Trial Outcomes & Findings for Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis (NCT NCT04999020)
NCT ID: NCT04999020
Last Updated: 2025-07-09
Results Overview
Data are presented for the number of participants with a TIS40 response, defined as an IMACS-TIS score ≥ 40 at Week 26. IMACS-TIS is a clinical instrument that encompasses 6 core set measure (CSMs) (physician, patient, extra-muscular global activity, muscle strength, Health Assessment Questionnaire \[HAQ\], and muscle enzyme levels). A Total Improvement Score (TIS: 0-100), was determined by summing scores in each CSM, and was based on the improvement and relative weight of each CSM. A higher score indicated greater improvement. TIS40 was considered a moderate improvement score.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
38 participants
Primary outcome timeframe
Week 26
Results posted on
2025-07-09
Participant Flow
The study was planned to be conducted in 2 parts - Part A and Part B. The study was terminated early and participants were not enrolled into Part B. Therefore, results are presented for Part A of the study only. Part A consisted of a Randomized Controlled Period (RCP) and an Open-Label Extension (OLE) period.
Participant milestones
| Measure |
RCP: Ravulizumab
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
OLE: Ravulizumab to Ravulizumab
Participants who received ravulizumab during the RCP continued to receive ravulizumab during the 130-week OLE. Participants received a blinded ravulizumab dose at Week 26, a maintenance dose at Week 28, then ravulizumab Q8W for the remainder of the OLE period.
|
OLE: Placebo to Ravulizumab
Participants who received placebo during the RCP received ravulizumab during the 130-week OLE. Participants received a blinded ravulizumab dose at Week 26, a maintenance dose at Week 28, then ravulizumab Q8W for the remainder of the OLE period.
|
|---|---|---|---|---|
|
Randomized Controlled Period (RCP)
STARTED
|
26
|
12
|
0
|
0
|
|
Randomized Controlled Period (RCP)
Received at Least 1 Dose of Treatment
|
26
|
12
|
0
|
0
|
|
Randomized Controlled Period (RCP)
COMPLETED
|
22
|
9
|
0
|
0
|
|
Randomized Controlled Period (RCP)
NOT COMPLETED
|
4
|
3
|
0
|
0
|
|
Open-Label Extension (OLE) Period
STARTED
|
0
|
0
|
22
|
9
|
|
Open-Label Extension (OLE) Period
Received at Least 1 Dose of Treatment
|
0
|
0
|
22
|
9
|
|
Open-Label Extension (OLE) Period
COMPLETED
|
0
|
0
|
0
|
0
|
|
Open-Label Extension (OLE) Period
NOT COMPLETED
|
0
|
0
|
22
|
9
|
Reasons for withdrawal
| Measure |
RCP: Ravulizumab
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
OLE: Ravulizumab to Ravulizumab
Participants who received ravulizumab during the RCP continued to receive ravulizumab during the 130-week OLE. Participants received a blinded ravulizumab dose at Week 26, a maintenance dose at Week 28, then ravulizumab Q8W for the remainder of the OLE period.
|
OLE: Placebo to Ravulizumab
Participants who received placebo during the RCP received ravulizumab during the 130-week OLE. Participants received a blinded ravulizumab dose at Week 26, a maintenance dose at Week 28, then ravulizumab Q8W for the remainder of the OLE period.
|
|---|---|---|---|---|
|
Randomized Controlled Period (RCP)
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
|
Randomized Controlled Period (RCP)
Physician Decision
|
1
|
1
|
0
|
0
|
|
Randomized Controlled Period (RCP)
Adverse Event
|
2
|
0
|
0
|
0
|
|
Open-Label Extension (OLE) Period
Withdrawal by Subject
|
0
|
0
|
3
|
3
|
|
Open-Label Extension (OLE) Period
Study Terminated by Sponsor
|
0
|
0
|
17
|
4
|
|
Open-Label Extension (OLE) Period
Physician Decision
|
0
|
0
|
1
|
0
|
|
Open-Label Extension (OLE) Period
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Open-Label Extension (OLE) Period
Adverse Event
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis
Baseline characteristics by cohort
| Measure |
Ravulizumab
n=26 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then Q8W during the 26-week RCP.
|
Placebo
n=12 Participants
Participants received placebo on Day 1, Weeks 2, 10 and 18 during the 26-week RCP.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 10.38 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 9.31 • n=7 Participants
|
53.4 years
STANDARD_DEVIATION 10.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group.
