Trial Outcomes & Findings for ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab (NCT NCT03056040)
NCT ID: NCT03056040
Last Updated: 2025-03-12
Results Overview
Lactate dehydrogenase (LDH) is an indicator of intravascular hemolysis that occurs in participants with paroxysmal nocturnal hemoglobinuria. A decrease in LDH indicates reduction (improvement) in hemolysis. Baseline was defined as the average of all available on-study assessments prior to the first study drug infusion. The percent change in LDH was analyzed using a mixed-effect model for repeated measures (MMRM) with the fixed, categorical effects of treatment, study visit, and study visit by treatment group interaction, as well as the continuous, fixed covariate of baseline LDH and the stratification randomization indicator of packed red blood cells transfusion history (yes/no within 12 months prior to Day 1).
COMPLETED
PHASE3
202 participants
Baseline, Day 183
2025-03-12
Participant Flow
Participants were stratified into 1 of 2 groups based on their transfusion history. Stratified participants were randomly assigned in a 1:1 ratio to receive ravulizumab or eculizumab.
Participant milestones
| Measure |
Ravulizumab/Ravulizumab
On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Eculizumab/Ravulizumab
Participants received 900 mg of eculizumab every 2 weeks (q2w) for 26 weeks. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
|---|---|---|
|
Primary Evaluation Period
STARTED
|
98
|
99
|
|
Primary Evaluation Period
Received at Least 1 Dose of Study Drug
|
97
|
98
|
|
Primary Evaluation Period
Participants in the Full Analysis Set (FAS)
|
97
|
98
|
|
Primary Evaluation Period
COMPLETED
|
96
|
95
|
|
Primary Evaluation Period
NOT COMPLETED
|
2
|
4
|
|
Extension Period
STARTED
|
96
|
95
|
|
Extension Period
COMPLETED
|
92
|
88
|
|
Extension Period
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Ravulizumab/Ravulizumab
On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Eculizumab/Ravulizumab
Participants received 900 mg of eculizumab every 2 weeks (q2w) for 26 weeks. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
|---|---|---|
|
Primary Evaluation Period
Withdrawal by Subject
|
1
|
1
|
|
Primary Evaluation Period
Lack of Efficacy
|
0
|
1
|
|
Primary Evaluation Period
Pregnancy
|
0
|
1
|
|
Primary Evaluation Period
Randomized, not treated
|
1
|
1
|
|
Extension Period
Physician Decision
|
3
|
3
|
|
Extension Period
Lost to Follow-up
|
0
|
1
|
|
Extension Period
Death
|
0
|
3
|
|
Extension Period
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
Baseline characteristics by cohort
| Measure |
Ravulizumab/Ravulizumab
n=97 Participants
On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Eculizumab/Ravulizumab
n=98 Participants
Participants received 900 mg of eculizumab q2w for 26 weeks. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 14.41 • n=5 Participants
|
48.8 years
STANDARD_DEVIATION 13.97 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 14.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
50 participants
n=5 Participants
|
61 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
23 participants
n=5 Participants
|
19 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 183Population: Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab).
Lactate dehydrogenase (LDH) is an indicator of intravascular hemolysis that occurs in participants with paroxysmal nocturnal hemoglobinuria. A decrease in LDH indicates reduction (improvement) in hemolysis. Baseline was defined as the average of all available on-study assessments prior to the first study drug infusion. The percent change in LDH was analyzed using a mixed-effect model for repeated measures (MMRM) with the fixed, categorical effects of treatment, study visit, and study visit by treatment group interaction, as well as the continuous, fixed covariate of baseline LDH and the stratification randomization indicator of packed red blood cells transfusion history (yes/no within 12 months prior to Day 1).
Outcome measures
| Measure |
Ravulizumab/Ravulizumab
n=97 Participants
On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Eculizumab/Ravulizumab
n=98 Participants
Participants who were randomized to the eculizumab group in the Primary Evaluation Period received a weight-based loading dose of ravulizumab on Day 183 followed by weight-based maintenance doses of ravulizumab 2 weeks later and q8w until the end of study (up to 4 years).
|
|---|---|---|
|
Percent Change In Lactate Dehydrogenase Levels From Baseline To Day 183
|
-0.82 percent change
Interval -7.75 to 6.11
|
8.39 percent change
Interval 1.47 to 15.32
|
SECONDARY outcome
Timeframe: Baseline through Day 183Population: Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab).
Breakthrough hemolysis (BTH) was defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, dyspnea, anemia \[hemoglobin \<10 grams (g)/deciliter (dL)\], major adverse vascular event \[including thrombosis\], dysphagia, or erectile dysfunction) in the presence of elevated LDH ≥2 times the upper limit of normal (ULN).
