
9.8%
4/41 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
4.2%
5/119 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.1%
4/78 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
3.4%
4/119 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Pneumonia
|
7.3%
3/41 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
3.4%
4/119 • Number of events 6 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Infections and infestations
Sinusitis
|
7.3%
3/41 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
3.4%
4/119 • Number of events 8 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Injury, poisoning and procedural complications
Contusion
|
14.6%
6/41 • Number of events 10 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.1%
4/78 • Number of events 6 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
8.4%
10/119 • Number of events 16 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
7.3%
3/41 • Number of events 8 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
3.8%
3/78 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.0%
6/119 • Number of events 11 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Injury, poisoning and procedural complications
Fall
|
7.3%
3/41 • Number of events 14 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.5%
3/119 • Number of events 14 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Investigations
Blood pressure increased
|
7.3%
3/41 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.5%
3/119 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.5%
8/41 • Number of events 13 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
19.2%
15/78 • Number of events 25 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
19.3%
23/119 • Number of events 38 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
5/41 • Number of events 9 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
14.1%
11/78 • Number of events 24 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
13.4%
16/119 • Number of events 33 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.2%
5/41 • Number of events 13 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
9.0%
7/78 • Number of events 22 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
10.1%
12/119 • Number of events 35 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.2%
5/41 • Number of events 7 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
6.4%
5/78 • Number of events 6 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
8.4%
10/119 • Number of events 13 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/41 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.1%
4/78 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
4.2%
5/119 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/41 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
6.4%
5/78 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
4.2%
5/119 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Nervous system disorders
Headache
|
29.3%
12/41 • Number of events 34 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
19.2%
15/78 • Number of events 140 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
22.7%
27/119 • Number of events 174 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Nervous system disorders
Dizziness
|
7.3%
3/41 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
6.4%
5/78 • Number of events 7 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
6.7%
8/119 • Number of events 10 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Nervous system disorders
Hypoaesthesia
|
4.9%
2/41 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
6.4%
5/78 • Number of events 6 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.9%
7/119 • Number of events 9 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Nervous system disorders
Paraesthesia
|
7.3%
3/41 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
3.8%
3/78 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.0%
6/119 • Number of events 7 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Psychiatric disorders
Insomnia
|
7.3%
3/41 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
3.8%
3/78 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.0%
6/119 • Number of events 8 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.3%
3/41 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
1.3%
1/78 • Number of events 1 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
3.4%
4/119 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.1%
7/41 • Number of events 10 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
6.4%
5/78 • Number of events 9 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
10.1%
12/119 • Number of events 19 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.8%
4/41 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
6.4%
5/78 • Number of events 9 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
7.6%
9/119 • Number of events 13 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.9%
2/41 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.1%
4/78 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.0%
6/119 • Number of events 7 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.3%
3/41 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.6%
2/78 • Number of events 2 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
4.2%
5/119 • Number of events 7 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
2/41 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.1%
4/78 • Number of events 5 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
5.0%
6/119 • Number of events 8 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.3%
3/41 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.5%
3/119 • Number of events 3 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.3%
3/41 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
0.00%
0/78 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
2.5%
3/119 • Number of events 4 • Baseline up to end of study (up to 6.5 years)
The Extension Safety Set consisted of all participants who had received at least 1 dose of eculizumab in Study ECU-NMO-302.
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: +1 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place