Data are presented for the number of participants with a TIS40 response, defined as an IMACS-TIS score ≥ 40 at Week 26. IMACS-TIS is a clinical instrument that encompasses 6 core set measure (CSMs) (physician, patient, extra-muscular global activity, muscle strength, Health Assessment Questionnaire \[HAQ\], and muscle enzyme levels). A Total Improvement Score (TIS: 0-100), was determined by summing scores in each CSM, and was based on the improvement and relative weight of each CSM. A higher score indicated greater improvement. TIS40 was considered a moderate improvement score.
Outcome measures
| Measure |
RCP: Ravulizumab
n=26 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Number of Participants With International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS-TIS) (TIS40) Response at Week 26 of the Randomized Controlled Period
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group. Overall number of participants analyzed = participants with evaluable data for the outcome measure.
TIS scores ranged from 0-100 with higher scores indicating a greater improvement. Scores were determined by summing scores in each of the 6 CSMs of the IMAC (physician, patient, extra-muscular global activity, muscle strength, HAQ, and muscle enzyme levels). Clinically meaningful thresholds for improvement were defined as ≥ 20 point improvement response on IMACS-TIS (TIS20; mild), ≥ 40 point improvement response on IMACS TIS (TIS40; moderate) and ≥ 60 point improvement response on IMACS-TIS (TIS60; severe). Scores were based on the improvement and relative weight of each CSM. Data are presented for TIS (least squares mean) at Week 26.
Outcome measures
| Measure |
RCP: Ravulizumab
n=25 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
TIS at Week 26
|
31.16 scores on a scale
Standard Error 4.185
|
43.28 scores on a scale
Standard Error 6.650
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group. Overall number of participants analyzed = participants with evaluable data for the outcome measure.
The CDASI is an instrument that separately measures activity and damage in the skin of dermatomyositis (DM) participants. It contains 3 activity measures (erythema, scale, and erosion/ulceration) and 2 damage measures (poikiloderma and calcinosis). CDASI score is calculated by rating the severity of skin disease in 15 anatomical locations on the body based on the activity and damage components. CDASI was completed by the Clinician or Clinician-Investigator while examining the participant. Total CDASI scores ranged from 0-100, with higher scores indicating a greater disease severity. Change from baseline in CDASI Total Activity Score at Week 26 was analyzed using a mixed model repeated measures (MMRM). The MMRM model included the observed Total Activity Score values at post baseline visits (Week 26) as the dependent variable.
Outcome measures
| Measure |
RCP: Ravulizumab
n=25 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Change From Baseline In Cutaneous Dermatomyositis Disease Area And Severity Index (CDASI) Activity Score at Week 26
|
-3.80 scores on a scale
Standard Error 1.249
|
-7.47 scores on a scale
Standard Error 2.021
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group.
Laboratory tests were conducted to measure serum activities of muscle associated enzymes including creatine kinase (CK), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and aldolase. Data are presented for the number of participants who had an abnormal muscle enzyme at baseline that had been normalized at Week 26.
Outcome measures
| Measure |
RCP: Ravulizumab
n=26 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Number of Participants With Response Related to Muscle Enzymes: Normalization of Most Abnormal Baseline Enzyme at Week 26
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group. Overall number of participants analyzed = participants with evaluable data for the outcome measure.
The MDAAT assesses disease activity of extra-muscular organ systems and muscles in participants with DM. The validated MDAAT tool measures the degree of disease activity of extra-muscular organ systems and muscle on a 0-10 centimeter (cm) visual analog scale (VAS). Extra-muscular activity ranged between 0 and 10, where, 0 cm = absent and 10 cm = maximum disease activity.
Outcome measures
| Measure |
RCP: Ravulizumab
n=25 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Change From Baseline In IMACS CSMs: Extra-Muscular Disease Activity Based on Myositis Disease Activity Assessment Tool (MDAAT) at Week 26
|
-0.92 scores on a scale
Standard Error 0.383
|
-2.13 scores on a scale
Standard Error 0.614
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group. Overall number of participants analyzed = participants with evaluable data for the outcome measure.
