Trial Outcomes & Findings for Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies (NCT NCT03453619)
NCT ID: NCT03453619
Last Updated: 2025-02-13
Results Overview
Change from baseline in proteinuria was assessed based on urinary protein-to-creatinine ratio (uPCR). Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Baseline (Day 1) and Week 48
Results posted on
2025-02-13
Participant Flow
This prospective Phase 2, open-label study was conducted in subjects clinically diagnosed with immunoglobulin A nephropathy (IgAN), lupus nephritis (LN), primary membranous nephropathy (PMN), or C3 glomerulopathy (C3G) between 26 February 2018 and 25 August 2023.
The study consisted of 2 parts: Part A (core study phase; 48 weeks) and Part B (long-term extension phase; until pegcetacoplan was commercially available for the disease under treatment). Subjects were screened within 4 weeks prior to the start of dosing on Day 1. A total of 21 subjects were enrolled in this study.
Participant milestones
| Measure |
IgAN Subjects
Subjects diagnosed with IgAN received pegcetacoplan 360 milligram (mg) subcutaneous (SC) infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
LN Subjects
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
PMN Subjects
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
C3G Subjects
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
|---|---|---|---|---|
|
Core Study (Part A)
STARTED
|
6
|
2
|
5
|
8
|
|
Core Study (Part A)
COMPLETED
|
4
|
1
|
1
|
7
|
|
Core Study (Part A)
NOT COMPLETED
|
2
|
1
|
4
|
1
|
|
Long-Term Extension (Part B)
STARTED
|
4
|
1
|
0
|
7
|
|
Long-Term Extension (Part B)
COMPLETED
|
2
|
0
|
0
|
5
|
|
Long-Term Extension (Part B)
NOT COMPLETED
|
2
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
IgAN Subjects
Subjects diagnosed with IgAN received pegcetacoplan 360 milligram (mg) subcutaneous (SC) infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
LN Subjects
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
PMN Subjects
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
C3G Subjects
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
|---|---|---|---|---|
|
Core Study (Part A)
Physician Decision
|
0
|
0
|
2
|
0
|
|
Core Study (Part A)
Withdrawal by Subject
|
2
|
0
|
2
|
1
|
|
Core Study (Part A)
Other
|
0
|
1
|
0
|
0
|
|
Long-Term Extension (Part B)
Adverse Event
|
1
|
0
|
0
|
0
|
|
Long-Term Extension (Part B)
Lost to Follow-up
|
1
|
0
|
0
|
1
|
|
Long-Term Extension (Part B)
Non-compliance with study drug
|
0
|
0
|
0
|
1
|
|
Long-Term Extension (Part B)
Physician Decision
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies
Baseline characteristics by cohort
| Measure |
IgAN Subjects
n=6 Participants
Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
LN Subjects
n=2 Participants
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
PMN Subjects
n=5 Participants
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
C3G Subjects
n=8 Participants
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 14.18 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 10.61 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 7.43 • n=5 Participants
|
22.5 years
STANDARD_DEVIATION 8.65 • n=4 Participants
|
40.5 years
STANDARD_DEVIATION 18.67 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: The intent-to-treat (ITT) population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and Week 48 are reported.
Change from baseline in proteinuria was assessed based on urinary protein-to-creatinine ratio (uPCR). Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug.
Outcome measures
| Measure |
Part A: IgAN Subjects
n=5 Participants
Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: LN Subjects
n=1 Participants
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: PMN Subjects
n=1 Participants
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: C3G Subjects
n=7 Participants
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part B: IgAN Subjects
Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: LN Subjects
Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: C3G Subjects
Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Proteinuria at Week 48
|
-0.1364 ratio
Interval -1.0641 to 0.7913
|
0.3560 ratio
The 95% confidence interval (CI) couldn't be determined as only 1 subject was analyzed.
|
0.3430 ratio
The 95% CI couldn't be determined as only 1 subject was analyzed.
|
-2.0347 ratio
Interval -3.9033 to -0.1662
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Part A, Week 48) and Week 168Population: The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and Week 168 are reported.
Change from baseline in proteinuria was assessed based on uPCR. Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
Outcome measures
| Measure |
Part A: IgAN Subjects
n=2 Participants
Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: LN Subjects
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: PMN Subjects
n=4 Participants
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: C3G Subjects
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part B: IgAN Subjects
Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: LN Subjects
Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: C3G Subjects
Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Proteinuria at Week 168
|
-0.3385 ratio
Interval -3.8264 to 3.1494
|
—
|
0.9718 ratio
Interval -4.7933 to 6.7368
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168Population: The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported.