Outcome measures
| Measure |
Ravulizumab/Ravulizumab
n=97 Participants
On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Eculizumab/Ravulizumab
n=98 Participants
Participants who were randomized to the eculizumab group in the Primary Evaluation Period received a weight-based loading dose of ravulizumab on Day 183 followed by weight-based maintenance doses of ravulizumab 2 weeks later and q8w until the end of study (up to 4 years).
|
|---|---|---|
|
Number Of Participants With Breakthrough Hemolysis Through Day 183
|
0 number of participants
Interval 0.0 to 3.73
|
5 number of participants
Interval 1.68 to 11.51
|
SECONDARY outcome
Timeframe: Baseline, Day 183Population: Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab).
FACIT-Fatigue score ranges from 0 to 52, with a higher score indicating less fatigue. Baseline was defined as the last non-missing assessment value prior to first study drug dose. Change in FACIT-Fatigue score from Baseline to Day 183 was analyzed using an MMRM with the fixed, categorical effects of treatment, the stratification randomization indicator of packed red blood cells transfusion history (yes/no within 12 months prior to Day 1), study visit, and study visit by treatment group interaction, as well as the continuous fixed covariate of Baseline FACIT-Fatigue score.
Outcome measures
| Measure |
Ravulizumab/Ravulizumab
n=97 Participants
On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Eculizumab/Ravulizumab
n=98 Participants
Participants who were randomized to the eculizumab group in the Primary Evaluation Period received a weight-based loading dose of ravulizumab on Day 183 followed by weight-based maintenance doses of ravulizumab 2 weeks later and q8w until the end of study (up to 4 years).
|
|---|---|---|
|
Change From Baseline To Day 183 In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Scores
|
2.01 units on a scale
Interval 0.64 to 3.39
|
0.54 units on a scale
Interval -0.84 to 1.93
|
SECONDARY outcome
Timeframe: Baseline through Day 183Population: Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab).
Transfusion avoidance was defined as the percentage of participants who remained transfusion free and did not require a transfusion per protocol-specified guidelines (hemoglobin value of ≤9 g/dL with signs or symptoms of sufficient severity to warrant a transfusion, or a hemoglobin value of ≤7 g/dL regardless of presence of clinical signs or symptoms) through Day 183.
Outcome measures
| Measure |
Ravulizumab/Ravulizumab
n=97 Participants
On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Eculizumab/Ravulizumab
n=98 Participants
Participants who were randomized to the eculizumab group in the Primary Evaluation Period received a weight-based loading dose of ravulizumab on Day 183 followed by weight-based maintenance doses of ravulizumab 2 weeks later and q8w until the end of study (up to 4 years).
|
|---|---|---|
|
Percentage Of Participants Who Achieved Transfusion Avoidance Through Day 183
|
87.6 percentage of participants
Interval 81.08 to 94.18
|
82.7 percentage of participants
Interval 75.16 to 90.15
|
SECONDARY outcome
Timeframe: Baseline through Day 183Population: Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab).
Stabilized hemoglobin was defined as avoidance of a ≥2 g/dL decrease in hemoglobin level from Baseline in the absence of transfusion through Day 183.
Outcome measures
| Measure |
Ravulizumab/Ravulizumab
n=97 Participants
On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Eculizumab/Ravulizumab
n=98 Participants
Participants who were randomized to the eculizumab group in the Primary Evaluation Period received a weight-based loading dose of ravulizumab on Day 183 followed by weight-based maintenance doses of ravulizumab 2 weeks later and q8w until the end of study (up to 4 years).
|
|---|---|---|
|
Percentage Of Participants With Stabilized Hemoglobin Levels Through Day 183
|
76.3 percentage of participants
Interval 67.82 to 84.75
|
75.5 percentage of participants
Interval 67.0 to 84.02
|
SECONDARY outcome
Timeframe: Baseline through end of study (up to 4 years)Population: Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab). Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
BTH was defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, dyspnea, anemia \[hemoglobin \<10 g/dL\], major adverse vascular event \[including thrombosis\], dysphagia, or erectile dysfunction) in the presence of elevated LDH ≥2 times the ULN.