The physician global activity assessment provides an overall rating of disease activity related to myositis. Disease activity is judged by the physician based on all information available at the time of evaluation, including the participant's appearance, medical history, physical examination, laboratory testing, and prescribed medical therapy. The global disease activity score is recorded on a 10-cm VAS, where 0 cm= no evidence of disease activity and 10 cm= extremely severe disease activity.
Outcome measures
| Measure |
RCP: Ravulizumab
n=25 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Change From Baseline In IMACS CSMs: Physician Global Activity Assessment at Week 26
|
-1.18 scores on a scale
Standard Error 0.413
|
-1.97 scores on a scale
Standard Error 0.649
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group. Overall number of participants analyzed = participants with evaluable data for the outcome measure.
The patient global activity assessment provides an overall rating of disease activity related to myositis from the participant's perspective. Participants were asked to consider all of the active inflammation in their own muscles, skin, joints, intestines, heart, lungs, or other parts of the body that can improve with treatment. The patient global disease activity score was recorded on a 10-cm VAS that contained a smiley face at the 0-cm anchor and a sad face at the 10 cm anchor to help participants understand the scale. Scores ranged from 0 (no evidence of disease activity) to 10 (extremely active or severe disease activity).
Outcome measures
| Measure |
RCP: Ravulizumab
n=25 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Change From Baseline In IMACS CSMs: Patient Global Activity Assessment at Week 26
|
-1.43 scores on a scale
Standard Error 0.432
|
-1.12 scores on a scale
Standard Error 0.699
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group. Overall number of participants analyzed = participants with evaluable data for the outcome measure.
The purpose of the MMT-8 was to measure muscle strength as part of the physical examination. It included a subset of 8 muscle groups: neck flexors, deltoids, biceps, wrist, extensors, gluteus maximus and medius, quadriceps, and ankle dorsiflexors. Total MMT8 scores ranged from 0 (lowest strength) to 150 (highest strength).
Outcome measures
| Measure |
RCP: Ravulizumab
n=25 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Change From Baseline In IMACS CSMs: Manual Muscle Testing Subset 8 Muscles (MMT-8) at Week 26
|
9.5 scores on a scale
Standard Error 1.85
|
12.6 scores on a scale
Standard Error 2.98
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group. Overall number of participants analyzed = participants with evaluable data for the outcome measure.
The HAQ is a brief self-report questionnaire that assesses physical function pertaining to activities of daily living in a variety of domains. The HAQ includes 20 questions relating to 8 domains of function: dressing and grooming, arising, eating, walking, hygiene, reach, grip and usual activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score is calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do), with higher values indicating higher disability.
Outcome measures
| Measure |
RCP: Ravulizumab
n=25 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Change From Baseline In IMACS CSMs: Health Assessment Questionnaire (HAQ) at Week 26
|
-0.1289 scores on a scale
Standard Error 0.08607
|
-0.4188 scores on a scale
Standard Error 0.13676
|
SECONDARY outcome
Timeframe: Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group.
The CDASI is an instrument that separately measures activity and damage in the skin of dermatomyositis (DM) participants. It contains 3 activity measures (erythema, scale, and erosion/ulceration) and 2 damage measures (poikiloderma and calcinosis). CDASI score is calculated by rating the severity of skin disease in 15 anatomical locations on the body based on the activity and damage components. CDASI was completed by the Clinician or Clinician-Investigator while examining the participant. Total CDASI scores ranged from 0-100, with higher scores indicating a greater disease severity. Data are presented for the number of participants with a CDASI response. Response was defined as a \>=7 point improvement in participants who did not have an intercurrent event at or prior to the relevant timepoint.
Outcome measures
| Measure |
RCP: Ravulizumab
n=26 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Number of Participants With CDASI Response (>=7-point Improvement) at Week 26
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group.
CDA-IGA is a scale that was created to measure disease severity in participants with skin disease. It is a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) with morphologic descriptors for each score. The CDA-IGA was completed by the Investigator and was used to describe the overall appearance of lesions at a given time point. Data are presented for the number of participants with a CDA-IGA response at Week 26. A response was defined as participants with clear or almost clear skin (score of 0 or 1) who did not have an intercurrent event at or before the relevant timepoint.