Blood samples were collected to measure serum C3 levels. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
Outcome measures
| Measure |
Part A: IgAN Subjects
n=6 Participants
Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: LN Subjects
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: PMN Subjects
n=1 Participants
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: C3G Subjects
n=7 Participants
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part B: IgAN Subjects
n=2 Participants
Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: LN Subjects
Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: C3G Subjects
n=4 Participants
Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
|---|---|---|---|---|---|---|---|
|
Parts A and B: Change From Baseline in Serum Complement 3 (C3) Levels at Week 48 of Part A and Week 168 of Part B
|
153.17 milligram per deciliter
Interval 27.94 to 278.39
|
—
|
324.00 milligram per deciliter
The 95% confidence interval (CI) couldn't be determined when only 1 participant was analyzed.
|
194.43 milligram per deciliter
Interval 109.45 to 279.41
|
-74.00 milligram per deciliter
Interval -506.01 to 358.01
|
—
|
-48.50 milligram per deciliter
Interval -214.73 to 117.73
|
SECONDARY outcome
Timeframe: Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168Population: The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported.
Blood samples were collected to measure AH50 activity. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
Outcome measures
| Measure |
Part A: IgAN Subjects
n=6 Participants
Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: LN Subjects
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: PMN Subjects
n=1 Participants
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: C3G Subjects
n=6 Participants
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part B: IgAN Subjects
n=2 Participants
Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: LN Subjects
Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: C3G Subjects
n=4 Participants
Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
|---|---|---|---|---|---|---|---|
|
Parts A and B: Change From Baseline in Alternative Pathway Hemolytic Assay (AH50) Activity at Week 48 of Part A and Week 168 of Part B
|
-17.3 units per milliliter
Interval -71.0 to 36.3
|
—
|
-48.0 units per milliliter
The 95% CI couldn't be determined when only 1 participant was analyzed.
|
4.0 units per milliliter
Interval -59.7 to 67.7
|
9.0 units per milliliter
Interval -16.4 to 34.4
|
—
|
27.0 units per milliliter
Interval -89.7 to 143.7
|
SECONDARY outcome
Timeframe: Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168Population: The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported.
Blood samples were collected to measure C3a concentrations. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
Outcome measures
| Measure |
Part A: IgAN Subjects
n=6 Participants
Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: LN Subjects
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: PMN Subjects
n=1 Participants
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: C3G Subjects
n=5 Participants
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part B: IgAN Subjects
n=2 Participants
Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: LN Subjects
Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: C3G Subjects
n=4 Participants
Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
|---|---|---|---|---|---|---|---|
|
Parts A and B: Change From Baseline in C3a Concentrations at Week 48 of Part A and Week 168 of Part B
|
1283.93 microgram per liter
Interval -1963.09 to 4530.95
|
—
|
56.30 microgram per liter
The 95% CI couldn't be determined when only 1 participant was analyzed.
|
55.16 microgram per liter
Interval -173.33 to 283.65
|
-10.00 microgram per liter
Interval -41.77 to 21.77
|
—
|
-100.65 microgram per liter
Interval -361.2 to 159.9
|
SECONDARY outcome
Timeframe: Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168Population: The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported.
Blood samples were collected to measure serum albumin levels. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
Outcome measures
| Measure |
Part A: IgAN Subjects
n=6 Participants
Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: LN Subjects
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: PMN Subjects
n=2 Participants
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: C3G Subjects
n=7 Participants
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part B: IgAN Subjects
n=2 Participants
Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: LN Subjects
Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: C3G Subjects
n=3 Participants
Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
|---|---|---|---|---|---|---|---|
|
Parts A and B: Change From Baseline in Serum Albumin Levels at Week 48 of Part A and Week 168 of Part B
|
-0.17 gram per deciliter
Interval -0.81 to 0.48
|
—
|
0.20 gram per deciliter
Interval -6.15 to 6.55
|
0.59 gram per deciliter
Interval -0.29 to 1.46
|
-0.30 gram per deciliter
Interval -6.65 to 6.05
|
—
|
-0.53 gram per deciliter
Interval -3.6 to 2.53
|
SECONDARY outcome
Timeframe: Part A: Week 48; Part B: Week 168Population: The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported.
The complete clinical remission was defined as normalization of proteinuria as defined by \<200 mg/g uPCR.
