Trial Outcomes & Findings for Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis (NCT NCT05067127)
NCT ID: NCT05067127
Last Updated: 2026-01-29
Results Overview
Baseline uPCR value was calculated as the average of the uPCR measurements from at least 6 of the 9 first-morning spot urine (FMU) samples collected between the start of screening and Day 1, inclusive. The uPCR values used to calculate baseline included those from the samples collected on Day -2, Day -1, and before dosing on Day 1. In situations where less than 6 samples or more than 9 samples were collected, the average of all collected samples was used for baseline derivation. The difference between treatment groups using a composite contrast of equal-weighted average over Weeks 24, 25, and 26 was estimated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
124 participants
Primary outcome timeframe
Baseline (Day -70 to Day 1) to Week 26
Results posted on
2026-01-29
Participant Flow
This Phase 3 randomized, placebo-controlled, double-blinded study was conducted in subjects with complement 3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) at 122 sites.
This study consisted of a screening period (10 weeks), 26-week randomized controlled period (RCP), followed by a 26-week open-label period (OLP) and follow-up period (8 weeks). Subjects were randomized to receive pegcetacoplan or placebo in a ratio of 1:1 in RCP. A total of 124 subjects were enrolled in this study.
Participant milestones
| Measure |
Randomized Controlled Period: Pegcetacoplan
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kilogram (kg) received pegcetacoplan 1080 milligram (mg) subcutaneous (SC) infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
Open-Label Period: Pegcetacoplan to Pegcetacoplan
All eligible adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg who received pegcetacoplan in RCP continued to receive pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 35 to \<50 kg who received pegcetacoplan in RCP continued to receive pegcetacoplan 810 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 30 to \<35 kg who received pegcetacoplan in RCP continued to receive pegcetacoplan 648 mg SC infusion twice weekly for 26 weeks in OLP.
|
Open-Label Period: Placebo to Pegcetacoplan
All eligible adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg who received placebo in RCP entered OLP to receive pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 35 to \<50 kg who received placebo in RCP entered OLP to receive pegcetacoplan 810 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 30 to \<35 kg who received placebo in RCP entered OLP to receive pegcetacoplan 648 mg SC infusion twice weekly for 26 weeks in OLP.
|
|---|---|---|---|---|
|
Randomized Controlled Period (26 weeks)
STARTED
|
63
|
61
|
0
|
0
|
|
Randomized Controlled Period (26 weeks)
COMPLETED
|
61
|
57
|
0
|
0
|
|
Randomized Controlled Period (26 weeks)
NOT COMPLETED
|
2
|
4
|
0
|
0
|
|
Open-Label Period (26 weeks)
STARTED
|
0
|
0
|
61
|
57
|
|
Open-Label Period (26 weeks)
COMPLETED
|
0
|
0
|
59
|
55
|
|
Open-Label Period (26 weeks)
NOT COMPLETED
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Randomized Controlled Period: Pegcetacoplan
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kilogram (kg) received pegcetacoplan 1080 milligram (mg) subcutaneous (SC) infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
Open-Label Period: Pegcetacoplan to Pegcetacoplan
All eligible adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg who received pegcetacoplan in RCP continued to receive pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 35 to \<50 kg who received pegcetacoplan in RCP continued to receive pegcetacoplan 810 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 30 to \<35 kg who received pegcetacoplan in RCP continued to receive pegcetacoplan 648 mg SC infusion twice weekly for 26 weeks in OLP.
|
Open-Label Period: Placebo to Pegcetacoplan
All eligible adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg who received placebo in RCP entered OLP to receive pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 35 to \<50 kg who received placebo in RCP entered OLP to receive pegcetacoplan 810 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 30 to \<35 kg who received placebo in RCP entered OLP to receive pegcetacoplan 648 mg SC infusion twice weekly for 26 weeks in OLP.