Outcome measures
| Measure |
RCP: Ravulizumab
n=26 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Number of Participants With Cutaneous Dermatomyositis Activity Physician's Global Assessment (CDA-IGA) Response at Week 26
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group.
TIS20 was defined as a ≥20-point improvement response on IMACS-TIS. IMACS-TIS is a clinical instrument that encompasses 6 CSMs (physician, patient, extra-muscular global activity, muscle strength, HAQ, and muscle enzyme levels). A Total Improvement Score (TIS: 0-100), was determined by summing scores in each CSM, and was based on the improvement and relative weight of each CSM. Higher scores indicated greater improvement/response. TIS20 is considered a mild improvement score.
Outcome measures
| Measure |
RCP: Ravulizumab
n=26 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Number of Participants With ≥ 20-Point Improvement Response on IMACS-TIS (TIS20) Response at Week 26
|
14 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group.
TIS60 was defined as a ≥60-point improvement response on IMACS-TIS. IMACS-TIS is a clinical instrument that encompasses 6 CSMs (physician, patient, extra-muscular global activity, muscle strength, HAQ, and muscle enzyme levels). A Total Improvement Score (TIS: 0-100), was determined by summing scores in each CSM, and was based on the improvement and relative weight of each CSM. Higher scores indicated greater improvement/response. TIS60 is considered a severe improvement score.
Outcome measures
| Measure |
RCP: Ravulizumab
n=26 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Number of Participants With ≥ 60-Point Improvement Response on IMACS-TIS (TIS60) Response at Week 26
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participant evaluable for the specified category.
TIS20, 40 and 60 were defined as a ≥20, ≥40 and ≥60-point improvement response on IMACS-TIS respectively. IMACS-TIS is a clinical instrument that encompasses 6 CSMs (physician, patient, and extra-muscular global activity, muscle strength, HAQ, and muscle enzyme levels). A Total Improvement Score (TIS: 0-100), was determined by summing scores in each CSM, and was based on the improvement and relative weight of each CSM. Higher scores indicated greater improvement/response. TIS20, 40 and 60 were considered mild, moderate and severe improvement scores respectively. Data are presented for the time to first response of TIS20, TIS40, or TIS60. The median time to TIS20, TIS40, and TIS60 was defined at the time in which 50% of the participants experienced TIS20, TIS40, or TIS60, respectively, based on a Kaplan-Meier analysis.
Outcome measures
| Measure |
RCP: Ravulizumab
n=26 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Time to First Response of TIS20, TIS40, or TIS60
Time to TIS20
|
10.43 weeks
Interval 10.14 to 17.86
|
10.14 weeks
Interval 2.14 to 10.14
|
|
Time to First Response of TIS20, TIS40, or TIS60
Time to TIS40
|
25.86 weeks
Interval 18.14 to
As fewer than 50% of the participants experienced the event of TIS40 and the median time to TIS40 event was close to the maximum follow-up period, there was not enough information on longer follow-up times to estimate the upper bound of the confidence interval.
|
26.0 weeks
Interval 10.14 to 26.29
|
|
Time to First Response of TIS20, TIS40, or TIS60
Time to TIS60
|
NA weeks
As fewer than 50% of the participants in the arm experienced TIS60 response during the RCP (the Week 26 period), the median time could not be estimated along with the associated 80% confidence intervals using Kaplan-Meier analysis.
|
NA weeks
Interval 26.14 to
As fewer than 50% of the participants in the arm experienced TIS60 response during the RCP (the Week 26 period), the median time could not be estimated along with the associated upper 80% confidence interval using Kaplan-Meier analysis.
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group.
CW was defined as one of the following: 1. Physician's global activity VAS worsening ≥ 2 cm and MMT-8 worsening ≥ 20% compared to baseline 2. Global extra muscular activity worsening ≥ 2 cm on the MDAAT VAS compared to baseline 3. Any 3 of 5 CSMs (excluding muscle enzymes) worsening by ≥ 30% compared to baseline Data are presented for the number of participants with clinical worsening during the RCP at 2 consecutive visits.