Outcome measures
| Measure |
Part A: IgAN Subjects
n=5 Participants
Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: LN Subjects
n=1 Participants
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: PMN Subjects
n=1 Participants
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: C3G Subjects
n=7 Participants
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part B: IgAN Subjects
n=2 Participants
Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: LN Subjects
Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: C3G Subjects
n=4 Participants
Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
|---|---|---|---|---|---|---|---|
|
Parts A and B: Number of Subjects With Complete Clinical Remission at Week 48 of Part A and Week 168 of Part B
>=200
|
5 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
—
|
3 Participants
|
|
Parts A and B: Number of Subjects With Complete Clinical Remission at Week 48 of Part A and Week 168 of Part B
<200
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168Population: The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported.
The eGFR stabilization or improvement was defined as an eGFR value that was no more than a 25% decrease relative to baseline. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
Outcome measures
| Measure |
Part A: IgAN Subjects
n=6 Participants
Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: LN Subjects
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: PMN Subjects
n=2 Participants
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: C3G Subjects
n=7 Participants
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part B: IgAN Subjects
n=2 Participants
Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: LN Subjects
Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: C3G Subjects
n=3 Participants
Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
|---|---|---|---|---|---|---|---|
|
Parts A and B: Number of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 48 of Part A and Week 168 of Part B
Stable GFR: no more than 25% (+/-) change
|
3 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
—
|
3 Participants
|
|
Parts A and B: Number of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 48 of Part A and Week 168 of Part B
Improvement in GFR: >25% increase
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Parts A and B: Number of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 48 of Part A and Week 168 of Part B
Worsening of GFR: >25% decrease
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
Adverse Events
Part A: IgAN Subjects
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: LN Subjects
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: PMN Subjects
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: C3G Subjects
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B: IgAN Subjects
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B: LN Subjects
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: PMN Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: C3G Subjects
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: IgAN Subjects
n=6 participants at risk
Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: LN Subjects
n=2 participants at risk
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: PMN Subjects
n=5 participants at risk
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: C3G Subjects
n=8 participants at risk
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part B: IgAN Subjects
n=4 participants at risk
Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: LN Subjects
n=1 participants at risk
Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: PMN Subjects
Eligible subjects diagnosed with PMN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: C3G Subjects
n=7 participants at risk
Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
60.0%
3/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Renal and urinary disorders
End-stage renal disease
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
Other adverse events
| Measure |
Part A: IgAN Subjects
n=6 participants at risk
Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: LN Subjects
n=2 participants at risk
Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: PMN Subjects
n=5 participants at risk
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part A: C3G Subjects
n=8 participants at risk
Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A.
Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B.
|
Part B: IgAN Subjects
n=4 participants at risk
Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: LN Subjects
n=1 participants at risk
Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: PMN Subjects
Eligible subjects diagnosed with PMN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
Part B: C3G Subjects
n=7 participants at risk
Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Surgical and medical procedures
Fracture treatment
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Surgical and medical procedures
Polypectomy
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Chills
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Fatigue
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
2/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
40.0%
2/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
2/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
50.0%
1/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
37.5%
3/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
28.6%
2/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
37.5%
3/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Chest pain
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Injection site bruising
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Injection site discomfort
|
33.3%
2/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Injection site erythema
|
33.3%
2/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Injection site induration
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
2/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Injection site rash
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
2/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Injection site swelling
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Injury associated with device
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Oedema
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
28.6%
2/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Pain
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
2/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
42.9%
3/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Bronchitis
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
40.0%
2/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
37.5%
3/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Tinea cruris
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Tinea pedis
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
2/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
28.6%
2/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Injury, poisoning and procedural complications
Acoustic shock
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Injury, poisoning and procedural complications
Skin procedural complication
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
28.6%
2/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Investigations
Blood potassium increased
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Investigations
Cystatin C increased
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
50.0%
1/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Musculoskeletal and connective tissue disorders
Chronic kidney disease-mineral and bone disorder
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
50.0%
1/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
50.0%
1/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
37.5%
3/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Nervous system disorders
Migraine
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
2/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Psychiatric disorders
Persistent depressive disorder
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
14.3%
1/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
1/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Reproductive system and breast disorders
Prostatitis
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
25.0%
2/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
12.5%
1/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
50.0%
1/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Skin and subcutaneous tissue disorders
Acne cystic
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
100.0%
1/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
20.0%
1/5 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/8 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/4 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
—
0/0 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
0.00%
0/7 • TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
|
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