|
|---|---|---|---|---|
|
Randomized Controlled Period (26 weeks)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Randomized Controlled Period (26 weeks)
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
|
Randomized Controlled Period (26 weeks)
Investigator or Medical Monitor Decision
|
1
|
0
|
0
|
0
|
|
Randomized Controlled Period (26 weeks)
Pregnancy
|
0
|
1
|
0
|
0
|
|
Randomized Controlled Period (26 weeks)
Death
|
1
|
0
|
0
|
0
|
|
Open-Label Period (26 weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Open-Label Period (26 weeks)
Investigator or Medical Monitor Decision
|
0
|
0
|
2
|
1
|
Baseline Characteristics
Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
Baseline characteristics by cohort
| Measure |
Randomized Controlled Period: Placebo
n=61 Participants
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
Total
n=124 Participants
Total of all reporting groups
|
Randomized Controlled Period: Pegcetacoplan
n=63 Participants
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
|---|---|---|---|
|
Age, Continuous
|
23.6 years
STANDARD_DEVIATION 14.26 • n=4328 Participants
|
26.0 years
STANDARD_DEVIATION 15.86 • n=8687 Participants
|
28.2 years
STANDARD_DEVIATION 17.08 • n=35 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=4328 Participants
|
70 Participants
n=8687 Participants
|
37 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=4328 Participants
|
54 Participants
n=8687 Participants
|
26 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
1 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=4328 Participants
|
18 Participants
n=8687 Participants
|
9 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
1 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=4328 Participants
|
91 Participants
n=8687 Participants
|
45 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=4328 Participants
|
13 Participants
n=8687 Participants
|
7 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=4328 Participants
|
25 Participants
n=8687 Participants
|
15 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
47 Participants
n=4328 Participants
|
88 Participants
n=8687 Participants
|
41 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 Participants
n=4328 Participants
|
8 Participants
n=8687 Participants
|
6 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
1 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -70 to Day 1) to Week 26Population: The ITT analysis set included all randomized subjects.
Baseline uPCR value was calculated as the average of the uPCR measurements from at least 6 of the 9 first-morning spot urine (FMU) samples collected between the start of screening and Day 1, inclusive. The uPCR values used to calculate baseline included those from the samples collected on Day -2, Day -1, and before dosing on Day 1. In situations where less than 6 samples or more than 9 samples were collected, the average of all collected samples was used for baseline derivation. The difference between treatment groups using a composite contrast of equal-weighted average over Weeks 24, 25, and 26 was estimated.
Outcome measures
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=63 Participants
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=61 Participants
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
|---|---|---|
|
Randomized Controlled Period: Change From Baseline in Log-Transformed Urine Protein-to-Creatinine Ratio (uPCR) at Week 26
|
-1.114 log (uPCR)
Interval -1.38 to -0.848
|
0.029 log (uPCR)
Interval -0.09 to 0.148
|
SECONDARY outcome
Timeframe: Week 26Population: The ITT analysis set included all randomized subjects.
Subject who achieved a composite renal endpoint was defined as: (1) a stable or improved estimated glomerular filtration rate (eGFR) compared to baseline (\<=15% reduction in eGFR), and (2) a \>=50% reduction in uPCR compared to baseline. Percentages are rounded off to the hundredth decimal place.
Outcome measures
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=63 Participants
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=61 Participants
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
|---|---|---|
|
Randomized Controlled Period: Percentage of Subjects Who Achieved the Composite Renal Endpoint at Week 26
|
49.21 percentage of subjects
|
3.28 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline (Day -70 to Day 1) and Week 26Population: The ITT analysis set included all randomized subjects.
Baseline uPCR value was calculated as the average of the uPCR measurements from at least 6 of the 9 FMU samples collected between the start of screening and Day 1, inclusive. The uPCR values used to calculate baseline included those from the samples collected on Day -2, Day -1, and before dosing on Day 1. In situations where less than 6 samples or more than 9 samples were collected, the average of all collected samples was used for baseline derivation. Percentages are rounded off to the hundredth decimal place.