Outcome measures
| Measure |
RCP: Ravulizumab
n=26 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Number of Participants With Clinical Worsening (CW) During the RCP At 2 Consecutive Visits
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: Randomized Set, which included all randomized participants grouped by randomized treatment group.
Acute rescue therapy with standard DM treatment included an increased dose of a medication that was being taken for DM or the initiation of a new DM treatment (glucocorticoid and/or immunosuppressive/immunomodulatory therapy \[ISTs\]). Data are presented for the number of participants who received acute rescue therapy with standard DM treatment.
Outcome measures
| Measure |
RCP: Ravulizumab
n=26 Participants
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=12 Participants
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
|---|---|---|
|
Number of Participants Who Received Acute Rescue Therapy With Standard DM Treatment
|
2 Participants
|
0 Participants
|
Adverse Events
RCP: Ravulizumab
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
RCP: Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
OLE: Ravulizumab to Ravulizumab
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
OLE: Placebo to Ravulizumab
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RCP: Ravulizumab
n=25 participants at risk
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=13 participants at risk
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
OLE: Ravulizumab to Ravulizumab
n=22 participants at risk
Participants who received ravulizumab during the RCP continued to receive ravulizumab during the 130-week OLE. Participants received a blinded ravulizumab dose at Week 26, a maintenance dose at Week 28, then ravulizumab Q8W for the remainder of the OLE period.
|
OLE: Placebo to Ravulizumab
n=9 participants at risk
Participants who received placebo during the RCP received ravulizumab during the 130-week OLE. Participants received a blinded ravulizumab dose at Week 26, a maintenance dose at Week 28, then ravulizumab Q8W for the remainder of the OLE period.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
4.5%
1/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
General disorders
Impaired healing
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
4.5%
1/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Infections and infestations
COVID-19
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
4.5%
1/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/18 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
6.2%
1/16 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/6 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Skin and subcutaneous tissue disorders
Cutaneous calcification
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
4.5%
1/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
Other adverse events
| Measure |
RCP: Ravulizumab
n=25 participants at risk
Participants received a loading dose of ravulizumab on Day 1 followed by a maintenance dose at Week 2 and then ravulizumab once every 8 weeks (Q8W) during the 26-week RCP.
|
RCP: Placebo
n=13 participants at risk
Participants received placebo on Day 1, and Weeks 2, 10, and 18 during the 26-week RCP.
|
OLE: Ravulizumab to Ravulizumab
n=22 participants at risk
Participants who received ravulizumab during the RCP continued to receive ravulizumab during the 130-week OLE. Participants received a blinded ravulizumab dose at Week 26, a maintenance dose at Week 28, then ravulizumab Q8W for the remainder of the OLE period.
|
OLE: Placebo to Ravulizumab
n=9 participants at risk
Participants who received placebo during the RCP received ravulizumab during the 130-week OLE. Participants received a blinded ravulizumab dose at Week 26, a maintenance dose at Week 28, then ravulizumab Q8W for the remainder of the OLE period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
15.4%
2/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Gastrointestinal disorders
Anal erosion
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.0%
4/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
22.2%
2/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
9.1%
2/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Gastrointestinal disorders
Tongue movement disturbance
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
General disorders
Influenza like illness
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
9.1%
2/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
General disorders
Pyrexia
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
General disorders
Vaccination site swelling
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
9.1%
2/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Infections and infestations
COVID-19
|
8.0%
2/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
23.1%
3/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
9.1%
2/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Infections and infestations
Influenza
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
9.1%
2/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Infections and infestations
Sepsis
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
9.1%
2/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
9.1%
2/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
2/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
15.4%
2/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord leukoplakia
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
11.1%
1/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.0%
3/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
|
Vascular disorders
Hypertension
|
0.00%
0/25 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
7.7%
1/13 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/22 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
0.00%
0/9 • Up to approximately 130 weeks
Safety Set for the RCP, which included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention received. One participant who was randomized to ravulizumab during the RCP received placebo. This participant was analyzed in the placebo group for safety data collection and reporting. OLE Set for the OLE period, which included all randomized participants who received at least 1 dose of ravulizumab from Week 26 onward.
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place