Outcome measures
| Measure |
Ravulizumab/Ravulizumab
n=96 Participants
On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Eculizumab/Ravulizumab
n=95 Participants
Participants who were randomized to the eculizumab group in the Primary Evaluation Period received a weight-based loading dose of ravulizumab on Day 183 followed by weight-based maintenance doses of ravulizumab 2 weeks later and q8w until the end of study (up to 4 years).
|
|---|---|---|
|
Number Of Participants With Breakthrough Hemolysis Through End of Study
|
9 number of participants
Interval 4.38 to 17.05
|
6 number of participants
Interval 2.35 to 13.24
|
SECONDARY outcome
Timeframe: Baseline, End of Study (up to 4 years)Population: Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab). Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
FACIT-Fatigue score ranges from 0 to 52, with a higher score indicating less fatigue. Baseline was defined as the last non-missing assessment value prior to first study drug dose. Change in FACIT-Fatigue score from Baseline to Day 183 was analyzed using an MMRM with the fixed, categorical effects of treatment, the stratification randomization indicator of packed red blood cells transfusion history (yes/no within 12 months prior to Day 1), study visit, and study visit by treatment group interaction, as well as the continuous fixed covariate of Baseline FACIT-Fatigue score.
Outcome measures
| Measure |
Ravulizumab/Ravulizumab
n=14 Participants
On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Eculizumab/Ravulizumab
n=13 Participants
Participants who were randomized to the eculizumab group in the Primary Evaluation Period received a weight-based loading dose of ravulizumab on Day 183 followed by weight-based maintenance doses of ravulizumab 2 weeks later and q8w until the end of study (up to 4 years).
|
|---|---|---|
|
Change From Baseline To End of Study In FACIT-Fatigue Scores Through End of Study
|
-1.43 units on a scale
Standard Deviation 5.694
|
0.00 units on a scale
Standard Deviation 5.944
|
SECONDARY outcome
Timeframe: Baseline through end of study (up to 4 years)Population: Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab). Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Transfusion avoidance was defined as the percentage of participants who remained transfusion free and did not require a transfusion per protocol-specified guidelines (hemoglobin value of ≤9 g/dL with signs or symptoms of sufficient severity to warrant a transfusion, or a hemoglobin value of ≤7 g/dL regardless of presence of clinical signs or symptoms) through the end of study.
Outcome measures
| Measure |
Ravulizumab/Ravulizumab
n=96 Participants
On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Eculizumab/Ravulizumab
n=95 Participants
Participants who were randomized to the eculizumab group in the Primary Evaluation Period received a weight-based loading dose of ravulizumab on Day 183 followed by weight-based maintenance doses of ravulizumab 2 weeks later and q8w until the end of study (up to 4 years).
|
|---|---|---|
|
Percentage Of Participants Who Achieved Transfusion Avoidance Through End of Study
|
70.83 percentage of participants
Interval 60.67 to 79.67
|
70.53 percentage of participants
Interval 60.29 to 79.44
|
SECONDARY outcome
Timeframe: Baseline through end of study (up to 4 years)Population: Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab). Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Stabilized hemoglobin was defined as avoidance of a ≥2 g/dL decrease in hemoglobin level from Baseline in the absence of transfusion through end of study.
Outcome measures
| Measure |
Ravulizumab/Ravulizumab
n=96 Participants
On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Eculizumab/Ravulizumab
n=95 Participants
Participants who were randomized to the eculizumab group in the Primary Evaluation Period received a weight-based loading dose of ravulizumab on Day 183 followed by weight-based maintenance doses of ravulizumab 2 weeks later and q8w until the end of study (up to 4 years).
|
|---|---|---|
|
Percentage Of Participants With Stabilized Hemoglobin Levels Through End of Study
|
58.33 percentage of participants
Interval 47.82 to 68.32
|
67.37 percentage of participants
Interval 59.68 to 76.64
|
Adverse Events
Primary Evaluation Period (26 Weeks) Ravulizumab Treatment
Primary Evaluation Period (26 Weeks) Eculizumab Treatment
Extension Period (Ravulizumab To Ravulizumab)
Extension Period (Eculizumab to Ravulizumab)
Serious adverse events
| Measure |
Primary Evaluation Period (26 Weeks) Ravulizumab Treatment
n=97 participants at risk
On Day 1, participants received weight- based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127.
|
Primary Evaluation Period (26 Weeks) Eculizumab Treatment
n=98 participants at risk
Participants received 900 mg of eculizumab q2w for 26 weeks.
|
Extension Period (Ravulizumab To Ravulizumab)
n=96 participants at risk
After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Extension Period (Eculizumab to Ravulizumab)
n=95 participants at risk
After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
2.0%
2/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
4.2%
4/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Gastrointestinal disorders
Colitis
|
1.0%
1/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
General disorders
Hyperthermia
|
1.0%
1/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
General disorders
Pyrexia
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
3.1%
3/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.2%
5/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Influenza
|
1.0%
1/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
3.2%
3/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.0%
1/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Nervous system disorders
Epilepsy
|
1.0%
1/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
1/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
2.1%
2/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Blood and lymphatic system disorders
Breakthrough haemolysis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
COVID-19
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Infection
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
2.1%
2/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Pneumococcal infection
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Septic shock
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Nervous system disorders
Cerebrospinal fluid retention
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Investigations
Liver function test increased
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive papillary breast carcinoma
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.1%
1/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
Other adverse events
| Measure |
Primary Evaluation Period (26 Weeks) Ravulizumab Treatment
n=97 participants at risk
On Day 1, participants received weight- based doses of ravulizumab ranging from 2400 to 3000 mg. Thereafter, weight- based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127.