Outcome measures
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=63 Participants
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=61 Participants
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
|---|---|---|
|
Randomized Controlled Period: Percentage of Subjects With a Reduction of At Least 50% From Baseline in Urine Protein-to-Creatinine Ratio at Week 26
|
60.32 percentage of subjects
|
4.92 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 26Population: The ITT analysis set included all randomized subjects. Since adolescents subjects were not required to provide post-screening biopsies, this endpoint was analyzed based on adult subjects only.
The C3G histologic index used to assess disease activity and chronicity in C3G. The C3G total activity score ranges from 0 (worse) to 21 (best). Higher scores indicate better outcome. Baseline was defined as the most recent non-missing measurement prior to taking the first dose of study drug.
Outcome measures
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=35 Participants
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=34 Participants
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
|---|---|---|
|
Randomized Controlled Period: Change From Baseline in the C3 Glomerulopathy (C3G) Histologic Index Activity Score at Week 26
|
-3.482 units on a scale
Interval -4.721 to -2.244
|
-2.480 units on a scale
Interval -3.775 to -1.186
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 26Population: The ITT analysis set included all randomized subjects. Since adolescents subjects were not required to provide post-screening biopsies, this endpoint was analyzed based on adult subjects only.
Subject who showed decrease in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Percentages are rounded off to the hundredth decimal place.
Outcome measures
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=35 Participants
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=34 Participants
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
|---|---|---|
|
Randomized Controlled Period: Percentage of Subjects Who Showed Decrease in C3c Staining on Renal Biopsy From Baseline at Week 26
|
74.29 percentage of subjects
|
11.76 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 26Population: The ITT analysis set included all randomized subjects.
Serum samples were collected to determine the eGFR, calculated by using chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation for adults and the Bedside Schwartz equation for adolescents. Baseline eGFR value was calculated using the last non-missing assessment prior to first dose of study drug.
Outcome measures
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=63 Participants
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=61 Participants
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
|---|---|---|
|
Randomized Controlled Period: Change From Baseline in Estimated Glomerular Filtration Rate at Week 26
|
-1.497 milliliter (mL)/minute/1.73 m^2
Interval -5.892 to 2.899
|
-7.808 milliliter (mL)/minute/1.73 m^2
Interval -11.57 to -4.047
|
SECONDARY outcome
Timeframe: Week 24Population: The ITT analysis set included all randomized subjects.
Urine samples were collected to determine the proteinuria. Percentage of subjects who achieved proteinuria \<1 g/day was assessed by 24-hour urine protein. Percentages are rounded off to the hundredth decimal place.
Outcome measures
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=63 Participants
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=61 Participants
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
|---|---|---|
|
Randomized Controlled Period: Percentage of Subjects Who Achieved Proteinuria <1 Gram (g)/Day at Week 24
|
36.51 percentage of subjects
|
11.48 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 26Population: The ITT analysis set included all randomized subjects. Only subjects with serum albumin levels below lower limit of normal (LLN) at baseline are analyzed.
Baseline serum albumin value was calculated as the average of up to 2 serum albumin measurements preceding and including Day 1. Week 26 serum albumin values was calculated as the average of up to 2 serum albumin measurements preceding and including Week 26, no earlier than Week 20 measurement. Percentages are rounded off to the hundredth decimal place.
Outcome measures
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=27 Participants
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=23 Participants
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
|---|---|---|
|
Randomized Controlled Period: Percentage of Subjects With Normalization of Serum Albumin Levels at Week 26
|
77.78 percentage of subjects
|
4.35 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 26Population: The ITT analysis set included all randomized subjects. Only subjects with serum C3 levels below LLN at baseline are analyzed.
Baseline serum C3 value was calculated as the average of up to 2 serum C3 measurements preceding and including Day 1. Week 26 serum C3 value was calculated as the average of up to 2 serum C3 measurements preceding and including Week 26, no earlier than Week 20 measurement. Percentages are rounded off to the hundredth decimal place.
Outcome measures
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=41 Participants
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=49 Participants
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
|---|---|---|
|
Randomized Controlled Period: Percentage of Subjects With Serum C3 Levels Above the Lower Limit of Normal at Week 26
|
90.24 percentage of subjects
|
6.12 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 26Population: The ITT analysis set included all randomized subjects.
The FACIT-Fatigue scale was a 13-item Likert scaled instrument that was self-administered by subjects. Subjects were presented with 13 statements and asked to indicate their responses as it applied to the past 7 days. The 5 possible responses were "not at all" (0), "a little bit" (1), "somewhat" (2), "quite a bit" (3) and "very much" (4). With 13 statements the total score has a range of 0 (worse health-related quality of life) to 52 (best health-related quality of life). Higher scores indicate better quality of life. Baseline was defined as the most recent non-missing measurement prior to taking the first dose of study drug.
Outcome measures
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=63 Participants
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=61 Participants
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
|---|---|---|
|
Randomized Controlled Period: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 26
|
0.929 units on a scale
Interval -1.549 to 3.407
|
0.367 units on a scale
Interval -1.949 to 2.683
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 26Population: The ITT analysis set included all randomized subjects.
The KDQOL score was constructed as the KDQOL-36 Summary Score (KSS) by averaging the 24 items from Burden of Kidney Disease, Symptoms and Problems of Kidney Disease, and Effects of Kidney Disease on scale ranging from 0 (worse health-related quality of life) to 100 (best health-related quality of life). Higher scores indicate better quality of life. Baseline was defined as the most recent non-missing measurement prior to taking the first dose of study drug.
Outcome measures
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=63 Participants
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=61 Participants
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
|---|---|---|
|
Randomized Controlled Period: Change From Baseline in the Kidney Disease Quality of Life (KDQOL) Score at Week 26
|
0.757 units on a scale
Interval -2.385 to 3.9
|
-0.587 units on a scale
Interval -3.847 to 2.672
|
Adverse Events
Randomized Controlled Period: Pegcetacoplan
Serious events: 6 serious events
Other events: 53 other events
Deaths: 1 deaths
Randomized Controlled Period: Placebo
Serious events: 6 serious events
Other events: 56 other events
Deaths: 0 deaths
Open-Label Period: Pegcetacoplan to Pegcetacoplan
Serious events: 6 serious events
Other events: 47 other events
Deaths: 0 deaths
Open-Label Period: Placebo to Pegcetacoplan
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=63 participants at risk
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=61 participants at risk
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
Open-Label Period: Pegcetacoplan to Pegcetacoplan
n=61 participants at risk
All eligible adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg who received pegcetacoplan in RCP continued to receive pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 35 to \<50 kg who received pegcetacoplan in RCP continued to receive pegcetacoplan 810 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 30 to \<35 kg who received pegcetacoplan in RCP continued to receive pegcetacoplan 648 mg SC infusion twice weekly for 26 weeks in OLP.
|
Open-Label Period: Placebo to Pegcetacoplan
n=57 participants at risk
All eligible adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg who received placebo in RCP entered OLP to receive pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 35 to \<50 kg who received placebo in RCP entered OLP to receive pegcetacoplan 810 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 30 to \<35 kg who received placebo in RCP entered OLP to receive pegcetacoplan 648 mg SC infusion twice weekly for 26 weeks in OLP.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
1.6%
1/63 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.6%
1/63 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster meningoencephalitis
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
1.6%
1/63 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/63 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Shunt infection
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Maternal exposure during pregnancy
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/63 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
3.3%
2/61 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
3.3%
2/61 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
1.6%
1/63 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/63 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
1.6%
1/63 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Randomized Controlled Period: Pegcetacoplan
n=63 participants at risk
All adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg received pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 35 to \<50 kg received pegcetacoplan 648 mg for the first SC infusion and 810 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
Adolescent subjects with body weight 30 to \<35 kg received pegcetacoplan 540 mg for the first 2 SC infusions and 648 mg SC infusion thereafter twice weekly for 26 weeks in RCP.
|
Randomized Controlled Period: Placebo
n=61 participants at risk
All adult subjects (regardless of weight) and adolescent subjects (with body weight: 30 to \<35 kg, 35 to \<50 kg, and \>=50 kg) received placebo matching with pegcetacoplan SC infusion twice weekly for 26 weeks in RCP.