|
Primary Evaluation Period (26 Weeks) Eculizumab Treatment
n=98 participants at risk
Participants received 900 mg of eculizumab q2w for 26 weeks.
|
Extension Period (Ravulizumab To Ravulizumab)
n=96 participants at risk
After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
Extension Period (Eculizumab to Ravulizumab)
n=95 participants at risk
After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants received weight-based doses of ravulizumab for up to 4 years.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.2%
5/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
3.1%
3/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
4.2%
4/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
7.4%
7/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.2%
7/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
9.2%
9/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
12.5%
12/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
11.6%
11/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
6/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.1%
5/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
3.1%
3/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.3%
5/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.3%
9/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
7.1%
7/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
15.6%
15/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
14.7%
14/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Gastrointestinal disorders
Nausea
|
8.2%
8/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
9.2%
9/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
13.5%
13/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
16.8%
16/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
6/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
4.1%
4/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
7.3%
7/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
4.2%
4/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
General disorders
Chest pain
|
3.1%
3/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
9.2%
9/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.2%
5/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.3%
5/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
General disorders
Fatigue
|
7.2%
7/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
6.1%
6/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
18.8%
18/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
20.0%
19/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
General disorders
Influenza like illness
|
6.2%
6/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
8.2%
8/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
9.4%
9/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
9.5%
9/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
General disorders
Pyrexia
|
9.3%
9/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
2.0%
2/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
15.6%
15/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
16.8%
16/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Nasopharyngitis
|
20.6%
20/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
20.4%
20/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
28.1%
27/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
22.1%
21/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Rhinitis
|
5.2%
5/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
4.1%
4/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
10.4%
10/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
7.4%
7/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Upper respiratory tract infection
|
19.6%
19/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
10.2%
10/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
25.0%
24/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
20.0%
19/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.1%
5/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
5/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
4.1%
4/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
9.4%
9/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
11.6%
11/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
1/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.2%
5/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
4.2%
4/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Nervous system disorders
Dizziness
|
3.1%
3/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
7.1%
7/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
8.3%
8/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
15.8%
15/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Nervous system disorders
Headache
|
27.8%
27/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
17.3%
17/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
21.9%
21/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
22.1%
21/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
5/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
10.2%
10/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
16.7%
16/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
12.6%
12/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
6.1%
6/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
8.3%
8/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
8.4%
8/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.1%
4/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
9.2%
9/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
7.3%
7/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
10.5%
10/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.1%
2/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
7.3%
7/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
8.4%
8/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
6.2%
6/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.3%
5/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
7.3%
7/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
8.4%
8/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Gastroenteritis
|
1.0%
1/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
7.3%
7/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
3.2%
3/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Influenza
|
1.0%
1/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.2%
5/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
4.2%
4/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
4/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
10.4%
10/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
13.7%
13/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
5/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
11.5%
11/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
7.4%
7/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
2/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
3.1%
3/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
6.3%
6/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.2%
5/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.3%
5/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.2%
5/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
3.2%
3/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.3%
5/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.2%
5/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
4.2%
4/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
General disorders
Oedema peripheral
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.2%
5/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
4.2%
4/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
General disorders
Asthenia
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.2%
5/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
2.1%
2/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
2.1%
2/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.3%
5/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
COVID-19
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.2%
5/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
3.2%
3/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
2.1%
2/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.3%
5/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Infection
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.3%
5/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
6.2%
6/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
2.1%
2/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.2%
5/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
2.1%
2/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Nervous system disorders
Migraine
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
3.1%
3/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.3%
5/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
1.0%
1/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.3%
5/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
5.2%
5/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
2.1%
2/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
|
Infections and infestations
Viral infection
|
0.00%
0/97 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
0.00%
0/98 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
6.2%
6/96 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
|
3.2%
3/95 • From Baseline (after first dose) to end of study (up to 4 years)
Primary Evaluation Period (26 weeks)- Ravulizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for participants in the Ravulizumab-Treated Set. Eculizumab Treatment: data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Safety Set. Extension Period-data for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events are for the participants in the Ravulizumab-Treated Set.
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Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place