|
Open-Label Period: Pegcetacoplan to Pegcetacoplan
n=61 participants at risk
All eligible adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg who received pegcetacoplan in RCP continued to receive pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 35 to \<50 kg who received pegcetacoplan in RCP continued to receive pegcetacoplan 810 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 30 to \<35 kg who received pegcetacoplan in RCP continued to receive pegcetacoplan 648 mg SC infusion twice weekly for 26 weeks in OLP.
|
Open-Label Period: Placebo to Pegcetacoplan
n=57 participants at risk
All eligible adult subjects (regardless of weight) and adolescent subjects with body weight \>=50 kg who received placebo in RCP entered OLP to receive pegcetacoplan 1080 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 35 to \<50 kg who received placebo in RCP entered OLP to receive pegcetacoplan 810 mg SC infusion twice weekly for 26 weeks in OLP.
Eligible adolescent subjects with body weight 30 to \<35 kg who received placebo in RCP entered OLP to receive pegcetacoplan 648 mg SC infusion twice weekly for 26 weeks in OLP.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
8.2%
5/61 • Number of events 5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
7.0%
4/57 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.3%
4/63 • Number of events 6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
3.3%
2/61 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
5.3%
3/57 • Number of events 3 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
2/63 • Number of events 3 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
11.5%
7/61 • Number of events 8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
14.0%
8/57 • Number of events 9 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
9.5%
6/63 • Number of events 8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
9.8%
6/61 • Number of events 10 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
3.5%
2/57 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
5/63 • Number of events 7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
14.8%
9/61 • Number of events 13 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
11.5%
7/61 • Number of events 10 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
3.5%
2/57 • Number of events 3 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
6.3%
4/63 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
3.3%
2/61 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Infusion site erythema
|
6.3%
4/63 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 54 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Infusion site pain
|
1.6%
1/63 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
3.5%
2/57 • Number of events 3 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Infusion site swelling
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
5.3%
3/57 • Number of events 3 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Injection site pain
|
3.2%
2/63 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
8.2%
5/61 • Number of events 11 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Injection site swelling
|
3.2%
2/63 • Number of events 33 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
11.5%
7/61 • Number of events 48 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 44 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
7.0%
4/57 • Number of events 22 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
4.8%
3/63 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
8.2%
5/61 • Number of events 6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
19.0%
12/63 • Number of events 14 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
11.5%
7/61 • Number of events 7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
8.2%
5/61 • Number of events 7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
7.0%
4/57 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
3.2%
2/63 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
4.9%
3/61 • Number of events 3 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
9.5%
6/63 • Number of events 6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
4.9%
3/61 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
17.5%
11/63 • Number of events 15 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
11.5%
7/61 • Number of events 8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
11.5%
7/61 • Number of events 9 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
5.3%
3/57 • Number of events 3 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
4/63 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
8.2%
5/61 • Number of events 5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.3%
4/63 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
9.8%
6/61 • Number of events 6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
4.9%
3/61 • Number of events 3 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
12.7%
8/63 • Number of events 20 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
18.0%
11/61 • Number of events 14 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
12.3%
7/57 • Number of events 8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/57 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
6/63 • Number of events 7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.6%
1/61 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/63 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
1.8%
1/57 • Number of events 1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
2/63 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
6.6%
4/61 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
5.3%
3/57 • Number of events 5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
4.8%
3/63 • Number of events 5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
8.2%
5/61 • Number of events 5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
9.8%
6/61 • Number of events 6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
3.5%
2/57 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
3.2%
2/63 • Number of events 2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
0.00%
0/61 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
5.3%
3/57 • Number of events 4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug (Week 52), up to 60 weeks. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 137 weeks.
The safety set included all subjects who received at least 1 dose of study drug.
|
Additional Information
Apellis Clinical Trial Information Line
Apellis Pharmaceuticals, Inc
Phone: 1-833-284-6361
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place